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100 drugs, including sophisticated chemotherapy compounds and addictive prescription painkillers, had been approved for sale in the United States at least in part on the strength of Cetero Houston’s tainted tests
“If there are problems with the scientific studies, as there have been in this case, then the FDA’s review of those problems needs to be transparent,” said David Kessler, who headed the FDA from 1990 to 1997 and who is now a professor at the University of California at San Francisco. Putting its reviews in public view would let the medical community “understand the basis for the agency’s actions,” he said. “FDA may be right here, but if it wants public confidence, they should be transparent. Otherwise it’s just a black box.”
On Friday, a coalition of public interest groups sent a letter urging FDA to overturn its policy of redacting certain information from federal documents before turning them over to journalists, regulators and others requesting the data, the AP/Washington Post reports.
U.S. District Judge Phyllis Hamilton in Oakland, California, said the agency has “admittedly failed to comply with the mandatory rule-making schedule” of the Food Safety and Modernization Act
The Food and Drug Administration will conduct fewer food safety inspections this year because of the government sequester
delay the agency's implementation of the 2011 Food Safety Modernization Act
as FDA figures out how to absorb the $209 million cut to food and drug regulation, the agency is saying food safety inspections will be spared too. FDA will scale back training and travel and not facility inspections
Whether the food industry likes it or not, when it comes to GMO labeling, the “train appears to have left the station”, according to former FDA associate commissioner of foods Dr David Acheson.
In a ruling May 17, Judge Phyllis Hamilton of the Oakland U.S. District Court said FDA and CFS now have until June 10 to agree on a schedule for releasing the yet-unpublished food safety rules, mandated by the Food Safety Modernization Act of 2011.
amendment by Rep. Dan Benishek (R-MI) that would have required the U.S. Food and Drug Administration to conduct “a scientific and economic analysis” of FSMA regulations before they can be rolled out.
In May, Benishek introduced a separate bill, the Stopping Costly Regulations Against Produce, or the SCRAP Act, which seeks to altogether de-fund the implementation of FSMA produce safety rules.
Consumer advocates said they are dismayed by FDA’s refusal to agree to a shorter timeline for many key food safety rules, many of which are already well passed the statutory deadlines set by Congress.
it appears that the F.D.A. has once again refused to do all it could to protect public health.
I think we’re looking at an industry-friendly response to the public health emergency of diseases caused by antibiotic-resistant bacteria, resistance that is bred in industrially raised animals.
Michael Taylor, the agency’s deputy commissioner for foods and veterinary medicine (and — just in case you think the notion that there is a revolving door between the F.D.A. and the food industry is hyperbole — a former vice president for public policy at Monsanto)
The replay of the December 11 FDA's teleconference, which I attended (available by calling 866-501-0089), gives the strong impression that the FDA's top priority is to not upset the pharmaceutical industry's apple cart.
Based on their findings, the authors called for more transparency in the rulemaking process.
Taylor said that the agency has enough resources to issue the final rules, but not to implement FSMA.
The U.S. Food and Drug Administration has reached a settlement with the Center for Food Safety (CFS) and the Center for Environmental Health regarding the deadlines for publishing final rules implementing the Food Safety Modernization Act (FSMA).
When the Food and Drug Administration unveiled its revision of the iconic Nutrition Facts label that appears on processed foods and beverages earlier this year, nutritionists and consumer groups applauded the changes.
industry has been reviewing the agency’s proposal, preparing to mount what will likely be a hefty pushback.
As was rumored last week, congressman Mike Pompeo (R-KS) introduced legislation Wednesday that would block the efforts in multiple states to require mandatory labeling of genetically modified foods.
Kathleen Sebelius, the health and human services secretary, is resigning, ending a stormy five-year tenure marred by the disastrous rollout of President Obama’s signature legislative achievement, the Affordable Care Act.
nominate Sylvia Mathews Burwell, the director of the Office of Management and Budget, to replace her
The FDA has not approved a new sunscreen ingredient in almost two decades.
Sen. Orrin Hatch joined a bipartisan group of senators in urging the Food and Drug Administration, FDA, to provide further clarity and transparency in its policy regarding medical mobile apps.
The FDA takes an average of 7.3 years to finalize rules that determine its regulation process, a study published in the February issue of Health Affairs found.
The federal agency’s rulemaking is controversial because of its perceived complexity, lack of transparency, and lengthy duration.
Experts say the nutrition label should be revisited more frequently to keep up with research. But the FDA wants to make sure scientific evidence is solid before updating regulations. That can cause the government to lag behind research, said former FDA official Jim O’Hara, an original developer of the nutrition label and current director of health promotion policy at the Center for Science in the Public Interest.
On Thursday, 5 June 2014 the full US Senate voted 78-17 to confirm Sylvia Matthews Burwell, former director of the Office of Management and Budget (OMB), to the position of secretary of the Department of Health and Human Services (DHHS).
Gone are the days when an agency received a petition, especially from a consumer organization, and the optimal course of action was to do nothing. Inaction today will buy you a greater resource burn down the road, along with media attacks and cries of inefficiency and inappropriate public health priorities.
by placing primary responsibility for food safety on the industry itself, FDA intends to dedicate its resources to providing technical expertise, setting and fostering compliance with food safety standards, responding to food safety problems should they nevertheless occur, learning from problems and modifying protocols as needed.
The Food and Drug Administration has given a controversial Houston doctor the green light to resume administering experimental cancer treatments.
"This puts patients at risk," says Peter Adamson, chairman of the Children's Oncology Group and chief of clinical pharmacology and therapeutics at the Children's Hospital of Philadelphia.
Jaffe says the board, which put Burzynski on probation from 1994 to 2004, is "under tremendous pressure to take away Burzynski's license" because of negative publicity that Burzynski has received in recent years.
The U.S. Food and Drug Administration (FDA) is announcing a public meeting on the following two proposed rules that appeared in the FEDERAL REGISTER on March 3, 2014:
“Food Labeling: Revision of the Nutrition and Supplement Facts Labels”
“Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments.”
FDA will discuss the proposed rules aimed at updating nutrition information and serving size requirements on the Nutrition and Supplement Facts labels to provide consumers with information that could be used to maintain healthy dietary practices. The meeting will be held June 26, 2014
In May 2012, the White House instructed the FDA and other federal agencies to immediately begin implementing a new "digital strategy" aimed at making governmental information more readily and easily accessible to the public.
Open APIs would hypothetically allow people to access the raw data FDA puts out through its various databases-approvals, adverse event reports, recall notices, etc-and repurpose them, potentially making them easier to use or more enjoyable to read.
The Food and Drug Administration this week released software designed to let people tap into 3.6 million reports about drug side effects.
“From an FDA standpoint, we want to engage in smart regulation, (which) means knowing when to regulate, and how to regulate,” said Jeff Shuren, the director of FDA's device center. “We're trying to provide greater predictability, and clarity. And we're trying to get out of the way,” he said, citing the agency's decisions to “deregulate scores of technologies” from apps to medical-device-data-systems.
For the first time in more than a decade, the FDA was mulling over making significant changes to the Nutrition Facts label (pdf) found on just about every food item sitting on grocery store shelves around the nation. More than five months later, the agency is still hearing vehement support from a number of advocacy groups and vicious dissent from several major food associations, and much of it is about one subtle but crucial proposed addition: an "added sugar" label.
The FDA has been outgunned and overmatched for years as a rising tide of imported food has found a place at the U.S. dinner table. For budget reasons, only 1 to 2 percent of food imports are physically inspected by the agency. Congressional funding has lagged, and consumers continue to become sick.
When it comes to fighting antibiotic resistance, Richard Carnevale of the Animal Health Institute, which represents the veterinary pharmaceutical industry, wonders, “Are we putting more resources into this than need be?”
The FDA today revealed a draft version of its 4-year plan, laying out strategic priorities and goals for keeping patients and consumers safe while addressing industry concerns.
The Food and Drug Administration (FDA) is proposing to revise the Nutrition Facts label that must appear on virtually all packaged foods in the United States. The agency's proposals are strong, urgently needed, and likely to make an important contribution to consumer behavior. But I believe they don't go far enough — additional labeling requirements can do more to influence food choices, reduce obesity, and promote health.
“Today’s decision allows the FDA to openly declare that a particular animal drug is unsafe, but then refuse to withdraw approval of that drug,” wrote Judge Robert Katzmann in his dissent. “It also gives the agency discretion to effectively ignore a public petition asking it to withdraw approval from an unsafe drug. I do not believe the statutory scheme can be read to permit those results.”
Centers for Disease Control and Prevention in a report last year that recommended minimizing inappropriate use.
As for the FDA, a spokeswoman writes us that “the FDA is currently reviewing the decision but is pleased with the outcome.”
The F.D.A. has issued a toothless voluntary guidance document for the industry, which requires no action to reduce antibiotic use and will therefore do little to nothing to stop the spread of antibiotic-resistant superbugs.
The FDA is now defined by others. You must speak up and take the FDA back. It is yours, not theirs. You do more good, day in and day out, than most others, inside or outside government.
FDA silence about its own investigations is discretionary, not required. When the public and President Obama were upset about contaminated peanut butter, the agency fell over itself to talk about its diligent investigations into Peanut Corporation of America. Beyond the limelight, however, small enforcement matters that millions don't care about are routinely hidden because the agency's culture is more comfortable with not having to explain itself.
FDA has been outgunned and overmatched for years as a rising tide of imported food has found a place at the U.S. dinner table. Because of budget constraints, ordinarily only 1 to 2 percent of food imports are physically inspected by the agency at the border each year.
In 2012 the U.S. Food and Drug Administration banned the sale of baby bottles that contain bisphenol A (BPA), a compound frequently found in plastics.
recent research reveals that a common BPA replacement, bisphenol S (BPS), may be just as harmful.
Nineteen medical officers identified a total of 27 approved new drugs in the past three years that they reviewed that they thought should not have been approved. Most of these medical officers said that current FDA standards were “lower” or “much lower” than previous ones.
In my view, the draft guidance, which is open for public comment until August 25, 2014, has the potential to undermine the FDA’s drug safety laws and regulations and should be changed.
As written, the draft guidance would allow pharmaceutical companies who believe that the FDA-approved drug-labeling information overstates the risks of their drug to tell physicians that the risks are, in fact, lower.
Unfortunately, the draft guidance strikes the balance more toward the industry’s view of its First Amendment right to commercial speech than toward the agency’s mandate for patient protection.
The explosion of new food additives coupled with an easing of oversight requirements is allowing manufacturers to avoid the scrutiny of the Food and Drug Administration
“We simply do not have the information to vouch for the safety of many of these chemicals,” said Michael Taylor, the FDA’s deputy commissioner for food.
“I’ve given up on the FDA protecting the public; they are protecting businesses,” said Grovit, who also has Crohn’s disease.
Many people presume that some federal agency is overseeing the safety of the ingredients in our food supply. That's reasonable, because that is actually what the federal Food and Drug Administration (FDA) is supposed to be doing, and what Congress told it to do in a 1958 law.
But since 1997, FDA has punted on that core responsibility, allowing companies to make their own secret determinations of a substance's safety for use in our food.
The Telecommunications Industry Association supports Food and Drug Administration intentions not to enforce some regulatory controls that apply to medical device data systems (MDDS), which the agency deems to be low risk to patients.
The Food and Drug Administration has issued draft guidance informing industry that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients.
Comments of the Telecommunications Industry Association concerning the Food and Drug Administration’s Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Draft Guidance for Industry and Food and Drug Administration Staff (Docket No. FDA-2014-D-0798)
Today the food industry is congratulating itself for sharing a database of its food additive safety studies with regulators at the Food and Drug Administration. That this is seen as a step forward neatly illustrates the dysfunction built into the current system.
Food companies are trying to beat the federal government’s push to make chemicals in food more transparent.
Pressure has been building on FDA for years to look more closely at food chemicals, which are mostly self-approved by food companies relying on publicly available science and panels of industry-paid experts. But the agency hasn’t gotten around to it.
“I think most scientists working today agree that BPA is an ovarian toxicant,” Dr. Flaws said. A review of research into BPA, published this summer in the journal Environmental Health Perspectives, noted that ovarian toxicity is among the most consistent and strongest effects found “in both animal models and in women.”
With US politics swimming in so much corporate money that it's pretty much an oligarchy
But thanks to 16-year-old Nick Rubin, keeping track of just how much politicians have sold out has become a lot easier. He created Greenhouse
The U.S. Food and Drug Administration (FDA) yesterday announced that it has completed a review of how it evaluates the harmful effects of chemicals in foods, cosmetics, dietary supplements, animal food/feed and veterinary drugs. Based on the findings, the agency is taking steps to strengthen internal processes.
Last month, the US Food and Drug Administration (FDA) announced it would soon seek to regulate lab-developed tests more similarly to in vitro diagnostics (IVDs), citing the devices' increasing complexity and role in critical clinical decision-making.
And perhaps unfortunately for FDA, the House Energy and Commerce Committee is in the midst of its 21st Century Cures Initiative, which is tasked with determining how medical advances and cures can be brought to patients more quickly, with a specific focus on re-tailoring regulations to be more flexible.
Conflicts of interest are real, and they are still influencing decisions from the level of the patient all the way up to national health policy. We will never be able to eliminate them all. But acknowledging them and talking about them openly is an important first step toward minimizing their impact.
“The court deadlines are really driving all of the timelines and planning that we’re doing, necessarily,” Taylor said. “My boss is potentially held in contempt if we don’t get the rules out.”
Such a revolving door creates the appearance of a conflict of interest and threatens to undermine public confidence in the objectivity of FDA advisory committee members.
The overuse of antibiotics, both in human patients and, importantly, in livestock, has led to an explosion of antibiotic-resistant bacteria, both in the U.S. and around the world. Deaths from resistant infections are currently at about 700,000 per year, and estimated to rise to 10 million per year by 2050.
Major U.S. poultry firms are administering antibiotics to their flocks far more pervasively than regulators realize, posing a potential risk to human health.
Not until 2016 does the FDA plan to gather data about antibiotic use on farms, said Craig Lewis, a veterinary medical officer with the agency. Today, “none of us have an idea first-hand of what’s going on” at the farm level, Lewis said this summer, at a public meeting on antibiotic resistance.
Drug-resistant bacteria mean we're entering a post-antibiotic world — and it won't be pretty. There are, however, things we can do ... if we start right now.
For these reasons, a company may want to attempt to prohibit an FDA investigator from taking photos inside its plant.
Disastrous EU decision- Pharma reg shifted from Health & Consumers to Enterprise & Industry
english.prescrire.org/en/79/207/4630…
Guess why
In 2010, the EMA announced a proactive policy on transparency and public access to the data on which the Agency bases recommendations that directly affect the health of European citizens. This policy was in line with an inexorable international trend towards greater transparency and with what MEPs and the European Council wanted to achieve as part of the new regulations governing clinical trials. To the astonishment of observers and of activists who had been deeply involved in this positive development, the EMA made a spectacular retreat in recent months, coinciding with the arrival of the new head of its legal service (whose background was in the pharmaceutical industry).
Well, here’s a shocker: apparently, there appears to be a difference between internal drug company documents about the research trials that they fund, and the articles reporting that research that end up in medical journals. The New England Journal of Medicine calls this ‘selective outcome reporting’, but for the sake of clarity, let’s just call it ‘lying’.
A major part of the problem is that the FDA itself is a split agency. In the food and drug arena, if a product is shown to cause a deadly illness in one in 350 to 500 people, it is pulled off the market. But the FDA's Center for Devices and Radiological Health (CDRH) is a different story.
The primary mission of the CDRH is to get "life-saving" technologies to the marketplace efficiently. Patient safety is secondary.
Dr. Angell charges that the industry is “primarily a marketing machine to sell drugs of dubious benefits, using its wealth and power to co-opt every institution that might stand in its way, including the U.S. Congress, the Food and Drug Administration, academic medical centers and the medical profession itself.”
Conclusions and Relevance Despite the legal requirement that scientific evidence of substantial equivalence be publicly available for medical devices cleared by the FDA through the 501(k) process, such information is lacking for most implanted medical devices cleared between 2008 and 2012, as well as for their predicates.
The FDA's mission is determining whether drugs are effective and safe before approval. In Zohydro's case, the FDA flouted the recommendation of its own expert panel, which voted 11-2 against approval.
“FDA estimates that it needs an additional $300 million over the next two to three years to fully implement FSMA,” wrote the organizations, which include the Pew Charitable Trusts, the American Public Health Association, the American Academy of Pediatrics and the Infectious Diseases Society of America.
Europe's medicines regulator has endorsed a scheme to publish detailed clinical reports underpinning new drug approvals from next year, though campaigners for full transparency said they were concerned some data would still be missing.
the same federal judge, Richard J. Leon of the U.S. District Court in Washington, D.C. Leon’s rulings have reflected concern about government overreach, and a tone of deep skepticism about the FDA’s legal positions “Please! This conclusion defies common sense,” he wrote, dismissing one of the agency’s arguments.
Whenever the FDA gets involved, the cost of approval for any new invention or technology will be huge. The time it takes to get approval will be measured not in years but in decades. Hundreds of thousands of innovations that could have helped you and me will never come to market.
"It took people getting sickened by it — having bleeds in their heads, dropping dead running marathons, that pathologists realized were due to DMAA — that finally moved the Food and Drug Administration to get DMAA off the market. That was seven years after it was introduced."
"As a result, an application for a fixed-combination submitted under section 505(b) of the FD&C Act will be eligible for 5-year NCE exclusivity if it contains a drug substance, no active moiety of which has been approved in any other application under section 505(b).30," FDA explained. "For example, a fixed-combination drug product that contains a drug substance with a single, new active moiety would be eligible for 5-year NCE exclusivity, even if the fixed-combination also contains a drug substance with a previously approved active moiety."
According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus, the number of regulatory requirements imposed by the US Food and Drug Administration (FDA) increased by 15% between the years 2000 and 2012.
A few facets of the law actually make sense. Giving the FDA mandatory recall authority, as the law did, is an important tool for forcing foods that have been found to be a definitive hazard off the market.
When Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012, its patient-centered provisions were among the biggest changes set to impact the culture of the US Food and Drug Administration (FDA). Now, two years later and with major planning already underway regarding the future of FDA's patient-centered activities, agency regulators are reaching out to the public to ask what more they can do to improve their efforts.
The US government's Office of the Federal Register (OFR) has finalized a rule calling on the federal agencies, including the US Food and Drug Administration (FDA), to offer more information about third-party standards they require companies to comply with.
A “culture of increased transparency” is needed at the U.S. Health and Human Services Department, Secretary Sylvia Mathews Burwell said, after Obamacare enrollment data were padded with dental plan customers in what she has called an error.
NGA will continue to work with Congress to pass bipartisan legislation to address this regulatory overreach
The Medical Electronic Data Technology Enhancement for Consumers’ Health, or MEDTECH, Act joins a handful of other bills that would restrain FDA’s regulatory powers in the health IT domain.
Industry groups are happy to hear it.
#FDA Under Fire for Perceived Lack of AdComm Transparency, and more news in today's #Regulatory Recon: ow.ly/FBKj7
There's $2.589 billion for the Food and Drug Administration, a $37 million increase from last year. There's $27 million in new funding for the Food Safety Modernization Act. The Food Safety and Inspection Service would receive $1.016 billion, a $5 million increase.
Since 2012, FDA has launched several initiatives meant to better take into account the views of patients. Some, like its patient-focused drug development initiative, have involved patients in more than a dozen meetings and solicited extensive feedback. Others, such as its medical device-focused Patient Preference Initiative (PPI) are still in the early stages of development.
Why doesn't FDA disclose all financial ties between its advisers and device firms? Here's the short answer: on.wsj.com/1vHluxP
The FDA says its disclosure policies are designed to balance the needs to retain public trust and recruit leading experts.
Science, Hamburg stressed throughout her speech, must inform regulatory policy. And innovation must be harnessed to science-informed regulation if it is to “bridge the gap between scientific discovery, good ideas, and meaningful products and actions to address the public health issues of today and tomorrow.”
Objectivity key for FDA Director of Biostatistics when working toward possible cures. go.usa.gov/FPYP pic.twitter.com/1YdOiuUO3C
Statisticians on both sides of the application process often have a dubious reputation of throwing cold water on any excitement.
What sets a statistician apart
A statistician’s objectivity comes in large part from our training in logic, probability theory, and the application of sound statistical methods to data analysis. Years ago, when I was training, statisticians were uniquely focused on the data. We were the data managers, the data analysts, and the translators explaining what the data meant to non-statisticians. Now, people from other disciplines are often involved in data manipulation, data mining, and data exploration. This can be a good thing because important information is more likely to be found when more people with diverse backgrounds are looking at the data. A downside to this abundance of both “big data” and data analysts is that the proliferation of analyses and results can make separating true signals from noise more difficult.
There are some data or results that statisticians might focus on a little differently than other analysts. Our heightened awareness of uncertainty and ability to appropriately quantify that uncertainty also set us apart. To me, statistics is not just using the tools; it’s a way of thinking, a way of approaching things, and a way of interpreting results.
Exploring novel statistical solutions for a development challenges both old and new
This bi-weekly newsletter provided by the Office of Health and Constituent Affairs at the Food and Drug Administration (FDA) is intended to inform you of FDA-related information on a variety of topics, including new product approvals,significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates. Subscribe or update your subscriber preferences.
Will the US Food and Drug Administration (FDA) ever regulate your FitBit, Apple iWatch or calorie-tracking mobile apps? Almost certainly not, the regulator confirmed today in a new draft policy document covering all "low-risk" general wellness devices.
The Food and Drug Administration's proposal to regulate the accuracy of laboratory-developed tests has drawn heated opposition from the laboratory testing industry, hospitals and most medical specialty societies.
Medical practitioners and the public deserve protection from test purveyors making unproven claims.
A committee of the European Medicines Agency (EMA) has recommended suspending the sale of roughly four dozen generics for conditions such as diabetes, depression, and hypertension because their approvals were based on flawed clinical studies conducted in India, the agency announced today.
According to the FDA statement, the agency inspected GVK Biosciences in September 2014 on the heels of the French inspection in May 2014 and failed to find any evidence "that affects the safety or efficacy of drug products subject to pending applications or products approved in the US."
The effort to protect decision support tools like Watson from Food and Drug Administration regulation is part of a proposal by the Republican chairman of the House Energy and Commerce Committee, Michigan’s Fred Upton. Called the 21st Century Cures initiative
IBM has called current regulations outdated. “It is important to recognize that the current Food and Drug Administration regulatory framework was largely developed during the decades before the rise of today’s sophisticated IT technologies,”
One company, for example, had fixed a defect in one of its devices on a case-by-case basis but had never sought to systematically check and fix the issue in all the units it had sold. Other companies had relied on suppliers for various components, such as batteries and electrodes, that didn’t meet certain standards.
Lawmakers are talking about what the food industry itself has bantered about for years: creating a single food safety agency, bringing together the oversight functions of the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and other agencies.
The bill, known as the Safe Food Act of 2015, is set to strip several regulatory bodies of their authority to regulate food products and transfer that authority to a new regulator, the Food Safety Administration (FSA), whose sole job would be to regulate food.
“This budget accurately reflects the challenges FDA faces in a global regulatory environment, which is becoming increasingly complex and scientifically demanding,” said Commissioner Margaret A. Hamburg, M.D. “As FDA’s mission expands on several fronts –– from the regulation of tobacco products to supporting the development of personalized medicine to ushering in a new era of food safety – we must possess the resources to run a modern agency that fosters innovation and ensures the safest possible drug and food supply for the American people.”
Hamburg's resignation comes at a crucial time for the FDA as Congress pushes initiatives to speed new drug development, and food safety advocates, backed by Obama, back the creation of a separate agency combining the food safety functions of the FDA and the U.S. Department of Agriculture.
Her temporary replacement will be the FDA’s chief scientist, Dr. Stephen Ostroff. One possible permanent successor is Robert Califf of Duke University, whom Dr. Hamburg recently selected as her deputy commissioner for medical products and tobacco.
The new FDA commissioner will require approval from the Republican-controlled Congress.
This pressure to grease the track for drug and device makers at the expense of safety, she said, could become more intense if Republican lawmakers, now in control of both the House and Senate, manage to enact their 21st Century Cures initiative. It is designed, in their words, "to accelerate the pace of cures and medical breakthroughs."
Wil S. Hylton is the author of a terrifying New Yorker article about lax food safety titled, “A Bug in the System: Why Last Night’s Chicken Made you Sick.” Food safety lawyer Bill Marler is the man leading the charge against unsafe food in Hylton’s story.
Together they weigh in on the president’s proposal and the state of food safety in America.
FDA's approach was clear: It would take a risk-based approach that would leave most consumer devices free from regulatory requirements (such as registration with FDA, meeting good manufacturing practices or filing premarket applications) as long as they did not make disease-specific claims.
Now the agency is finalizing its approach toward two types of products: Mobile medical applications ("apps”) and medical device data systems.
That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted.
The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market.
home-use genetic testing for other carrier genes will be exempt from premarketing approval
The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information.
The regulatory argument had been that providing such medical results should be done only by a trained and credentialed medical intermediary
the genetic-testing company backed by Google Inc.
approval of 23andMe’s test for Bloom syndrome
The approval also opens the way for 23andMe to pursue its ambitious plan to become a repository for humanity’s genetic makeup, and to turn data gathered from $99 saliva tests sold to consumers into multimillion-dollar deals with drugmakers who want the information to help develop drugs.
I was struck by the need for an FDA announcement to users of duodenoscopes—the endoscopes used in endoscopic retrograde cholangiopancreatographies, or ERCPs--that they should be extra careful about cleaning the scopes to avoid transmittal of drug resistant bugs.
So, people knew about this problem: MDs, the AGA, the FDA, the manufacturers. Everybody but you and me.
The findings, outlined in the report "Grading Government Transparency: Scientists' Freedom to Speak (and Tweet) at Federal Agencies," are meant to spur discussion about whether FDA's employees are free to speak out on issues in an unofficial capacity.
In 2013, more than two years after the Obama administration had issued a directive ordering reform of federal scientific integrity policies—including those governing media access—we published the first version of Grading Government Transparency. This new report added social media policies to the mix, and expanded the number of agencies to 17.
The Food and Drug Administration works at striking the proper balance between insisting on safety but not standing in the way of innovative products that promote health and well-being. In doing so, it’s dealing with increasingly complex products of the software and digital age, including some aimed directly at consumers, such as medical apps.
Dr. Acheson, for one, says that nothing short of a catastrophe may be necessary to rattle officialdom sufficiently to redesign the safety system. Rather grimly, he told Retro Report, “We need — I hate to say it, but — bodies in the street before we get it.”
Although the evidence hasn't improved since the FDA's last rejection of flibanserin in 2013, the marketing push around the drug has gained traction: Sprout put together the "Even the Score" campaign accusing the FDA of being sexist for not getting the pink pill on the market to help women.
the panel was convinced by the many women who had been brought there by Sprout to talk about the tragedy of their low libido
DeWaal, who served as CSPI’s director of food safety for 21 years, will join FDA’s Center for Food Safety and Applied Nutrition on Monday as the international food safety policy manager.
CSPI Executive Director Michael F. Jacobson, adding, “I know she’ll continue to make significant contributions to a safer food supply in her new position.”
The lack of action by the F.D.A., he said, has undermined his faith in generics. “We’re as much in the black as the patients are.
“You’re a regulator. Regulate.”
Terrific study in @bmj_latest by @US_FDA on how company press releases do not include real reasons why drugs fail goo.gl/H6fm6y
Conclusions
FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies. In many cases, press releases were not issued in response to those letters and, when they were, omitted most of the statements in the complete response letters. Press releases are incomplete substitutes for the detailed information contained in complete response letters.
ProPublica first disclosed in 2009 that the agency ignored two of its own medical reviewers who wanted to ban Omniscan for patients with severe kidney disease. In 2010, the FDA did act
Jacobs said the new studies “confirm that the linear gadolinium-based contrasting agents such as GE’s product Omniscan and Bayer’s product Magnevist are being retained at much higher levels than radiologists and the FDA have acknowledged.”
It comes as a shock to most Americans that the vast majority of medical devices used in hospitals across the nation do not undergo any clinical trials, safety testing or surveillance for harmful outcomes. The Food and Drug Administration (FDA) uses a piece of legislation commonly referred to as “510(k)” to formally “clear” medical devices despite it leading to an astonishing absence of adequate safety checks.
perhaps more unacceptable is that the FDA's 510(k) clearance label on medical devices effectively also serves to sway our court system away from delivering justice - where patients have been harmed by, or died, because of faulty medical devices
Science won out," Kummerow, who sued the FDA in 2013 for not acting sooner
Frustrated by the lack of action, Kummerow filed a 3,000-word citizen petition with the FDA in 2009
sometimes the FDA and other agencies are very late to the party. As I have noted in my Antidote blog at ReportingOnHealth.org, Denmark and Argentina are among a host of countries around the world that have acted more aggressively to rid food products of trans fats, often starting with requiring that trans fats be noted on food labels and then setting a limit for trans fat content.
probably the single most important change in our food supply, if not in decades then ever," said Michael Jacobson, the executive director of the Center for Science in the Public Interest, and a longtime advocate for the change.
Amazing @US_FDA will not release info on #hepc drugs. What about #openscience? @YaleLawSch files complaint. Kudos. law.yale.edu/news/19674.htm…
The FDA has informed the groups that they should not expect to receive a response for 18 to 24 months and have made no guarantee that the data will even be released then
This delay will leave doctors and patients in the dark for too long
If this drug is as promising as it appears to be, what does the FDA have to hide?
Debate from the latest research: what—or who—should we trust: the FDA or the journal publication? blogs.bmj.com/bmj/2015/06/12…
Wolfe points to a little known letter written in 2013 by the US pharmaceutical trade organization. The letter documents the group’s opposition to the European Medicines Agency’s far reaching data disclosure policies—an interesting contrast to its public declarations that same year in favor of research transparency.
The agency has already recommended letting some medical apps go to market without regulatory supervision, and the new guidance is arguably just an extension of that fact. But as the scope of medical devices has increased, device makers have asked the FDA to define exactly where the regulatory line is.
The Cures Act, you may recall, weakens already weak regulation of new medical technologies — which include the kinds of products that Holmes’s company Theranos is introducing to make it easier to draw blood from squeamish patients.
Inaccurate and unreliable medical tests are prompting abortions, promoting unnecessary surgeries, putting tens of thousands of people on unneeded drugs and raising medical costs, the Food and Drug Administration has concluded.
Representative Michael C. Burgess, Republican of Texas and a physician, expressed concern that the proposals “could stifle medical innovation and open the door to federal regulation of the practice of medicine.”
What does the FDA’s rejection of new sunscreen ingredients tell us about how the agency works? @drJoshS nejm.org/doi/full/10.10…
In recent months, the FDA has declined to permit use of eight new sunscreen ingredients without additional data, although those ingredients have been used in Europe for more than 5 years and despite the recent passage of a U.S. law intended to expedite the marketing-approval process for new products. The controversy says as much about the challenges facing the agency as it does about sunscreen regulation.
How Does the FDA Approve a Drug? youtu.be/WUsO6PH_O54 via @YouTube @HCTriage
The FDA’s new social media policy, posted online today, earns an A, or 90 out of 100 points on the scale created for the Union of Concerned Scientists’ Grading Government Transparency report.
The Food and Drug Administration has worked to better include patients in the development of treatments after a 2012 directive from Congress. While patient support can help a drug’s chances, the key is having evidence the FDA can trust, said Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research. That includes randomized clinical trials where patients receiving an experimental drug are compared with others who don’t -- a step some drugmakers have skipped, especially when the disease is rare or particularly deadly.
If patient-reported outcomes matter equally as doctor-reported outcomes, those patients’ impressions should count as data, as evidence in a trial, as reasons to recommend a drug.
when it comes to drug approval and interpreting clinical information, it seems, some people turn or stay hard and cry about the e-word (emotion), as if mothers telling an FDA panel about what’s happening to their kids is the opposite of science.
PROs have been defined as "any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else.
Beyond this one medicine, the meeting was something of a caucus on regulatory policy.
The fate of the Sarepta drug has been closely watched as a litmus test for an intensifying struggle between the FDA and patient groups that want the agency to take a more expansive view toward approving medicines for unmet medical needs.
Anecdote and emotion do not change the data with which we are confronted, no matter the attendance
. Critics say that approving drugs that do not really work is offering false hope to patients and removing an incentive for drug companies to develop better products.
In addition, the F.D.A., in response to a 2012 law, has become more systematic in considering patient input. It has been meeting with patients with different diseases and working to evaluate drugs partly based on outcomes that patients say are meaningful to them, not just those specified by the drug company.
Jeffrey M. Drazen, a Harvard Medical School professor and editor of the New England Journal of Medicine, wrote in an editorial last fall that lawmakers should confirm Califf “as soon as possible."
Advocates have said the bill would help accelerate the agency's reviews and get needed innovations to patients more quickly, though some experts worry the legislation could force the FDA to compromise its high standards for safety and efficacy in the name of speed.
He may get pulled into the debate over drug prices, too.
adopting a two-tier system, using limited, focused trials for medications expected to make a big impact on a small population, and very large trials using electronic heath records and social media.
The FDA is still in in the midst of implementation of the Food Safety Modernization Act, passed in 2010
the communications unearthed by Inside Health Policy and then passed on in a piece by John Tozzi of Bloomberg News ten days later add up to an uncommonly cozy relationship with much of the public being none the wiser. They should be.
The Act would allow the FDA to approve such devices not based on randomized controlled trials, the gold standard for determining safety and efficacy, but on less scientific, anecdotal evidence such as case histories.
Astroturfers gather ordinary citizens from the grassroots to advocate for various causes while in reality shilling for the trade associations, PR firms, corporations, and political organizations that set them up. Now along comes a new patient advocacy organization, Patients Rising and its sister group Patients Rising Now, which debuted in late summer shortly after the House of Representatives passed the 21st Century Cures Act.
From a policy perspective, the FDA has a mandate to keep the public safe, but medical products are associated with two types of risk: that caused by using the products and that caused by preventing their use.
The tendency to focus on eliminating an immediate harm while failing to consider potentially greater harms caused by that reaction is heightened by the power of tragic stories.
Not all anecdote-driven policies are misguided, but since we can’t know in advance every consequence a regulation will have, it’s worth considering how anecdote can skew risk perception
The consumer advocacy group Public Citizen, which petitioned the FDA in 1998 to ban powdered surgical latex gloves, on Monday chastised the agency for waiting so long to take such an action.
Most doctors do not fully understand the drug approval process for the US Food and Drug Administration (FDA) or the FDA's "breakthrough" drug classification, according to a survey published April 12 in JAMA.
"Physicians tended to overestimate the minimum evidence of efficacy required of new drugs," write Aaron S. Kesselheim, MD, JD, MPH, from Brigham and Women's Hospital in Boston, Massachusetts, and his colleagues. "Similarly, many misinterpreted the term breakthrough—believing these drugs were supported by stronger evidence than required by the statute."
They claim the companies were complicit by staying silent, helping deceive the editors while the companies were in the midst of providing the very same data to regulators in the United States and Europe.
In other words, the makers of supplements don’t have to win FDA approval before bringing a product to market, unless it contains a new ingredient that’s never been marketed before. The FDA does oversee labeling, but it usually can’t determine whether a manufacturer is following its guidelines until there’s a problem.
the agency only inspects a fraction of companies
The ethical complexities of compassionate use were perhaps nowhere more evident than in my conversation last July with Richard Plotkin, the activist who had vilified Chimerix and Moch. He told me that he had become much more informed about compassionate use since the #savejosh crusade.
“When you’re desperately ill, you’re kind of coerced by your disease. The fact that you’re desperate and you’re willing to take anything doesn’t mean the best way we can respond is to honor that request,” he said. “Because we can make you die faster, and we can absolutely make you die sicker.”
“When you hear the word breakthrough, it’s understandable to think that it means something definitively or a game changer,” said study co-author Dr. Steven Woloshin, a professor of medicine at the Dartmouth Institute. “But it gets confusing because the FDA uses it in a very different way.”
And since it is lay people to whom the CBS News is targeted – by definition, a “broadcast” audience – I think the network should stop and explain what FDA breakthrough status means before putting up a “CANCER BREAKTHROUGH” graphic for about 40 seconds to lead a newscast.
the ad omits something that most consumers would like to know: There are many older and cheaper treatments that are just as effective
Of course, the goal of drug companies is not to educate, but to sell products.
What I propose is a universal scorecard for all new drugs, to be overseen by the Food and Drug Administration, with information on how their cost and effectiveness measure up against similar medications.
At issue is an agency practice to redact portions of the resumes submitted by the scientific and medical experts who serve on FDA advisory committees, according to a lawsuit filed on Wednesday by Public Citizen in a federal court in Washington. The consumer group charged the redactions are “unlawful.”
There is a stubbornness about me that never can bear to be frightened at the will of others. My courage always rises with every attempt to intimidate me.
Conclusions FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies. In many cases, press releases were not issued in response to those letters and, when they were, omitted most of the statements in the complete response letters. Press releases are incomplete substitutes for the detailed information contained in complete response letters.
Part of the problem, he said, is that clinical trials often cherry-pick patients likely to produce the best results. “We don't get a real-world representation,” he said.
U.S. President Donald Trump’s vow to roll back government regulations at least 75 percent is causing anxiety for some pharmaceutical executives that a less robust Food and Drug Administration would make it harder to secure insurance coverage for pricey new medicines.
“Any change at the FDA that allows drugs to be tried out on patients without clinical evidence is a damaging approach,” said Jeremy Levin
President Donald Trump wants to remake the Food and Drug Administration. And he happens to have a “fantastic person” in mind to do it, he said Tuesday — someone who will turn the agency into an industry-friendly shop that cranks out new cures on the double.
Thiel, a libertarian iconoclast, has repeatedly made the case that the FDA gets in the way of drug innovation by making it too difficult for new medicines to get to the market. Some of the FDA candidates he’s identified — including Silicon Valley’s Jim O’Neill and Balaji Srinivasan — have similarly argued that the agency should dump its requirement that drugs be proven effective before reaching the market, and that we’d be better off if the FDA operated more like a “Yelp for drugs.”
It took the infamous scandal around thalidomide, a morning-sickness medication that caused severe birth defects, to strengthen the FDA
The regulations that oversee the prescription drug industry and protect consumers from dangerous products are surprisingly fragile and young.
Researchers who study the agency say the agency's standards are slowly and methodically being eroded — particularly with the forthcoming implementation of the 21st Century Cures Act.
The Cures Act, formally known as H.R. 34 or the 21st Century Cures Act,1 passed overwhelmingly in the U.S. House of Representatives and Senate in the waning days of the 114th Congress and was signed into law by President Barack Obama on December 13, 2016.
the final provisions are well worth heralding, including increased support for state efforts to combat opioid abuse, new steps aimed at improving mental health services, and important changes affecting the Food and Drug Administration and the National Institutes of Health (NIH)
Basically, the pharmaceutical industry and its lackeys in Congress bought off biomedical research advocates with the promise of more funding to the NIH and to efforts to combat the opioid crisis in the US. The price was a hole host of industry-friendly provisions weakening the FDA and producing new expedited pathways for drug approval, as well as permission to promote off-label drug use.
Expect more Vioxx disasters, now that the 21st Century Cures Act threatens to turn the FDA into a puppet of the pharmaceutical and medical device industry
I’ve seen stories suggesting that “Cures” is all about perks for pharmaceutical companies, and that industry-funded advocacy groups are parading patients, like puppets, before legislators to promote the bill.
I support most of the “Cures” provisions, for three big-picture reasons.
More than 1,300 lobbyists roamed the halls of Congress on the Cures Act, and disclosure reports show most of them were working for pharmaceutical companies.
The $500 million designated for the FDA is meant to pay for the agency’s new responsibilities under the Cures Act. There is virtually nothing in it to improve some of FDA’s longtime problems.
The Government Accountability Office considers two of the FDA’s areas of focus especially “high-risk”: food safety and post-approval oversight of medical products that went through the fast track.
Every year in the U.S., doctor's offices and hospitals order billions of laboratory tests to measure everything from cholesterol levels in the blood to the presence of a gene thought to increase the risk of developing Alzheimer's disease. Physicians and patients typically assume that they can trust the results of these tests.
Through a quirk of regulatory history, many such tests are not subject to the same medical standards as other tools used to identify risk for disease or to definitively diagnose a condition.
The federal Food & Drug Administration puts lives at risk by not moving swiftly enough on food recalls, according to an ongoing audit of the recall program by the Office of Inspector General for the Department of Health and Human Services.
Specifically, the audit found that the agency would negotiate voluntary recalls, but then fail to either prescribe or enforce any timeline, leaving it up to companies to decide the pace at which they would proceed.
But health researchers have called the Cures Act "lipstick on a pig" and the "19th Century Fraud Act" for good reason. The bill offsets research spending by cutting public health spending. And critics worry the bill could seriously damage the regulatory authority of the Food and Drug Administration.
As members of the National Physicians Alliance (NPA), we have been closely following the 21st Century Cures Act legislation and its potential impact on what “FDA approved” would mean for new drugs and devices. Our interest in the 21st Century Cures Act emerged from overarching concerns among ourselves and other alliance members that the FDA’s mission to protect public health by “assuring the safety, efficacy, and security” of new treatments was being hijacked by the pharmaceutical and medical device industries.
The passage of the 21st Century Cures Act, which sailed through the House of Representatives last week on its way to a future White House signing ceremony, is due in no small measure to the activities of hundreds of patient advocacy groups and assorted other stakeholders that worked in overdrive the past two years pushing the bill to the finish line. Their lobbying and advocacy paid off with a 996-page bill that according to the Energy and Commerce Committee (whose slick lobbying campaign was also crucial) would “modernize” the FDA and its approval process while speeding the delivery of cutting-edge, lifesaving medicines to patients.
Where was the dot connection between the 200 or so patient advocacy groups and their links to PhRMA?
There is an unlimited supply of safe but ineffective molecules that can be applied to just about any condition. If we allow them to be sold because they do no harm, and perhaps might help someone, that’s what we are going to get—placebo-like drugs that are exorbitantly priced, and masquerade as the real thing.
Here is a short study of 18 new oncology drugs already given expedited approval by the US Food and Drug Administration (FDA). Of these, 13 were priced above $100K annually, and the most expensive, cabozantinib, did not improve overall survival and reduced quality of life compared to placebo. Thank goodness that we have Vinay Prasad and Bishal Gyawali blazing away at this, because it looks as if we can forget about any kind of regulation by the FDA.
Several high-profile hospitals were included in the list, including Los Angeles-based Cedars-Sinai Medical Center and Boston-based Brigham and Women’s Hospital, for their failure to keep written medical device reporting procedures and to report adverse events.
“Between a Trump presidency and a radically pro-business Congress, the next few years may see a removal of numerous consumer protections,” said Michael Jacobson, cofounder and president of the Center for Science in the Public Interest.
One former FDA official, who spoke on condition of anonymity to speak candidly, said support for the “Right to Try” movement signals a broader disapproval of regulation.
Unger then got even more pointed: “Perhaps granting accelerated approval to drugs that show a mere scintilla of an effect on a surrogate endpoint represents a stroke of brilliance – one that will stimulate investment in the development of drugs for these disorders. But in my opinion, this approach should receive broader public (and FDA) input before being implemented.”
The Lancet’s press release on this trial was very sensible; but the press release from UCL Institute for Child Health / Great Ormond Street Hospital made misleading allusions to benefit on real-world outcomes which never appeared anywhere in the academic paper.
“I think embargoes that attempt to control sourcing are dangerous because they limit the role of the reporter whose job it is to do a full look at a subject,” says New York Times former public editor Margaret Sullivan. “It's really inappropriate for a source to be telling a journalist whom he or she can and can't talk to.”
For example, the FDA assures the public that it is committed to transparency, but the documents show that, privately, the agency denies many reporters access—including ones from major outlets such as Fox News—and even deceives them with half-truths to handicap them in their pursuit of a story.
Pharmaceutical and ingredients manufacturers in China and India have come under intense scrutiny in recent years due to a series of disturbing events. In 2008, for instance, 246 deaths in the United States were linked to a fake ingredient from China that was found in the blood thinner heparin. China is now the world’s largest supplier of active pharmaceutical ingredients.
The FDA is currently part of the Department of Health and Human Services (HHS). Making it a Cabinet-level organization or finding another way to give it more autonomy would be a step in the right direction for public health, the former commissioners argued.
Earlier this year, a raging controversy regarding a new drug spilled into the pages of a leading medical journal: the head of the U.S. Food and Drug Administration and another official publicly called for the retraction or correction of a peer-reviewed article about the drug. They didn’t get their wish. Now, documents released by the FDA via a lawsuit shed light on the attempt — and show how tricky it can be to correct the official record.
TO: Robert M. Califf, M.D.
Commissioner of Food and Drugs
Food and Drug Administration
FROM: /Daniel R. Levinson/
Inspector Genera
l
SUBJECT: Early Alert: The Food and Drug Administration Does Not Have an Efficient and Effective Food Recall Initiation Process (A-01-15-01500)
We found that FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply. Specifically, FDA did not have policies and procedures to ensure that firms1 or responsible parties2 (collectively referred to in this document as “firms”) initiated voluntary food recalls promptly. This issue is a significant matter and requires FDA’s immediate attention.
To help ensure the safety of the Nation’s food supply, we recommended that FDA consider our findings when implementing the FDA Food Safety Modernization Act (FSMA) and follow its own procedures for monitoring recalls.
FDA generally relies on firms to voluntarily recall harmful articles of food.3 Before 2011, FDA did not have the authority to require a firm to recall certain articles of food. However, the FSMA added section 423 to the FD&C Act,4 which gives FDA the authority to order a firm to recall certain articles of food after FDA determines that there is a reasonable probability that the food is adulterated or misbranded and that it will cause serious adverse health consequences or death to humans or animals (this is commonly referred to as SAHCODHA). FDA has used its authority under FSMA twice.5
Donald Trump’s three most likely picks for FDA Commissioner all favor loosening drug approval standards. Two are cronies of Peter Thiel, of which one believes that the FDA shouldn’t require evidence of efficacy, only safety, and the other believes that a “Yelp for drugs” would do a better job than the FDA. The third candidate is a bona fide, honest-to-goodness pharma shill. If any of them becomes FDA Commissioner, drug safety standards will take a nosedive.
He is currently a resident fellow at the conservative American Enterprise Institute, where he analyzes health policy, regulation and public health. He is on the Federal Health IT Policy Committee, a group that advises the Department of Health and Human Services on health care IT issues. His resume also boasts stints as the FDA’s deputy commissioner, and at the Centers for Medicare and Medicaid Services as a senior official focused on new medical technologies.
At his confirmation hearing in April, Dr. Gottlieb told senators that he believed in upholding the F.D.A.’s reputation as the world’s “gold standard” for drug approval. If confirmed, he said then, he would be “an absolutely objective regulatory watchdog” and would not do anything that could “besmirch the agency” or undermine public confidence in its work.
early tests on a small number of patients can suggest great promise, but subsequent, more robust studies often disappoint
At best, the proposed budget suggests that the White House doesn’t understand how the NIH and the FDA function. At worst, it suggests a disregard for the millions of patients who are desperate for the scientific innovations, lifesaving therapies, and safeguards that emerge from these agencies. Cutting the NIH by the magnitude currently proposed — a staggering $6 billion — would cripple the incredible scientific momentum the health care community has been enjoying.
The food industry is moving to capitalize on the Trump administration's anti-regulation agenda by seeking to delay or do away with Obama-era rules governing the disclosure of calories, sugar, fiber and serving size, according to petitions filed with the Food and Drug Administration.
Bloomberg: What about drugs like EpiPen, would you come out with new rules there to create more competition? [EpiPen, made by Mylan NV, is what’s known as a drug-device combination, where both the medicine and the device that administers it can have patent protections.]
Mrs. Gardiner: Take care my love. That savors strongly of bitterness.
Makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress.
The deal is part of a pact between the F.D.A. and the $148 billion device industry.
A trade group for the generic-drug industry filed a lawsuit Thursday seeking to block Maryland’s new state law aimed at curbing steep price increases for generic drugs, the first law of its kind in the U.S.
what they call red tape often consists of essential public protections that defend our lives, our futures and the rest of the living world. The freedom they celebrate is highly selective: in many cases it means the freedom of the rich to exploit the poor, of corporations to exploit their workers, landlords to exploit their tenants and industry of all kinds to use the planet as its dustbin.
one in, two out rule for regulation
Promising to cut “red tape,” business-friendly politicians evidently judged that cost concerns outweighed the risks of allowing flammable materials to be used in facades.
Governments adopted slogans calling for the elimination of at least one regulation for each new one that was imposed, and the authorities in charge of fire safety took this to heart.
“If there’s a new regulation, they have to knock out two.
Trump met with business executives from some of America’s largest companies and promised to cut regulation by 75 percent. He also ordered a freeze on all new and pending regulation at the federal level via a memorandum—save for emergencies relating to “health, safety, financial, or national security matters,”—until a Trump-appointed department head could review prospective regulations.
the economic costs of the two so-called deregulatory actions must equal or exceed the economic cost of the new regulation.
The “two-for-one” order, signed January 30, applies only to “significant” regulations with an economic impact exceeding $100 million or meeting other specified criteria, and it may be working in a counterintuitive way: Although it was touted as a way to roll back old rules, its main impact appears to be simply erecting obstacles to new regulations.
Regulations have costs, but they also have benefits. The smoke scrubbers in our example reduce toxic emissions and the resulting illnesses. Lives are saved, health care expenses are reduced, and some jobs are created in the manufacture of the scrubbers.
Over the past 35 years, federal regulations in most areas have been issued only if their benefits were shown to exceed their costs.
In written testimony (PDF) for his confirmation hearing, Gottlieb pledged to run the FDA “as an impartial and passionate advocate for public health” guided by science. He said the “FDA’s enforcement tools are a bedrock of its mission.”
These initial numbers, however, have watchdogs such as Public Citizen’s Carome worried that Trump’s pledge to roll back red tape has reached the FDA—potentially endangering Americans who rely on the 17,000-employee agency to protect them.
“I consider access to medicine a matter of public health,” Dr. Gottlieb declared in a blog post
The FDA has traditionally taken the position that the agency’s sole role in medical-product approval is assessing safety and effectiveness, and that pricing is generally out of its purview.