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Author Topic: FDA  (Read 10391 times)

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Offline LinksEtc

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Re: FDA
« Reply #105 on: April 26, 2016, 12:33:33 PM »
"The FDA, for only the second time ever, wants to ban a medical device. Here’s why."
https://www.washingtonpost.com/news/to-your-health/wp/2016/03/21/what-do-powdered-surgical-gloves-and-prosthetic-hair-fibers-have-in-common-the-fda-doesnt-like-them/?postshare=5591458581633246&tid=ss_tw

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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.

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"Internists, Specialists Lack Knowledge About FDA Drug Approval Process"
Tara Haelle
April 12, 2016
Medscape

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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.
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"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."





« Last Edit: April 26, 2016, 06:53:08 PM by LinksEtc »

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Re: FDA
« Reply #106 on: April 26, 2016, 12:40:21 PM »
"Document Claims Drug Makers Deceived a Top Medical Journal"
http://www.nytimes.com/2016/03/02/business/document-claims-drug-makers-deceived-a-top-medical-journal.html?_r=1

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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.


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"Can Regulators Keep Up with the Supplements Industry?"
http://www.pbs.org/wgbh/frontline/article/can-regulators-keep-up-with-the-supplements-industry/

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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.

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the agency only inspects a fraction of companies



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Hashtag Prescription
The hidden cost of crowd-sourcing a cure
By Helen Ouyang
http://harpers.org/archive/2016/06/hashtag-prescription/1/

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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.

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“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.”






« Last Edit: September 18, 2017, 07:19:06 AM by LinksEtc »

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Re: FDA
« Reply #107 on: April 26, 2016, 02:26:11 PM »
CBS proclaims ‘cancer breakthrough’ – doesn’t explain what FDA means by that term
http://www.healthnewsreview.org/2016/05/cbs-proclaims-cancer-breakthrough-doesnt-explain-what-fda-means-by-that-term/

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“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.”

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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.


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"What Drug Ads Don’t Say"
http://www.nytimes.com/2016/04/24/opinion/sunday/what-drug-ads-dont-say.html

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the ad omits something that most consumers would like to know: There are many older and cheaper treatments that are just as effective

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Of course, the goal of drug companies is not to educate, but to sell products.

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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.


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"FDA sued for hiding too much info about its expert panel members"
https://www.statnews.com/pharmalot/2016/04/28/fda-secrets-redactions-drugs/

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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.”


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Bias






« Last Edit: May 16, 2016, 07:41:20 AM by LinksEtc »

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Re: FDA
« Reply #108 on: September 16, 2017, 09:55:39 AM »
Soooo ....

This:
Re: EpiPen Serious Manufacturing Violations

It's just a reminder to me that the interests of regular citizens & patients are better represented when we remain vigilant, when we remain active in the system, in government.  I'm interested in public health, in the public good ... what I've learned from my advocacy thus far ... I see that as relevant to understanding political problems on a larger level ...

so anyway, I've been keeping an eye on the FDA even though I've been quiet lately and it might be of some benefit to the FA community if I update this thread ...

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An added note to those who have treated me badly, who have been cruel ...


This quote from Jane Austen's "Pride and Prejudice" (Chapter 31) seems to fit:


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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.








« Last Edit: September 16, 2017, 10:49:57 AM by LinksEtc »

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Re: FDA
« Reply #109 on: September 16, 2017, 10:49:31 AM »
"Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study"

http://www.bmj.com/content/350/bmj.h2758

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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.


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The Washington Post
Democracy Dies in Darkness

"New safety risks detected in one-third of FDA-approved drugs"
https://www.washingtonpost.com/news/to-your-health/wp/2017/05/09/new-safety-risks-detected-in-one-third-of-fda-approved-drugs/?utm_term=.168cebeb2b28

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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.


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"Pharma industry shuns Trump push for radical shift at FDA"

Deena Beasley

http://www.reuters.com/article/us-usa-trump-healthcare-regulation-analy/pharma-industry-shuns-trump-push-for-radical-shift-at-fda-idUSKBN15U0GP

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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.

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“Any change at the FDA that allows drugs to be tried out on patients without clinical evidence is a damaging approach,” said Jeremy Levin







« Last Edit: September 16, 2017, 02:22:45 PM by LinksEtc »

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Re: FDA
« Reply #110 on: September 16, 2017, 02:28:25 PM »
"Trump wants to blow up the FDA. The drug industry? Not so much"

By Damian Garde  @damiangarde

February 1, 2017

https://www.statnews.com/2017/02/01/trump-blow-up-fda/

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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.

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"Peter Thiel vs. the FDA

Trump has tapped Thiel to help unleash the Silicon Valley mindset on the agency. Will it work?"

Updated by Julia Belluz@juliaoftorontojulia.belluz@voxmedia.com   Jan 31, 2017, 7:54am EST

https://www.vox.com/science-and-health/2017/1/31/14364090/peter-thiel-fda-trump-silicon-valley-oneill-gulfo-srinivasan-gottlieb

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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.”
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It took the infamous scandal around thalidomide, a morning-sickness medication that caused severe birth defects, to strengthen the FDA

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"The FDA is slowly getting weaker. Here’s why that’s dangerous."

Updated by Julia Belluz@juliaoftorontojulia.belluz@voxmedia.com   Dec 13, 2016, 3:10pm EST

https://www.vox.com/science-and-health/2016/12/12/13914068/fda-future-trump-jim-oneill

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The regulations that oversee the prescription drug industry and protect consumers from dangerous products are surprisingly fragile and young.
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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.




   
« Last Edit: September 16, 2017, 02:45:58 PM by LinksEtc »

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Re: FDA
« Reply #111 on: September 16, 2017, 03:03:48 PM »
The 21st Century Cures Act — A View from the NIH

Kathy L. Hudson, Ph.D., and Francis S. Collins, M.D., Ph.D.

N Engl J Med 2017; 376:111-113January 12, 2017DOI: 10.1056/NEJMp1615745

http://www.nejm.org/doi/full/10.1056/NEJMp1615745#t=article

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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.

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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)


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"The 21st Century Cures Act passes, potentially turning the FDA into a puppet of the pharmaceutical industry"

Posted by Orac on December 8, 2016

http://scienceblogs.com/insolence/2016/12/08/the-21st-century-cures-act-passes-turning-the-fda-into-a-puppet-of-the-pharmaceutical-industry/

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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.

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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


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"Why Patients Support The 21st Century Cures Act"

Nov 30, 2016 @ 09:54 AM

Elaine Schattner

https://www.forbes.com/sites/elaineschattner/2016/11/30/why-patients-support-the-21st-century-cures-act/#603acec44dd3

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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.

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I support most of the “Cures” provisions, for three big-picture reasons.



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"Winners and losers of the 21st Century Cures Act"

By Sheila Kaplan

December 5, 2016

https://www.statnews.com/2016/12/05/21st-century-cures-act-winners-losers/

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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.

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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.

   


« Last Edit: September 16, 2017, 04:17:20 PM by LinksEtc »

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Re: FDA
« Reply #112 on: September 16, 2017, 04:25:15 PM »
"Why the FDA Wants More Control over Some Lab Tests

The FDA finds that many so-called laboratory-derived tests may actually harm patients"

By Charles Schmidt on December 1, 2016

https://www.scientificamerican.com/article/why-the-fda-wants-more-control-over-some-lab-tests/

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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.

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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.


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"Audit: FDA Recall Process Puts Lives at Risk"
June 9, 2016
by Katie Worth

http://www.pbs.org/wgbh/frontline/article/audit-fda-recall-process-puts-lives-at-risk/

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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.

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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.


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"The biggest health reform bill since Obamacare, explained in 600 words"

Updated by Julia Belluz  @juliaoftoronto  julia.belluz@voxmedia.com   Dec 13, 2016, 2:44pm EST

https://www.vox.com/2016/12/2/13809984/what-is-21st-cures-act

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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.


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"21st Century Cures Act will distort the meaning of ‘FDA approved’"

By Reshma Ramachandran and Zackary Berger

December 1, 2016

https://www.statnews.com/2016/12/01/21st-century-cures-act-fda-approval/

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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.


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"With media watchdogs on the sidelines, pharma-funded advocacy groups pushed Cures Act to the finish line"

Trudy Lieberman

http://www.healthnewsreview.org/2016/12/with-media-watchdogs-sidelined-pharma-funded-advocacy-groups-pushed-cures-act-to-the-finish-line/

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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.

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Where was the dot connection between the 200 or so patient advocacy groups and their links to PhRMA?







« Last Edit: September 17, 2017, 06:43:53 PM by LinksEtc »

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Re: FDA
« Reply #113 on: September 17, 2017, 04:04:27 PM »
"Patients' Right To Try Should Not Be A License To Fleece Them"

 Bernard Munos

https://www.forbes.com/sites/bernardmunos/2016/12/08/patients-right-to-try-should-not-be-a-license-to-fleece-them/#55f2320a44ff

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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.


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"Richard Lehman’s journal review—5 December 2016"

http://blogs.bmj.com/bmj/2016/12/05/richard-lehmans-journal-review-5-december-2016/

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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.


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"FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation"

Posted 24 October 2016
By Zachary Brennan

http://raps.org/Regulatory-Focus/News/2016/10/24/26053/FDA-Targets-15-Hospitals-Over-Significant-Deviations-from-Medical-Device-Reporting-Regulation/

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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.







« Last Edit: September 17, 2017, 04:39:41 PM by LinksEtc »

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Re: FDA
« Reply #114 on: September 17, 2017, 04:45:46 PM »
"Could the FDA be dismantled under Trump?"

By Sheila Kaplan

November 22, 2016

https://www.statnews.com/2016/11/22/fda-donald-trump/

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“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.

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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.


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"FDA emails show how upset some officials were over the Sarepta approval"

By Ed Silverman @Pharmalot

November 4, 2016

https://www.statnews.com/pharmalot/2016/11/04/fda-emails-sarepta-duchenne/

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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.”


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"Sarepta, eteplirsen: anecdote, data, surrogate outcomes, and the FDA"

September 30th, 2016 by Ben Goldacre in bad science

http://www.badscience.net/2016/09/eteplirsen-anecdote-data-surrogate-outcomes-and-the-fda/

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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.


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"How the FDA Manipulates the Media

The U.S. Food and Drug Administration has been arm-twisting journalists into relinquishing their reportorial independence, our investigation reveals. Other institutions are following suit"

By Charles Seife on October 1, 2016

https://www.scientificamerican.com/article/how-the-fda-manipulates-the-media/


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“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.”

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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.





   
« Last Edit: September 17, 2017, 05:15:09 PM by LinksEtc »

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Re: FDA
« Reply #115 on: September 17, 2017, 05:16:05 PM »
"FDA warns Chinese drug maker over lying"

By Ed Silverman @Pharmalot

August 4, 2016

https://www.statnews.com/pharmalot/2016/08/04/china-drug-safety-fda-heparin/

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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.


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"FDA: We won’t regulate fitness trackers, wellness apps"
07.29.16
https://www.fastcompany.com/4015512/fda-we-wont-regulate-fitness-trackers-wellness-apps

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"Six former commissioners say FDA should be independent agency"

By Helen Branswell @HelenBranswell

June 25, 2016

https://www.statnews.com/2016/06/25/six-former-commissioners-say-fda-get-cabinet-status/

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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.


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Medical Product Oversight:

FDA Needs More Strategic Planning to Guide Its Scientific Initiatives

GAO-16-432: Published: May 16, 2016. Publicly Released: Jun 15, 2016.

http://www.gao.gov/products/GAO-16-432

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Food and Drug Administration:

Comprehensive Strategic Planning Needed to Enhance Coordination between Medical Product Centers

GAO-16-500: Published: May 16, 2016. Publicly Released: Jun 15, 2016.

http://www.gao.gov/products/GAO-16-500





« Last Edit: September 17, 2017, 06:14:13 PM by LinksEtc »

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Re: FDA
« Reply #116 on: September 17, 2017, 06:26:29 PM »
"Released FDA docs reveal details of agency’s (failed) attempt to retract paper"
http://retractionwatch.com/2017/08/21/released-fda-docs-reveal-details-agencys-failed-attempt-retract-paper/

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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.


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"Auditors slam FDA for dragging its feet on food recalls"

By Coral Beach | June 9, 2016

http://www.foodsafetynews.com/2016/06/127380/#.Wb8CuU0m7IU

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Dept of Health & Human Services

Office of Inspector General

June 8, 2016

https://oig.hhs.gov/oas/reports/region1/11501500.pdf

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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)

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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.

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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.

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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





« Last Edit: September 18, 2017, 01:33:41 PM by LinksEtc »

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Re: FDA
« Reply #117 on: September 17, 2017, 06:47:34 PM »
"Donald Trump and Peter Thiel vs. the FDA: Be afraid. Be very afraid."
https://sciencebasedmedicine.org/donald-trump-vs-the-fda-be-afraid-be-very-afraid-of-the-loosening-of-drug-approval-standards/

David Gorski  on January 16, 2017

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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.

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"Here's What We Know about Trump's FDA Head Nominee

Early tests for Scott Gottlieb, who was named to the post on Friday, will include a pair of bills immediately slated for congressional review"

By Dina Fine Maron on March 10, 2017

https://www.scientificamerican.com/article/heres-what-we-know-about-trumps-fda-head-nominee/

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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.

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"Senate Confirms Scott Gottlieb to Head F.D.A."

By KATIE THOMAS, MAY 9, 2017

https://www.nytimes.com/2017/05/09/health/scott-gottlieb-senate-fda-commissioner.html?mcubz=0&_r=0

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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.

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"Trump’s new FDA commissioner has a huge decision to make"

By William B. Schultz 


https://www.washingtonpost.com/opinions/trumps-new-fda-commissioner-has-a-huge-decision-to-make/2017/05/16/4ee187f8-3667-11e7-b412-62beef8121f7_story.html?utm_term=.818c2824acc6

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early tests on a small number of patients can suggest great promise, but subsequent, more robust studies often disappoint

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"Trump’s proposed budget would cripple the NIH and FDA"

By Ellen V. Sigal

May 24, 2017

https://www.statnews.com/2017/05/24/trump-budget-nih-fda/


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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.




« Last Edit: September 18, 2017, 08:20:56 AM by LinksEtc »

Offline LinksEtc

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Re: FDA
« Reply #118 on: September 18, 2017, 08:04:54 AM »
"Industry is counting on Trump to back off rules that tell you what’s in your food"

By Caitlin Dewey 

https://www.washingtonpost.com/news/wonk/wp/2017/04/27/industry-is-counting-on-trump-to-back-off-rules-that-tell-you-whats-in-your-food/?utm_term=.7bba28f6bf54

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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.

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"Trump's FDA Commissioner on Drug Prices, Regulations, Science"

By Anna Edney and Justin Mattingly

‎July‎ ‎24‎, ‎2017‎ ‎1‎:‎06‎ ‎PM

https://www.bloomberg.com/news/articles/2017-07-24/trump-s-fda-commissioner-on-drug-prices-regulations-science

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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.]




« Last Edit: September 18, 2017, 08:38:51 AM by LinksEtc »

Offline LinksEtc

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Re: FDA
« Reply #119 on: September 18, 2017, 08:39:04 AM »
I'd also recommend that patients/consumers who want health care to better address our needs read:

"An American Sickness: How Healthcare Became Big Business and How You Can Take it Back" by

Elisabeth Rosenthal

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It has chapters such as the following:

"The Age of Pharmaceuticals"

"The Age of Medical Devices"

"The Age of Research and Good Works for Profit: The Perversion of a Noble Enterprise"

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My opinion ... so much of health "care" is just not about patient well-being ...

ok ... not going to post emotionally ...

because what I am thinking should probably not be said now ...


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Instead, here is another "Pride and Prejudice" quote, this time from the 2005 movie:

Quote
Mrs. Gardiner:  Take care my love.  That savors strongly of bitterness.




« Last Edit: September 18, 2017, 10:06:30 AM by LinksEtc »