Tweeted by @hhask
"Proposed US Food and Drug Administration Guidance for Industry on Distributing Medical Publications About the Risks of Prescription Drugs and Biological Products"
http://tinyurl.com/mywhjjsIn my view, the draft guidance, which is open for public comment until August 25, 2014, has the potential to undermine the FDA’s drug safety laws and regulations and should be changed.
As written, the draft guidance would allow pharmaceutical companies who believe that the FDA-approved drug-labeling information overstates the risks of their drug to tell physicians that the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Unfortunately, the draft guidance strikes the balance more toward the industry’s view of its First Amendment right to commercial speech than toward the agency’s mandate for patient protection.