Drug manufacturers are supporting a proposal in front of the Food and Drug Administration that would allow them to contradict FDA drug warnings in sales presentations to customers.
Citing the First Amendment, the drug makers and sellers want to be able to provide customers with additional information about their drugs, some of which may refine existing knowledge of the drug’s possible side effects, and may also directly contradict the FDA’s position on a drug.
The drug makers and sellers want the ability to cite newer medical literature that support their products, minimize potential side effects, or both. The proposal would allow for such information to be used in sales presentations so long as the studies cited are “well-designed” and “at least as informative as the data sources” the FDA used in its warning of a particular drug. What constitutes this standard and who would enforce such standard are unclear.
You can read an article on the subject here:
[FDA proposes to let drug companies undermine official safety warnings][1]
As you might imagine, public health advocates oppose such a proposal as undermining the authority of the FDA by making drugs seem safer than they really are so that drug makers can sell more of them. Further, there are concerns that much of the literature supporting the drug makers’ positions on drugs is funded by the drug making industry itself.
From a medical / legal perspective, it is possible that a catastrophic injury could occur due to the use of a drug that was bought and prescribed with sales information contradictory to FDA warnings. When an action is brought against the physician who prescribed the drug, she may defend her actions as being appropriate considering the literature offered by the drug makers in support of the sale. If it was reasonable for the physician to rely on the drug makers’ sales pitch, and supporting literature, that physician may have a valid defense.
[1]: http://www.washingtonpost.com/blogs/wonkblog/wp/2015/03/11/how-the-first-amendment-is-undermining-the-fdas-power-to-regulate-drugs/ “FDA proposes to let drug companies undermine official safety warnings”
