US Food and Drug Administration MEDWATCH
and Other FDA Issues
You can voluntarily report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can also report suspected counterfeit medical products to FDA through MedWatch.
Reports of adverse events from drugs and products are vital to the researchers who analyse and report on the post-marketing hazards and dangers that may be related to some drugs or other products! So take the time to report if you have experienced a serious adverse event related to your medication.
"The Effect of FDA Advisories on Branded Pharmaceutical Firms Valuations and Promotional Efforts" by Rena M. Conti, Haiden A. Huskamp, Ernst R. Berndt, National Bureau of Economic Research, Working Paper 17528.
FDA Advisories about prescription drugs including Black Box Warnings and other medication labeling changes, as well as advisory letters to physicians has an impact on prescribing practices. After an FDA advisory the pharmaceutical company generally lessens promotion of its product to prescribers, and prescribers cut back on writing scripts for the drug mentioned in the advisory. Both actions, the advisory and the cut back of promotion, combine to have a strong effect on limiting dispensing of the mentioned drug.
"The Safety Risks of Innovation: The FDA's Expedited Drug Development Pathway" Thomas Moore, Curt Furberg; JAMA, September 5, 2012
"The fundamentals of clinical testing and drug safety have not changed. It takes years of development, costly clinical trials, and extensive analyses to
establish the clinical conditions under which new drugs will do more good than harm. Risks persist, even with standard approvals. Meanwhile, the US Senate, in approving a regular 5-year update to the Food, Drug, and Cosmetic Act, proposed a further expansion of expedited review, with a new category for “breakthrough drugs.” For physicians, the FDA’s emphasis on rapid drug approval underlines the importance of the 6 “principles of conservative prescribing” that include the warning, “Exercise caution and skepticism regarding new drugs.”