'More Needs To Be Done' At FDA To Ensure Safe, Effective Medications For Consumers, Op-Ed States

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Public Health;  Pharma Industry / Biotech Industry
Article Date: 08 Apr 2009 - 3:00 PDT

email to a friend   printer friendly   opinions  

"For too long [FDA] has behaved as though its job is to speed brand-name drugs to market, not to ensure that they are safe and effective," Marcia Angell, a senior lecturer in social medicine at Harvard Medical School, writes in a Boston Globe opinion piece. She continues that "while new leadership [at the agency] is crucial, more needs to be done."

According to Angell, Congress "should repeal the Prescription Drug User Fee Act" because it "puts the FDA on the payroll of the industry it regulates, and makes it more likely that drugs will be reviewed favorably -- a bargain for drug companies." In addition, "consultants for drug companies should no longer be permitted to serve on FDA advisory panels," she writes, adding that while "they are supposed to recuse themselves from decisions in which they have a large, direct financial interest, that requirement is often waived." FDA also "should see that the post-marketing studies it mandates are actually carried out" and should "review generic drugs as fast as brand-name drugs," as such reviews are "key to lowering drug prices," Angell writes.

In addition, Congress should give "FDA the authority to require drug companies to compare new drugs with existing drugs of the same type," and the agency "should stop approving" new medications that "are trivial variations of top-selling drugs" on "the basis of surrogate endpoints," according to Angell. Finally, FDA "should prohibit direct-to-consumer advertising for three years after drugs are approved," Angell writes. She concludes, "It is time to restore the FDA to its purpose, which is to protect the public from unsafe food, drugs and devices, not to accommodate the industries it regulates," adding that the "change in leadership [at the agency] is reason for optimism" (Angell, Boston Globe, 4/6).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

• Additional
• References
• Citations