Could the FDA Be Approving Drugs Based on Questionable Evidence?

Every time you turn on the television, you are most likely bombarded by a barrage of advertisements for prescription drugs. While you might be wary of marketer’s claims and promises as to their effect, you can at least rest assured that all have passed stringent analysis, testing and review by the Federal Drug Administration (FDA)—right? Well, two reports recently published in the Journal of the American Medical Association (JAMA) say different.

Examining the data on 22 drugs that were granted accelerated approvals by the FDA between 2009 and 2013, one of the studies showed that the trials fell short of the FDA’s typical criteria. Dr. Huseyin Naci from the London School of Economics and Political Science led the team of researchers that, according to Naci, “…found numerous situations in which required confirmatory studies with rigorous designs and outcomes are not pursued or are not completed in a timely fashion, and in these cases, we are concerned that regulators appear to accept data that would not otherwise meet FDA standards.”

While the FDA usually requires randomized controlled trials (RCTs) to demonstrate a drug’s safety and efficacy, it was found that the federal agency glossed over this part of the process with 14 out of the 22 drugs and made decisions based solely on far less-rigorous tests. To compensate for this “acceleration” of a compound’s review, the FDA claims to have required even more stringent testing to follow—yet, three or more years after their accelerated approvals, only half of the drugs had gone through the additional testing.

The second report featured in JAMA conveyed the findings of researchers from the University of California, San Francisco—investigating FDA-approval of medical device modifications. While they also found the accelerated approval process to be lacking in the way randomized testing, another issue surfaced that was even more disturbing.

“[We found] numerous discrepancies between the number of patients enrolled and the number of patients with data reported,” said the study’s leader, Dr. Rita F. Redberg. Whether it was data loss or incompleteness, the result was rushed and potentially biased approvals.

Ultimately, researchers urge consumers and patients to investigate any drug or medical device before use and to initiate conversations with their doctors about alternative options when in doubt. For those who have used such products and suffered adverse effects, a discussion with an experienced attorney would be a prudent first step.

Our law firm of Childers, Schlueter & Smith is well-versed in drug and medical device litigation and might be able to help you or a family member who is suffering due to this lacking process of the FDA. If you have questions, please give us a call at 1-800-641-0098. All initial inquiries are free of charge and without obligation.