Does FDA approval still hold weight?

Emily Rappleye - Friday, August 21st, 2015

A recent analysis commissioned by Forbes suggests we may be "living in a golden age of drug approvals."

When the Food and Drug Administration approved female libido pill Addyi earlier this week, it stirred up quite a controversy.

Some say it was a victory for women, given that there are many drugs made for men to improve their sex lives. Others condemn it as irresponsible, since Addyi is the first ever drug to treat libido for men or women, and the pill has a number of dangerous side effects such as low blood pressure, fainting, nausea and dizziness, especially when combined with alcohol.

Controversy aside, the approval of Addyi may signal a larger trend happening at the FDA — a new, lax attitude toward drug approval — which can be backed by data, according to Forbes.

Forbes commissioned an analysis from BioMedTracker, a company that analyzes and tracks clinical and regulatory events of pharmaceuticals. BioMedTracker tallies the rejections and approvals of each drug use, rather than each drug. However, it is important to note rejections are shared at the discretion of drugmakers.

Here is what BioMedTracker found.

So far this year, the FDA has an approval rate of 89 percent, rejecting only three uses for new chemical entities, or completely new drugs, and approving 25.
In 2008, the FDA rejection rate of new chemical entities was 66 percent.
The FDA's overall approval rate — including both new chemical entities and other requests — is 88 percent this year, compared to a 56 percent overall approval rate in 2008.

Forbes notes that the FDA defers to patient advocate preferences and many patients prefer the FDA approve drugs with marginal benefits rather than reject them. It also notes FDA leniency has fluctuated in the past, and could be a reflection of the current political environment.

Does FDA approval still hold weight?

More articles on infection control and clinical quality:

Featured Whitepapers

Featured Webinars