If you’re a new drug, the FDA loves you. Nineteen out of 20 new drug applications are approved by FDA, according to a recent analysis by BioMedTracker. This corresponds to a 96 percent approval rate, a big hike from 2008, when it was 66 percent.
“The FDA is basically approving everything,” concludes Forbes, which commissioned the study.
In the same vein, when a pharmaceutical company asks the FDA for a new marketing claim, it gets it nine out of 10 times.
Take Addyi, the “female Viagra,” which originally performed at par with sugar pills in daily placebo tests. Sprout Pharmaceuticals convinced FDA that it made more sense to switch to monthly reports from the female test subjects, because it delivered 0.7 more sexually satisfying experiences, at least statistically speaking. Sprout also launched a paid lobbying effort in parallel to paint FDA as a sexist organization, should it refuse to give women a treatment for sexual difficulties (a right already enjoyed by men).
The FDA officially attributes its higher approval ratings to new communication procedures with both drug companies and patient advocates, pre-screening procedures, and other factors. Forbes itself published a follow-up piece (or a “bend over”) to the study, listing “9 reasons why FDA is approving almost every drug application.”
The roots for fast tracking drugs goes back to 1997, when a bill called the 21st Century Cures Act was approved with bipartisan majority to “streamline the FDA.” The bill enabled companies to skip clinical trials to “revamp the agency’s regulatory authority and push it into the 21st century,” the former Republican Senator James M. Jeffords, the legislation’s chief architect, said in 1997.
The FDA commissioners have a long track record of aligning themselves with pharma interests. The previous commissioner, Margaret Hamburg, illegally held stock options on a dental amalgam company while overseeing a ruling that allowed the concealment of mercury in dental fillings. Under her reign, the threat of antibiotic-resistant superbugs had already been established by the CDC, yet the FDA only asked the drug companies to voluntarily restrict the use of antibiotics on farming practices.
President Obama’s latest nominee to head the FDA is Robert Califf, a former radiologist and clinical trial researcher who from 2009 through early 2015 has received consulting fees of roughly $205,000 from pharmaceutical companies including Johnson & Johnson, Merck & Co. and GlaxoSmithKline PLC.
Califf also played a role in the approval of an anti-coagulant medication, Xarelto, whose manufacturer, Janssen Pharmaceuticals and Bayer AG, are being sued for failing to warn patients and physicians of the increased risks of irreversible and fatal internal bleeding when using the drug. The principal investigator and co-chairman of the study that declared the drug safe was Dr. Robert Califf.
The Senate is expected to confirm Califf as commissioner of FDA “as quickly as possible.”
Jan Wellmann is co-founder of HoneyColony and an independent investigative journalist focusing on alternative health & energy. Follow him at @janwe.
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