Congress passed a series of legislative acts, beginning in 1992, known collectively as the Prescription Drug User Fee Acts (PDUFA). This legislation sought to expedite the U.S. Food and Drug Administration (FDA) drug-review process. Interestingly, drug companies are required to pay fees with their new drug applications, essentially making them a customer of FDA. Let’s look at a recent approval of a drug that puts in focus the power of the drug industry and brings into question the FDA’s independence.
According to extensive advertising by the drug company Noven, menopausal women will now have access to “the first and only FDA-approved non-hormonal therapy for moderate to severe hot flashes associated with menopause.” The phrase “non-hormonal” alludes to the practice of hormone replacement therapy (HRT), a menopause treatment primarily involving estrogens, which was widely in vogue until its many dangers to women’s health were discovered and documented. Lawyers in our firm’s Mass Torts Section represented a number of women who suffered from breast cancer as a result of HRT use.
Because of these dangers, few women now use HRT. So up steps Noven to fill the void with its new drug BRISDELLE, a drug also sold by GlaxoSmithKline as PAXIL (generic name: paroxetine), which is approved by the FDA to treat depression, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder and post-traumatic stress disorder.
In March 2013, an advisory committee of the Food and Drug Administration reviewed the evidence for the effectiveness and safety of BRISDELLE to treat hot flashes. Public Citizen testified against its approval, pointing out that the clinical trials failed to demonstrate any evidence of clinically significant benefits for paroxetine in comparison to placebo. Public Citizen presented evidence of previously documented dangers of paroxetine, including seizures or convulsions, manic episodes, agitation, sexual problems, and other adverse events found in studies of the drug.
The FDA advisory committee concluded, by a 10 to 4 vote, that BRISDELLE did not provide a clinically meaningful improvement in hot flashes compared to a placebo. An identical 10 to 4 vote also supported the conclusion that the drug’s benefits did not outweigh its risks and that it thus should not be approved. Nevertheless, the FDA overrode the advice of the committee and approved the drug. Public Citizen categorizes Brisdelle as a DO NOT USE drug. You have to wonder why the FDA would categorizes this drug as a DO USE drug? This poses an important question and that is does Big Pharma control the FDA and run the show?
Source: Public Citizen
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