Thursday, August 8, 2013

New Research Suggests Failure of FDA Post-Market Oversight System


This blog has published many posts that mention the United Stated Food and Drug Administration (FDA), and we have on a few occasions taken the position that the organization often fails in its duty to protect consumers from corporations whose goal is the bottom line at the expense of consumer safety. We have written about the legal snags the FDA’s inspectors have encountered in evaluating the safety of compounding pharmacies (Federal Inspectors Face Difficulties Investigating Fungal Meningitis Outbreak), its investigation of Intuitive Surgical (the manufacturers of the da Vinci surgical robot system—“Da Vinci Surgical Robot Subject of FDA Probe”) after many procedures with its products ended in injury and the Administration’s lax oversight of potentially dangerous products, like plastic water bottles whose linings contain the known carcinogen BPA, bisphenol A (“The Slip Between the Cup and The Lip: The FDA’s Lax Regulation of Potentially Harmful Products”).
About one year ago, we posted an article that details ways in which the non-governmental, independent non-profit Institute for Medicine (chartered by the National Academy of Sciences) disapproved of the FDA’s unsafe post-market inspections. In order for drugs to be approved for sale, they must meet the rather rigorous standards that the Administration has set, including three phases of testing in which several hundred (up to several thousand) people are given the drug in question over a period of six to ten months.
But a few months is not enough time to tell what the long-term effects of a treatment will be, and for this reason the organization needs a better system of post-market inspection, or oversight that keeps an eye out for long-term problems that may emerge from medications that have already been approved. For example, the anti-inflammatory Vioxx and the weight loss drug Fen-phen were both approved by the FDA only to be recalled later due to their associations with increased risk of heart attack and pulmonary hypertension, respectively.

- See more at: http://www.feldmanshepherd.com/blog/2013/07/new-research-suggests-failure-of-fda-post-market-oversight-system/#sthash.oMqQEKaJ.dpuf

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