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New Research Suggests Failure of FDA Post-Market Oversight System

July 31, 2013

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, its investigation of Intuitive Surgical 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 .

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.

While the FDA details its review and approval process in great detail, their web site says of post-market monitoring, “The sponsor (typically the manufacturer) is required to submit periodic safety updates to the FDA.” The onus is thus on the maker of the drug, whose interest is, obviously, to keep its product on the market. Martha Garcia of cites a letter from three Johns Hopkins researchers published in a recent issue of the Journal of the American Medical Association which found that “more than 40 percent of studies required by federal regulators had not even been started, leaving the FDA, doctors, and patients in the dark about whether those medications are actually safe.” While nearly half of these oversight studies have not been started, a staggering 85 percent are unfinished (in the past six years).

This is yet another example of the subpar job the Food and Drug Administration has done in protecting Americans from pharmaceutical companies who want to keep their drugs on the market. By allowing these companies to police themselves, the FDA has seemingly given up responsibility for post-market inspection, which is often the time at which problems with drugs present themselves. As always, this further highlights the role of consumer advocates, pharmaceutical industry watchdog groups and vigilant customers and the attorneys that represent them. As we have seen in the past, it is often a combination of these groups that make the public aware of potential dangers and mobilize others to prevent such carelessness in the future.


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