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Institute of Medicine Criticizes FDA for Unsafe Post-Market Inspection

August 8, 2012

Do you remember Vioxx, the anti-inflammatory drug recalled and later withdrawn because it was linked with elevated risk of heart attack or Fen-phen, the weight loss drug that was found to cause potentially fatal pulmonary hypertension? These medications were once approved by the Food and Drug Administration (FDA) and later found to be dangerous and thus recalled. Spurred on by these cases and those of similar drugs, the FDA called for a study of their own drug oversight system.

A report published by the FDA in May 2012 found that their safety nets have been working better in recent years. They have caught more problems and issued double the number of “drug safety communications” (short warnings released to the public about a given product) to 68 in 2011 as compared to 39 in 2010. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said, “Our oversight of the safety of marketed drugs has changed significantly over the past few years. This report shows that the quality, accountability, and timeliness of post-market drug safety decisions have been enhanced, and our public communication of this information is more effective.”

But another report, this one published by the independent non-governmental Institute of Medicine, disagrees. Researchers agree that the FDA has been more proactive in recent years with regard to monitoring drugs that have already been approved, but they call for a more thorough and transparent system. The idea behind this is that drugs have to go through a vetting and testing period, but it is impossible to model the long-term effects among the massive diversity of populations present in the entire country in a brief, small-sample clinical trial. The report reads:

“One of the committee’s key recommendations is that FDA should create a benefit and risk assessment and management plan for each drug. This would be a single, comprehensive, publicly available document that serves as a central repository of information for each product from its approval throughout its entire time on the market. The document should include a description of any safety questions that exist when a drug is approved or that emerge over the course of the product’s use, as well as benefit and risk assessments specific to these questions. It should also include details on regulatory actions taken on the medication, such as restrictions on its use or the decision to require further research, as well as the results of these actions.”

The Institute of Medicine’s report also discusses the fact that as more and more people take prescription drugs (currently 48 percent of Americans take at least one prescription drug daily), the number of drugs available will continue to rise; their entire life cycle must be monitored closely.

The researchers conclude: “The FDA’s current approach to drug oversight in the post-marketing setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over a drug’s life cycle. Adopting a regulatory framework that is standardized across all drugs, yet flexible enough to adapt to regulatory decisions of differing complexity, could help make the agency’s decision making process more predictable, transparent, and proactive, allowing the FDA to better anticipate post-approval research needs and improving drug safety for all Americans.”


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