FDA Defends Postmarket Drug Oversight, Amid Calls for Better Tracking

Although critics suggest that the FDA is not doing enough to monitor side effects of drugs once they are approved, the agency maintains that it has been doing a much better job monitoring potentially dangerous drugs and informing the public and health officials when a problem arises.

Last month, the FDA’s Center for Drug Evaluation and Research (CDER) released a report (PDF) highlighting the impact of a drug safety plan initiated in 2004 and the Food and Drug Administration Amendments Act of 2007, which gave the agency more authority to require post-market studies and demand label changes after drugs are approved.

The FDA pointed to dramatic increases in drug safety communications, which the agency uses to issue warnings about drug side effects and to make people aware of new label warnings.

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In 2010, the FDA issued 39 drug safety communications, but in 2011 that number almost doubled to 68 warnings.

“Our oversight of the safety of marketed drugs has changed significantly over the past few years,” said Dr. Janet Woodcock, director of CDER. ” This report shows that the quality, accountability, and timeliness of postmarket drug safety decisions have been enhanced, and our public communication of this information is more effective.”

The FDA statement was released just days before a report was released by the Institute of Medicine (IOM) of the National Academies, which found that the agency’s current approach to drug oversight after medications are approved is not sufficient and does not ensure that the benefits and risks of drugs are consistently monitored over the life cycle of the product.

The IOM evaluated the scientific and ethical aspects of conducting safety studies for approved drugs at the FDA’s request, concluding that a regulatory framework should be adopted that could help make the agency’s decision-making process more predictable, transparent and proactive.

Among recommendations include the use of a publicly available document to gather data about the drug over the entire time it is on the market. The document would describe the known side effects at the time of approval and highlight concerns that become evident as it is used by the public. It would also include all regulatory actions taken on the drug, including warnings, restrictions on use or post-marketing studies that have been ordered.

The agency has faced a lot of criticism in recent years over its heavy reliance on postmarketing data, which some say turns the entire population of the United States into guinea pigs for drugs that should have been more thoroughly vetted during the clinical trial phase before they were ever approved. In addition, it is difficult for individuals considering new drugs to gather information on emerging safety signals.

Two recent examples include the blood thinner Pradaxa and the diabetes drug Victoza.

Pradaxa was introduced in October 2010 as a potential replacement for Coumadin, also known by its generic name warfarin. Within just a couple months, reports of deaths and severe bleeding events began rolling into the FDA’s adverse event reporting system.

Coumadin has what is known as a reversal agent. If a patient begins bleeding too heavily, they can be given a dose of vitamin K to counteract the drug’s effects. Pradaxa has no reversal agent and bleeding events are much harder to stop. Recently, the FDA launched a safety investigation into the drug, but by then it was already entrenched in the market and has reportedly reached blockbuster status.

Victoza, a diabetes drug by Novo Nordisk, was approved in January 2010 by the FDA, despite two of the agency’s own safety reviewers who called for the drug’s application to be rejected. The FDA ignored its drug safety staff’s advice and approved it for the market. Since the drug was released, the FDA has added additional safety warnings for thyroid cancer, pancreatitis, kidney failure, birth malformations and hypersensitivity. There were signs of thyroid cancer and pancreas problems during pre-approval process in human and animal clinical trials.


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