Many Required Post-Marketing Studies for Drugs are Never Started: Report

A new study suggests that pharmaceutical companies often fail to conduct required studies to examine the safety and potential side effects of their drugs after they hit the market, and when they do start the research it is often never completed.

Serious questions about the drug industry’s commitments to conduct post-marketing studies were raised in by research letter published in the Journal of the American Medical Association (JAMA) on July 10, which found that more than 40% of studies required by federal regulators have not even been started, leaving the FDA, doctors and patients in the dark about whether those medications are actually safe.

The study also indicated that the rate of completion for post-marketing studies that the companies actual start is extremely low. In 2011, only 12% of studies had been completed, a “jump” from the under 7% that had been completed in 2007. The trend for completion has improved since 2007, however the rate of completion still leaves more than 85% unfinished.

Serious side effects associated with prescription drugs are often not discovered until after a medication has been approved and is available on the market, which highlight the importance of drug makers continuing to follow up with studies once the medications are being used by thousands or even millions of people. Until 2007, such studies were voluntary.

Congress Told FDA to Require Post-Marketing Studies in 2007

A 2006 report from the Office of Inspector General found that drug companies were seriously deficient in completing post-marketing studies and indicated that the FDA lacked the authority to enforce completion. Congress passed the FDA Amendments Act (FDAAA) in 2007, which required post-marketing studies as part of the drug approval process, and offered the FDA more latitude in mandating compliance with completing the studies.

G. Caleb Alexander, MD, and his team of researchers from Johns Hopkins University found only 56% of required studies had gotten underway in 2007. By 2011, only 43% of those studies were started.

The report also revealed that more than 13% of studies, approximately 241, had been delayed in 2011. This was an increase from 2007, where nearly 7% had been delayed. Now, nearly one in eight studies has been delayed.

The Institute of Medicine questioned the FDA’s role in ensuring post-marketing studies were being completed. Regardless of completion rates, with 40% of required studies still waiting to be started, the FDA is lacking in enforcement.

Critics have suggested that the FDA is failing to crack down on pharmaceutical companies, which are flaunting compliance with post-marketing study requirements, noting that issuing warning letters, initiating litigation for “significant failures,” and conducting seizures and injunctions are all within the FDA’s legal power.