FDA Issues Draft Guidelines For Monitoring Drug Side Effects, Risks After Approval

Federal regulators are proposing new best practices for monitoring the side effects of drugs after they hit the market, in yet another effort to make prescription medications safer for patients. 

The FDA issued a draft guidance on November 6, proposing guidelines drug postmarketing surveillance, which are directed at staff and officials of the agency.

The guidance focuses on surveillance and risk evaluation for drugs during the postmarket stage, once medications are already on the market. This involves combing adverse event reports and manufacturer reports for signs of problems with drugs that were not detected during their clinical trials.

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The FDA receives more than 2 million adverse event reports each year related to postmarket surveillance and risk evaluation, highlighting the need for better surveillance, officials say.

However, in a press release, the FDA claims the draft guidance also eliminates some redundancies in the postmarket surveillance process which were put in place as a result of the 21st Century Cures Act.

The Cures Act, implemented in 2016, requires the FDA to conduct a summary analysis of side effects received for a drug 18 months after approval, or after 10,000 individuals have used the drug.

At the time, critics claimed the Cures Act actually weakened the FDA’s protection of the drug supply in favor of kowtowing to industry and making it easier for dangerous drugs to get approved. Many indicated the pre-market approval process needed to be strengthened instead, saying postmarket surveillance is the equivalent of using the public as guinea pigs for unproven drugs.

According to the FDA, a 2016 analysis indicated the surveillance of some drugs already for sale is redundant to other surveillance practices of the agency. The FDA indicates this is not an efficient use of resources, because some drugs and biologics for rare diseases never meet the 10,000 individual use threshold.

Instead, the guidance outlines how the agency will use surveillance data to identify safety concerns and recommend actions to improve product safety and protect the public.

Critics are likely to see the move as a weakening of the agency’s postmarket surveillance rules.

The guidance also outlines the approach to timely postmarket analyses of drugs and biologics, includes an overview of tools, methods, and signal detection and evaluation activities for surveillance.

The FDA has come under fire in the past and was criticized for not doing enough to monitor drug side effects once the drug has been approved to go to market. In 2012, the FDA issued data detailing the impact of a drug safety plan, which the agency says increased drug safety communications and lead to more warnings.

In 2015 the FDA issued a plan for postmarket monitoring of medical devices after implantation. The plan laid out details on how to make that process safer for patients who need medical devices implanted to improve their health.

“Our best practices document incorporates the guiding principle that postmarket safety surveillance is a dynamic and constantly evolving field,” wrote Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research. “By using a risk-based approach, the FDA takes into account the nature of the drug, its potential adverse events, the intended population, and the potential for serious outcomes, as well as the impact on individuals and the overall potential impact on the health of the public.”


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