FDA to step up postmarketing activities

By Kirsty Barnes

- Last updated on GMT

Related tags: Drug safety, Food and drug administration

The US Food and Drug Administration (FDA) has outlined a new draft
plan designed to better enable it to flex its postmarketing muscle
which will significantly increase the number of employees that
focus on drug safety issues and post-market product surveillance .

The agency said it would implement the plan over the next year and into 2009, so that it can "better support and strengthen its postmarket safety activities​." Under the plan, titled: "Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan," staff levels of safety evaluators, epidemiologists, risk management experts, medication error experts, and regulatory project managers are all earmarked to rise. To enable its "enhancement and modernisation of the drug safety system​", the FDA said it will use additional Prescription Drug User Fees Act fees (PDUFA) IV fee revenues over a period of five years, to the tune of around $30m a year plus allowances for inflation. As part of the proposed plan, the agency´s Center for Drug Evaluation and Research (CDER) will be expanding its Office of Surveillance and Epidemiology (OSE), which is responsible for monitoring postmarket adverse event data, developing, reviewing and analysing observational pharmacoepidemiologic study protocols and results; providing risk management advice; and medication error analysis and prevention activities. Similarly, the watchdog's Center for Biologics Evaluation and Research (CBER) will be increasing the staff in the Office of Biostatistics and Epidemiology for safety activities and will also be taking steps to address issues surrounding pharmacovigilance plans for postmarketing safety studies involving vaccines, biologics, tissues and blood products. The FDA has been investigating ways of boosting its surveilance of new drug post marketing commitment studies in the wake of ongoing controversy over the agency's lack of enforcement. Two years ago, an FDA report showed that 65 per cent of the 1231 postmarketing safety studies, that pharma companies had agreed to conduct as a condition of approval of a drug, were not being completed, or were still classed as "pending​". 19 per cent were considered "ongoing​" and 2 per cent were "delayed​." Meanwhile, all the drugs in question were still being sold in the market. In September last year, an article was also published in the journal Archives of Internal Medicine suggesting the existing post-marketing safety system "is not adequately protecting patients"​ following findings that claimed serious adverse drug events had more than doubled in an eight year period to 2005, many of which were new and unexpected. Meanwhile, instances such as Merck's Vioxx (rofecoxib) episode in 2004 and the more recent Avandia (rosiglitazone) setback, where GlaxoSmithKline's diabetes blockbuster was found to increase the risk of heart problems, have left a shadow over the agency over its dealing of the incidents.

Related topics: Clinical Development

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