FDA to make safety reviews public
pharmafile | June 16, 2010 | News story | Research and Development, Sales and Marketing | FDA, drug safety
The US medicines regulator is to make safety reviews of recently approved prescription medicines more readily available to the public.
Summaries of FDA safety analyses on recently approved products will now be periodically prepared and posted on its website, along with a brief discussion of any related safety measures.
The director of the FDA’s Office of Surveillance and Epidemiology Gerald Dal Pan said the ”systematic, comprehensive, safety reviews” would provide an early detection mechanism for potentially serious risks.
The regulator is already obliged to carry out strict post-marketing checks as set out by the Food and Drug Administration Amendments Act (FDAAA), a new law passed in 2007.
The legislation was introduced in response to the withdrawal of painkiller Vioxx in 2003, after post-marketing studies revealed it significantly increased the risk of heart attacks and strokes, and could have been responsible for hundreds of deaths.
The FDA has already stepped up its post-marketing surveillance, but the new announcement gives the process a dedicated channel for consumers and doctors to visit.
The has committed to preparing safety summaries within 18 months after a product’s approval or after it has been used by 10,000 patients, whichever comes later.
“These summaries will provide clear and useful information in a timely manner that can be used by providers and patients to make informed decisions about an individual’s health,” said Robert Ball, director of the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research.
Andrew McConaghie
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