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news.The FDA Science Board subcommittee has highlighted the shortfalls of FDA and the inherent dangers they pose to the American health system in its report to the US House Committee on Energy and Commerce, according to the PharmaTimes.com.
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According to Gail Cassell, vice president for scientific affairs at Eli Lilly, FDA is steeped in a plethora of inadequacies like dearth of scientists who understand new technologies, inability to speed the development of new therapies; a rudimentary import system; and a resource poor information technology infrastructure that proved to be burdensome to FDA’s programs and centers.
The recent uproar over GlaxoSmithKline’s antidiabetes drug Avandia (rosiglitazone) and the confusing and contradictory messages in the press about the safety of Merck & Co/Schering-Plough’s lipid-lowerer Vytorin (ezetimibe/simvastatin) – have raised questions about FDA’s ability to safeguard public interests.
Garret FitzGerald, director of the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania, called for the FDA to have access to a neutral testing ground where its staff can interact with experts in emerging sciences to pursue evidence that is important to clarify drug safety or efficacy, both before and drug approval. It is opined that the FDA’s budget has to be doubled and its staff has to be increased by 50% over the next two years in order to meet the needs of the healthcare sytem that is rapidly spiralling towards chaos.