Sunday, November 28, 2010

The FDA now says there is no problem with generics

About a month ago, Bloomberg News reported (here) that Dr. Janet Woodcock, head of the Food & Drug Administration’s Center for Drug Evaluation and Research has stated publicly she has ongoing concerns about the level of equivalence between generic drugs and name brand drugs on which the generics are based and about whether generics really meet quality standards. I posted a comment about this here. However, as part of a response to a state senator from New Jersey, the FDA is denying there is a problem. The senator had asked the FDA for its views on a proposed bill in the New Jersey legislature that would prevent pharmacists from switching anti-epilepsy pills over concerns that some patients have reacted poorly to generics that are deemed bioequivalent (read here). In its reply to the senator, the FDA wrote that it has many years of experience reviewing, approving and monitoring of generics and asserted that "we have not seen evidence that demonstrates a problem with therapeutic equivalence for this group of products [generic drugs].” However, it went on to say that the concerns “can not be dismissed lightly” and that out of respect and concern “that patients may lose confidence in their prescribed medications, we have sought to conduct further study.” Go to Pharmalot for the full story. In response to this, the Washington Legal Foundation again reacted with strong criticism of the FDA stating: "Either FDA felt it didn’t owe this state senator any information about impending studies, or nothing in fact is pending. In denying the existence of any problems with any generic drugs and stressing that there is no doubt at the agency, FDA seems to betray its extreme sensitivity to scrutiny of its generic drug approvals. FDA’s own senior leadership has called the Office of Generic Drugs on the carpet for public concern over generic quality, and the agency has been strongly challenged recently over its sudden alterations of bioequivalence criteria for generic versions of complex medicines including extended-release products and locally acting drugs. The bureaucratic hubris FDA exhibits on bioequivalence is irresponsible and unhealthy, given the dire potential consequences of breakthrough seizures if a generic [Anti Epileptic Drug] is ineffective, or if a copycat locally acting anti-bacterial medicine fails to stop an infection. FDA certainly doesn’t feel accountable for any of this to a state senator who represents epilepsy sufferers. Nor is the agency in any hurry to be accountable to Congress on concerns over epilepsy drugs – FDA is almost two months overdue with a report federal elected officials sought on generic AED bioequivalence standards . . ." Go here for the WLF's full comment. For more go to the FDA law blog.

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