Generic user fees could boost FDA inspection powers
pharmafile | August 22, 2011 | News story | Manufacturing and Production |Â Â Mylan, generics, pharma manufacturing newsÂ
Generic drugmakers have forged a tentative deal with the US government that could see user fees being used to help the FDA inspect overseas active pharmaceutical ingredient manufacturing plants.
The proposal could see almost $300 million in additional user fees funding coming into the agency, which would help extend the FDA’s currently limited inspection capacity and – the generic industry hopes – speed up approval of abbreviated new drug applications.
Generic drugs currently are used to fill more than two-thirds of all prescriptions dispensed in the US, and because the number of applications awaiting FDA action has been steadily increasing the median time for review of such applications has grown, according to the agency.
Delays in approvals are often intimately related to inspections, for example if the API used in a generic formulation is made at a facility with inadequate or no inspection history.
The lack of FDA oversight over overseas facilities has been a bone of contention for years, and last year the Government Accountability Office published a report indicating that in 2009 the agency was able to inspect just 11% of the 3,700-plus overseas facilities supplying APIs and finished drugs.
In contrast, US facilities are inspected every two years, and some generic industry executives, including Mylan chief executive Heather Bresch, have argued that overseas facilities should be held to the same standard. Mylan has also been at the forefront of generic drugmakers pushing for the introduction of a fee system.
At this year’s Generic Pharmaceutical Association (GPhA) meeting, FDA Commissioner Margaret Hamburg gave assurances that the introduction of user fees would help the agency raise its game.
“Right now, resources limit the speed with which we review establishments involved in the manufacture of generic drugs”, she said, adding that generics are the only major medical product industry in which FDA provides marketing review that doesn’t have such a programme.
“A user fee would allow us to be in these facilities on a regular inspection schedule,” she said.
Phil Taylor
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