Regulatory Developments

Industry Comments on Generic Drug User Proposal

March 30, 2011 PRINT

Two of the trade associations named as negotiators by the U.S. Food and Drug Administration (FDA) regarding its proposal for the imposition of generic drug user fees have filed comments regarding the proposal that may frame their negotiating posture with the Agency going forward. The Society of Chemical Manufacturers and Affiliates' (SOCMA) Bulk Pharmaceutical Task Force and the European Chemical Industry Council's (CEFIC) Fine Chemicals Group urged FDA to impose a registration fee on each foreign plant manufacturing Active Pharmaceutical Ingredients and to charge a fee for the inspection of any such plant. The comments are available online.

The associations stated that the fees collected should be used to fund additional reviewers to improve the timely response to Abbreviated New Drug Applications and supplements filed, and to make new personnel available to review, revamp, and increase the FDA inspection staff to provide for a larger number of more thorough compliance inspections. These changes would, according to the comments filed, accomplish an overriding purpose by improving public safety.

The comments filed in February came after FDA held a public meeting on September 17, 2010, to obtain input on a generic fee program described in the main as a vehicle for improving the timely review of generic drug applications. FDA provided an update on February 23, 2011, with the close of an extended comment period, and indicated that it would begin negotiation with trade associations on a generic drug user fee proposal on February 28, 2011. See "Generic Drug User Fee Stakeholder Update," available online. As referenced above, SOCMA and CEFIC were two of the three associations named as participants in the negotiations, along with the Generic Pharmaceutical Association.


 
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