FDA Plans for Generic Drug User Fees, More Foreign Inspections
The Food and Drug Administration is announcing a December 19, 2011 public meeting and seeking comments on proposed recommendations it has developed with the regulated community toward a draft Generic Drug User Fee Act. The draft legislation would authorize FDA to collect user fees related to human generic drugs and use them for the human generic drug application review process and associated submissions, to conduct related inspections (particularly of foreign manufacturers), and to engage in other related activities for fiscal years 2013-2017.
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(According to FDA, generic drugs currently are used to fill more than two-thirds of all prescriptions dispensed in the U.S., and they provide important cost-effective alternatives to consumers. Due to the increase in applications awaiting FDA action, the median time for review of such applications has grown. FDA believes the supplementary revenues from generic drug user fees would allow the Agency to review generic drug applications in a timely manner and provide flexibility, adequacy, and predictability in the funding of FDA's review of generic drug applications.)
Holding Dec 19 Meeting on Proposal, Seeking Written Comments by Jan 6
In the interest of transparency, FDA is publishing the negotiated recommendations, holding a December 19, 2011 meeting at which the public may present its views, and seeking written comments by January 6, 2012. Registration is required to attend or present at the public meeting, which will also be webcast live here. Further information on the meeting, including the January 6, 2012 date for comments available here.
Fees on Generic Drug Submissions & Facilities Would Raise $299M Annually
If enacted as negotiated, the program would provide FDA with additional funding of $299 million per year by deriving fees from two primary sources: generic drug-related submissions and generic drug-related facilities.1
Would Use Fees to Act Faster on Generic Drug Applications, Increase Inspections
With those additional user fee funds, FDA would agree to undertake a series of immediate program enhancements and performance goals including, but not limited to:
- By fifth year, act on applications w/in 10 months - application metrics that increase to an eventual year 5 goal of FDA reviewing and acting on 90 percent of complete electronic abbreviated new drug applications (ANDAs) for generic drugs within 10 months after the date of submission;
- Address backlog. - backlog metrics of FDA reviewing and acting on 90 percent of all ANDAs, ANDA amendments, and ANDA prior approval supplements pending on October 1, 2012, by the end of FY 2017; and
- Increase inspections of foreign generic mnfrs, etc. - conduct current good manufacturing practice (CGMP) inspection metrics under which FDA will conduct risk-adjusted biennial CGMP inspections of generic active pharmaceutical ingredient (API) and generic finished dosage form (FDF) manufacturers with the goal of achieving parity of inspection frequency between foreign and domestic firms in FY 2017.
1The generic drug-related submission fees would include fees for abbreviated new drug applications (ANDAs) and prior approval supplements, as well as for certain Drug Master Files (DMFs), for first reference only, as DMFs may be referenced multiple times by different sponsors. The facility fees would include fees for facilities that manufacture active pharmaceutical ingredients (APIs) for generic drugs as well as facilities that manufacture generic finished dosage forms (FDFs). In the first year of the program, there would also be a fee assessed for applications that are pending on October 1, 2012, the so-called “backlog.”
(See ITT’s Online Archives 11022358 for summary of an FDA official urging negotiation of a generic drug industry user fee program.
See ITT’s Online Archives 11101817 for summary of business organization support during a Senate hearing for more foreign inspections, a generic drug user fee to fund some of this work, the disclosure of actual manufacturing sites by foreign ingredient suppliers, etc.)
Additional FDA information on possible generic drug user fees available here.
FDA contact - Mari Long (301) 796-7574
(FR Pub 12/08/11, D/N FDA-2010-N-0381)