FDA's Office of Generic Drugs expects to receive 806 abbreviated new drug applications in fiscal year 2005, representing a 43% increase over the 563 received in FY 2004.

FDA received 505 ANDA submissions in the Oct. 1 to April 30 period, nearly as many as the entire FY 2004.

One key reason for the significant up-tick is the increased number of applications submitted by firms which have never before filed ANDAs. These firms tend to be small and based outside the U.S., many located in India.

The increase in submissions has yet to affect approval times for ANDAs. The agency still reviews applications in roughly 16 months, down from 17 months in FY 2003.

The impact of the up-tick may not be felt fully for some time. The office is still reviewing applications submitted over the last two years.

OGD is continuing to increase its staff in anticipation of the regulatory challenge ahead; however, current department policy has taken the hiring responsibility out of the Center for Drug Evaluation & Research and placed it within HHS, potentially slowing down the process.

The office could also face budget roadblocks in increasing its capacity because annual resource amounts are based on past trends.

FDA's FY 2006 budget proposes a cut in positions at CDER outside its user fee and drug safety functions. OGD is currently not supported by user fees (¹ Also see "Drug Safety Funding Boost Means Cuts Elsewhere In CDER" - Pink Sheet, 14 February, 2005., p. 5).

Generic Pharmaceutical Association CEO Kathleen Jaeger said recently that the group will seek input from its members on whether GPhA should support the creation of user fees for ANDA reviews. In the past, the group has not supported user fees for generic drug applications.

At a May 18 House Energy & Commerce/Health Subcommittee hearing, Jaeger was asked by Chairman Nathan Deal (R-Ga.) if the association would be in favor of user fees.

"As we go forward I think our industry could certainly consider that plot again," Jaeger replied. "We can have our industry look at that and get back to you."

"In the past, [user fees] didn't make much sense because there were so many loopholes in the Hatch/Waxman model that even if our industry did pay a user fee, the applications were going to languish there because of all of the loopholes that the brand industry could utilize to delay the generics applications," Jaeger maintained.

Provisions in the Medicare Modernization Act removed some of the "loopholes," including limiting of 30-month stays on approvals to one per ANDA based on patents filed before the generic application.

Jaeger also said that another reason for extended ANDA review times is the "needlessly protracted legal and scientific consults" that add months or years to review times, due to "lack of sufficient oversight and accountability at the commissioner and center levels."

ANDA submissions are subject to FDA legal scrutiny if a citizen petition is filed for the product. OGD has recently seen an increase in citizen petitions filed for ANDAs.

The generic drug industry has long urged action by FDA or Congress to prevent "abuse" of the citizen petition process, arguing that brand name companies use eleventh-hour petitions as a de facto patent extension to delay generic drug approvals (² Also see "FDA Re-Examining Citizen Petition Process To Speed Generic Approvals" - Pink Sheet, 7 March, 2005., p. 34).

CDER Acting Director Steve Galson said earlier in the year that FDA would take another look at its citizen petition review process in an attempt to expedite decisions on generic drug applications.

FDA proposed regulations in 1999 to limit the filing of "frivolous" petitions; however, the rule was withdrawn in 2003 based on concerns about the agency's ability to limit use of the petition process, and on the agency's belief that response times had improved considerably (³ Also see "Citizen Petition Proposed Rule Withdrawn; FDA Cites Improved Response Rate" - Pink Sheet, 7 April, 2003., p. 28).

FDA Expecting 43% Increase In ANDA Submissions For FY 2005

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