FDA plans to spend $5.7 million in fiscal 2011 to develop drug review standards and make other preparations for an approval pathway for follow-on biologics.

The money will enable the agency "to maximize program readiness" for reviewing biosimilar applications when they come in, FDA says in supporting documentation for the FY '11 budget proposed by President Barack Obama Feb. 1.

By putting money for biosimilars in the budget now, FDA anticipates being ready to launch a program when FOB legislation is enacted, Assistant Commissioner for the Budget Patrick McGarey explained during a press briefing on the proposed $4.03 billion FDA spending plan for the fiscal year that begins Oct. 1. That figure represents a 23 percent increase over the agency's current $3.28 billion budget.

The biosimilars initiative involves development of regulatory policy to clarify agency expectations and requirements for biosimilar applications, as well as acquisition of needed equipment and the hiring and training of scientific and review staff.

Should biosimilars legislation fail to pass this year as part of a revived health care reform measure or stand-alone bill and get pushed into the next Congress, FDA's preparations could put the agency in a better position to consider existing mechanisms for approving follow-ons.

The Obama administration supports shorter brand exclusivity than the maximum 12.5 years included in the follow-on biologics provisions that cleared the House and Senate. Having FDA move forward with developing a pathway in the absence of a legislative framework would seem to give the President more leverage should FOBs be taken up by Congress again.

The $5.7 million biosimilars funding includes $2 million in federal money and $3.7 million from user fee carry-over balances. At least four full-time equivalent employees would be added as part of the effort.

FDA Continues Quest For Generic Drug User Fees

Generic drug user fees are again on the FDA wish list, at a level of $38 million. The administration requested $36 million in generic fees for fiscal 2009, but Congress failed to make the authorization.

Regardless of the generic user fees' fate in Congress this time around, FDA plans to spend $88.5 million on the generic drug review process - $81 million at CDER and $7.5 million for field activities.

If the fees are authorized, the $38 million would pay for an additional 73 full-time equivalent employees to review generic drug applications and six inspectors for manufacturing facilities.

Generic Pharmaceutical Association CEO Kathleen Jaeger iterated the group's interest in working with the administration "to develop a meaningful program with measurable results," in Feb. 1 comments on the budget.

FDA projects that the measurable results by the end of the first five years of the user fee program would be: a complete review and response for an estimated 80 percent of applications within 12 months of receipt, with the exception of applications excluded because of exclusivity or challenges.

For fiscal 2010, Senate appropriators recommended that the agency spend $93 million on its generic drugs program and that any user fees be an add-on to that figure (¹ Also see "FDA Appropriations In Senate: Money For Generics; Worry About Tobacco" - Pink Sheet, 13 July, 2009.). The CDER funds include $51.5 million for the Office of Generic Drugs.

A Multi-Faceted Budget

Elsewhere in the FDA budget, funding for human drug activities would rise to $1 billion. This includes $412 million for new drug reviews, with another $34 billion for field operations for manufacturing and clinical trial inspections and data verification.

The generic user fees are included in the budget as part of the Protecting Patients Initiative, funded at $100.8 million. This program extends across the medical products arena, providing funds to improve the safety of drugs, devices, vaccines and the blood supply (see ² Also see "FDA Budget Enhances Safety Programs, But Relies On Theoretical User Fees" - Pink Sheet, 8 February, 2010.). Another proposed $25 million increase in agency funding would advance regulatory science through strengthening the agency's scientific capacity (see ³ Also see "FDA Regulatory Science Infrastructure Gets $25 Million Push In Budget" - Pink Sheet, 8 February, 2010.).

- Cathy Dombrowski ( ⁴ c.dombrowski@elsevier.com)

FDA Biosimilars Program Gets Seed Money In Administration's FY '11 Budget

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