Coalition Releases Letter In Support Of Follow-On Biologics

Main Category: Pharma Industry / Biotech Industry
Also Included In: Biology / Biochemistry;  Regulatory Affairs / Drug Approvals
Article Date: 11 Apr 2008 - 12:00 PDT

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The Coalition for a Competitive Pharmaceutical Market has been gathering signatures for a so-called "mega-letter" in support of legislation that would allow FDA to approve follow-on biologics, CongressDaily reports. The coalition includes AARP, the AFL-CIO, Blue Cross Blue Shield and General Motors. A draft letter states, "We believe that any workable pathway for biogenerics should be science-driven and prioritize patient safety," adding, "Failure to do so allows for the unacceptable continuation of monopoly pricing for biotech products." The draft letter includes a seven-point wish list that the coalition believes the legislation should consider. Follow-on biologic advocates support legislation (HR 1038) by House Committee on Oversight and Government Reform Chair Henry Waxman (D-Calif.) that would not provide brand-name biologics an exclusivity period. Last year, the coalition sent similar letters to senators when the Senate Health, Education, Labor and Pensions Committee was working to pass follow-on biologics legislation.

The Biotechnology Industry Organization and supporters of follow-on biologics "have sparred over many aspects of what the legislation should entail," with the majority of the focus on whether FDA should be allowed to deem follow-on biologics interchangeable with brand-name counterparts at the pharmacy counter without physician consent, as well as how long brand-name products should be able to retain exclusivity before a follow-on can be approved. BIO believes biologics are too complex to allow pharmacists to substitute them for brand-name treatments, while supporters believe FDA should be able to deem follow-on biologics interchangeable on a case-by-case basis.

BIO has drafted its own letter supporting a follow-on biologics bill (HR 5629) proposed by Rep. Anna Eshoo (D-Calif.) and House Energy and Commerce ranking member Joe Barton (R-Texas). According to BIO's draft letter, the legislation's approach "provides a degree of patient protection." The legislation would provide 12 years of market exclusivity, which could be increased to 14 1/2 years (Edney, CongressDaily, 4/10).

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