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Obama administration rejects long exclusivity periods for biotech drugs


WASHINGTON The Obama administration gave a boost to the generic drug industry Wednesday with a letter to Rep. Henry Waxman, D-Calif., rejecting calls by the biotech and pharmaceutical industries for guarantees of long market-exclusivity periods in biosimilars legislation.

The letter cited a recent Federal Trade Commission report saying that market exclusivity periods of 12 to 14 years were unnecessary to ensure innovation and competition, and that seven years would suffice. Signed by Office of Health Reform director Nancy-Ann DeParle and Office of Management and Budget director Peter Orszag, the letter was a response to Waxman’s June 8 letter responding to proposals for a regulatory approval pathway for biosimilars in the administration’s fiscal year 2010 budget.

The generic drug industry has welcomed the letter. “As Congress debates healthcare reform, the White House has sent a strong signal to members that it is critical to ensure that affordable, life-saving biogeneric medicines get to patients in need sooner rather than later,” Generic Pharmaceutical Association president and CEO Kathleen Jaeger stated. “In citing the recent FTC report on biogenerics, the president rejects attempts by the pharmaceutical and biotech industries to needlessly extend market exclusivity provisions to an unprecedented period of 12 to 14 years simply to maintain their monopolies on biopharmaceutical products.”

Meanwhile, the organization representing the biotech industry criticized the letter, calling seven years’ market exclusivity a “risky short cut” to biosimilars. “As we have consistently said, any pathway to biosimilars should provide a fair period of time for innovators to protect their proprietary data from competitors in order to promote the continued development of breakthrough medicines, therapies and cures,” Biotechnology Industry Organization president and CEO Jim Greenwood said. “We continue to believe that 14 years of data exclusivity will strike the appropriate, reasonable and fair balance between our common desire to expand access to breakthrough biotech medicines and the need to preserve the protections necessary to promote further biomedical advances.”

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