Thursday, July 16, 2009

Obama offers 7-year protection for biotech drugs

The Obama administration said biogeneric drugs should be protected from competition for seven years.

The biopharmaceutical industry has argued that the five years of protection offered by Waxman in H.R. 1427 would stifle innovation. But the Federal Trade Commission in a report earlier this month said the 12 to 14 years that the industry has said publicly that it wants also would hurt innovation and delay patients’ access to cheaper drugs.

Eshoo’s H.R. 1548 calls for a 12-year period of data exclusivity, basically protecting the patents covering innovative biotech therapies.

In a letter to Waxman, Nancy-Ann DeParle, Obama’s health-care reform director, and budget director Peter Orszag said “the seven-year policy in the FY 2010 Budget is a generous compromise between what the FTC research has concluded and what the pharmaceutical industry has advocated.”

The Biotechnology Industry Organization, however, said it is “extremely concerned” that the seven-year plan is “a risky shortcut to biosimilars.”

“We believe this abbreviated period will undermine the incentives necessary for continued biotech research into breakthrough medicines and cures for diseases such as cancer, multiple sclerosis, Alzheimer’s and HIV/AIDS as well as unmet medical needs,” BIO President and CEO Jim Greenwood said in a statement.

Besides patent exclusivity, the industry has argued that drugs like those developed by South San Francisco’s Genentech and other biotech companies can’t be copied like pharmaceutical drugs because they are complex to make and the finished products can differ.

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