Thursday, July 16, 2009
US Senate Committee Approves 12-yr Exclusivity for Biologics
WASHINGTON (AP) — Senators agreed Monday to give high-tech biologic drugs 12 years of market protection before generic versions can compete.
The vote in the Senate Health, Education, Labor and Pensions Committee was a victory for the biotechnology and pharmaceutical industries but a defeat for the Obama administration and AARP.
The Obama administration had pushed for a seven-year exclusivity period so that patients could get quicker access to cheaper versions of costly medicines used to treat ailments including cancer, Parkinson's, diabetes and rheumatoid arthritis.
Proponents of the longer time frame say products like the blockbuster cancer drug Avastin deserve longer market protection because they are more expensive and time-consuming to produce than regular drugs, and the extra time and money is needed to attract investors and promote innovation.
The vote came as the health committee worked to complete a sweeping health overhaul bill it expects to finish Tuesday. The biotech drug portion was a major unresolved issue, but Monday's action doesn't mean it's over. The decision would still need agreement from the full Senate and the House, where Energy and Commerce Committee Chairman Henry Waxman, D-Calif., strongly supporters a shorter exclusivity period.
Biotech drugs currently don't face generic competition because the Food and Drug Administration doesn't have power to approve copies of such medications. Efforts to change that have been held up for nearly a decade by squabbling between the biotech and generic drug industries and their allies on Capitol Hill.
Biotech companies had demanded at least 14 years on the market before their products face generic competition, but the drug industry welcomed Tuesday's vote.
"The overwhelming majority of senators on the committee voted to do what's best in the end for patients and the U.S. economy," said Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America. "Our companies in return remain committed to developing the cutting-edge medicines which allow patients everywhere to live longer, healthier and more productive lives."
The powerful senior citizens' lobby AARP expressed disappointment, suggesting it might oppose the underlying bill over the issue.
"While we applaud many of the aspects of the HELP Committee's overall bill, AARP has great difficulty supporting legislation that would delay the availability of safe, affordable generic biologic drugs and impede consumer access to these lifesaving drugs," said Jim Dau, AARP national spokesman.
The health committee voted 16 to 7 in favor of the 12-year measure offered by Sens. Mike Enzi, Orrin Hatch and Kay Hagan. It's the time period previously endorsed by committee Chairman Edward M. Kennedy, whose home state of Massachusetts is a biotech stronghold. Kennedy is away from the Senate while being treated for brain cancer.
By a 5 to 17 vote the committee rejected an alternate measure by Sen. Sherrod Brown, D-Ohio, that would have started with a seven-year exclusivity period, with additional years possible for innovations.
Biotech drugs were not included in the 1984 law that first allowed the FDA to approve copies of traditional, chemical drugs. At the time the biotech industry successfully argued that their drugs, which are made from living cells, were too complex to be duplicated by generic competitors.
By ERICA WERNER
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