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Biologic drug regulation examined.

As part of the overall debate on health care reform, Congress is examining the regulation of generic biologic drugs. Congress wants to lower the cost of biologic drugs for patients, but not at the cost of stifling innovation by drugmakers.

Biologic drugs are the fastest-growing and most expensive element of prescription drug costs in the United States. Brand-name biologics can cost between $48,000 and $120,000 a year. Biologic drugs are made from living organisms or in living cells and are much more structurally complex and environmentally sensitive than small-molecule pharmaceuticals. A biologic drug is often unique to the specific processes used to produce it, which makes it extremely difficult to produce an exact copy of a biologic drug. Consequently, companies have begun developing "biosimilar" drugs or follow-on biologics.

At issue in the biologics debate is the length of a data-exclusivity period for developers of a drug. Data exclusivity, which is separate from patent protection, is the protection of clinical test data that is provided to the Food and Drug Administration (FDA) for the approval process. Under the 1984 Hatch-Waxman Act, generic drug applicants are not required to duplicate the clinical testing of drugs already approved by the FDA. Applicants need to show only that the generic drug is chemically the same as the original drug and can use the clinical test data from the original drug for this process once its protections expire.

Rep. Anna Eshoo (D-CA) has introduced the Pathway for Biosimilars Act (H.R. 1548), which provides 12 years of data exclusivity to brand-name biologic drug companies. The bill has 142 cosponsors. At a July 14 House Judiciary Committee hearing, representatives from the Biotechnology Industry Organization (BIO), the National Venture Capital Association, and the American Intellectual Property Law Association backed Eshoo's bill. Witnesses testified that complexity and loopholes in the patent system require a longer data-exclusivity period as a "necessary backstop" to ensure that novel drugs are protected from competition and that innovation is encouraged. In addition, because minute differences in the structure of a biologic can sometimes cause major differences in the efficacy of the drug, BIO and other groups believe that they should not be approved without additional clinical testing.

Also present at the hearing were opponents of a long data-exclusivity period. Bruce Leicher of Momenta Pharmaceuticals testified that a longer exclusivity period will slow innovation and provide a disincentive to companies to create true generic replicas instead of mere biosimilars. Patient advocacy groups stressed that a long data-exclusivity period will hinder the creation of the generic biologic market for the creation of cheaper alternatives to name-brand drugs.

Rep. Henry Waxman (D-CA) has introduced the Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427), which calls for five years of exclusivity and is supported by the Generic Pharmaceutical Association, Consumers Union, American Association of Retired Persons, and the AFL-CIO. Waxmans bill models the current generic pathway for small-molecule drugs, which have a five-year data-exclusivity period.

In the Senate, a long data-exclusivity period has won approval from the Health, Education, Labor and Pensions Committee. The Committee voted 16-7 to approve an amendment by Sens. Orrin Hatch (R-UT) and Mike Enzi (R-WY) that would grant 12 years of exclusivity to brand-name biologics.

The Executive Branch is examining the issue as well. The Federal Trade Commission released a report concluding that a data-exclusivity period is not necessary at all. The Obama administration has announced its support for a compromise period of 7 years.
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Title Annotation:FROM THE HILL
Publication:Issues in Science and Technology
Geographic Code:1USA
Date:Sep 22, 2009
Words:578
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