(article) Obstacles to Genereic Drugs Criticized

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source:http://www.washingtonpost.com/wp-dyn...041801589.html

Drugmakers' Control of Branded Product Affects Possible Savings


By Marc Kaufman
Washington Post Staff Writer
Wednesday, April 19, 2006; Page A06
The brand-name drug industry is aggressively working to keep blockbuster drugs widely used by the elderly from being sold in cheaper generic versions when their patents expire, the organization that represents pharmacy benefit managers said yesterday.
With an unprecedented number of top-selling drugs scheduled to go off patent within five years, the organization said, branded drug companies are constructing roadblocks to potential savings of $23 billion to seniors and the Medicare system.
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<SCRIPT>setTimeout('update_delicious_form(deliciou s_cookie)',1)</SCRIPT></TD></TR></TBODY></TABLE>"There's an agenda to prevent generics from getting to the market as soon as they could," said Mark Merritt, president of the Pharmaceutical Care Management Association, which conducted the study. The association represents companies that administer prescription drug plans for employers and government programs.
"If they succeed," Merritt said, brand-name drug companies "could reduce the savings significantly."
Ken Johnson, senior vice president for the Pharmaceutical Research and Manufacturers of America, disputed the charge and pointed to the high rate of generic drug usage in the United States as proof that branded companies are not keeping generics off the market. More than 53percent of prescriptions are filled with generic drugs.
"It would be more useful for the Pharmaceutical Care Association to collaborate with physicians and others in the health-care system to help achieve the highest quality of care for patients, and this includes use of new medicines which play a critical role in saving lives and reducing overall health costs," Johnson said.
Merritt's association identified 14 drugs commonly used by older people that are set to go off patent by 2010.
Four of them -- the cholesterol drugs Zocor and Pravachol, the antidepressant Zoloft and the prostate medication Proscar -- would together save Medicare $13 billion if generic competitors come on the market as scheduled, the report said.
Merritt said efforts by the branded companies to keep generics from the market have become more aggressive.
"We're seeing it in the legislative arena and in terms of general litigation" to keep patents in force, he said. "Many of the branded companies have pretty empty pipelines, with few big blockbusters on the horizon. So they're fighting to keep their current big sellers free of competition."
Under federal legislation passed in 1984, drugmakers have 20 years after discovery of a drug to sell it exclusively. Many of those years can be taken up in development and review by the Food and Drug Administration, however, so some drug companies are lobbying for longer patent exclusivity.
Even though more than 53 percent of U.S. prescriptions are filled with generics, they make up only about 12 percent of the $250 billion a year in drug spending because the price of a drug generally plummets after a generic version is approved. Makers of generic drugs have to prove to the FDA that their products are "bioequivalent" to the brand-name product.
IMS Health, a company that tracks the industry, predicts that the percentage will exceed 65 percent within four years if the blockbuster drugs with expiring patents do get generic competition.
Much of the friction between the branded and generic drug industries is playing out in Congress and state legislatures amid competing proposals to make it either easier, or more difficult, to bring generic drugs to market. For instance, Sens. Trent Lott (R-Miss.) and Debbie Stabenow (D-Mich.) have introduced a bill that would speed the approval of new generics, and a number of states have bills that would require Medicaid and some other programs to prescribe them.
The branded drug industry has generally fought those proposals and also has faced increasingly stiff opposition from major corporations such as General Motors Corp. and Caterpillar Inc. looking to slow the rise in employee health-care costs.
"We must encourage Congress to continue to take steps to promote generic utilization and the savings that will result," said Kathleen Jaeger, head of the Generic Pharmaceutical Association.
She called for formalizing regulations to allow for generic versions of complex drugs created through biotechnology, keeping branded companies from undermining generic competition with "authorized generics," and making sure that the FDA's Office of Generic Drugs gets more funding to tackle its backlog of more than 800 applications.