FDA Head Cool to Import| of Cheaper Foreign Drugs

     WASHINGTON (CN) – The head of the Food and Drug Administration resisted calls by Democratic senators Tuesday to allow cheaper foreign drugs to compete in the American market, but said she is open to a Republican proposal to ease regulation on certain U.S. drugs.




     Democratic Sen. Herb Kohl of Wisconsin said, “We’re paying double and triple and quadruple the prices that other people are paying around the world.”
     Americans pay more than twice as much per person as other developed nations for health care, and the high cost of prescription drugs in the United States has been blamed as a contributing cause.
     FDA Commissioner Margaret Hamburg testified before the Senate Agricultural Appropriations Subcommittee chaired by Kohl. When he asked if one of her missions is to lower drug prices, Hamburg avoided a direct answer.
     “Our mission is to provide Americans with access to safe and effective drugs,” Hamburg replied, and said that safety is often compromised when drugs are bought from abroad, where the agency can’t observe the manufacturing methods.
     Kohl asked whether “powerful political interests and lobbying interests” are keeping the U.S. market from opening its doors to foreign drugs.
     But Hamburg said there are other reasons for the restrictions. She said that even drugs sold under the same name can vary in formula and dose size, especially in a world where counterfeit drugs sold over the Internet is a growing problem.
     North Dakota Democrat Byron Dorgan asked about supposedly identical drugs, pointing to the anti-cholesterol drug Lipitor, which is also manufactured in Ireland. He said the same drug is sold in the United States for three times its cost in other countries. “Why should [Americans] not have access to that FDA-approved drug?” he asked.
     But Hamburg maintained that even these supposedly identical drugs can vary.
     Hamburg did say, however, that the agency diverts about $5 million each year to develop an import strategy for foreign food and drugs, and that the agency has opened foreign offices in countries like China, India, Mexico and Italy, where the European food safety industry is located.
     The agency, which recently extended its reach to tobacco products, has benefited from a string of budget increases. The fiscal year 2011 budget proposal is set at $4 billion, a $789 million increase from this year.
     But the proposed growth is only half the growth that was seen in the 2010 budget.
     Ranking Member Sam Brownback, a Kansas senator, focused on reducing laws regulating U.S. drug companies. He said there should be a second, less stringent category for drugs that could treat patients with few alternatives.
     The $800 million to $1.7 billion cost of developing a drug means it is not cost-effective for pharmaceutical companies to focus on rare diseases, Sen. Brownback said. And of the roughly 7,000 rare diseases affecting 30 million Americans, treatments have been developed for only 200.
     “We develop very few products for them,” Brownback said.
     Hamburg thanked Brownback for his input and said the agency would be interested in looking into it.

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