WASHINGTON (AP) – As the Obama administration renews its health care reform effort on Capitol Hill, a top Democrat is calling for speedy action on a yearslong effort to create generic competition for costly biotech drugs.
President Barack Obama used his weekly radio address on Saturday to call on Congress to act on his proposal to overhaul the nation’s health care system.
In a letter Monday, Rep. Henry Waxman, D-Calif., reminded the president of his stated commitment to lower the price of biotech drugs, high-tech injectable medications that cost more than $40 billion per year.
Biotech drugs 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 disagreements between the biotech and generic drug industries and their respective allies on Capitol Hill.
Biotech drugs from companies like Amgen Inc. and Genentech can easily cost more than $1,000 a month.
Waxman asked the White House whether the FDA might be able to approve some low-cost versions of biotech drugs even before legislation passes.
“I urge the administration to consider what steps can be taken under existing authority to prepare and even begin to use a pathway for generic biologics,” said Waxman, who chairs the powerful Energy and Commerce Committee.
The Federal Trade Commission is scheduled to issue its report later this week on the competitive impact of a pathway for generic biotech drugs.
Much of the delay over generic biotechs has revolved around how much competition-free marketing the original drugs should get before cheaper versions can launch.
The biotechnology industry has called for up to 14 years of exclusivity for their drugs before a copy can be introduced. But a bill from Waxman mirrors the current system for traditional drugs, which allows for five years of market exclusivity for new drugs.
The administration’s fiscal 2010 budget proposed seven years of exclusivity for the original drugmakers.
Biotech and pharmaceutical industry groups have warned that a shortened exclusivity period could discourage companies from investing in drug development, jeopardizing new medicines.
“The Biotechnology Industry Organization continues to support strongly the development of a pathway for the review and approval of biosimilars … (but Waxman’s bill) does not strike the necessary balance for patients or the economy,” the group’s president and chief executive Jim Greenwood said in a statement.
BIO spent $1.9 million in the first quarter to lobby the federal government on a host of issues, including generic biotech, according to a recent disclosure form. The Pharmaceutical Research and Manufacturers of America, whose position on the subject mirrors BIO’s, spent $6.9 million on lobbying during the same period.
By comparison, the Generic Pharmaceutical Association, which represents generic companies like Teva Pharmaceuticals, spent $535,563 lobbying the government during the first quarter.
Date: June 8, 2009
Source: Associated Press