June 9, 2009

Democrat Calls on President to Push Generic Biotech Drug Legislation

The chairman of the Energy and Commerce Committee on Monday called on President Barack Obama to speed up legislation that would approve the use of generic biotech drugs.

Rep. Henry Waxman, D-Calif. praised the President for his approval of generic biologics as a part of the fiscal year 2010 budget, but he urged the President to take steps that would prepare for and even begin to approve biotech drugs in advance of legislation.

"The speed of FDA's action will determine how quickly safe and effective generic biologics become available to patients," Waxman wrote in a letter addressed to President Obama.

The Food and Drug Administration currently is unable to approve generic copies of expensive biotech drugs.

"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," Waxman wrote.

In March, Chairman Waxman introduced bipartisan bill H.R. 1427, the "Promoting Innovation and Access to Life-Saving Medicine Act," which would give the FDA the ability to approve more affordable generic copies of biotech drugs.

"This is the kind of policy that can bend the cost curve - a key priority for this president," said White House spokesman Reid Cherlin.

According to the Associated Press, the Federal Trade Commission is expected to issue its report this week to determine the "competitive impact of a pathway for generic biotech drugs."

"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," said Jim Greenwood, president of BIO, which spent $1.9 million in the first quarter on lobbying efforts on an array of issues, including generic biotech.

The Generic Pharmaceutical Association, which represents generic companies like Teva Pharmaceuticals, spent $535,563 lobbying the government during the first quarter, according to the AP.


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