House Committee on Energy and Commerce Chairman Waxman Writes President Obama Regarding Generic Biologics

WASHINGTON, June 8, 2009--In a letter to President Obama, Chairman Waxman praised the President for his support of generic biologics in the FY 2010 Budget, with a term of exclusivity consistent with that granted to other drugs under Waxman-Hatch. Chairman Waxman urged the President to consider what steps can be taken under current law to prepare and even begin to approve safe and effective generic biologics, in advance of legislation. In March, Chairman Waxman introduced H.R. 1427 the "Promoting Innovation and Access to Life-Saving Medicine Act," a bipartisan bill to allow the FDA to approve affordable generic biologic drugs.

The President

The White House

Washington, DC 20500

Dear Mr. President:

I am pleased that your FY 2010 Budget provides a substantial increase for the Food and Drug Administration (FDA) and includes a proposal to establish a pathway for FDA approval of generic biologics.

On March 11,2009, my colleagues and I introduced H.R. 1427, the "Promoting Innovation and Access to Life-Saving Medicine Act," a bipartisan bill to allow the FDA to approve affordable generic biologic drugs. Biotech drugs, while often life-saving, are the fastest growing and most expensive components ofthe nation's prescription drug costs. Many ofthem cost tens and thousands ofdollars a year and impose an unsustainable burden on patients, employers, and the federal and state governments. This legislation, which I believe is consistent with the principles outlined in your budget is one ofmy highest priorities this year.

When this legislation passes, it is important for FDA to begin implementing the program as soon as possible. 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. The speed ofFDA's action will determine how quickly safe and effective generic biologics become available to patients.

In addition, I would be interested in your Administration's analysis oflong-term savings generated from generic biologics not only for Medicare and Medicaid, but also for businesses, insurers, and families. Generic biologics are a significant way to control costs and I agree with you that controlling costs is integral to reforming our health care system.

With your support I am hopeful we can achieve our shared vision for Americans to get access to safe, effective, and affordable generic biologic therapeutics.

I thank you for your attention on this matter and look forward to working with you.

Sincerely,

Henry A. Waxman

Chairman

cc: Nancy-Ann DeParle Counselor to the President and Director, Office of Health Refonn

Peter Orszag Director, Office ofManagement and Budget
 

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