[Ip-health] Chairman Waxman Asks President Obama to Increase Support for Generic Biologics

[Sarah Rimmington]

The following information was sent out by the House Commitee on Energy
and Commerce on 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 text of the letter
follows:

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 of the nation?s prescription drug costs.
Many of them cost tens and thousands of dollars 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 of my 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 of
FDA?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 of
long-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

/This mailbox is not attended. Please call the Energy and Commerce
Committee Press Office at (202) 225-5735 with any questions./


--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: +1 (202) 387-8030
Cell: +1 (202) 422-2687
www.essentialaction.org/access/