Consumer, Public Health and Labor Groups plus State Legislators Support Bi-Partisan U.S. Biogeneric Bills

On April 22, 2009, Essential Action, along with the American Medical Student Association (AMSA) , Breast Cancer Action, Consumers Union, the Department for Professional Employees of the AFL-CIO, Knowledge Ecology International (KEI), National Legislative Association on Prescription Drug Prices (NLARx), National Women’s Health Network, Public Citizen, Universities Allied for Essential Medicines (UAEM) and U.S. PIRG (Public Interest Research Group) sent a letter to U.S. House and Senate members endorsing the bipartisan Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427/ S.726), which introduces a much-needed pathway for Food and Drug Administration (FDA) approval of safe, effective and affordable generic biotech drugs.

“Biologic drugs — including key treatments for cancer, diabetes, heart disease, MS and autoimmune disorders like arthritis — are the fastest growing part of the nation’s prescription drug bill,” says the letter. “By 2010 it is estimated that 50% of all new drug approvals will be biologics. At the same time, brand-name biologic drugs are priced significantly higher on average than brand-name conventional pharmaceuticals, heightening the need for generics. In some cases, prices approach or exceed $100,000 per patient, per year.”

The letter lauds the bills –whose lead co-sponsors are Democrat Henry Waxman and Republican Nathan Deal in the House and Democrat Charles Schumer and Republican Susan Collins in the Senate, — because they “will result billions of dollars of cost savings for individual patients, insurers, and national and state government programs.”

The groups are endorsing these identical bills even though they offer brand-name pharmaceutical and biotech companies marketing monopolies of at least five years because this proposal is much better than alternatives such as that spearheaded by Representatives Anna Eshoo and Joe Barton (H.R. 1548).

The original version of both the senate and house letters (where are identical except for the addressees) can be downloaded here:
SchS726supportletter2009.pdf
WaxHR1427supportletter2009.pdf

You can also read the text of the complete house letter in the continuation of this post.
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April 22, 2009

The Honorable Henry A. Waxman
Chairman, Committee on Energy and
Commerce
United States House of Representatives
Washington, D.C. 20515

The Honorable Frank Pallone, Jr.
Chairman, Subcommittee on Health
Committee on Energy and Commerce
United States House of Representatives
Washington, D.C. 20515

The Honorable Nathan Deal
Ranking Member, Subcommittee on Health
Committee on Energy and Commerce
United States House of Representatives
Washington, D.C. 20515

The Honorable Jo Ann Emerson
Ranking Member, Subcommittee on
Financial Services and Government
Committee on Appropriations
United States House of Representatives
Washington, D.C. 20515

Dear Chairman Waxman and Representatives Deal, Pallone and Emerson,

We, the undersigned consumer, patient and public health groups and unions, are pleased to endorse the bipartisan Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427). This important bill will create a much-needed pathway for Food and Drug Administration (FDA) approval of safe, effective and affordable biogenerics. Your proposal will result billions of dollars of cost savings for individual patients, insurers, and national and state government programs. At a time when health care costs are spiraling out of control and health care reform is an urgent priority, the time is ripe for action.

There is a lot at stake in crafting biogenerics legislation. Biologic drugs — including key treatments for cancer, diabetes, heart disease, MS and autoimmune disorders like arthritis — are the fastest growing part of the nation’s prescription drug bill. By 2010 it is estimated that 50% of all new drug approvals will be biologics. At the same time, brand-name biologic drugs are priced significantly higher on average than brand-name conventional pharmaceuticals, heightening the need for generics. In some cases, prices approach or exceed $100,000 per patient, per year. Biologics priced at tens of thousands of dollars per patient per year are commonplace. In 2006, the five top-selling biologic drugs alone constituted 30 percent of Medicare Part B spending. These prices make it very difficult and sometimes impossible for large numbers of Americans to gain access to the most cutting edge life-saving treatments.

Of course, how much consumers will save — and when — depends crucially on the details of the new FDA regulatory approval process. Your bill would establish a rational and streamlined pathway for the timely introduction of generic price competition for biologics.

We thank-you for your leadership and look forward to working with you to build support for this essential element of health care reform.

Sincerely,

American Medical Student Association (AMSA)

Breast Cancer Action

Consumers Union

Department for Professional Employees, AFL-CIO

Essential Action

Knowledge Ecology International (KEI)

National Legislative Association on Prescription Drug Prices (NLARx)

National Women’s Health Network

Public Citizen

Universities Allied for Essential Medicines (UAEM)

U.S. PIRG (Public Interest Research Group)

Contact person:
Sarah Rimmington
Attorney
Essential Action
Access to Medicines Project
Tel: (202) 387-8030
Mobile: (202) 422-2687
Email: [email protected]