Biologics

On Friday, the House Committee on Energy and Commerce adopted a proposal for biosimilars that provides an excessive period of monopoly while allowing vast loopholes which could allow evergreening - ie under the proposal, companies could potentially restart the monopoly period for minor tweaks to the medicine.

Read an analysis of the evergreening problem by Essential Action here.

Read a joint statement from consumer and health advocates along with individual quotes below.

Statement of Consumer Groups Regarding Adoption of Industry-Backed Eshoo-Barton Amendment to Health Care Reform Legislation

We are deeply disappointed by the decision of the House Committee on Energy and Commerce to adopt the BIO and PhRMA-backed amendment on generic biologics. Instead of opening the door to less expensive generic drugs and the potential for enormous savings to patients and healthcare providers, including federal and state governments, this amendment will insure that BIO and PhRMA companies can charge monopoly prices for a minimum of 12 years. The proposal that passed today will also make it much easier for brand companies to wait until the eleventh hour to make minor changes to old biologics, and then renew the 12 year marketing monopoly an unlimited number of times.

Neither the brand industry nor the supporters of the amendment have ever credibly explained why the manufacturers of brand biologics should be entitled to a guaranteed 12 years of exclusivity, which is in effect 12 years of monopoly prices, when the patent system has been adequate to protect innovation in every other industry. They have also never explained why 12 years of exclusivity is appropriate for the manufacturers of biologics, when since 1984 the manufacturers of chemical drugs have thrived with five years of exclusivity.

July 20, 2009

Dear Senator or Representative,

Congressional consideration of healthcare reform has two overriding goals: expand health coverage to the uninsured, and contain costs. It is widely understood that the first goal cannot be achieved absent success with the second objective.

It is therefore vital that Congress take steps to lower the price of the most expensive drug treatments, rather than aid Big Pharma and the biotech industry's ability to price gouge consumers and the government. For this reason, we urge you to support the Promoting Innovation and Life Savings Medicines Act, H.R. 1427 and reject attempts to pass other biologics legislation that will leave affordable care out of reach.

Contact Information for Key Representatives to Contact HERE
Find the Phone Script HERE
Find a Sample Email HERE

Download a PDF of the letter
Download a PDF of the press release

July 14, 2009

Robert M. Berdahl
President
American Association of Universities
1200 New York Avenue, NW, Suite 550
Washington, DC 20005

RE: June 3, 2009 AAU Endorsement of Eshoo-Inslee-Barton Follow-on Biologics Bill

Dear Dr. Berdahl,

As early as TOMORROW (Tuesday), the Senate Health, Education, Labor and Pensions (HELP) Committee will decide how much additional monopoly to give to biologic drugs -- those engineered from living cells such as cancer treatments and vaccines -- as part of the health care reform package. Specifically, supported by the American Association of Universities, major research universities in the U.S.

Download a pdf of the press release

Download the April 16, 2009 UAEM letter to AAU

Read the November 12, 2008 AAU response to our initial letter

Read our original October 15, 2008 letter to AAU

Read AAU's June 10, 2008 endorsement of the Eshoo-Barton legislation

Read AAU's May 2, 2008 comment on the legislation

Contact: Eleanor Blume
Phone: (781) 640-7750
Email: eleanor dot blume at gmail dot com

For Immediate Release

AAU ONCE AGAIN ENDORSES LEGISLATION THAT WILL IMPEDE ACCESS TO AFFORDABLE BIOLOGIC DRUGS

UAEM CALLS ON AAU TO WITHDRAW SUPPORT

The Association of American Universities (AAU) has once again endorsed legislation, (newly numbered H.R. 1548 in the new Congress), that would impede access to lower-cost follow-on biologics such as vaccines and cancer treatments. The AAU previously declined to withdraw its endorsement from H.R. 5629 of the previous Congress, the “Pathway for Biosimilars Acts,” following a call to do so from Universities Allied for Essential Medicines (UAEM). The new bill, as with the previous one, would effectively increase the length of patents on biologic drugs by allowing market registration data exclusivity of up to 14.5 years, delaying the onset of cheaper follow-on biologics while inhibiting patent challenges and impeding access to these essential medicines. This is in contrast to the normal five years of market registration data exclusivity currently in place for small-molecule drugs. Alternative legislation proposed by a bi-partisan group from the House and Senate includes more reasonable terms of data exclusivity is now available.

UAEM has argued that this obviously commercially-motivated provision is not in line with the non-profit mission of the university.