BIO Submits Letter to Congress Detailing Concerns Regarding Clinton-Schumer Legislation

BIO Submits Letter to Congress Detailing Concerns Regarding Clinton-Schumer Legislation Urges Congress to Consider Any Action on Follow-Ons Independent of PDUFA. Urges Congress to Consider Any Action on Follow-Ons Independent of PDUFA.</p>

WASHINGTON, D.C. (March 8, 2007) -- The following statement was issued today by Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood in conjunction with a hearing held this morning on follow-on biologics before the Senate Health, Education, Labor and Pensions Committee:

“BIO opposes the follow-on biologics legislation proposed by Senators Hillary Clinton (D-NY) and Charles Schumer (D-NY) – as well as similar legislation introduced in the House of Representatives by Congressman Henry Waxman (D-CA).  As explained in written testimony delivered today by Dr. Jay Siegel of Johnson & Johnson, these proposals jeopardize patient safety in numerous ways.  More, they undermine the incentives that enable the development of life-enhancing and life-saving medicines, as detailed in a letter we submitted today to the hearing record (

“Biotechnology medicines have revolutionized the treatment of millions of people worldwide suffering from cancer, diabetes, multiple sclerosis, cystic fibrosis and a host of rare diseases. Any legislative discussion of creating a pathway for follow-on biologics must first seek to protect patient safety and preserve the intellectual property rights and incentives that drive biomedical innovation.

“This is a complex issue.  Follow-on biologics involve difficult questions surrounding science, patient safety and intellectual property.  Because of these complexities, Congress should not rush to develop a pathway for approval of follow-ons.  Both the House and the Senate should give full and deliberate consideration to any follow-on biologics proposal as standalone legislation. 

“Specifically, we urge Congress to consider action relating to establishing a statutory pathway for approving follow-on biologics independent of the reauthorization of the Prescription Drug User Fee Act (PDUFA).  Although PDUFA formally expires on September 30, 2007, reauthorization needs to occur earlier this year to avoid potential delays in review of innovative new medicines.  Attaching follow-on biologics legislation to PDUFA would potentially jeopardize reauthorization of the user fee program to the detriment of patients waiting for new therapies, FDA’s internal scientific capabilities, and biomedical innovation.

“Our industry will continue to urge Congress to place patient safety first.  Unlike most traditional drugs, biologics are complex substances produced using living organisms.  In turn, follow-on biologics are not equivalent to generic drugs.  Even small changes between follow-on biologics and an original biotechnology medicine can cause differences that may have an impact on patient safety. 

"In addition to our concerns about this legislation, we echo the statements of numerous organizations about the potential safety implications of unproven follow-on biotechnology medicines: 


·        “With protein products, as of today, the FDA has not determined how interchangeability can be established for complex proteins.  Different large protein products, with similar molecular composition may behave differently in people and substitution of one for another may result in serious health outcomes.” – Food and Drug Administration, September 2006


·         “Due to the complexity of biological/biotechnology-derived products the generic approach is scientifically not appropriate for these products” - European Medicines Agency, October 2005


“Congress also should be wary as it looks to follow-on biologics to provide potential savings in federal healthcare programs.  Recent analyses by various stakeholders regarding potential savings have been shown to be based on deeply flawed assumptions and calculation methods.  Research, development and production costs for biologics, including follow-on biologics, exceed those of traditional pharmaceuticals.  Moreover, biologics often address rare diseases where there are not likely to be many competitors entering the market, even if a new follow-on pathway is established.

“For more than 20 years, the exceptional creativity of the biotechnology industry has been directed toward discovering, developing, and delivering innovative treatments for patients worldwide, in many cases providing the first approved treatment for a condition.  BIO members invest heavily in research and development, and are committed to creating new therapies that will help patients live longer and better lives.  We need to ensure our continued ability to do so." 

About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products.  BIO also produces the annual BIO International Convention, the global event for biotechnology.