BIO Restates Opposition to H.R. 1038
WASHINGTON, D.C. (March 26, 2007) -- The following statement was issued today by Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood in conjunction with a hearing being held this morning on follow-on biologics before the House Oversight and Government Reform Committee:
“Any legislative discussion of creating a pathway for follow-on biologics must ensure patient safety and preserve incentives for biomedical research and innovation. We strongly oppose the Access to Life-Saving Medicine Act (H.R. 1038) as it fails to do either. H.R. 1038 would permit the approval of follow-on biologics that do not meet the same rigorous standards of safety, purity, and potency that innovator products must meet; would restrict the ability of the FDA to require whatever clinical testing it believes appropriate to determine the safety and efficacy of such products; would prohibit the FDA from requesting post-marketing safety studies; and would improperly dictate scientific conclusions that the FDA should reach about the comparability or similarity of such products. The legislation also eviscerates incentives to develop new therapies through its one-sided alteration of long-standing patent law in ways that favor follow-on biologics’ manufacturers, who would be able to restrict and infringe the intellectual property rights of various parties including universities and innovative biotechnology companies.
“More, the legislation contains no prohibition on the FDA approving a follow-on product relying on innovator data immediately following approval of the reference product. Devaluing property rights and denying data exclusivity will reduce incentives for the investment needed for a strong, vibrant pioneer biologic industry upon which any follow-on market would wholly depend.
“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-on biologics.
“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, the FDA’s internal scientific capabilities, and biomedical innovation.
“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 are based on deeply flawed assumptions and calculation methods and are therefore unrealistic, as detailed in our analysis of the recent studies conducted by Express Scripts and the Pharmaceutical Care Management Association (http://www.bio.org/healthcare/followon/20070222.pdf).
“Furthermore, a report on follow-on biologics by the Congressional Research Service released earlier this month also recognized the vast difference between generic pharmaceuticals and follow-on biologics, including anticipated savings: ‘High manufacturing costs, the need for additional safety and efficacy trials to test these products, and augmented efforts directed at doctors and patients to encourage the use of similar, but not identical drugs, are expected to add to the prices associated with the follow-on product.’
“For more than 20 years, the biotechnology industry has been dedicated to 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 to enhance and extend the lives of patients. We need to ensure our continued ability to do so."
BIO also submitted a letter for the record for the House Committee on Oversight and Government Reform hearing held today entitled, “Safe and Affordable Biotech Drugs – The Need for a Generic Pathway,” The letter, which can be found at http://bio.org/healthcare/followonbkg/20070326Waxman-Davis.pdf, details BIO’s specific objections to H.R. 1038 and lays out additional considerations as Congress considers pathways to approve follow-on biologics.
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.
Upcoming BIO Events
· BIO International Convention
May 6-9, 2007
Boston, MA
· BIO VentureForum-East 2007
June 18-20, 2007
Montreal, Canada
· BIO Mid-America VentureForum 2007
Sep. 24–26, 2007
Milwaukee, WI
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