FDA News

FDA Tells House Committee that Scientific Expertise Exists for Review of Biogenerics

(March 26, 2007)-- Generic Pharmaceutical Association (GPhA) President and CEO Kathleen Jaeger issues the following statement on House Committee on Oversight and Government Reform hearing on biogenerics:

"Countless patients seeking safe, effective and affordable biogenerics received good news today with the FDA stating that the science exists and, furthermore, it has the scientific expertise to review these life-saving medicines. The Agency and witnesses confirmed that the same scientific principles that apply to the review of changes made to brand products after approval would also be the underpinning for the review of biogenerics. Moreover, FDA Deputy Commissioner Janet Woodcock noted that the Agency needs flexibility in its ability to review products on a case-by-case basis and that this flexibility is in the best interest of the public and the Agency. This flexibility and authority are specifically granted in the Access to Life-Saving Medicine Act.

"The statement by Dr. Woodcock echoed those by former FDA officials who also testified at today's hearing that the Agency has the scientific expertise to review biogenerics. Moreover, Dr. Woodcock and the former officials stated that clinical trials are not always the most sensitive means in analyzing safety and efficacy and that the Agency has an array of analytical tools to best determine safety and efficacy for intended use. Dr. Woodcock also noted that most post-approval product changes, such as cell line change, are not supported by clinical outcome studies. In fact, Dr. Woodcock stated that about one in 50 post-approval changes are supported by such trials. As Congressman Waxman stated, the Access to Life-Saving Medicine Act would give the FDA the authority it needs to ask for any tests it deems necessary to ensure safety and efficacy, including clinical trials.

"Today's hearing also proved that the claim by PhRMA and BIO that the legislation will restrict FDA's ability to require testing is simply FALSE. As they did in 1984 during the Hatch-Waxman Act debate, brand companies are playing the safety scare card to maintain their monopolies. And, as Congressman Waxman said, 'They were wrong then ... and they are wrong now.'

"As the patients testifying at today's hearing so eloquently stated, the need is there for biogenerics. And, as the FDA stated, the scientific expertise is there. Now we need Congress to act. Safety will always be priority number one and the Access to Life-Saving Medicine Act will make certain that safety is ensured. The FDA, Congress and our industry will accept nothing less.

"Finally, on the issue of immunogenicity, the Committee heard that both brand and generic biologic products share the same concern of immunogenicity and that FDA has the ability to assess that risk. While immunogenicity is an important consideration for both brands and biogenerics, it is not an obstacle to their development.

"We thank Chairman Waxman for holding this important hearing today and for his leadership, along with the leadership of Representative Jo Ann Emerson and other members from both sides of the aisle who are sponsoring this critical legislation to bring safe, effective and affordable biogenerics to consumers."

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