Senior Scientist from Johnson & Johnson Testifies Before Senate HELP Committee on Follow-On Biologics

WASHINGTON, March 08, 2007 /PRNewswire-USNewswire/ -- Johnson & Johnson representative Jay P. Siegel, M.D., testified before the Senate HELP committee today, providing a scientific perspective on the issues relevant to any proposed framework for the approval of follow-on biologics. Johnson & Johnson fully supports transparent, science-based discussions -- such as the Senate HELP Committee hearing -- to identify a pathway for the development of safe follow-on biologic products with the goal of increasing patient access to these important therapies.

"As we examine proposed legislative pathways for follow-on biologics, I encourage all parties to continue to pursue scientifically driven public debate to ensure that public policy is well-founded in science and supports the development of follow-on biologics that are safe and effective for the patients who need them," said Dr. Siegel.

Group President of Research & Development for Johnson & Johnson's Biotechnology, Immunology and Oncology research and development companies, Dr. Siegel is a scientist with specific expertise in the fields of biotechnology, immunology, and clinical trial design. He has dedicated much of his life and career to public health, working 20 years regulating biologics at the Food & Drug Administration (FDA), most recently as Director of the Office of Therapeutics Research and Review within the Center for Biologics Evaluation and Research (CBER). Particularly relevant to today's hearing, he led efforts to develop FDA policy regarding scientific standards for demonstrating the comparability of biological products before and after a manufacturing change.

In his testimony, Dr. Siegel outlined the following five science-based principles that should be addressed in any regulatory paradigm allowing abbreviated applications for follow-on biologic product. All merit close attention in the crafting of a legislative framework:

    * There will always be a need for appropriate pre-marketing clinical data

      to help ensure that a follow-on biologic is safe and effective.  The

      complexities of biologics make them particularly susceptible to

      clinically significant changes when changes are made to the process by

      which they are manufactured.  As the production of follow-on biologics

      will necessarily involve many changes in process, there will always be

      the potential for subtle, but clinically meaningful differences to occur

      with follow-on products.  Since laboratory testing has proven

      insufficient to detect many clinically important differences in

      biologics, testing in humans will be necessary to help ensure their

      safety and efficacy.


    * There cannot be allowance for determinations of "comparability" for

      products that are so different in structure that they should be

      considered different products entirely, or for products that may have

      clinically meaningful differences.  Products that are substantially

      different in structure should be regulated as different products

      requiring full testing for safety and efficacy.


    * A follow-on biologic product should not be considered interchangeable

      with its reference product.  Follow-on biologics can be similar, but

      never identical to an innovator biologic.  Any application of

      "interchangeability" status to a follow-on could lead to inappropriate

      assumptions of sameness and substitution of one for the other, with

      potentially serious adverse health consequences.  Such substitution of

      biologics should be discouraged.


    * The FDA must be empowered to require post-marketing clinical studies and

      post-marketing safety surveillance to ensure safety.  Some risks

      associated with a follow-on biologic, like all pharmaceuticals, will

      become apparent only in the post-marketing period.  To optimize patient

      safety and control such risks, the safety of follow-on biologics, like

      other drugs and biologics, should be monitored by the license holder

      through a robust post-marketing safety surveillance program.  Also, FDA

      must not be limited in its ability to request post-marketing clinical

      studies when appropriate.


    * There should be no constraints placed on the FDA for ensuring the safety

      of follow-on products.  As we enter this new field with new safety

      risks, the FDA should be unhampered in its ability to request and

      receive additional data from a manufacturer as the need becomes

      apparent.

Dr. Siegel noted it is additionally critical that such a framework provides appropriate incentives for innovation so that the promise of new and innovative biologic therapies can continue to be realized for patients for generations to come.

"Patient safety and welfare are important concerns that we all share and that must guide us as we develop a statutory pathway for follow-on biologics," said Dr. Siegel.

"It is my hope and that of Johnson & Johnson that a scientifically-based public process will provide a framework and pathway for follow-on biologics in the US -- a pathway which reflects an overriding concern for patient safety and which provides appropriate incentives for innovation so that the promise of new and innovative biologic therapies can continue to be realized for patients for generations to come," added Dr. Siegel.

Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical and medical devices and diagnostics markets. The more than 200 Johnson & Johnson operating companies employ approximately 122,000 men and women and sell products throughout the world.

CONTACT: Mark T. Wolfe, +1-908-541-4058, +1-908-672-4988 cell

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