Activities
Senator Hatch and Rep. Waxman Receive FDAAA Wiley Award
Each year the FDAAA awards a lectureship named in honor of Dr. Harvey W. Wiley. Dr Wiley was the renowned physician-chemist who, at the turn of the 20th century, championed a legislative crusade against food adulteration, earning him the title of "Father of the Pure Food and Drugs Act" when it was enacted into law in 1906.
This year, the Harvey W. Wiley Lectureship Award was presented during the FDLI plenary session of the FDLI Annual Conference on April 22, 2009. In commemoration of the 25th anniversary of the Hatch-Waxman Act the 2009 recipients of the award were The Honorable Orrin G. Hatch, and the Honorable Henry A. Waxman.
Senator Hatch was introduced by Liz Krell and the award was presented to him after his lecture by FDAAA's Chairman Krell and President Celeste.
After praising Harvey Wiley, Senator Hatch noted that the Hatch-Waxman Act legislation worked well, it continues to save consumers one-billion dollars per year, and has led to innovation that ultimately results in the availability of more generics. Generics account for 60% of the pharmaceutical market while they held 18% twenty-five years ago.
Senator Hatch presented his position on health care reform, biosimilars and what the future holds for FDA.
Among other things, he said health care reform should address cost growth, quality and value, prevention, system modernization, provision of information to consumers, the need for States to have flexibility. A proposal on health care reform is expected in June.
When he spoke about biosimilars, generic versions of biological products, Senator Hatch stated that the innovator products are complex drugs, 20 to 100 times more expensive to produce than small molecule drugs and have funding provided by venture capital thus needing data exclusivity and patent protection for the funding to continue. The Senator cited several legislative proposals related to generic biological products and stressed the need for adequate incentive to continue innovation, suggesting the need for 12 years exclusivity and a pathway for biosimilars to come to market.
Concerning the future of FDA, Senator Hatch indicated that medical research and the current state of the economy drives the agency into new areas that should lead to better integrated approval of pharmaceuticals and to the development of comparative effectiveness approaches that should yield medical therapies that are the best rather than the cheapest. After touching on the advantages of personalized medicine, Senator Hatch moved to stem cell research, about which he said, "Being pro-life means helping the living as well as the unborn," but appropriate legal and ethical safeguards such as a ban on human cloning must be in place. Finally the Senator posed several questions touching on FDA's struggle for funding through the Agriculture Subcommittee, the Office of Generic Drugs not being funded through user fees, and the wisdom of adding tobacco to the heavy load of responsibilities. H e also asked "Why split FDA into 2 agencies?" and "Why isn't White Oak completed?" Senator Hatch closed with the comment that he loved addressing this audience and looked forward to returning next year.
A transcript of the Senator Hatch's lecture is provided in its entirety.
Rep. Waxman was unavailable to receive the award as scheduled due to conflicting Congressional obligations. Attempts are being made to schedule another time for him to receive the award in person.