WASHINGTON If the FDA is providing technical advice to the Bush administration on cloning techniques and their anticipated importance to the future of medicine, “then someone is not doing a very good job,” a Washington lawyer said at a conference on Wednesday.
Edward Korwek, former scientist and lawyer for Hogan & Hartson LLP in Washington, questioned FDA representative Philip Noguchi about the agency’s position on human and therapeutic cloning, as well as its role in explaining things to President George W. Bush.
But Noguchi, director of the Division of Cellular and Gene Therapy for the FDA’s Center for Biologics Evaluation and Research, said nothing more than, “I believe the Bush administration opposes all forms of cloning.”
Korwek served as moderator for a three-member panel of experts who discussed technical, legal and bioethical issues of cloning and genomics at the Food Drug and Law Institute’s (FDLI) 45th annual education conference held at the Renaissance Washington D.C. Hotel.
In the next few weeks, Congress is expected to take up the debate on whether human and therapeutic cloning should be banned. In reality, the debate will focus on therapeutic cloning, since generally the public considers human cloning to be a repugnant form of the science.
Several bills have been introduced in the House and Senate that either ban all forms of cloning or just therapeutic cloning. A bill (HR2505) banning all cloning introduced by Rep. Dave Weldon (R-Fla.) passed in the House last summer, and in the Senate, Sam Brownback (R-Kan.) introduced similar legislation (S1899). Bush supports both these bills. (See BioWorld Today, Aug. 6, 2001; Nov. 27, 2001; and April 11, 2002.)
In support of therapeutic cloning, Sen. Edward Kennedy (D-Mass.), along with Arlen Specter (R-Pa.) and Dianne Feinstein (D-Calif.), is expected to introduce a bill that would allow therapeutic cloning but ban human cloning. Meanwhile, about a week ago Sen. Byron Dorgan (D-N.D.) introduced legislation (S2076) to ban human cloning, and in December, Feinstein introduced a bill (S1758) that bans human cloning while preserving medical research, including stem cell research.
Sen. Orrin Hatch (R-Utah), a keynote speaker at the FDLI conference, stopped short of saying how he’ll vote on the cloning issue. Instead, he said, “I usually come down on the side of science that is, sound science.”
If therapeutic cloning is legalized, another series of questions and legal issues will arise. Namely, should methods and products of cloning be patented?
James Czaban, a panel member and attorney with Heller, Ehrman, White & McAuliffe LLP in Washington, raised a few cloning questions in his discussion on patenting the human genome. He said Patent and Trademark Office policy prohibits patenting humans and the human genome sequence itself, but allows gene patents that cover the isolation of a gene, which requires human intervention (isolated genes do not occur in nature).
“A colleague of mine made the analogy [that] penicillin occurs naturally, but not in purified form. Thus, purified penicillin was patentable,” Czaban said.
Then there’s always the question of whether patents encourage or stifle research.
And if Rep. Lynn Rivers (D-Mich.) has her way, that question partially may be answered. The congresswoman introduced legislation (HR3967) that would allow scientists to conduct research using patented genetic sequence information without obtaining permission from the patent owner. Furthermore, another section of Rivers’ bill allows “medical practitioners” to freely use patented genetic diagnostic tests without fear of lawsuits. (See BioWorld Today, April 1, 2002.)
The prospect of the Rivers bill making it through Congress scares groups like the Washington-based Biotechnology Industry Organization. Lila Feisee, director, federal government relations for BIO, previously told BioWorld Today that the legislation is unnecessary, and “is sort of a solution to a problem that doesn’t exist.”