By Kim Coghill

Washington Editor

WASHINGTON ¿ Rep. Tom Allen (D-Maine) said the public has the right to know how much money biotechnology companies are spending developing a product before they can win FDA approval of a new drug application.

And although his amendment requiring such disclosure died due to a technicality on the House floor Wednesday, the Democrat reportedly will look for other legislation on which to attach his controversial proposal. The amendment was latched on to the Fiscal Year 2002 Agriculture Appropriations Bill. (See BioWorld Today, July 12, 2001.)

Allen could not be reached for comment Thursday, but according to a statement released by his office, the representative has a ¿desire¿ to continue pursuing the amendment.

If approved, the amendment would be a devastating blow for both pharmaceutical and biotechnology companies because it would require them to submit to the FDA detailed records of research and development costs.

In his statement on the House floor Wednesday, Allen said, ¿What the industry fails to disclose is that breakthroughs in new drugs are the result of a partnership with the public. A good portion of our nation¿s pharmaceutical research is conducted by publicly funded institutions such as the National Institutes of Health as well as universities.¿

Allen said companies should disclose all records related to tax credits, tax deductions and any other private or public contributions including funds granted by the NIH.

¿The pharmaceutical industry receives generous benefits from public funds for the development of new drugs, and that is good,¿ he said. ¿Yet the drug companies return the favor by charging the American public the highest prices in the world. Taxpayers deserve to know the size of their contribution.¿

The Washington-based Biotechnology Industry Organization (BIO) opposed the amendment, saying much of the information it calls for is proprietary and has no bearing or relationship to the mission of the FDA, which is to review the safety and efficacy of drugs.

Allen further stated that the lack of adequate coverage provided under Medicare regulations combined with the high price of prescription drugs means ¿seniors are left to make choices that no one should have to make.¿

But Thursday, in a Rose Garden press conference, President Bush presented a prescription drug plan that would help seniors on Medicare save money.

If the president has his way, seniors will use a government-issued drug discount card to purchase medicine at participating pharmacies. The card would cost a dollar or two a month.

¿The drug discount plan is the first necessary step to provide immediate help to seniors without destabilizing Medicare¿s finances,¿ Bush said. ¿It is the first step, but it is not a substitute for a drug benefit and for strengthening Medicare.¿

Bush¿s Medicare proposal gives seniors an option to choose between public and private insurers, and it places a cap on the amount of money a senior would be required to pay annually.

In a prepared statement, Sharon Cohen, BIO¿s vice president of health care policy, said Bush¿s plan recognizes important aspects of how to provide Medicare coverage for prescription drugs and biologics without unnecessary and burdensome government control.

Debate Continues Over Federally Funded Stem Cells

While the media are increasing the pressure on Bush to decide whether the federal government should pay for research on embryonic stem cells, at least two companies on the East Coast are making strides in the controversial research.

The Washington Post Thursday reported that scientists at Advanced Cell Technology (ACT), of Worcester, Mass., have started experiments aimed at developing human embryos from which stem cells can be collected. If successful, ACT scientists would be the first to use cloning technology to turn a human cell into an embryo as a source of stem cells, the newspaper said.

The news comes a day after it was widely reported that scientists at Jones Institute for Reproductive Medicine in Norfolk, Va., harvested embryonic stem cells from human embryos that were developed for research. According to The Washington Post, 12 women were paid between $1,500 and $2,000 each to donate eggs.

Scientist Supports Safeguards Against Misuse Of Genes

Craig Venter, president and chief scientific officer of Rockville, Md.-based Celera Genomics, testified Wednesday on behalf of BIO before the House subcommittee on Consumer Protection of the Committee on Energy and Commerce about genetic discrimination.

Venter said both he and BIO support national legislation to ensure that individuals¿ personal medical information, including genetic information, is safeguarded against misuse.

Venter said there is increasing evidence that people fear their genetic information will be used to deny them health insurance or a job and that fear is keeping them from seeking medical help.

¿If people believe that a new system of individualized medicine will lead to denial of health insurance or other benefits, they will not take advantage of what the new system could offer,¿ he said in a prepared statement. ¿The revolution at hand may not be realized because people are afraid to take part in it.¿

Before drafting legislation to protect the public against genetic discrimination, Venter reminded the subcommittee to avoid restricting biomedical research.

No Comments