By Kim Coghill

Washington Editor

WASHINGTON ¿ A controversial proposal designed to force biotechnology companies to submit detailed records of research and development costs to the FDA before any drug can be reviewed died on the House floor Wednesday.

The proposal, introduced by Rep. Tom Allen (D-Maine), was in the form of an amendment to the Fiscal Year 2002 Agriculture Appropriations Bill. The amendment was withdrawn before any vote after the House parliamentarian ruled that it would change existing law, and that can¿t be done in an appropriations bill. The measure could resurface later in other legislation.

In a 324-to-101 vote, however, the House did approve an amendment introduced by Rep. Gil Gutknecht (R-N.M.) that would prohibit FDA money from being used for policing the reimportation of drugs. As part of the agriculture bill, that amendment must be approved by the Senate and then by President Bush.

Under the Allen amendment, which would dramatically impact the biotech industry if it got through, the FDA would require a list of R&D costs as well as a cataloguing of any costs paid to a company by federal or state governments.

¿The problem is, no one knows what information the FDA would want,¿ said Sharon Cohen, vice president of health policy for the Washington-based Biotechnology Industry Organization [BIO]. ¿What is R&D information? Does that mean what I spend for a specific product? Even if a drug failed? What if I acquired a small biotech company, do I include that?¿

Cohen went on to say that BIO opposed the amendment because much of the information it would require is considered proprietary and has no bearing or relationship to the mission of the FDA, which is to review the safety and efficacy of drugs. ¿They are not Big Brother in terms of what happens in research and development costs. This would divert money and attention from the overall mission of the FDA and in our minds, there¿s no clear and intended purpose ¿ it is just kind of a nuisance.¿

The amendment initially would have shut down FDA approvals for about 18 months while federal guidelines are written, Cohen said.

Drug Reimportation Issue Resurfaces

The debate surrounding reimportation of prescription drugs simmered down for a few months, but Wednesday started bubbling again when the House considered two amendments in the same agricultural bill that would deny the FDA money to police U.S. borders.

Initially, the plan to allow reimportation excluded biologics, and biotech officials feared they would be added in, especially when the likes of Rep. Marion Berry (D-Ark.) promised to find a way to include them.

And that is just what has happened.

¿This version is actually worse for biotechnology because the exclusion for it doesn¿t exist in either amendment,¿ Cohen said.

The Gutknecht amendment would allow reimportation by an ¿individual who is not in the business of reimporting prescription drugs¿ as long as such products are not regulated or controlled substances. (The other amendment was voted against.)

In a prepared statement, BIO said adoption of either of these measures would create an ¿open season¿ on the flow of counterfeit and potentially dangerous prescription and biotech drugs into the U.S. from ¿unscrupulous¿ mail-order and Internet-based companies.

The reimportation legislation was part of last year¿s Agriculture Appropriations Bill and was signed in October by former President Bill Clinton. It permits reimportation of FDA-approved prescription drugs for personal use from countries with lower drug prices. And, in provisions authored by Sen. Jim Jeffords (I-Vt.), the plan permits pharmacists and wholesalers to purchase FDA-approved drugs from countries where the identical drug is sold for less. (See BioWorld Today, July 26, 2000; July 17, 2000; Oct. 2, 2000; and Dec. 29, 2000.)

In one of his last acts as president, Clinton directed Donna Shalala, his secretary of Health and Human Services, to begin implementing the plan. But in mid-December, Shalala notified her boss that she would not certify the plan because she could not demonstrate that it was safe or that it would reduce costs.

The issue kind of died down for a while until Jeffords stepped out and vowed to convince the Bush administration to implement this plan, referred to by Carl Feldbaum, BIO¿s president, as a ¿stop-gap, election-year solution to the prescription drug issue.¿

The intent of reimportation was to provide cheaper prescription drugs to the elderly and anyone else looking for a bargain. But Feldbaum said all along that it would harm the FDA and could put the health of seniors at risk.

¿[HHS Secretary Tommy] Thompson and Shalala said this cannot be done in such a way as to ensure public safety and I would say that there are a number of companies that have experienced counterfeit products, fake drugs that are packaged and look like the real things, and they are being brought in now while the border is being policed,¿ Cohen said. ¿When you take away money for policing, what do you think is going to happen?¿

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