Washington Editor

Biotechnology firms that have been unable to win Small Business Incentive Research grants due to a technicality in the law might be in the game again if legislation recently introduced in the House makes it to the president's desk.

Rep. Samuel Graves (R-Mo.) recently introduced legislation designed to amend Internal Revenue Code language that limits Small Business Incentive Research (SBIR) grants to firms that are 51 percent owned by "individuals" who are citizens or permanent residents of the U.S.

At issue here is the definition of "individuals."

Steve Lawton, vice president and general counsel at the Washington-based Biotechnology Industry Organization, told BioWorld Today the problem cropped up about two years ago when the term "individuals" was interpreted to exclude venture capital funds, which often heavily fund emerging biotechnology firms.

"That means a lot of our companies were not eligible for the SBIR program because 51 percent is not owned by individuals," Lawton said, adding that the Graves legislation resolves that issue.

Lawton said the language partially was intended to stop a firm that was perhaps a subsidiary of a foreign-based company from accessing SBIR money.

The legislation would allow companies majority owned by venture capitalists to have a chance at SBIR grants. Specifically, Graves' legislation seeks "to permit business concerns that are owned by venture capital operating companies or pension plans to participate in the SBIR program."

Government To Discuss Buying Canadian Drugs

Stakeholders and ordinary citizens will have the chance to present their opinions on importing FDA-approved drugs from other countries at a public hearing sponsored by the FDA and Department of Health and Human Services.

The hearing is scheduled from 9 a.m. to 5 p.m. Wednesday at the Natcher Auditorium, Building 45, of the National Institutes of Health in Bethesda, Md.

The Medicare Prescription Drug, Improvement and Modernization Act of 2003, signed by President Bush in December, authorizes HHS Secretary Tommy Thompson to implement a system for the importation of Canadian prescription drugs if he is able to certify that the practice is safe and cost-effective. (See BioWorld Today, Dec. 1, 2003.)

As part of the certification process, Thompson formed a task force to study the potential impact of bringing drugs in from Canada or possibly other countries in the future. The group will evaluate the financial impact on drug prices, wholesalers, pharmacies and R&D, and it will study whether importing will increase the flow of nonapproved or counterfeit drugs into the country.

The FDA will accept public comments on the issue through June 1. Comments may be sent to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1016, Rockville, Md. 20852. For more information on the public hearing visit the agency's website at www.fda.gov and click on "meetings."

Website For Gene Therapy

The FDA and the NIH have launched a web-accessible database on human gene transfer, called the Genetic Modification Clinical Research Information System (GeMCRIS).

A statement released by the agencies said the system is meant to provide information to the public and to improve the government's ability to monitor adverse events in gene transfer research, also known as gene therapy.

Database users can learn the locations of trials taking place, which diseases or health conditions are being studied and what investigational approaches are being taken.

Furthermore, investigators and trial sponsors conducting human gene transfer trials also will be able to report adverse events using a secure electronic interface on the GeMCRIS system.

The site is located at www.gemcris.od.nih.gov.