Washington Editor

WASHINGTON - Project BioShield is getting a makeover.

Not long after unveiling long-awaited strategic plans on biodefense product development priorities, which should help guide interested companies' research decisions, the Department of Health and Human Services last week officially established an office to manage the Biomedical Advanced Research and Development Authority (BARDA). It is structured under the recently confirmed HHS Assistant Secretary for Preparedness and Response, Craig Vanderwagen, to whom the still-undetermined BARDA director will report.

Legislation to authorize BARDA was passed at the end of last year to use federal funds to help finance biodefense firms' late-stage research and development, essentially helping those businesses across the so-called valley of death by getting the government to share some risks while simultaneously helping seed national stockpile needs. But the law that created BARDA did not include appropriated funds, so it will incorporate all the programs, mission responsibilities and organizational functions previously housed in the Office of Public Health Emergency Medical Countermeasures, which will be subsumed in the reorganization process. That division has been funded and operating for several years, an HHS spokesperson told BioWorld Today.

Advanced development activities will depend on congressional approval of President Bush's budget request of $189 million for the next fiscal year. Future funding levels for BARDA remain to be determined.

The BARDA office will manage BioShield, which includes the procurement and advanced development of products such as vaccines, drugs, therapies and diagnostic tools to counter chemical, biological, radiological and nuclear agents, as well as the advanced development and procurement of products for pandemic influenza and other emerging infectious diseases that fall outside BioShield.

Under the new plan for procuring products through BioShield, HHS said it would give priority to therapeutics, diagnostics or post-event prophylaxis products for most threats, while preventative measures would be appropriate only for threats of potential catastrophic consequence. Near-term priorities include antibiotics and vaccines for anthrax, smallpox vaccines and countermeasures for acute radiation sickness. Other threats have been designated longer-term concerns.

S. 1082 Heading To Senate Floor

The Senate today is scheduled to begin considering comprehensive FDA legislation that would renew the Prescription Drug User Fee Act (PDUFA) and authorize new safety powers at the agency, among other things.

The wide-reaching bill, called the "Food and Drug Administration Revitalization Act," recently cleared the Health, Education, Labor and Pensions Committee by a vote of 15-5. Discussion is expected to last a few days, followed by a vote from the full Senate. Similar action in the House of Representatives is moving more slowly.

It wasn't clear as of Friday's deadline whether an amendment to incorporate follow-on biologics language would be part of the floor action in the Senate. A staffer for Chairman Edward Kennedy (D-Mass.) said details of the debate were still being worked out.

An existing follow-on bill put forth by Sens. Charles Schumer (D-N.Y.) and Hillary Rodham Clinton (D-N.Y.), labeled S. 623, is less than palatable to pioneer drugmakers, so there's an expectation that alternate language will come out at some point. That's already happened in the House, where companion follow-on legislation to S. 623, H.R. 1038 from Rep. Henry Waxman (D-Calif.), has been countered by a new follow-on bill from Rep. Jay Inslee (D-Wash.), H.R. 1956.

The House Energy and Commerce Health Subcommittee has scheduled a hearing on the follow-on issue this week, and while those bills might be discussed contextually, the event will not focus specifically on any legislation, according to a staffer for Chairman Frank Pallone (D-N.J.).

Genetic Discrimination Bill Clears House

House members last week overwhelmingly passed the "Genetic Information Nondiscrimination Act" by a vote of 420-3.

The bipartisan bill, designated H.R. 493, is written to prohibit employers and insurance companies from discriminating because of an individual's genetic makeup by establishing protections against using someone's genetic information in making decisions about jobs or health coverage.

The legislation was introduced by Rep. Louise Slaughter (D-N.Y.), and a companion bill sponsored by Sen. Olympia Snowe (R-Maine), S. 358, cleared the Health, Education, Labor and Pension Committee in January. However, its progress has stalled because of a procedural hold placed by Sen. Tom Coburn (R-Okla.).