Washington Editor

WASHINGTON - Those in the biodefense space should take comfort in congressional action last week around federal funding for advanced research - work that companies have had to finance themselves on the way to the pot of gold at the end of the rainbow: Project BioShield.

The House Energy and Commerce Committee unanimously cleared the "Biodefense and Pandemic Vaccine and Drug Development Act of 2006," a bill that would add another dangling carrot for developers of medical countermeasures to respond to bioterrorism and natural disease outbreaks. The measure would create a new government agency to fund product development for antidotes and vaccines against biological weapons and infectious diseases through the so-called valley of death, a period in which the industry has struggled to make progress. It would provide a single point of federal authority - the Biomedical Advanced Research and Development Authority (BARDA) - to do so.

This money, it's argued, would bridge the gap for companies that have succeeded in funding early research projects through the National Institutes of Health but don't have their own backing to reach the point at which the federal government would purchase products under Project BioShield.

"Advanced research and development gets exponentially more expensive, and therefore more risky for investors," said Chris Colwell, the director of health care regulatory affairs at the Biotechnology Industry Organization (BIO). "We need more partnership," he added. "Our companies are struggling to get to the point of commercialization."

BARDA would mete out contracts and grants for efforts around developing appropriate animal models, creating surge-capacity manufacturing techniques and coming up with diagnostic products, for example. The funds would amount to $160 million in each of the next two government fiscal years, representing a federal commitment "to help carry the water a little further through than they have been," Colwell said.

BARDA would be housed within the Department of Health and Human Services.

The bill, labeled H.R. 5533, is sponsored by Reps. Mike Rogers (R-Mich.) and Anna Eshoo (D-Calif.). Eshoo said she hoped the full chamber would urgently take up the matter, and Rogers indicated that it should reach the House floor this week.

A Senate bill, sponsored by Sens. Richard Burr (R-N.C.) and Ted Kennedy (D-Mass.), also includes a provision for creating BARDA. A broader bill that also includes antitrust protections to allow drug companies to more easily collaborate in times of an emergency is labeled S. 2564.

Once H.R. 5533 is adopted by the House, it would be sent to the Senate to merge with its companion.

Biogeneric Supporters Line Up

Biogenerics remained front and center during the second day of last week's meeting of the Generic Pharmaceutical Association (GPhA), with Sen. Orrin Hatch (R-Utah) and Rep. Nathan Deal (R-Ga.) addressing the matter in separate speeches.

Hatch, who said he has met with Acting FDA Commissioner Andrew von Eschenbach about biogenerics, expressed frustration with those in the biotech industry that oppose a fast-track approval process because they say it's "undoable." Instead, he called on stakeholders on both sides of the issue "to engage in constructive discussions" about the scientific and legal issues around biogenerics. Hatch said he remains interested in developing a legislative fix to allow for the abbreviated approvals of such products, an avenue he would likely pursue next year.

Deal, the chairman of the House subcommittee on health today, said he plans to hold a hearing on biogenerics before the end of this year.

Their comments came a day after Rep. Henry Waxman (D-Calif.) vowed to soon introduce legislation to empower the FDA to define pathways for biogeneric approvals. Under current law, the agency says it lacks power to do so. (See BioWorld Today, Sept. 20, 2006.)

New Draft Guidance Issued

Indicating that a new drug's metabolism and transport should be defined during its development, and that its interactions with other drugs should be explored as part of safety and effectiveness assessments, the FDA recently released a draft guidance titled "Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling." It is intended to provide recommendations to sponsors of new drug applications and biologic license applications on carrying out in vitro or in vivo drug-drug interaction studies. Notice of the draft was published in the Federal Register.