Washington Editor

WASHINGTON - Amid talks on further bioterror legislation, some in the biotech industry are pressing lawmakers for changes to improve Project BioShield, which was passed in 2004 to produce and stockpile countermeasures to bioterror threats.

Industry critics and allies in Congress have charged that the program has been slow to produce results.

"More must be done," said Peter Young, president and CEO of AlphaVax Inc., of Research Triangle Park, N.C. His comments, which came during testimony before the House Energy and Commerce Subcommittee on Health, also included a call for essential reforms to the BioShield partnership" between industry and government.

Young also was speaking on behalf of the Biotechnology Industry Organization (BIO) in Washington.

He appealed for Congress to authorize funding to fill the gap between early stage research and commercialization, the so-called "valley of death" in which small biotech outfits say they are unable to secure private backing.

That recommendation was echoed by Bruce Cohen, president and CEO of Cellerant Therapeutics Inc. in San Carlos, Calif., who complained to the subcommittee about the dearth of clinical trial funds associated with BioShield's current iteration.

Young also stressed better coordination among the federal agencies that mete out BioShield projects.

That request was seconded by David Wright, president and CEO of PharmAthene Inc., who said there were "too many players" on the field.

"Clarity in establishing a central authority is imperative," he said, noting that a single source for identifying research areas, funding clinical development and overseeing stockpile procurement would streamline the whole system.

In addition, Wright said his company's venture capital supporters now are backing away because of a lack of market guarantees, an issue not unique to Annapolis, Md.-based PharmAthene - many think big pharma has not gotten behind BioShield due to a missing market incentive.

Cohen, who agreed that the current setup is not drawing private capital, added that it "can be fixed."

Although the government is the intended buyer of countermeasures developed under BioShield, all in attendance were critical of an inability to predict the sizes of future orders and an unclear focus on priority areas of research.

There was a resolute demand for more money in the coming versions of BioShield; the original legislation authorized $5.6 billion. "A real commitment to fund biosecurity is paramount," Wright said.

Tara O'Toole, CEO and director of the Center for Biosecurity at the University of Pittsburgh Medical Center, called for an increase of 10 times the current amount.

"Sufficient, sustained funding is absolutely critical to Project BioShield," Wright added.

In the background of the hearing is a good deal of criticism. There is fear of liability protection that proponents said are necessary to entice better industry involvement. In addition, there is opposition to the so-called wildcard patent incentive, which would allow successful countermeasure developers to extend a patent on another product in their portfolio, at their discretion and regardless of its importance to BioShield.

In addition, the biotech company that received the largest single government contract to date under Project BioShield, VaxGen Inc., has come under fire. A congressman has called for an investigation into the Brisbane, Calif.-based firm's 75 million-dose, $877 million anthrax vaccine contract for the national stockpile. VaxGen replied that the November 2004 award resulted from an open, competitive and fair solicitation.

However, the company recently conceded a potential delay in delivering on the contract - estimated to be ready for the Department of Health and Human Services in the fourth quarter - should HHS require additional data beyond what is currently required. VaxGen has reformulated its original vaccine due to issues that arose with its adjuvant, but has stressed the vaccine's safety and immunogenicity was maintained.

Von Eschenbach Leaving NCI Post

Acting FDA Commissioner Andrew von Eschenbach said last week that he would resign his position as the director of the National Cancer Institute, according to a Reuters report.

He has held both roles for more than six months, since being tapped by President Bush to lead the FDA on an interim basis following the abrupt departure of its previous commissioner, Lester Crawford. Critics have voiced concern over his dual capacity because of conflict-of-interest matters. (See BioWorld Today, Sept. 27, 2005.)

Leaving the NCI isn't likely to satisfy those critics, even though von Eschenbach previously indicated that he would recuse himself from issues related to products and companies that could be tied to his NCI position. He has other opponents as well, namely two senators who have indicated that they would block von Eschenbach's FDA nomination because of the agency's failure to act on an application to make the Plan B birth control product available over the counter.

Bush nominated him for the FDA commissioner's job last month. (See BioWorld Today, March 17, 2006.)

Since von Eschenbach first took control of the FDA, operational control of the NCI has been assumed by John Niederhuber, its deputy director and deputy director for translational and clinical sciences.

Von Eschenbach, a urologist and cancer survivor, received a presidential appointment to head the NCI in January 2002.

FDA Contracts For Phase IV Analysis

In an effort to get a better grip on post-marketing studies, the FDA has enlisted the consulting firm Booz Allen Hamilton Inc. to evaluate the whole process.

The FDA has been criticized for failing to enforce Phase IV study commitments, which often are requested as part of a product's approval but seemingly go unchecked, critics have charged. They are designed to enhance product knowledge by further defining safety, efficacy and optimal use in larger settings than those employed in pre-approval studies.

Agency Clears First Generic HIV/AIDS Capsule

The FDA approved the first generic capsule for HIV and AIDS, zidovudine (Retrovir, GlaxoSmithKline plc). Tablet and oral solution forms received approval in September. A nucleoside reverse transcriptase inhibitor, it initially was approved in March 1987 as the first in its class. The antiretroviral drug is intended for use with other antiretrovirals for HIV-1 infection. The capsule is manufactured by Aurobindo Pharma Ltd., of Hyderabad, India.