Washington Editor

WASHINGTON - Project BioShield, President Bush's $6 billion plan designed to encourage drug companies to develop biomedical countermeasures, isn't likely to win approval by the end of the year.

BioShield made it through the House in a lopsided 421-2 vote in July, but it never got through the Senate. (See BioWorld Today, March 28, 2003; April 7, 2003; and July 23, 2003.)

In a speech before the Chemical and Biological Arms Control Institute last week on behalf of the Biotechnology Industry Organization, Una Ryan, president and CEO of Avant Immunotherapeutics Inc. in Needham, Mass., told a lunch crowd of academic and government officials that BioShield is being held up due to some sticky issues like the lack of indemnification.

Without legal protection, many in Washington fear larger companies with the financial and scientific resources to discover and develop countermeasures will refuse to take on BioShield drugs.

"If you're big and rich, you're going to get sued," Ryan said. "I've seen lawsuits put companies out of business."

BioShield, proposed to cost about $6 billion over a decade, is supposed to help speed development of bioterrorism countermeasures by streamlining government research, creating incentives for companies and giving the government the ability to make products widely available in a public emergency. Failure to provide legal protection is particularly concerning because countermeasures are expected to make it through the FDA's approval process on an abbreviated timeline, meaning companies could skip traditional large Phase III trials used to prove safety and efficacy.

Nevertheless, BioShield is an attractive proposition to a company like Avant, which is willing to discover and develop such countermeasures, especially if the government will guarantee a market for the drugs. Avant works on vaccines that support the national biodefense effort.

Outside of indemnity, Ryan said BioShield's failure to provide adequate funds for research and development phases could be a problem. "We need more money for a longer period of time," she said, adding that money likely will be available for discovery and procurement phases.

She expects a bulk of the money to be spent on smallpox, anthrax and botulinum toxin. Ebola and plague probably will receive the least amount of funding.

Bush Gives FDA Authority On Pediatric Trials

President Bush signed legislation authorizing the FDA to force drug companies to conduct clinical trials of adult drugs used off-label in the pediatric population.

The legislation, known as the Pediatric Research Equity Act of 2003, covers all biologics and pharmaceuticals that can be used in children (for example, drugs specific to Alzheimer's disease would not be included). Companies may request an FDA waiver or deferral under the new law.

The Pediatric Research Equity Act (Senate bill 650 and House bill 2857) is effective immediately and retroactive to April 1998, when the Pediatric Rule, which essentially gave the FDA similar authority, was challenged. The U.S. District Court for the District of Columbia overturned the Pediatric Rule a year ago, saying the FDA lacked sufficient statutory authority to require such studies.

Opponents to the legislation argue that it will add another layer to the drug-review process and has the potential to discourage off-label use of drugs.

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