Senate passes BioShield; $5.6B slated for industry 

With bipartisan support from the likes of Sens. Bill Frist and Edward Kennedy, Project BioShield passed the Senate in a 99-0 vote.

If signed into law by President Bush in the next few weeks, BioShield would flood the industry with $5.6 billion over the next decade for the procurement of vaccines against chemical, biological, nuclear or radiological attacks. The federal budget for 2004 allocates $890 million to the project.

Products under consideration for BioShield are a recombinant protective antigen (rPA) anthrax vaccine, anthrax therapeutics, a next-generation smallpox vaccine, antitoxins to Clostridium botulinum neurotoxins, a plague vaccine, and a botulism vaccine. Potential future products include an Ebola-Marburg vaccine, a Rift Valley fever vaccine, novel antibiotics and anti-infectives, polyclonal human anthrax and botulism antibodies, and a third-generation anthrax vaccine.

Bush introduced the nation to Project BioShield in his January 2003 State of the Union address. The idea behind the plan was to speed development and availability of countermeasures by streamlining government research, creating incentives for companies to take on the research and providing the FDA with the authority to make investigational products widely available in a public emergency.

As passed, BioShield would not provide companies with research and development money, said Frank Rapoport, a partner with McKenna Long of Philadelphia. He also is an attorney for Aventis Pasteur Inc., the vaccine business of Aventis SA, of Strasbourg, France.

Under BioShield, "the government will enter into a contract promising to buy a product that [a company] promises to develop with its own money in the next eight years," he told BioWorld Today.

FDA initiative seeks to speed up approvals 

Pressure from Congress and the public to gain access to more efficacious, less expensive drugs and biologics has caused the FDA to rethink its role in the drug development process.

Earlier this year, the agency introduced the critical path initiative, a project to create a new generation of performance standards and predictive tools aimed at providing better and quicker results on safety and effectiveness of investigational products.

FDA officials over the last several months have taken the podium at conferences in Washington looking to sell the plan as a positive step for drug companies, and recently kicked off its campaign called "The Critical Path, From Concept to Consumer."

Each year, new guidance on different diseases or indications will be issued under the critical care initiative. For example, if an obesity drug were the subject of a critical path, the FDA would provide descriptive guidance about what is expected in the clinical and regulatory process from concept to bedside. Also, the FDA expects to provide scientists, investors, and companies with information on the types of diseases needing new treatments and on research grants available through the NIH in Bethesda, MD.

The initiative also calls for the FDA to work with the industry, academia and other government agencies to develop the "Critical Path Opportunities List," which is designed to identify areas that would most benefit from a modernized path of medical product testing and manufacture.

Janet Woodcock, former director of the Center for Drug Evaluation and Research who now serves as the agency’s acting deputy commissioner for operations, said the FDA contends that companies will get to market with fewer hurdles if they use the critical path once they come up with an idea for a drug.

OHRP to require IRB registration 

The Office for Human Research Protections (OHRP) is proposing to require registration of IRBs that review human subjects research conducted or supported by the Department of Health and Human Services (HHS) and that are designated under an assurance of compliance approved for federalwide use by OHRP.

Under the current OHRP IRB registration system, the submission of certain information is required by the existing HHS human subjects protection regulations and certain other information may be submitted voluntarily. Under the proposed rule, all registration information will be required, making the IRB registration system uniform with the proposed IRB registration requirements of the FDA and creating a single HHS IRB registration system. FDA simultaneously is publishing a proposed rule regarding FDA IRB registration requirements.

Comments on the OHRP notice must be received on or before Oct. 4, 2004. The notice can be accessed as a PDF document at www.hhs.gov/ohrp/news/irbnotice.pdf.