President Bush gave out an early Christmas present to the biotech industry on Tuesday after signing a bill that creates a somewhat controversial bureaucracy that would give tax dollars to private companies and universities to develop vaccines and treatments. The bill, the “Pandemic and All-Hazards Preparedness Act” (S. 3678) creates the Biomedical Advanced Research and Development Agency (BARDA), which will dole out $1.07 billion over two years to be used to help biotechnology companies make the leap from initial research to market ready – a gap known now as the “Valley of Death.”
Earlier, Congress appropriated $3.3 billion for pandemic preparation. Project Bioshield, created in 2004, set aside $5.6 billion over 10 years for drugs against bioterrorism threats such as anthrax, smallpox, and the plague. Project Bioshield was intended to promote the development of medical defenses against biological, chemical, and radiological weapons by guaranteeing that the government would buy promising products, which otherwise would be unlikely to find a market. Large pharmaceutical companies have shown little interest in pursuing BioShield contracts so contracts have gone to smaller companies.
The problem remained that most companies didn’t want to take on all the risk of the drug development process for a chance at the sale. The cost of the liability (and, hence, liability insurance) in relation to the projected profit margin made the deal unattractive to most companies. It is noteworthy that eighteen percent of all biotechnology companies rate the cost of product liability insurance as the most important problem facing their firms. It is hoped that BARDA will help fund the early development and share in the risk. The legislation says the HHS Secretary will coordinate the product research and development by:
- facilitating collaboration between HHS and other agencies, industry, academia, and other persons, with respect to such advanced research and development;
- promoting countermeasure and product advanced research and development;
- facilitating contacts between interested persons and the offices or employees authorized by the Secretary to advise such persons regarding requirements under the Federal Food, Drug, and Cosmetic Act; and
- promoting innovation to reduce the time and cost of countermeasure and product advanced research and development.
The Act will also reform the contracts authorized by Project BioShield to include advanced payments worth up to 5 percent of the value of a contract. It will also create exemptions from anti-trust laws for such work developing and manufacturing countermeasure products. That provision is set to end six years after enactment.
The bill was supported in Congress by Sen. Richard Burr, R-N.C., who spent the last two years trying to create a program acceptable both to biotechnology companies and to the public. There were lots of critcs to the original language that would have exempted BARDA from the Freedom of Information Act when no other government agency has such a broad veil of secrecy.
The act signed into law contains a provision prohibiting disclosure of “technical data or scientific information” that would reveal vulnerabilities of the nation’s defenses that aren’t publicly known. Defining that trigger is up to the secretary of health and human services.The legislation limits any disclosure of “specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under subsection (c) that reveals significant and not otherwise publicly known vulnerabilities of existing medical or public health defense against biological, chemical, nuclear, or radiological threats.”
The Federation of American Scientists fears the secrecy could prevent any information from coming out.Meanwhile, the Department of Health and Human Services (HHS) has canceled its $877.5 million contract with VaxGen Inc. for a new anthrax vaccine, after problems with the vaccine’s stability caused the company to miss a critical deadline for starting a clinical trial. Because of concerns about the vaccine’s stability, the Food and Drug Administration (FDA) refused to allow VaxGen to start a Phase II Clinical Trial on Dec 18, as required by HHS so the government terminated for default.
The contract, awarded in 2004, called for VaxGen to produce 75 million doses of a new anthrax vaccine — enough to immunize 25 million people. The hope was that the vaccine would improve on the anthrax vaccine used by the US military, called anthrax vaccine adsorbed (AVA). The VaxGen vaccine is based on a recombinant form of protective antigen (rPA), a key anthrax protein. It was expected to provide immunity in 3 doses, rather than the 6 doses required for AVA, and to cause fewer side effects.
See earlier post: Bioshield Bill Would Provide Drug Patent Term Extension.
