BARDA Officially Born!

And apparently it happened last month... I think I need better RSS feeds or something, but its a done deal. Here's The Scientist with the scoop:

"Last month, U.S. President George Bush signed into law the US Biodefense Advanced Research and Development Authority (BARDA), designed to speed up the development of biodefense countermeasures by funding products in the so-called advanced development stage, between the end of initial testing and commercial manufacture. However, many details about how the new entity will operate -- and its potential effect on existing drug research and development -- have not yet been entirely settled.

BARDA, a program of the Department of Health and Human Services (HHS), is intended to reinvigorate Project Bioshield, the HHS agency created in July 2004 to stockpile anti-bioterror drugs and vaccines. Project Bioshield has been criticized by large pharmaceutical companies who claim its provisions make biodefense manufacturing too risky and not profitable enough, while smaller companies interested in bioterror research say they have lacked the financial backing to develop these products.

One example of a company that might have been helped by BARDA is VaxGen, the small California biotech whose $877.5 million contract to create a new anthrax vaccine was cancelled by HHS in December because its vaccine broke down too quickly to survive long storage. VaxGen, a small biotech with limited funds, could not afford to try a different formulation; under BARDA, VaxGen might have been eligible for periodic payments to find a solution.

It is not yet clear how BARDA will distribute its anticipated funding ($1.07 billion through fiscal year 2008). Although Senator Richard Burr (R-NC), the legislation's Senate sponsor, has said that BARDA will act as an "aggressive venture capitalist," HHS spokesman Bill Hall told The Scientist the BARDA legislation doesn't give his agency the authority "to start infusing cash into organizations in a fashion akin to ‘venture capitalists,'" who typically invest money in return for partial ownership in companies.

Sen. Burr has also suggested that BARDA could fund universities and research institutions to do advanced development -- in effect, to become drug manufacturers themselves. Although this novel opportunity could point to more profits for universities, it might also spell trouble, according to some experts. Anthony Sinskey, co-director of the Program on the Pharmaceutical Industry at the Massachusetts Institute of Technology Sloan School of Management, said, "University people can't do [manufacturing] well. They think they can but they can't." Mani Subramanian, who is overseeing the construction of a small biologics manufacturing plant at the University of Iowa, agreed. "The university is not a good place to develop large-scale process and manufacturing."

The BARDA legislation was designed so there would be little overlap with the National Institutes of Health -- NIH will handle basic research, and BARDA will develop and manufacture the drugs. "So I really look at it very much so as a complimentary thing, not that they're going to be encroaching on our turf at all," said Tony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID)."

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Incredible! No DHS pie-fingering, and a total blow both Big Pharma and the FDA! I think it's quite obvious to anyone who has paid attention to the vaccine situation in this country that pharmaceutical companies don't want to produce them (they're not big money makers) and the FDA takes far too long to approve them.

I foresee the future of BARDA being very bright, and hopefully they may also take on the job of producing the treatments for rare diseases that Big Pharma also hates to make. I think giving Universities the go ahead to produce the drugs they develop is also a brilliant move.

This bill is in the true spirit of the Free Market, and I am surprised the President signed it, seeing as Big Pharma is one of his main special interest contributors. Then again, he is practically roiling in duck sauce.

Fuck you Pfizer and Merck, BARDA is coming!!!!!!