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Lawmakers concerned over slow pace of anthrax vaccine acquisition

http://www.govexec.com/dailyfed/0907/091107z1.htm
By Zack Phillips, zphillips@govexec.com

More than three months have passed since the Health and Human Services Department closed an early solicitation for anthrax vaccine, and a bipartisan group of lawmakers wants to know the results.

Rep. Bennie Thompson, D-Miss., chairman of the House Homeland Security Committee, and six other panel members wrote HHS Secretary Michael Leavitt on Monday to express concern that the department is not moving aggressively enough to acquire the anthrax vaccine.

In May, HHS released a notice seeking to identify potential manufacturers of a next-generation vaccine based on recombinant protective antigen (rPA) technology that does not use the anthrax germ itself. That solicitation closed in June. The notice said the department anticipated that a formal solicitation would be released in July, with proposals due in November, but HHS has yet to release such a request.
The lawmakers asked Leavitt how many responses the department received to the notice, and what the timeline is for issuing a formal request for information or proposals.

Spokesman Marc Wolfson said the department was expecting to release a request for proposals before the end of the year.

Delays have beset Project BioShield, a $5.6 billion program meant to lure pharmaceutical companies to the traditionally less lucrative biodefense market. The anthrax program has been a particular problem. Last December, the department terminated a contract with Brisbane, Calif.-based VaxGen Inc., the highest profile BioShield contractor, for 75 million doses of a next-generation anthrax vaccine based on the rPA technology.

VaxGen had pushed back its delivery date several times and was unable to begin its Phase 2 trial by the HHS-imposed deadline of Dec. 18. The department subsequently released the sources-sought notice for 25 million doses of a new rPA-based anthrax vaccine, but it has not said how many responses it received.

"We remained concerned that this cancellation impedes development work and sends the wrong signal to private sector companies who would seek contracts under BioShield," the letter said.

VaxGen and San Diego-based Hollis Eden Pharmaceuticals, which formerly was developing a countermeasure to radiation sickness, have said they will no longer pursue biodefense products out of frustration with HHS. And Thompson's letter said that British vaccine manufacturer Acambis, the government's main supplier of smallpox vaccine, also has decided to leave the biodefense market.

The letter also expressed concern about an implementation plan HHS released in April, because the plan scheduled the next round of acquisition of anthrax antitoxins -- which would counter multidrug-resistant anthrax -- until at least fiscal 2009, and possibly as late as fiscal 2013.

Acquisition delays are significant because many private sector firms say that for investors to fund the costly drug development process, they need unambiguous commitments on how much of a countermeasure the government plans to buy. Delays and uncertainties make investors less interested in funding such projects, they say.
As of September, the government's Strategic National Stockpile had 10 million doses of the current generation anthrax vaccine, made by Lansing, Mich.-based Emergent BioSolutions. That vaccine also has had problems, with concerns about side effects and safety leading some soldiers to sue to stop a mandatory vaccination program in the military. HHS posted a notice in April of its intent to buy another 10.4 million doses from Emergent, with an option for another 8.35 million doses, around July 24. The department and company are still in negotiations.

Emergent and the British firm Avecia Biotechnology are developing rPA vaccines, which would require fewer doses than the current generation vaccine. VaxGen is trying to sell its rPA vaccine program to another entity, although HHS' sources-sought notice precluded responses from companies with an Investigational New Drug application on hold with the Food and Drug Administration -- a condition that applies to VaxGen's vaccine.

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