Washington Editor

WASHINGTON - Congress, the Obama administration and taxpayers need to come to grips with the fact that drugmakers are not going to pursue discovery and development of emergency medical countermeasures out of the kindness of their hearts and they must provide industry more incentives to maintain and sustain those products, said Gerald Kovacs, director of CBRN countermeasures at the Biomedical Advanced Research and Development Authority (BARDA).

Unfortunately, Kovacs said, his agency still struggles to convince lawmakers and others that chemical, biological, radiological or nuclear (CBRN) countermeasures remain a priority for U.S. national security.

BARDA manages Project BioShield, created by Congress in 2004 to accelerate R&D of medical countermeasures. Congress established a special reserve fund of $5.6 billion to be appropriated for BioShield from 2004 through 2013.

Kovacs said $2.6 billion of those funds have been spent, with "$3 billion to spend between today and the end of fiscal year 2013."

But, he told drugmakers and government officials Thursday at the annual Public Health Emergency Medical Countermeasures Enterprise conference, BARDA has had to spend an "inordinate amount of time" protecting its funds against reallocation efforts.

Indeed, a recent report from the bipartisan Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, which was established by Congress to build on the 9/11 Commission's work, noted that the administration has attempted to "raid" funding intended for biopreparedness programs. (See BioWorld Today, Oct. 26, 2009.)

BARDA's budget also recently has been funded by continuing resolutions rather than regular budget cycles, which has restricted long-term planning for the agency, Kovacs said.

"We are educating our new administration and appropriators . . . as to the need for funding in advanced research and development," he said, urging industry and state and local officials to assist in that venture.

Kovacs surmised about the devastation the nation may be facing had the current health crisis in the U.S. been a broad attack of weaponized anthrax rather than pandemic flu.

CBRN medical countermeasure development should be made a priority, similar to the urgency that was placed on pandemic influenza when Congress appropriated emergency supplemental funds in 2005 and 2006, he contended.

Kovacs noted that most late-stage CBRN programs have already been procured by Project BioShield, with only a limited number of new programs ready for submission. Nearly all of those projects are from the biotech community, with little interest from big pharma, Kovacs added.

Nonetheless, he said, BARDA-funded programs have largely been a success. One such program has been Annapolis, Md.-based PharmAthene Inc.'s recombinant protective antigen anthrax vaccine, said Kovacs.

But PharmAthene CEO David Wright noted that his company has been awaiting a BARDA contract award since last year for its anthrax vaccine based on a request for proposal issued in February 2008.

"We don't know if it will be awarded this week or next year," Eric Richman, senior vice president of development and strategic planning at PharmAthene, told BioWorld Today.

He noted that the RFP has undergone five amendments since it was originally issued, which Richman said has been costly for companies responding to those requests. Several BARDA officials contacted at the conference could not provide the status of the anthrax contract.

"The industry is very frustrated by BARDA's lack of execution," Wright charged.

Kovacs acknowledged that the animal rule, which permits a drug's effectiveness to be demonstrated in animals when it is unethical or not feasible to conduct controlled clinical trials in humans, also has been somewhat challenging for drugmakers pursuing CBRN agents.

Rockville, Md.-based Human Genome Sciences Inc. recently ran into a problem with the animal rule with its application for its investigational inhalational anthrax treatment raxibacumab.

The company received a complete response letter last month after regulators had raised concerns whether the animal model used in the company's studies had adequately reflected the findings from patients with inhalational anthrax whose response to antimicrobials approximated the 55 percent seen during the spread of anthrax spores in the mail in the fall of 2001. (See BioWorld Today, Oct. 26, 2009, Oct. 27, 2009, and Nov. 17, 2009.)

"In certain respects, the complete response letter appears to be inconsistent with the FDA's published final rule governing the development of new drugs when human efficacy studies are not ethical or feasible," Sally Bolmer, senior vice president of development and regulatory affairs at HGS said in a statement.

PharmAthene's Wright said HGS' experience is evidence that the FDA needs a special division to review medical countermeasure products.

But Boris Lushniak, assistant commissioner of counterterrorism policy at the FDA, disputed that notion.

"Our approach thus far, and we think it has been successful, is we go back to the experts in our centers who know those product lines," he told BioWorld Today.

Lushniak noted that each of FDA's centers includes medical countermeasure experts who, while not involved in the drug review process, do provide feedback or expertise when needed.

Lushniak said his office, which is focused on policy, also provides input when asked.

What his office does not do, he emphasized, is get involved with BARDA or Department of Defense contract awards to drugmakers.

"It is best that we don't stick our nose into the idea of who is getting contracts for what or who is getting paid for what, because at the end of the day, we still have to look at a product on its own merits," he said.