Lawmakers press improvements to Project Bioshield

By Chris Schneidmiller

June 7, 2006

Legislation is being introduced again this year intended to go beyond Project Bioshield in promoting development of drugs that would be needed to treat victims of an act of biological terrorism.

Reps. Mike Rogers, R-Mich., and Anna Eshoo, D-Calif., on Tuesday submitted the House Biodefense and Pandemic Vaccine and Drug Development Act of 2006. Senator Richard Burr, R-N.C., filed a largely identical bill in April, following a failed initiative last year.

Sponsors hope the legislation would fill gaps in the 2-year-old Bioshield program, which critics say has failed to spur industry to develop new vaccines and countermeasures. Lawmakers propose to create a single point of contact within the Health and Human Services Department to work with pharmaceutical and biotechnology companies on determining the priorities for biosecurity funding and research.

The bills would also allow government financing to companies during the extended period of drug development and study known within the industry as the "valley of death." Those two to five years in which firms now receive no federal financial support, and cannot be sure their product will be purchased, reduce the incentive to create treatments for an inevitable terrorist attack, speakers said at a meeting Tuesday.

Rogers and representatives from academia and industry painted a dire picture of a nation unprepared for a natural pandemic or the use of biological weapons by terrorists or an enemy state.

"It's not a question of if that happens but when that happens," said former Congressman Jim Greenwood, president and CEO of the Biotechnology Industry Organization. Adversaries of the United States have "both the will and the ability to launch these bioterror attacks," he said.

Weapons spreading infectious agents have the potential to cause hundreds of thousands to millions of deaths, said Tom Inglesby, deputy director for the University of Pittsburgh Center for Biosecurity. Destabilization caused by such a crisis could undermine the economy, a sense of community and even basic services such as electricity, he said.

Advances in science are creating the potential for stronger agents capable of inflicting greater damage, while access grows to the technology and expertise needed to produce those weapons, Inglesby said. Those developments are outstripping efforts meant to save those exposed to agents such as smallpox, plague or Ebola. "It is truly a race, and right now the defense is losing to the offense," he said.

The 2004 Project Bioshield Act designated $5.6 billion for development of weapons of mass destruction countermeasures. The program to date has funded production of only a few drugs. The largest order, for 75 million doses of anthrax vaccine, is two years behind schedule.

It costs on average $800 million to produce a single drug. Industry experts have said there is little incentive under Project Bioshield for large pharmaceutical companies to spend huge amounts of money and time -- up to 15 years from conception to production -- on a treatment that is likely only to be used during a crisis. Pharmaceutical firms prefer to manufacture drugs that are used regularly.

Smaller firms are less able to push a drug through extended periods in which they receive no government funding, and tire of bureaucratic hurdles along the way, critics say.

"Bioshield was a great start, it was a good start, it was a well-intended start to get us to where we are defended in the United States against bioterrorism," Rogers said. "But what we found is there were a series of problems, problems that we're going to fix today."

The House and Senate bills would allow HHS for the first time to offer milestone payments to companies as work progresses, and to fund development of drug manufacturing capacities.

As proposed in the Senate last year, the agency would be allowed to enter into exclusive contracts with a specific company for a particular drug. The House legislation, however, encourages HHS to pursue multiple bids in an effort to offset criticism that the single-provider provision would increase the cost of drugs.

The legislation again calls for a "Biomedical Advanced Research and Development Authority" within HHS to lead federal biodefense investment. Representatives from the federal government, pharmaceutical and biotechnology industries, academia and other areas would sit on a board within the office to help identify priorities. It is hoped that such involvement would also promote countermeasure research and development by those entities.

Supporters of the legislation hope it will prod more companies into developing weapons of mass destruction countermeasures and speed work once it is under way. Burr's legislation last year faced criticism for exempting the new HHS office from the Freedom of Information Act and other sunshine rules. Those exemptions remain in this year's proposals.

While there is a need to withhold some information, broad secrecy would make it difficult for the public to determine the value of the biodefense work being conducted and could create suspicions by other nations on the intent of the effort, said Alan Pearson, director of the Biological and Chemical Weapons Control Program at the Center for Arms Control and Nonproliferation.

"The danger is that you cold withhold a lot of information about your ongoing biodefense activities, information that we feel should be released to the public for safety reasons," he said Wednesday.

There are no liability provisions in either 2006 bill. Democrats objected to a component of last year's Senate bill that required the HHS secretary to approve liability lawsuits against manufacturers of treatments used during a declared biological public health emergency.

One biodefense industry representative said the legislation would "markedly help" promote production of new drugs. He said, however, that more needs to be done to improve HHS' partnership with industry. The agency has failed to seek contracts for "obvious" biological threats -- such as a new smallpox vaccine that would fully replace existing stocks -- and has made "unilateral" modifications to contracts after work is under way by the contractor, he said. "The agency hasn't behaved like a partner in many cases," he said.

A department spokesman did not respond to a request for comment Wednesday.

Rogers and other speakers Tuesday called on Congress to act on the bills this year.

"We think this is incredibly important," he said. "This is one of the most important things we're going to do in the near term to make sure in American research and development and know-how to build that biodefense system around this great country of ours so that this doesn't come to a town near you."


By Chris Schneidmiller

June 7, 2006

http://www.govexec.com/defense/2006/06/lawmakers-press-improvements-to-project-bioshield/21986/