Bioterrorism Response Hampered by Problem of Profit

Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), said in an interview that the organization is discussing the bill and has not taken a formal position on it. But he said concerns about product liability and antitrust law at times of emergency are major obstacles.

Marie Vodicka, PhRMA's senior director for biologics and biotechnology, said companies also have to balance where they put their research dollars.

"Our companies are dedicated to meeting current health needs, and that has to be factored in when looking at the theoretical threats of the future," she said.

One of the authors of the Hatch-Lieberman bill recently called the wildcard patent extension proposal essential to getting major drugmakers involved. Chuck Ludlam, former legislative counsel to Lieberman, said at another recent hearing that big drug companies will get involved with vaccines, antibiotics and other possibly money-losing endeavors only if shareholders can be convinced that the money will be made up elsewhere.

"People have to understand that there's basically no interest in this market to start with," Ludlam said. "The question is how to incentivize it, and that means something like the wildcard extensions."

Some of the most vocal critics of the bill are officials of the generic drug industry, which makes medications at significantly lower prices after their patents expire. Their trade group, the Generic Pharmaceutical Association, agrees that BioShield needs to be broadened to include liability protection, guaranteed government purchases of bioterrorism drugs and greater government investment in research and development, but argues that the wildcard provision will have broad and negative effects.

"The wildcard would destroy the generic industry," association president Kathleen Jaeger said. "We would never know which products might be protected by the branded maker, and so we would lose the predictability we need to do our own research and development into drugs coming off patent."

The bill is now before the subcommittee on bioterrorism, chaired by Sen. Richard Burr (R-N.C.), and spokesman Douglas Heye said Burr will hold more hearings after the August recess and wants the committee to vote on it in the fall. Burr is talking with Senate leaders about getting time for a possible floor vote, Heye said.

Burr has an open mind when it comes to the wildcard provision, Heye said. But he also said that "we're definitely looking for some way to incentivize the industry. Without that, we probably won't make much progress getting them involved."