In 2000, the Pentagon's Defense Science Board concluded that to successfully respond to a bioterrorist attack, the United States would need 57 specific drugs, diagnostic tools and vaccines. At the time, only one was available.
Five years later, officials say that number has increased to two.
Despite the promises of the drug industry after the 2001 anthrax attacks, and last year's passage of the $5.6 billion Project BioShield bill designed to speed development of new products, officials say the nation is scarcely any better protected than it was in 2000.
Now, in a renewed effort to encourage the drug industry to develop and produce the needed countermeasures, senators are aggressively promoting legislation that would grant companies unprecedented enticements to work on meeting the bioterrorism defense needs on the classified list.
One of the key incentives -- extending patent protection on the most profitable drugs of companies that develop new defenses against biological weapons -- has set off sharp protests.
This "wild-card patent extension" could be worth billions by shielding a drug company's products from generic competition for up to 18 additional months.
The bill's sponsors, including Sens. Orrin G. Hatch (R-Utah), Joseph I. Lieberman (D-Conn.) and Sam Brownback (R-Kan.), say that without an incentive of this magnitude, big drug companies will not invest in financially risky bioterrorism research. Although vaccines and antibiotics for smallpox, anthrax, plague and other potential biological weapons may be lifesavers some day, they are unlikely ever to be profitable.
Opponents say the patent extension is a giveaway to the drug industry that would keep the costs of widely used drugs unnecessarily high. Last month, Sen. Charles E. Schumer (D-N.Y.) called the patent extension provision "outrageous" and a boondoggle that would help the pharmaceutical industry more than Americans.
Hatch said critics of the BioShield II bill were misguided. Although the bill may be criticized as going too far, he said, "the day after the next bioterrorist attack or natural disease outbreak, I bet there will be 535 members of Congress who will be thinking that it did not go fast or far enough."
He added that drugmakers have "largely voted with their feet, or at least their pocketbooks" and not engaged "in the search for medical countermeasures to bioterror agents and emerging infectious disease."
Drugmakers and their supporters say companies could face ruinous lawsuits if their admittedly risky products unintentionally harm people. Under new Food and Drug Administration regulations announced after the 2001 anthrax attacks, bioterrorism defense products can be approved without the clinical testing on people that is required for new drugs and vaccines, and so might be riskier than most medications.
The BioShield II bill would give companies broad liability protection. In a recent Senate hearing, only George W. Conk, a product liability specialist and professor at Fordham University School of Law, aggressively criticized the provision, saying it went too far and would protect companies that acted negligently and irresponsibly.
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."