Washington Editor

WASHINGTON The decision on whether the biotechnology industry will be protected in pending bioterrorism legislation likely will end up in the hands of President George Bush, a government official told BioWorld Today Thursday.

House and Senate versions of bioterrorism bills headed to conference committees fail to fully address protections and incentives necessary to encourage the biotechnology industry to take an interest in developing vaccines and medicines to combat bioterrorism, Chuck Ludlam, counsel for Sen. Joseph Lieberman, said.

But Lieberman, a Democrat from Connecticut, introduced legislation late last year that was considered friendly to the industry. In his bill (S. 1764), biotechnology companies would be assured pre-established prices in a predictable market, and they would be protected against liabilities that could arise from limited product trials.

Since the Lieberman bill didn’t make it into conference, it will be up to Bush to decide the bill’s fate.

“We have to give the biotechnology industry a good reason to do the research,” Ludlam said. “This is an industry that lost $5 billion last year and it needs protections in this research.”

The Lieberman bill, as well as the House and Senate versions, was discussed by a panel of lawyers and government officials, including Ludlam, Thursday at a Food and Drug Law Institute conference here.

The House bill (HR 3448), known as “The Public Health Security and Bioterrorism Response Act of 2001,” authorizes $3 billion in fiscal year 2002 spending, including $1 billion in state and local grants that could be used to develop drugs, therapies or vaccines. Introduced by Reps. Billy Tauzin (R-La.) and John Dingell (D-Mich.), the legislation made it through the House in a 418-to-2 vote. (See BioWorld Today, Dec. 17, 2001.)

Meanwhile, around the same time in the Senate, Edward Kennedy (D-Mass.) and Bill Frist (R-Tenn.) introduced the “Bioterrorism Preparedness Act of 2001” (S.1765), which calls for $3.25 billion in fiscal 2002 spending, including $1.46 billion in local and state grants. The Kennedy-Frist legislation was introduced with 74 co-sponsors. (See BioWorld Today, Dec. 17, 2001.)

Ludlam was quick to point out that the Lieberman bill complements, rather than competes with, the House and Senate versions.

As he sees it, one primary problem since Sept. 11 has been the allocation of federal money. “So far the focus on the executive level has been on government spending and response not on the entrepreneurial aspect.”

Ludlam and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, and another conference speaker, agreed that another bioterrorism threat whether in the form of anthrax or smallpox is certainly a possibility.

“It may be in five or 10 years, but at some point these terrorist groups will probably have Ph.D.s on their teams, and we need to be ready,” Ludlam said.

The issue in the future, though, is how the government and the health care industry will respond.

Fauci said in most cases, hospitals and other health care providers lack the most basic diagnostic tests to even determine whether a patient has something like smallpox.

The U.S. has 15 million smallpox vaccine doses, but several months ago a study commenced to determine whether the vaccines could be diluted to 75 million doses. Fauci said the results will be released in the first week of March. He said the study went well.

The anthrax scare last fall may have served as a wake-up call for some officials around Capitol Hill, panelists agreed.

“Cipro [Bayer AG’s anthrax antibiotic] gave us a false sense of security last year,” Ludlam said. “It was kind of like a game go down and have your nose swabbed and take Cipro. But I think if you have vaccines and no medicine, then you could have a real mess on your hands.”