Washington Editor

WASHINGTON - In nearly unanimous votes last week, the House and Senate passed bioterrorism legislation containing a few provisions of which the Biotechnology Industry Organization is particularly proud.

"The Public Health Security and Bioterrorism Preparedness and Response Act" sailed through the Senate in a 98-0 vote, and through the House in a 495-1 vote. (Rep. Ron Paul, a Republican from Texas, voted against it.)

With support like that, no one expects it to have trouble when it lands on President Bush's desk in the next week or so.

While the legislation pumps millions of dollars into programs aimed at improving public preparedness in the event of a biological attack, it also eases certain regulations on companies dealing in deadly biological agents, and it offers advantages to companies making drugs to fight biological warfare.

In the realm of deadly biological agents, the legislation includes a list of 36 materials and toxins that would fall under new registration requirements as imposed by Tommy Thompson, secretary of Health and Human Services, according to a statement released by Rep. Billy Tauzin (R-La.).

"If your product is on the list, there would be a whole new set of requirements imposed on you," Sharon Cohen, vice president of government relations for the Biotechnology Industry Organization (BIO), told BioWorld Today. "We argued very strongly that if something is already approved by the FDA, then imposing new regulations was somewhat redundant and unnecessary and that the secretary should provide an exemption for materials that have already been approved."

Furthermore, Cohen said BIO argued that if any of those materials were the subject of clinical trials, "there should be some pathway available for companies to seek an exemption."

In the final legislation, the lawmakers agreed. A Congressional report on the subject cited Botox as an example. "HHS currently exempts the FDA-approved medical product Botox, which is the select agent botulinum toxin, when it is used by licensed physicians in the treatment of patients. However, when it is used in purely research settings or as part of early stage clinical trials, HHS has chosen not to exempt Botox from current regulations."

The legislators said they would not alter that flexibility.

Cohen said the bill includes a provision for speeding the FDA approval process for drugs or biologics designed as countermeasures for bioterrorism. "If you look at the historical pattern for biotech drugs, it can take a very long time to get through the approval process. Well, now we need things a little faster, so the legislation speeds up the FDA's ability to review and approve new therapeutics or other items for defending the nation."

In other areas, the legislation authorizes the FDA and the U.S. Department of Agriculture to hire new inspectors to monitor U.S. borders, to develop new methods to detect contaminated foods and to work with state food safety regulators to protect crops and livestock.

And a portion of roughly $1.5 billion would be awarded in the form of grants to help pay development costs of new drugs, therapies and vaccines. Furthermore, $300 million has been set aside to upgrade and improve capabilities at the Centers for Disease Control and Prevention in Atlanta, and $1.15 billion will be spent by the Department of Health and Human Services to expand the national stockpiles of medicines and other supplies, including the purchase of additional smallpox vaccines.

PDUFA Attached To Terrorism Bill

When negotiations about reauthorization of the Prescription Drug User Fee Act (PDUFA) got under way several months ago, representatives at BIO estimated that the law would be reauthorized this summer, well before it expires in September.

It appears that BIO was correct, given that PDUFA has been added to the bioterrorism bill.

Approved in 1992 and reauthorized in 1997 (it expires every five years), PDUFA lets the FDA charge biotechnology and pharmaceutical companies fees when they submit drug applications. (See BioWorld Today, March 26, 2002, and Nov. 26, 2001.)

The reauthorized version - as formulated by BIO, the FDA and the Pharmaceutical Research and Manufacturers of America - would increase fees from about $300,000 in 2001 to $400,000 per application. Income from fees would increase from about $160 million in 2001 to $223 million in 2003, with the amount expected to be near $260 million by 2007. (See BioWorld Today, May 23, 2002.)