Vaccination News Home Page

http://www.nytimes.com/2002/05/22/politics/22BIO.html

Negotiators Reach Compromise on Measure to Strengthen Safeguards Against Bioterror

By ROBERT PEAR

ASHINGTON, May 21 — House and Senate negotiators announced tonight that they had finished work on a bill to defend the nation against bioterrorist attacks, to expand government stockpiles of antibiotics and vaccines and to tighten federal regulation of laboratories handling deadly microbes.

The bill, which reconciles measures passed by the two chambers, would also improve food safety and protect water systems that supply drinking water to most Americans. In addition, it reauthorizes a program of user fees paid by drug companies to speed the review and approval of new medicines.

President Bush is expected to sign the bill. The House plans to approve the compromise measure this week, with the Senate expected to follow suit early next month.

Congress began work on the legislation within days of the attacks on the World Trade Center and the Pentagon on Sept. 11. Lawmakers saw a much greater need for the legislation when anthrax infections caused panic a few weeks later. The House and Senate approved different versions in December.

Representative Billy Tauzin, Republican of Louisiana, chairman of the House-Senate conference panel that wrote the final version of the legislation, said, "This bill will improve our ability to respond effectively and quickly to bioterrorist threats and other public health emergencies."

Senator Edward M. Kennedy, Democrat of Massachusetts, who led the Senate negotiators, said the bill "will add as much to the security of this nation as any investment we could make in planes, tanks, missiles or other conventional arms."

Under the bill, states would get $1.5 billion in federal grants to prepare for a biological attack.

The bill includes a provision extending a 1992 law that imposes user fees on manufacturers of brand-name prescription drugs. The money, used to hire hundreds of federal drug reviewers, speeds the approval of new medicines.

The user fees, about $530,000 for each new drug application, generate $177 million a year, or slightly more than half the budget of the Food and Drug Administration for review of new drugs and vaccines. The authority to collect these fees would be extended for five years under the agreement reached tonight.

House and Senate negotiators considered imposing similar user fees on certain low-cost generic versions of prescription drugs. But this plan was dropped today after protests by lobbyists from the Generic Pharmaceutical Association, who said the fees would create new barriers to the marketing of generic drugs.

The bill provides money for the food and drug agency to monitor the safety of drugs and medical devices already on the market. The agency is supposed to keep better track of illnesses, injuries, birth defects and deaths caused by such products.

In addition, the bill provides $27 million over the next five years for the Food and Drug Administration to scrutinize the advertising and promotion of prescription drugs. Many lawmakers say they believe that consumer advertising contributes to rapid growth in drug spending, as patients ask doctors to prescribe drugs advertised on television.

The legislation authorizes up to $45 million in the next five years for the Food and Drug Administration to speed the review and approval of generic drugs.

Researchers working with deadly biological agents and toxins would have to register with the federal government. Many noncitizens would be denied access to about three dozen microbes deemed by the government to be particularly dangerous.

The $3 billion bill provides money to buy hospital equipment and to train medical workers to deal with incidents of bioterrorism. Up to $520 million is designated for hospitals to prepare for medical emergencies.

Lawyers said the food safety provisions of the bill represented the most significant expansion of federal authority over the food industry in more than six decades.

The legislation would increase inspections of imported foods, require importers to give notice of shipments, require food manufacturers and processors to register with the government, and authorize the F.D.A. to detain food products without a court order if the items appeared to endanger public health.

The bill also gives federal agents broad new powers to inspect company records that might help trace the source or the chain of distribution of tainted foods. Federal health officials estimate that foodborne diseases cause 76 million illnesses, 325,000 hospitalizations and 5,000 deaths in the nation each year.

Under the bill, operators of drinking water systems will have to assess their vulnerability to terrorist attack, develop emergency plans and submit those plans to the Environmental Protection Agency. House Republicans had said the agency did not have the ability to handle such sensitive information, but the compromise includes strict security measures to protect the information.

The bill also provides $300 million to the Centers for Disease Control and Prevention to upgrade its laboratories and scientific equipment.

House and Senate negotiators were near agreement on a provision that would have speeded federal review of new medical devices, as requested by the makers of such devices. But no such provision was adopted. In the end, Democrats said, they could not accept the industry's request to have outside experts conduct the primary review of many devices for the F.D.A.

The principal negotiators who worked out the agreement, besides Mr. Tauzin and Mr. Kennedy, were Senator Bill Frist, Republican of Tennessee, and Representative John D. Dingell, Democrat of Michigan.

Vaccination News Home Page

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.