House, Senate Negotiators Reach Agreement on Bioterrorism Preparedness Legislation
House and Senate negotiators reached an agreement yesterday on legislation to strengthen the nation's preparedness against bioterrorist attacks, the New York Times reports. The House is expected to approve the measure this week, with Senate passage and President Bush's signature expected early next month. The bill, which will likely cost about $3 billion a year, with half of that amount going to states, is a compromise between separate measures approved by the House (HR 3348) and Senate (S 1715) last December in the wake of the Sept. 11 attacks and subsequent anthrax incidents (Pear, New York Times, 5/22). The agreement calls for greater stockpiling of vaccines and antibiotics to protect against biological and chemical weapons, as well as expanded supplies of potassium iodide for communities near nuclear plants to handle contamination in the event of an attack (Dewar, Washington Post, 5/22). Under the legislation, hospitals would receive up to $520 million to purchase new equipment and train workers to respond to a bioterrorist attack. The bill also would expand the federal government's authority over the food supply, as it would "increase inspections of imported foods, require importers to give notice of shipments, require food manufacturers and processors to register with the government, ... authorize the FDA to detain food products without a court order if the items appeared to endanger public health" and "giv[e] federal agents broad new powers to inspect company records that might help trace the source or chain of distribution of tainted foods," the Times reports. The agreement also would require operators of drinking water systems to evaluate their vulnerability to a bioterrorist attack, develop emergency plans and submit them to the EPA. Under the agreement, the CDC would receive $300 million to upgrade its scientific equipment and laboratories (New York Times, 5/22). "Because of this bipartisan legislation, Americans will be able to sleep better at night in the knowledge that our nation is taking the steps necessary to protect them and their families against the deadly threat of bioterrorism," Sen. Edward Kennedy (D-Mass.), a co-sponsor of the Senate bill, said.
The compromise legislation also would reauthorize and expand the Prescription Drug User Fee Act, under which pharmaceutical manufacturers pay the FDA for an expedited review of a new drug application (Washington Post, 5/22). The measure would extend by five years the agency's authority to collect those fees, which now total $177 million a year, accounting for more than 50% of the FDA's budget for review of new drugs and vaccines. It also would provide funding for the FDA to conduct post-market oversight of drugs and medical devices. In addition, the FDA would receive $27 million over five years to scrutinize drug advertising and marketing and $45 million over the same period to speed the review and approval of generic drugs. A plan to create a similar user fee program for generic drugs was dropped yesterday following protests from generic drug industry officials, who said such fees would impede the introduction of generics to the market (New York Times, 5/22). "If [the] cost of doing [a] review is more than the cost of doing the product, there is not much incentive to do it," Jake Hansen, Barr Laboratories' vice president for government affairs, said (Fulton, CongressDaily, 5/21). Lawmakers also dropped from the bioterrorism legislation a bill that would have created a user fee program for new medical devices after Democrats objected to an industry demand that some devices be reviewed by groups other than the FDA (Fulton, CongressDaily/AM, 5/22).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.