House Overwhelmingly Approves Bioterrorism Preparedness Legislation

The House yesterday overwhelmingly approved a $4.6 billion bill (HR 3448) to strengthen the nation's defenses against a bioterrorist attack, the Atlanta Journal-Constitution reports. The measure, approved 425-1 one day after House and Senate negotiators reached a conference agreement on the legislation, would provide $1.5 billion in grants to help states and localities improve the public health system's ability to respond to an attack. It also would:

• Strengthen protections of the nation's food and water supply;
• Increase the nation's stockpile of vaccines and medications to protect against biological and chemical weapons;
  
• Place stronger controls on laboratories and universities that "possess dangerous pathogens";
  
• Create a national database to track such pathogens;
  
• Provide $300 million to upgrade the CDC's laboratories and equipment;
  
• Provide grants to colleges and universities "that have food and agriculture science programs to review and assess security standards and practices"; and
  
• Develop "rapid detection field kits to detect biological threats to animals and plants" (Moscoso, Atlanta Journal-Constitution, 5/23).

The bioterrorism legislation also includes a measure that would reauthorize for five years the Prescription Drug User Fee Act, under which drug makers pay the FDA in exchange for an expedited review of a drug (Goldreich, CQ Monitor News, 5/23). Negotiators on the bioterrorism bill said yesterday that they would consider this summer several FDA-related provisions that were dropped from the final agreement. Those provisions include the creation of user fee programs for medical devices and veterinary medicines and a requirement that the FDA continue to enforce a pediatric drug testing rule (Fulton, CongressDaily/AM, 5/23). Earlier this year, the FDA announced it was suspending the pediatric rule -- under which drug makers are required to test certain medications on children -- but later reversed itself amid pressure from public health groups and lawmakers (California Healthline, 4/22). Sens. Hillary Clinton (D-N.Y.), Christopher Dodd (D-Conn.) and Mike DeWine (R-Ohio) have sponsored a bill to give the rule the force of law. Sen. Edward Kennedy (D-Mass.), chair of the Senate Health, Education, Labor and Pensions Committee, said the committee would mark up the bill this summer (CongressDaily/AM, 5/23).

The Washington Post today looks at the reauthorization of PDUFA, which is "speeding toward final approval after receiving unusually little public debate or scrutiny" and will make the FDA "increasingly dependent on the businesses that it regulates." Under the plan, the FDA would collect $1.2 billion in user fees over the next five years, allowing the agency to hire nearly 500 more employees for review of new treatments, "bringing the FDA workforce funded by industry to at least 1,530." The pharmaceutical industry and most lawmakers say the decade-old program allows the agency to review new drug applications "more promptly and efficiently and with the same intense scrutiny as before," allowing new drugs to reach the market and help patients more quickly. HHS Secretary Tommy Thompson said that PDUFA -- as well as the proposed user fee programs for medical devices and veterinary drugs -- are "vitally important" to his department given its "scarce resources." But critics say that user fees have the potential to "undermine [the FDA's] independence and credibility with the public" and that the program "encourages the agency to move too quickly when it reviews new drug applications and without enough attention to safety." Rep. Bart Stupak (D-Mich.) said, "Our concern is that with so much industry money coming in, the fox may be guarding the henhouse at the FDA." Still, patient groups and consumer advocates are pleased that the reauthorization would provide the FDA with $20 million in industry funds to expand its post-market oversight of prescription drugs (Kaufman, Washington Post, 5/23).