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Bush Administration will Seek New Legislation for Mandatory Pediatric Drug Testing

Date: December 16, 2002
Source: Department of Health and Human Services (DHHS)

HHS Secretary Tommy G. Thompson today announced that HHS will pursue rapid passage of legislation giving the Food and Drug Administration (FDA) authority to require pharmaceutical manufacturers to conduct appropriate pediatric clinical trials on drugs and biologics. Clearer legislative authority is needed, instead of pursuing appeals in the courts, he said.

"The fastest and most decisive route for establishing clear authority in this area is to work with Congress for new legislation," Secretary Thompson said. "Children are a special population that need to have access to drugs that can benefit them, and these drugs need to be properly tested for pediatric use, not prescribed and sold without testing. Congress alone can speak clearly on the authority that FDA needs and the provisions that may be appropriate for drug manufacturers when they are required to carry out these tests."

The announcement came as the federal government decided not to appeal an October decision in the U.S. District Court for the District of Columbia, which held that FDA lacks the legal authority to impose certain requirements for pediatric testing on drug manufacturers. That decision has prevented the FDA from enforcing such requirements which were mandated in final regulations published in 1998 and known as the "pediatric rule."

"We have strongly defended the pediatric rule in court because public health will be best served by enabling FDA to require testing of drugs for pediatric use," said FDA Commissioner Mark B. McClellan, M.D. "But continued litigation is likely to take years, and its outcome is uncertain. The better course now is to work with the committees in Congress and enact new, specific legislation rapidly.

Secretary Thompson said he looked forward to working with Senate HELP Committee Chairman Judd Gregg and ranking member Edward Kennedy as well as House Energy and Commerce Committee Chairman Billy Tauzin and ranking member John Dingell toward achieving legislation in the first session of the new Congress. He also outlined principles for the new legislation, saying it should include clear FDA authority for:

  • Consultation between manufacturers and the FDA early in the drug development process regarding pediatric plans.
  • Pediatric data to be provided by manufacturer at the time of new drug approval application, or timeline for pediatric data submission, if deferral deemed appropriate.
  • Pediatric studies of already marketed products
  • Creation of a new FDA Pediatric Advisory Committee.

Secretary Thompson also announced today further steps in the implementation of the Best Pharmaceuticals for Children Act (BPCA), which President Bush signed into law in early 2002, including announcement of the first products to be named for testing under this Act.

This new law did two things. First, it reauthorized an existing economic incentive (extended protection from market competition) for pharmaceutical companies that conduct pediatric studies requested by FDA. However, this economic incentive only applies to drugs with existing patents or exclusivity. For these drugs, this incentive has resulted in a significant increase in the number of pediatric studies performed.

Unfortunately, many medicines used in children (but never specifically properly studied for use by children) are not eligible for this kind of incentive because they no longer have patent protection or exclusivity. Therefore, BPCA also provides a new mechanism to help study these types of products, providing for a listing of candidate drugs and federally-funded testing of these drugs.

Working with FDA and the American Academy of Pediatrics and other experts, HHS' National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health, is developing the list, to be published next month.

NICHD today released the names of the first two drugs for which requests to perform proposed clinical trials under the provision of BPCA will be issued in early 2003: nitroprusside, for the controlled reduction of blood pressure; and lorazepam, for the treatment of status epilepticus and for sedation in the pediatric intensive care unit.

Early in 2003, the NICHD will also request proposals to establish a BPCA Coordinating Center, which will help those conducting pediatric clinical trials funded under BPCA.

"Working with our partners, we are making good progress toward development of the full list of off-patent products that need review under the BCPA," said NICHD Director Duane Alexander, M.D. "This kind of look-back at older drugs is an important complement to the clear legislative authority FDA will seek for pediatric testing."

The Pediatric Rule was first proposed on August 15, 1997 and the final rule was promulgated on December 2, 1998. The plaintiffs in the litigation filed a citizen's petition on December 2, 1999. On November 1, 2000, the FDA denied the petition. Plaintiffs then filed a lawsuit on December 4, 2000 in the U.S District Court for the District of Columbia. The court denied the government's motion to dismiss on procedural issues on October 25, 2001. The court granted the plaintiffs motion for summary judgment on October 17, 2002.

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