FDA Announces Intention to Suspend Rule Requiring Children’s Clinical Trials; Democrats Object

FDA officials on March 18 said that the agency plans to suspend for two years a rule that requires drug companies to conduct clinical trials on children, the Washington Post reports. The FDA will use the two years to determine whether the regulation "is still needed." The Clinton administration enacted the rule in 1997 to provide doctors and parents with "better information when giving children medications, which mostly have only been tested in adults" (Connolly, Washington Post, 3/19). In announcing the delay, the FDA said that the pediatric rule might be redundant given the pediatric exclusivity provision of the 1997 FDA Modernization Act, which gives drug companies an extra six months of patent protection for medications they test on children. In response to the FDA's annoucement, Democrats on the House Energy and Commerce Committee are urging President Bush to prevent the agency from suspending the rule, CongressDaily/AM reports. In a letter sent to Bush March 18, House Energy and Commerce ranking member John Dingell (D-Mich.), health subcommittee ranking member Sherrod Brown (D-Ohio) and Rep. Henry Waxman (D-Calif.) wrote that the 1997 law does not go as far as the pediatric rule in protecting children. "Under the exclusivity provisions, manufacturers have focused their pediatric studies on the largest-selling drugs ... rather than on the drugs most needed by children," they wrote, adding that the "incentive [with the exclusivity law] has not been large enough" to entice drug makers to conduct follow-up studies on "many drugs important to children." They also said that because only the pediatric rule -- and not the exclusivity law -- requires drug makers to include the results of clinical studies on a drug's label, "[S]ome manufacturers have delayed putting information from the studies in their drugs' labels, particularly where the information reveals adverse consequences from the use of the drug in children." White House spokesperson Scott McClellan said the administration is "urging [the] FDA to resolve this as soon as possible," adding, "We think [evaluating the pediatric rule] can be done much quicker" than the two-year delay the agency has proposed (Rovner, CongressDaily/AM, 3/20). The Democrats' letter is online. Note: You will need Adobe Acrobat Reader to view the letter.