House Democrats Oppose FDA Decision to Suspend ‘Pediatric Rule’ for Pharmaceutical Companies
Democrats on the House Energy and Commerce Committee are urging President Bush to prevent the FDA from suspending a rule allowing the agency to require drug makers to conduct clinical trials of their products on children, CongressDaily/AM reports. The FDA announced on Monday that it would delay the "pediatric rule" -- implemented by former President Clinton in 1997 -- for two years while it decides whether to eliminate the regulation altogether. That decision resulted from the settlement of a lawsuit filed in 1998 against the rule, which the drug industry opposes. 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.
However, in a letter sent to Bush on Monday, 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 exclusivity 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 focus 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 available online. Note: You will need Adobe Acrobat Reader to view the letter.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.