FDA Drops Suspension of Pediatric Testing Rule

Reversing course, the FDA announced on Friday that it would not suspend a regulation requiring drug makers to test certain medications on children and would instead revise and improve the rule, the Washington Post reports (Kaufman/Connolly, Washington Post, 4/20). The agency came under fire from public health groups and lawmakers last month when it said it planned to suspend for two years the pediatric testing rule, under which the FDA can require pharmaceutical companies to conduct pediatric clinical trials of drugs, both new and old, that are widely used by children (Lueck, Wall Street Journal, 4/22). The FDA had cited two factors in its decision to suspend the rule. First, three groups are suing the agency, alleging that it did not have the authority to issue the rule. FDA officials hoped that a judge would suspend the case once it suspended the rule, giving the agency time to see whether it could require pediatric testing under a different vehicle, according to Murray Lumpkin, the FDA's senior associate commissioner (Washington Post, 4/20). Second, the agency wanted to study whether the pediatric testing rule, adopted in 1997, was redundant in light of another program -- known as the pediatric exclusivity rule and reauthorized by Congress in January -- that gives drug makers who conduct pediatric tests of their treatments an additional six months of patent protection (AP/Las Vegas Sun, 4/19). "A quick review showed us the situation was more complicated and that we needed more public input into how the rule and the laws interact," Lumpkin said, adding that the FDA is now asking for public comment on improving the testing rule. Announcing the decision not to suspend the rule, HHS Secretary Tommy Thompson said that the NIH would spend $7 million this year to conduct pediatric trials of certain drugs. "Children need access to the same kinds of safe, effective treatments that are available to their parents, and that means conducting appropriate clinical trials," he said.

Lawmakers and public health groups praised the administration's decision to improve the rule, which is designed to address the fact that most drugs come to the market with little or no information about their effects on children. "I give them a lot of credit for being willing to reverse field when the details were pointed out to them," Richard Gorman, chairman of American Academy of Pediatrics drug committee, said, adding, "We and others had worked very hard to have the pediatric rule enacted and were very surprised that it was being suspended." Still, supporters of the rule on Capitol Hill said they would continue their efforts -- initiated last week before the FDA announced the reversal -- to give the pediatric rule the force of law. "While I am pleased that the FDA has changed its mind about the pediatric rule, the fact that it can change its mind illustrates how important it is to make this rule the law of the land," Sen. Hillary Clinton (D-N.Y.) said. Sam Kazman, an attorney for the Competitive Enterprise Institute, one of the groups challenging the rule in court, said he was disappointed that the administration "caved in to the mini-firestorm that broke out after they announced they were thinking of withdrawing the rule," adding that the rule lengthened the drug approval process. But the drug industry, which initially opposed the pediatric rule, has come to accept it, as long as the pediatric exclusivity program continues, according to Jeff Trewhitt, a spokesperson for the Pharmaceutical Research and Manufacturers of America. "Frankly, we were surprised when the administration said they were going to suspend the rule," he said (Washington Post, 4/20).