FDA Wants to Suspend Pediatric Study Rule

WASHINGTON (Reuters) Mar 19 - US health officials said on Monday they planned to suspend a rule that requires drug companies to study how the medicines they make affect children, drawing swift criticism from Democrats.

In response to a lawsuit challenging its authority to impose such requirements, which are opposed by drugmakers, the US Food and Drug Administration (FDA) said it would put its "pediatric rule" on hold for two years while it evaluated whether recent legislation made the rule unnecessary.

Studying medicines in children had been a neglected area of medical research, leaving doctors guessing which medicines and what doses were safe for them. The pediatric rule, put in place in 1998, mandated that drug companies study how new medicines affect children, except when the FDA grants waivers.

Two free-market advocacy groups and a physicians organization challenged the rule in a December 2000 lawsuit.

In a filing Monday in the US District Court for the District of Columbia, the FDA requested a two-month stay on the lawsuit so it can publish a notice suspending the rule for two years.

During that time, the FDA will study whether another measure, the pediatric exclusivity law signed in January, has made the rule unnecessary. The law provides an incentive to drug makers who study products in children. Each medicine studied can gain an extra six months without generic competition, time that can mean hundreds of millions of dollars to drugmakers.

Pediatricians and lawmakers widely view the law a success, noting it has prompted an explosion in pediatric research.

It is unclear how often the FDA has invoked the rule to force pediatric studies. An FDA spokeswoman said the agency had used the authority but she did not know how often.

While the FDA proposed a two-year suspension of the rule, "our intention is to resolve this issue quickly," the agency said in a statement late Monday.

"We remain deeply committed to ensuring that prescription drugs used in children are safe and properly studied and labeled," FDA Deputy Commissioner Lester Crawford said.

Congressional Democrats said both the rule and the law were necessary to ensure drug companies research medicines important for children's health. The rule gives the FDA power to require pediatric studies, while the exclusivity law is voluntary for pharmaceutical companies.

"Without the rule, manufacturers of new drugs could limit their pediatric studies to those drugs that will produce the greatest profits rather than those drugs that children need most," three House Democrats wrote to President Bush, urging him to direct the FDA to maintain the rule.

The letter was signed by Representatives Henry Waxman of California, John Dingell of Michigan and Sherrod Brown of Ohio.

The Competitive Enterprise Institute, a free market advocacy group and one of the organizations that sued the FDA, said it would oppose the agency's motion, preferring instead that the court rule the regulation invalid. Drug companies, not the FDA, should decide whether to pursue approval for their products in children, Sam Kazman, the group's general counsel, said.

"Our basic argument is that the FDA does not have the authority to do this. This really turns the drug approval process on its head," Kazman said.

Drug companies believe the pediatric rule is unnecessary, pointing out that the exclusivity incentives have produced new pediatric information on labels for 29 drugs in the past three-and-a-half years. In addition, more than 400 pediatric clinical trials are underway, said Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, the drug industry's US lobbying group.

"The incentive provision has been working exactly as intended. It is producing a significant amount of new knowledge about the safety and efficacy of drugs commonly used in children," Trewhitt said.