Wall Street Journal - August 13, 1997.
Laurie McGinley

The policy could pose a quandary for the drug industry, which would face new research costs but can't afford to appear insensitive to children's needs. Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, the industry's Washington-based trade group, said manufacturers are committed to increasing their pediatric testing but questioned whether a government mandate is needed.

The drug-testing proposal follows an increasing clamor from children's health experts about what they see as a growing problem: Drugs commonly used for kids often don't -- and, indeed, aren't required to -- undergo pediatric testing. In the case of new AIDS drugs, doctors have been reluctant to prescribe them to children because they don't know how the drugs, which have severe side effects, will work.

Only about 40% of drugs considered highly beneficial for young patients undergo pediatric testing, including medications for such common childhood ailments as asthma, allergic reactions and ear infections, administration officials say. Only about 20% of the drugs on the market have been tested on children.

While pediatricians often prescribe drugs that haven't been studied in children, they frequently lack important information on precisely how much medication to use and how it will affect their patients.

As a result, physicians are sometimes forced to choose between "prescribing drugs without well-founded dosing and safety information or utilizing other potentially less effective therapy," says a copy of a draft Food and Drug Administration rule. In fact, administration officials say, the percentage of drugs tested on children is decreasing, and is largely absent for children under two years of age. In the case of AIDS, only five of the 11 approved drugs have been tested in children.

The administration estimates the plan would cost the drug industry between $13.5 million and $20.9 million a year. Part of that reflects a requirement that manufacturers develop drug formulations, such as liquids, that could be used by children.

Mr. Holmer of the drug makers' group called the administration's cost estimate too low. "It widely misses the mark and fails to reflect the enormous scientific difficulties that are often involved" in conducting pediatric tests and developing formulations for children, he said.

Industry officials say that pediatric trials are particularly challenging because parents are often reluctant to enroll their children. Another problem: The tests may have to be repeated in children of different ages to get enough useful information.

But health groups and administration officials note that drug companies have been conducting safe clinical trials involving children for years. "Safety isn't a concern," says Susan DeLaurentis, cofounder of the Pediatric AIDS Foundation, a Santa Monica, Calif., group that has pushed hard for increased pediatric testing. She notes that both the American Academy of Pediatrics and the federal government have issued guidelines on how to conduct such tests ethically. And other AIDS activists say the regulation virtually ensures that manufacturers developing the next generation of AIDS drugs conduct pediatric testing before seeking FDA approval.

The Clinton administration's plan would require prescription drug makers to submit pediatric data to the FDA when they apply for approval to sell the drugs to adults, or shortly after approval is granted. The rule would cover drugs that are expected to be a significant advance for children and medications likely to be taken by more than 100,000 children a year. The FDA expects 12 of the new drugs it approves each year to trigger the requirements, and it would decide which they were.

While manufacturers that don't comply would face court action and fines, they wouldn't be threatened with drug-approval delays or product recalls -- enforcement actions the administration rejected as unethical.

For drugs already on the market, manufacturers would be required to submit pediatric information if there were "compelling circumstances" -- for example, if the drugs could help children but weren't being used because of a dearth of data. In cases where children and adults are affected similarly by a disease, companies would have to test a drug for safety and dosage but not perform more elaborate effectiveness testing.

Some drug companies are already testing their drugs in children. A Glaxo Wellcome PLC spokeswoman says the company includes pediatric studies for its HIV drugs, among others. Glaxo also tested its drug Ultiva, an analgesic used in anesthesia procedures, in children two and older, and it is now testing the drug in children ranging in age from newborn through 18. Various forms of Glaxo's asthma drug, Ventolin, are approved for children as young as two, she adds.

SmithKline Beecham PLC is testing its antidepressant, Paxil, in young people, a spokesman says. He also notes that the company conducted pediatric trials for its leading antibiotic, Augmentin.

A spokesman for Novartis AG, the company that makes Ritalin, says the drug to treat attention deficit disorder has pediatric approval but isn't recommended for children under six years of age. He declined to comment on the proposed requirement to test drugs in children because the company hasn't seen the proposal.

The new rule, which is still subject to change, will become effective sometime after the close of a 90-day public-comment period. Manufacturers submitting new drug applications would have between 15 and 21 months to hand in kids' studies, depending on when they filed their FDA application.

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Elyse Tanouye contributed to this article.

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