Extension expected for pediatric drug law

The federal provision encouraging the testing of drugs for children in exchange for patent exclusivity is found to be a success.

By Susan J. Landers, AMNews staff. June 4, 2001.

Washington -- A five-year extension looks promising for a federal law that provides financial incentives to pharmaceutical companies that conduct studies to determine the safety and proper dosage of drugs for children.

There was widespread support at recent House and Senate hearings for the continuation of the pediatric exclusivity provision of the 1997 Food and Drug Administration Modernization Act. The act is up for reauthorization this year.

"In the short time the provision has been in effect, it has been a great success," said Sen. James Jeffords (R, Vt.), chair of the Senate Health, Education, Labor and Pensions Committee.

The provision, which is set to expire on Jan. 1, 2002, allows pharmaceutical companies six additional months of marketing exclusivity for drugs they test on children.

As of April 1, the FDA had approved the testing of 155 drugs already on the market and 33 new drugs not yet approved. In contrast, in the seven years prior to the law's passage, studies of only 11 marketed drugs were conducted.

In testimony before the House Committee on Energy and Commerce, Richard Gorman, MD, incoming chair of the American Academy of Pediatrics' Committee on Drugs, called the provision "one of the most extraordinarily successful federal initiatives that has ever been accomplished for children." [...]