Auditors say law helps drug studies

Auditors say law helps drug studies

	Published : Thu, 22 Mar 2007 23:44 By : Agencies Print this Story

WASHINGTON (AP) - A law that encourages pharmaceutical companies to study their drugs in children has led to important label changes in most products studied, government auditors said Thursday. They also said most studies arising from the law are still under way.

Under the Best Pharmaceuticals for Children Act of 2002, the Food and Drug Administration can request the studies, which are meant to examine whether drugs already approved for use in adults also work in children and, if so, at what dose levels. In exchange for doing the studies, the government extends the patent protection on the drugs for six months.

The studies are important because about two-thirds of drugs prescribed to children have never been studied or labeled for pediatric use. The law expires this year unless reauthorized by Congress.

Between January 2002 and December 2005, the FDA made 214 requests for pediatric drug studies. Drug companies agreed to do studies in children in response to 173 of the requests but have since completed just 59 of them, according to the Government Accountability Office report. The other 114 are ongoing.

Of the 59 drugs studied, the patents on 52 have been extended by six months. That sort of extension is especially lucrative to manufacturers of blockbuster drugs but provides more modest returns on other drugs, according to a February study in the Journal of the American Medical Association.

The studies also have led to label changes for 87 percent of the 59 drugs studied between 2002 and 2005, according to the GAO report. Those changes have included information on both underdosing and overdosing, as well as unexpected side effects in children, the report said.

While the law is praised as a boon to children for encouraging pediatric studies, it's also criticized as a windfall to drug companies.

'Today's report provides valuable recommendations for Congress to consider in reauthorizing these important programs. We must strike the right balance between ensuring that incentives to industry are responsible and responding to the urgent need to improve the availability of safe and effective medicines for children,' Sen. Edward M. Kennedy, D-Mass., said in a statement.

Kennedy is chairman of the Senate Health, Education, Labor and Pensions committee, which is to discuss reauthorization Tuesday.

The law also allows the FDA to refer drugs that companies have declined to study in children to the Foundation for the National Institutes of Health. The nonprofit corporation is meant then to underwrite the cost of those studies.

As of December 2005, the Foundation had yet to fund any of the nine studies referred to it, the report said. They include morphine and the depression drug bupropion. The GAO estimated the overall cost of the studies at $43 million, while the foundation raises just $1 million a year to defray their cost.

Charles Pucie, a foundation spokesman, said one of the studies is now on track to be carried out, at a cost of $7.8 million. The foundation has raised and will bear a little more than half the cost of the study, to examine the drug baclofen in treating spasticity in children with cerebral palsy, Pucie said.

In comments to the GAO, the Health and Human Services Department said the report fails to acknowledge the success of the Best Pharmaceuticals for Children Act program.