FDA Panel recommends Exhaustive Tests for new Diabetes Drugs

A Food and Drug Administration panel has recommended tougher safety tests of diabetes drugs before they win approval. Drugmakers must assess the potential heart risks of all new diabetes medicines, suggested the panel, comprising of outside medical experts.

"Although it might be a little more burdensome ... we need more studies," said Dr. Clifford Rosen, an endocrinologist at the Maine Center for Osteoporosis, who was in the panel.

The move might come as a blow to the $5 billion-plus diabetes drug market in the U.S. as it would costs millions to the manufacturers to carry out the sophisticated safety tests.

Through a 14-2 vote on Wednesday, the panel decided that all new diabetes drugs should undergo more comprehensive studies to make sure they don't aggravate heart problems.

This comes come less than a year after the FDA was condemned for its handling of heart risks connected with a widely used GlaxoSmithKline pill. The agency approved the drug back in 1999 but did not issue a warning about potential heart risks until last November.

At least five to seven years of studies are required to test a drug for heart attacks, strokes and other problems. The panel members suggested that drug companies could begin safety testing before they submit drugs to the FDA, and finish the studies after the drugs are on the market.

However, not all members on the panel agreed with the idea of exhaustive tests, like Dr. Eric Felner, a pediatric specialist at Emory University School of Medicine, who said “If you wait this amount of time for testing you're going to be preventing certain drugs from getting out there that may be better than what we already have.”

Several drugmakers, including Glaxo, Bristol-Myers Squibb Co, AstraZeneca Plc, Eli Lilly and Co and Amylin Pharmaceutical Co, are working to bring new diabetes drugs to the market.

Meticulous tests could benefit Merck & Co Inc by delaying rivals to its fast-selling drug Januvia, said Morningstar analyst Damien Conover.
Nearly 24 million Americans suffer from Type 2 diabetes, which can lead to kidney failure, blindness and heart disease.

Presently, no examination is done to check heart risks from diabetes drugs. The agency only considers the ability of the drug to lower blood sugar before approving it.

It is not obligatory for the FDA to act on panel’s advice, but the agency usually follows it.