FDA Panel Recommends Safety Tests For New Diabetes Drugs

FDA Panel Recommends Safety Tests For New Diabetes DrugsAn expert panel called on the drug companies to conduct stricter safety tests before marketing new diabetes drugs. The expert panel urged FDA, on Wednesday, to make the pharmaceutical companies test their diabetes drugs on a tougher standard.

The opinions from diabetes experts, cardiologists and statisticians come less than a year after the FDA was criticized for its handling of heart risks connected with a widely used GlaxoSmithKline pill, Avandia, a drug for type 2 diabetes. The drug was approved in 1999 but the agency didn't attach a warning about probable heart risks until last November.

John Jenkins, the director of FDA's Office of New Drugs, said, “We heard they wanted us to have greater certainty and assurance before approval about the cardiovascular effects of the drugs, and that they wanted us to ensure that the question was ultimately answered either before approval or after approval. It's a higher level of understanding and a higher level of assurance that you've excluded unacceptable cardiovascular risk.”

The face tougher safety standards could cost manufacturers millions but would definitely protect patients from unforeseen heart risks. GlaxoSmithKline PLC, AstraZeneca and Novartis AG are among the leading companies developing diabetes treatments to compete in the domestic market, which, according to pharmaceutical research firm IMS Heath, grew to more than $6 billion last year.