U.S. Food and Drug Administration (FDA) has set out more rigorous standards for testing diabetes drugs to screen them more closely for heart risks, according to media reports Thursday.
Dr. Mary Parks, head of the FDA division that oversees diabetes drugs, said the policy is intended to remove the uncertainty about new diabetes drugs.
Separately, the FDA is working on new guidance for already approved diabetes drugs.
"The more we know about the safety profile, the better it is for physicians to make decisions," Parks said.
The policy change should offer a greater assurance of safety to doctors and patients. But it will make it more costly and time-consuming for companies to develop drugs that lower blood sugars, FDA advisers and critic Nissen said.
"The idea is not to create such a high barrier that you will stifle innovation in developing new drugs, but to make sure clinicians have the information they need," Nissen said, "This will raise the level of evidence available, and that is good for patients."
Some 23 million people in the U.S. have Type 2 diabetes. People with diabetes are at higher risk for heart attacks, kidney problems, blindness and other serious complications, which result from the body's inability to use insulin.
The FDA already sent letters to drugmakers describing the changes, Parks said. Makers of some 100 to 150 medications under development were notified.
(Agencies via Xinhua December 19, 2008)