The U. S. Food and Drug Administration has said that all new drugs to treat type 2 diabetes will be screened more closely for heart risks. The companies that are looking for approval of any new drugs for the disease will have to undertake studies which establish that the drugs do not increase the heart risk for patients, a process that will make it more costly and time consuming for companies to develop drugs for the disease. More than 100 such medications are in some stage of development.

"I think the FDA got this one right," said Dr. Steven Nissen, a Cleveland Clinic cardiologist who raised the diabetes concern two years ago with a study indicating a popular new drug increased the risk of heart attacks.

The new requirement comes just after reports of two commonly prescribed blood sugar-lowering drugs already on the market, Avandia and Actos, being said to increase the risk of heart failure and, in the case of Avandia, increase the risk of heart attack. The medication, Avandia, remains on the market amid continuing debate.

Dr. Mary Parks, director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research during a Wednesday afternoon teleconference said, "The guidance document will help industry evaluate the cardiovascular risk associated with new therapies under development to treat type 2 diabetes." Currently the testing of a new drug is done on younger and healthier people than those the drug is actually intended for. Under the new FDA policy the drug companies will have to use elderly patients with diabetes and kidney problems to test their drugs. This would mean that the studies would last longer in order to allow for the emergence of subtle problems such as a gradual increase in high blood pressure.

Independent committees would have to be set up by the drug companies to monitor the rates of heart attacks, strokes, and heart-related deaths and hospitalizations linked to drugs in development. The companies would also have to conduct certain statistical analyses of the results, with an upper limit on how much risk is acceptable for a new drug.

These changes in the approval process do mean that it will take longer for new drugs to reach the market. "It's safe to assume that requiring a longer duration of trials, and a bolstering of the sample size, that it will add some years to the clinical development program," Parks said.

Following recommendations from FDA advisers and critics such as Nissen, the policy sets out more rigorous standards for testing diabetes drugs. "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. "This will raise the level of evidence available, and that is good for patients."

The FDA has sent 100 to 150 letters to companies with new diabetes products under development to alert them of the new guidance, which takes effect immediately, Parks said.

Scott Gottlieb, a former senior FDA official who is now a policy analyst at the business-oriented American Enterprise Institute said, "This is going to be hard risk to assess for and will add a lot of cost and time to development. You are looking for small risks that only become manifest after prolonged use, so it may often take big, long term studies to uncover these things."