FDA Raises The Bar For New Diabetes Drugs

The American Association of Justice (AAJ) reports that the FDA has moved to protect diabetes patients by requiring more testing of diabetes drugs. In a report appearing in at least 66 media outlets, the AP (12/18) reports,

Under new FDA policy, drug companies will have to test [diabetes] drugs on greater numbers of high-risk patients, such as the elderly, those with relatively advanced diabetes and those with kidney problems. The studies will have to take longer, which would allow for the emergence of subtle problems, such as gradual increases in blood pressure. Drug companies will have to set up independent committees to monitor the rates of heart attacks, strokes, and heart-related deaths and hospitalizations linked to drugs in development." However, "one bottom-line measure will not change: Diabetes drugs still will be judged on how well they lower blood sugars."

On its website, CNN (12/17) reported that the New FDA policy, outlined in an agency guidance document, "is effective immediately and affects future drug applications as well as those currently pending FDA approval, including an application from Bristol-Myers Squibb Co. and AstraZeneca for saxagliptin, and one from Eli Lilly and Co. and Amylin Pharmaceuticals Inc. for Byetta as a stand-alone treatment." Mary Parks, FDA’s director of metabolism and endocrinology products office, said previous guidelines "required companies to conduct additional assessments of cardiovascular risks in situations where such a safety signal arose during the drug-development process. Now the assessment is being required for all type 2 diabetes drugs regardless of whether there’s a signal."

The new FDA policy may delay for years more than 100 diabetes drugs because "longer, more in-depth studies on heart risks" are now required, reports Bloomberg News (12/18, Larkin). The FDA "sent 100 to 150 letters concerning each new diabetes drug under development to alert researchers to the new recommendations, Parks said. Companies that have already started testing were encouraged to discuss their plans with the FDA as soon as possible."