Regulators Impose Tight Restrictions on Diabetes Drug

Regulators Impose Tight Restrictions on Diabetes Drug, In a highly unusual coordinated announcement, drug regulators in Europe and the United States said Thursday that Avandia, the controversial diabetes medicine, will no longer be widely available. Regulators Impose Tight Restrictions on Diabetes Drug The drug’s sales will be suspended entirely in Europe, while patients in the United States will be allowed access to the medicine only if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of the drug’s substantial risks to the heart.

The Food and Drug Administration’s decision shows that the Obama administration is taking a harder line on drug safety issues even in the face of scientific uncertainty. Along with its announcement, the agency for the first time immediately posted on its Web site memorandums from top agency staff members that in some cases offered entirely contradictory advice. Dr. Margaret Hamburg, the agency’s commissioner, said that passions within the agency had run high on the Avandia decision.

The end of Avandia marks a new era in the treatment of diabetes, a disease that is reaching epidemic proportions in much of the industrialized world. From now on, drug regulatory authorities are unlikely to approve medicines simply because they help diabetics control blood sugar levels — the standard for more than 80 years. The Avandia story also marks a new and unsettling period for pharmaceutical companies because Avandia’s risks became known only after Dr. Nissen analyzed data from clinical trials that GlaxoSmithKline, the maker of the drug, had been forced to post on its Web site as a result of a legal settlement. Such public postings are increasingly the norm, which means that drug makers can no longer easily hide or control scientific information about their medicines.