The FDA’s Joshua Sharfstein, Principal Deputy Director, recently explained explains why the FDA isn’t pulling the popular but controversial diabetes drug Avandia and instead leaving it available to patients who need it.
Sharfstein claims in an Oct. 3 interview with a Washington, D.C., station that there is no absolute assurance on the safety of replacement drugs that will be available any time soon. The FDA’s recent decision to leave GlaxoSmithKline’s Avandia on the market also has a tremendous amount of restrictions attached, he notes.
In order to prescribe the drug, physicians now must sign a statement that shows that they will be in compliance with the approved indications before giving the prescription. Patients also have to show in writing that they understand the potential risks involved in taking the drug. Since the drug is no longer being marketed in Europe at all, the FDA decided not to pull Avandia in Europe based on the (REMS) defining access and use restrictions.
The agency also wants to force GSK to start its own re-adjudication of data from the RECORD Avandia cardiovascular outcomes study. Any of the results could end up with new regulatory decisions, Sharfstein was careful to say. In addition, he explained that the FDA is concerned about Avandia’s risks but doesn’t consider the evidence to be definitive as of yet. The agency has issued this interim solution to the potential crisis in a way that allows it to keep getting more information before doing anything drastic, Sharfstein says.
With Avandia having been proven to help control blood sugar levels in Type 2 diabetics that don’t get results from other drugs, this decision is important to those patients who would be out of options otherwise. The monitoring and full disclosure to patients of the drug’s risks and potentially fatal side effects is about as good as can be expected — that is, until there is better treatment available that doesn’t offer such life-threatening consequences.
This story is far from over. The debate over Avandia likely will continue as the lawsuits pour in.