Big news for the last couple of weeks has been FDA’s proposed withdrawal of orthostatic hypotension drug midodrine hydrochloride from the market because its manufacturer didn’t complete post-approval studies verifying the clinical benefit (rather than surrogate end points) of the drug. The drug was approved in 1996 under an accelerated approval process and its manufacturer had agreed to conduct these studies contingent on approval. The company said it had already determined it would remove the drug from the market at the end of next month and had notified the FDA of that decision last year.

The drug, after it’s removed from the market, will be available through an expanded access program. On a case-by-case basis, expanded-access programs allow the use of a drug outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or a condition that has no comparable or satisfactory alternative treatment options. Only about 100,000 use the drug.

The decision to propose to remove the drug from the market for failure to complete post-market studies is a new move for the FDA. The Government Accountability Office last year criticized the FDA for its hesitancy to use its withdrawal authority.

The ACC this week put out 2003 ACC/AHA/ESC Guideline for the Management of Patients With Supraventricular Arrhythmias, page 18), which remains appropriate as long as the drug is available. Should the drug become unavailable, an update will be posted and communicated expediently. The ACC will closely monitor the FDA proceedings and offer updated information as it becomes available.

This is really something to pass out about.