FDA Looking to New Paradigms for Getting Drugs to Patients More Quickly

Posted 08 March 2012 By Alexander Gaffney

The US Food and Drug Administration (FDA) is evaluating whether to upend several approval pathways, including the current over-the-counter (OTC) pathway with one that emphasizes more OTC medicines available to patients with chronic conditions, reports Bloomberg.

FDA Commissioner Margaret Hamburg and Center for Drug Evaluation and Research Director Janet Woodcock said that FDA is looking to hold a public hearing in March to discuss the possibility of accelerating how prescription medications receive an OTC monograph.

Hamburg and Woodcock are also set to appear before the House Energy and Commerce Committee 8 March to argue on behalf of an accelerated approval pathway that places a relaxed emphasis on effectiveness so long as safety is assured. The pathway could allow faster approval times for rare diseases and orphan drug indications.

Woodcock also noted that FDA is looking at narrower labeling indications for antibiotics, which she said were being overprescribed to the point of reaching "crisis proportions." Woodcock added that the agency is looking at similar provisions for obesity drugs to ensure safe prescribing.


Read more:

Bloomberg - FDA Weighing Non-Prescription Status for Chronic Disease Drugs

Share this article:

Categories: Drugs, FDA, CDER

Tags: Rx, OTC, Woodcock, Pharmaceuticals, House, Latest News, Hamburg, rare, Orphan, diseases, approval, Switch, pathway

Regulatory Exchange: Latest Updates From the Community