FDA may let pharma sell more drugs without scripts

Tools

The FDA may let more drugs go OTC. Commissioner Margaret Hamburg says the agency is "trying to get feedback from various stakeholders" about improving access to medications. And one of those improvements could well be allowing more drugs to be purchased without a prescription, The Wall Street Journal reports.

Janet Woodcock, director of the Center for Drug Evaluation and Research, said the number of newly over-the-counter medications wouldn't be "vast." But it could include, for instance, hypertension drugs for patients who don't have acutely high blood pressure. Some drugs might be sold without a prescription, provided patients consulted with pharmacists on their proper use.

To win OTC status, drugmakers would still have to conduct consumer-use studies to prove customers could use the medications correctly. And that's not necessarily a picnic. As the WSJ points out, Merck ($MRK) has tried repeatedly to win OTC status for its statin drug Mevacor, but the FDA has yet to be convinced that consumers would properly evaluate their need for statin therapy.

A new openness could prompt more drugmakers that are mulling an OTC move--such as Pfizer ($PFE) with its newly off-patent cholesterol drug Lipitor--to go forward with the necessary research.

- read the WSJ piece
- check out more from Bloomberg

Related Articles:
Pfizer's strategy for clinging to Lipitor sales
Pfizer eyes OTC Lipitor, but will FDA approve?

Filed Under