FDA moves toward a major overhaul of the way it approves OTC meds

The FDA, which has been talking for years about overhauling the over-the-counter (OTC) drug approval process, is taking steps it says will allow it to approve those products, and respond to safety concerns, faster. It is a shift that the industry has been anticipating and which accounts for part of the reason so many drugmakers are in the process of buying or selling OTC units.

"The current system isn't working well for the public or for us," FDA CDER Director Dr. Janet Woodcock told the Wall Street Journal. She said the agency wants the OTC process to more closely approximate the system used for prescription drugs, which has been updated and streamlined while the 40-year-old OTC system has languished. The FDA has posted a notice for a public hearing March 25 and 26 to get input from the industry and the public.

An estimated 100,000 OTC products are on the market, many of which have yet to make it through the laborious three-step "monograph" approval process set out in 1972. It has been recognized for some time that, for instance, moving some prescription drugs to OTC status could save consumers and the government billions of dollars in costs. The agency has suggested that cholesterol, asthma, migraine and blood-pressure drugs are the kinds of medications that may no longer need to be handled through prescriptions. Part of the idea is to give consumers with chronic conditions easier access to drugs, but the bigger driver is that it would save the government a boatload of money.

Drugmakers are positioning themselves for a new OTC landscape, some with plans to boost their OTC units to cash in on an expected sales boom. A handful of drugmakers are reportedly bidding on Merck's ($MRK) consumer healthcare unit, which it decided to unload in a streamlining move. Names of the interested range from Novartis ($NVS) and Bayer to consumer giant Procter & Gamble ($PG) and Reckitt Benckiser, which is considering selling off its pharma business to focus more on its consumer core.

French drugmaker Sanofi ($SNY) has put a lot of time, energy and money into building its consumer health unit. It likes the idea of moving Rx drugs to OTC status and last year got FDA approval to market its steroid-based nasal spray Nasacort over the counter. Since CEO Christopher Viehbacher took over, he has orchestrated the rebuilding of the OTC biz with a series of deals. It bought U.S.-based Chattem in 2009 for $1.9 billion to gain access to that company's U.S. infrastructure in anticipation of an Allegra OTC launch.

The drugmakers realize that there is also big interest globally for more, and better, OTC products, particularly in countries where some prescription drugs are out of consumers' reach. Pfizer ($PFE) has been building its global OTC presence. In December it said it had picked up Polocard, a low-dose aspirin product made in Poland sold for treating heart-attack risk. In 2012, Pfizer struck a deal with AstraZeneca ($AZN) to pick up global over-the-counter rights to heartburn blockbuster Nexium for $250 million up front plus milestones and royalties. One reason: the anticipated approval of the drug in the U.S. for over-the-counter sales.

- here's the WSJ story (sub. req.)
- here's the FDA meeting announcement

Suggested Articles

The future may be uncertain for AZ’s Imfinzi in first-line lung cancer, but its targeted med Tagrisso now boasts a green light in that setting.

Ultragenyx is back with another FDA nod, this time for Crysvita to treat X-linked hypophosphatemia in patients one year and older.

Roche got a two pieces of good Hemlibra news early this week—and what's good for Hemlibra must be good for Roche.