Merck proposal to sell Singulair without a prescription hits resistance

Most drugmakers can only watch wistfully as sales of blockbusters fade into the horizon when generics come online. Merck ($MRK) had hoped to keep the memory of asthma drug Singulair's former stature alive by turning it into an over-the-counter (OTC) product. But an FDA panel of experts thinks that is too risky for consumers.

The panel Friday voted 11-4 to recommend against the FDA allowing even limited OTC use of the blockbuster allergy med, MedPage Today reports. Merck was seeking approval for Singulair at a 10 mg dose to be sold OTC only to adults for treating the symptoms of hay fever and other allergies. But the panel felt that once it made the leap to OTC designation, there was a likelihood it would be used "off label" on minors, particularly for asthma, MedPage Today reports.

The FDA is interested in getting more drugs from prescription to OTC status as a cost savings for consumers, and the government, and there is some precident in the allergy arena. The FDA in October approved Sanofi's ($SNY) corticosteroid nasal spray Nasacort, and the French drugmaker's former blockbuster allergy treatment Allegra in 2011. But Singulair is in a different class of medications.

The FDA can approve the drug regardless of the recommendation but if it doesn't, it is too bad for Merck. The drug was Merck's top seller two years ago, turning in $3.2 billion in sales in 2012. Within four weeks of going off patent that year, sales had plummeted 90%. It generated about $1.2 billion in revenue for the company last year, and the revenue gap was a big reason the drugmaker instituted a major restructuring, with plans to cut 8,500 employees, and to sell off some units.

In fact, the news about Singulair might be hardest on Bayer Healthcare, which is expected to announce a deal any day to buy Merck's consumer health business. If the FDA would approve OTC use for Singulair and Merck were to make it a part of its consumer business, then it would be the German drugmaker that would reap the reward.

- read the MedPage Today story