The Importance of the FDA's Stance on Merck's (and now GSK's) OTC Mevacor

Implications: How will the FDA rule? What are the potential public health benefits? Are there risks of OTC statins?  Watching closely, will be Glaxo Smithkline (GSK), which will market OTC Mevacor. Approval could impact sales of Pfizer's Lipitor and other statins made by pharma's including AstraZeneca, Novartis and Bristol-Myers Squibb.  How will these companies respond to the FDA decision?

Analysis: There may be another shakeup in the $20 billion dollar statin market.

And that is because $20 billion dollars isn't enough. Really. Most cardiologists would agree that if more people were on statins, fewer people would suffer from the ill-effects of high cholesterol.
 
By selling Mevacor over the counter, Merck hopes to gain new ground in the battle for market-share, not by getting patients to switch- where a lot of the marketing dollars have been spent, but rather  by getting new patients -- perhaps even some who haven't yet visited their physician.

So it's not surprise that the FDA turned down two earlier applications.

But with new data supporting a new application, Merck is at it again. Together with GSK, Merck is hoping that this will be enough to satisfy the FDA panel reviewing the application before year's end.

Some, such as the WSJ's health blog, have speculated, based on comments from the FDA panel's previous denials, that the FDA may created new "Behind the Counter" rules, as are in place in Europe. This middle-ground approach might be enough to satisfy safety-concerned panelists, but will be a disappointment to GSK and Merck, since it would take a long time to get the guidelines of such a new system in place.

OTC approval would surely lead to an increase the number of American's on Statins- not a bad thing. However, some have argued that patients won't take the drug properly, and therefore need to see a physician for guidance. Furthermore, if patients feel they can treat potential heart disease simply by taking OTC Mevacor, they could miss out on important diagnostic tests and counseling from a physician. Allowing statins to be sold OTC requires the same type of risk/benefit analysis required when patients and physicians consider taking a drug in the first place.

If the FDA does permit Mevacor to go OTC, other statin players will feel pressure to do a risk/benefit analysis of their own: Keep the drug Rx, or go the OTC route? Sitting on the sidelines may mean a loss of market share.