In July of 2000, two companies tried to take statins from RX to OTC. The first was Bristol Myers Squibb attempting to switch Pravachol and the other was Merck trying to switch Mevacor. Today, there is a Federal Register notice published that Merck is back for more and will attempt to persuade the Non-Prescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee to vote for the switch.
I was present at both meetings in July 2000. One of the things that stood in the way of a switch was a key factor involved in RX-OTC switches – the ability of patients to self-diagnose and self-treat. A patient does not easily have a way to take and monitor cholesterol levels. In addition, the advisory committees seemed to be seeking a great deal of additional information and studies prior to an approval. Lastly, there were concerns about what dose people take the statin and how people can self-titrate if they can’t self monitor – yet the higher the dose, the higher likelihood of adverse events. It was a lot for a sponsor to work out. And the OTC statin presents unique challenges that are coming up not only with this meeting, scheduled for December 13, but which will occur just weeks after the FDA meets to consider the issue of behind-the-counter (BTC) drugs.
The environment for this proposed switch is in contrast to that of 2000. For one thing, the first attempt occurred when the FDA was still enjoying its gold standard. Will the agency’s risk-averse nature today affect a switch like this? Also, Since the time of the original OTC switch attempts, the cast of characters has changed – each committee is made up of different persons. And lastly, there is new research on statins that suggest added benefits beyond lipid lowering, i.e., a role in cancer prevention. That may spell a benefit of even greater magnitude, or it could mean that people who feel at risk for cancer, might start taking a statin for that benefit rather than lipid lowering. Is that a risk or a benefit. The committee will have a lot to talk about.
I have a ques – Can a generic company initiate a switch.. how can it show the safety profile of an existing prescription product if it were to initiate such a switch