I talked about this before back on October 3, 2007 (why does that feel like two years ago as opposed to two months ago?). Anyway, USA Today is reporting that the US Food and Drug Administration (FDA) will again consider whether cholesterol medication will be able to be available without a prescription.
For the third time, Merck is seeking FDA approval to sell over-the-counter Mevacor, the brand name for lovastatin. In 2000 and 2005, advisory panels recommended against that move. The FDA is not bound by advisory committee recommendations, but it usually goes along with them.Public Citizen, a watchdog group (and, in my opinion, sometimes goes too far in the alarming the pubic at times), is against making cholesterol medications over the counter. I would agree with this group on this issue.
"People can't, on their own, evaluate whether they are at sufficient enough risk that they could benefit from this drug," says [Sydney] Wolfe, [director of the Public Citizen Health Research Group.]On the other side of this issue is, of course, the pharmaceutical industry who has been chomping at the bit to push this entire drug class onto pharmacy shelves for patients to purchase and for docs to deal with the side effects.
Over-the-counter Mevacor "fits with the philosophy that patients should take more responsibility for their health care decisions," says Antonio Gotto, former president of the American Heart Association and dean of New York's Weill Cornell Medical College. He will serve as a Merck consultant Thursday.You betcha it would be a turning point. As a prescription medication class, cholesterol meds are a multi-Billion dollar industry. If this is made over the counter by the FDA, the pharmaceutical industry will see dollar signs. But, what will patients, doctors, nurses, and others who take care of patients see? I hope the FDA rejects this request again on Thursday...
Steve Francesco, a pharmaceutical industry consultant in West Orange, N.J., who specializes in prescription-to-nonprescription switches, says switching Mevacor "would be a real turning point."