Pfizer Inc. (NYSE:PFE) is hoping to obtain Food and Drug Administration approval to market its top-selling cholesterol-lowering drug Lipitor over the counter, according to the Wall Street Journal. Critics of the drug’s over-the-counter version claim that consumers cannot necessarily be trusted to take the drug appropriately without a physician’s guidance.
The company started a 1,200 participant clinical trial of the OTC version of the drug in October, which is meant to track whether consumers will get their own blood tests to check to see if their cholesterol is improving and then make the right decisions regarding use of the drug given the results.
In the study, participants are left alone with an empty box of the OTC Lipitor to read and follow the directions. The participants in the study will then self-assess and determine whether they meet the criteria for using the drug and then may enroll in the trial and purchase it. Participants can then take the drug once daily for 26 weeks.
The trial recruited patients from more than 35 different U.S. pharmacies and is expected to be completed by year’s end. The results of the trial will determine whether Pfizer will move forward to seek FDA approval for Lipitor’s over-the-counter version.
Should the drug succeed in gaining FDA approval, it would be the first over-the-counter statin on the market, a success that could be a huge financial boon to Pfizer, which has been struggling to regain market share since generic versions of Lipitor first launched in late 2011.
Criticisms of the over-the-counter Lipitor are due in part to recent changes in the way that people taking cholesterol-lowering statins like Lipitor are treated. New clinical guidelines no longer use the familiar and easy-to-understand target levels for cholesterol that consumers are familiar with, according to the Journal. The new guidelines are more complex and take into account a wider variety of health factors.
The uncertainty is amplified by the fact that the medical community doesn’t seem to agree on whether an over-the-counter statin would be safe. A co-author of the new guidelines says he doesn’t think statins should be used without consulting a physician, while other doctors and pharmacists say the opposite, claiming that over-the-counter statins could be useful. “The new guidelines insist on a patient-clinician discussion before a statin prescription is written,” Neil Stone, one of the guidelines’ co-authors, told the Wall Street Journal.
Pfizer’s senior vice president of global research and development, Mark Gelbert, said to the publication that “OTC status is another access point” and that “it’s our responsibility to demonstrate patients can safely and effectively use these products.”
Some doctors fear that the increased availability of cholesterol-lowering statins would actually cause consumers to under-treat their condition because the over-the-counter version of the drug would the drug’s lowest-dose form.
“There’s a chance that a lot of people would take less than needed,” said Steven Nissen, who currently serves as chairman of the department of cardiovascular medicine at the Cleveland Clinic, to the Wall Street Journal.
Regardless, Pfizer may find that the path to FDA approval of an over-the-counter statin is a thorny one. Merck tried to gain FDA approval for an over-the-counter version of its statin, Mevacor, and was rejected, with the government agency citing similar doubts that consumers wouldn’t be able to accurately assess and monitor themselves for changes in cholesterol and side effects.