Behind-the-counter access is "not necessary" if Johnson & Johnson/Merck's lipid-lowering drug Mevacor (lovastatin) were switched from prescription status to OTC, the joint venture maintains.

"There does not appear to be a need for a British third-class model for Mevacor given its well-established efficacy and safety record," Merck VP-Regulatory & Scientific Affairs Edwin Hemwall, PhD, stated.

"We really believe that the labeling and educational support program for both the consumers and the health care professionals - the pharmacists and physicians and others - that will accompany the product will enable consumers to use Mevacor appropriately on their own," he continued.

J&J/Merck said May 14 they will submit additional data to their original application to switch Mevacor OTC, but this time they will suggest a 20 mg dose. The firm has conducted focus groups, label comprehension studies and actual use trials involving 10,000 people to evaluate Mevacor OTC.

"We found in our studies [the proposed] program prompts people to interact with health care professionals, perhaps more so than they would have done without the existence of this program."

Still, "we want to be very responsible with how we market this product and make sure that consumers have all the information they need and not have to go that particular route," he concluded.

The issue of behind-the-counter status gained attention after the UK's Medicines & Healthcare products Regulatory Agency approved J&J/Merck's Zocor Heart-Pro (simvastatin 10 mg) for sale without a prescription.

Extrapolating results from the UK experience to the U.S. will be difficult because the Zocor Heart-Pro label is simplified, Hemwall noted. However, what is important is that the UK has "recognized that the risk factors alone are enough to benefit from cholesterol-lowering, and the actual baseline cholesterol value is of less interest."

If Mevacor is granted OTC status in the U.S., the firm will "strongly encourage interaction with health care professionals in the program," Hemwall said.

"There are a lot of things we can do voluntarily with regard to limiting distribution to, for instance, retail outlets that have pharmacies, and certainly we're open to considering those sorts of things, but to actually create a behind-the-counter class is not necessary."

"In fact, we think that consumers need to be able to access, in an open manner, the materials that come along with the product and the educational pieces that will be there available to them on the shelves without having to ask a pharmacist to show it to them," he maintained.

According to J&J/Merck's marketing plan, consumers will "have to know their [cholesterol] numbers before they decide to take this product or not," Jerry Hansen, VP-marketing, said. "What we've found from our research is the people interested in Mevacor OTC for the most part are seeing their doctor on a regular basis and have had a cholesterol test within the past year. So we're going to encourage those people to pick up the phone, and go visit their doctor and get their numbers."

"At about six weeks...people are going to have to take another cholesterol test to see if the product is working for them, and the good news is that there's a lot of options today for consumers, and we actually included all these options in our clinical trial," he noted.

Hansen said consumers can have their cholesterol levels checked at their doctor's offices, cholesterol-screening events at retail outlets, state-run satellite clinics and through at-home testing kits. "Consumers are going to have a lot of choices," he said.

The firm is committing to a "very comprehensive marketing program that we did in our actual use trial," Hemwall said. Information will be available on websites, in booklets, on videos and DVDs, at shelves and in boxes, and via training for pharmacists and other health professionals, he explained.

Participants in the "Mevacor Compliance Program will receive regular updates prompting them when to do certain things, such as 'Hey, it's time for your [six-week cholesterol] blood test' or 'Remember to stick with diet and exercise, that's important as well,'" Hemwall said. Heart-healthy recipes and lifestyle activities will feature prominently in the compliance program.

Actual use trial results revealed that "consumers either did as well as they were doing before, or better with regard to diet and exercise," Hansen said, noting that consumers' relapsing to bad behavior while on statins is an oft-heard concern.

Mevacor Behind-The-Counter Status Is “Not Necessary,” J&J/Merck Says

More from Archive

More from Pink Sheet