HEALTH

Merck-GSK team fails to turn FDA committee in Mevacor debate

BY Michael Johnsen

WHITEHOUSE STATION, N.J. Not even the ninth-inning addition of savvy switch-veteran GlaxoSmithKline could convince Food and Drug Administration advisory committee members that Merck’s statin Mevacor would be appropriate for sale over-the-counter.

Merck officially expressed disappointment in a vote yesterday by a pair of FDA advisory committees that recommended FDA not switch the company’s statin Mevacor to OTC status, though company officials also reminded reporters that no FDA decision has been made yet. The anticipated action date by the FDA is Jan. 26, Merck reported.

“We felt we presented a compelling case to the committee that non-prescription Mevacor 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider,” stated Edwin Hemwall, vice president of global OTC regulatory and scientific affairs for Merck.

The next question is whether or not Merck will make a fourth pitch for a Mevacor switch. A GlaxoSmithKline spokesman declined to speculate following the vote, though with the last-minute addition of GSK to the switch process, leveraging the full strength of GSK’s switch expertise from the beginning could make the fourth time a charm for the Merck-GSK tandem.

The FDA certainly wouldn’t object. When asked during a press conference if the latest vote against an OTC Mevacor amounted to “three strikes and you’re out,” Andrea Leonard-Segal, FDA director of the nonprescription clinical evaluation division of the office of nonprescription products, said no. “We are open-minded [at the FDA],” she said.

The FDA advisory committee vote was 10 against a switch and two in favor with one abstention.

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FDA panel votes to keep Mevacor statin prescription-only

BY Michael Johnsen

SILVER SPRING, Md. A pair of Food and Drug Administration advisory panels Thursday evening voted 10-to-2 (with one abstention) against the switch of Merck’s Mevacor 20 mg from prescription-only to over-the-counter status, suggesting that a statin will not be switched to OTC in this country.

During its presentation before the committees here Thursday morning on the potential switch of the statin Mevacor to over-the-counter status, Merck and new partner GlaxoSmithKline presented new consumer-usage studies claiming improved self-selection outcomes after implementing several label revisions recommended by the FDA following Merck’s 2005 Mevacor switch application, to be called Mevacor Daily if approved.

It was inadequate self-selection among consumers that was a significant factor in scuttling Merck’s last attempt to switch Mevacor, and it was a major factor in scuttling this attempt as well.

However, Merck’s new studies found that more consumers correctly self-selected as compared to 2005. “For the small fraction that made a mistake” the chance of a serious adverse event is extremely low, noted Edwin Hemwall, Merck’s executive director of worldwide OTC regulatory and scientific affairs. Indeed, consumers approached a 90 percent level in making appropriate decisions regarding the use of Mevacor Daily, Hemwall said.

“We know that Mevacor Daily is indicated for a motivated, [health-conscious] consumer,” commented George Quesnelle, president of consumer healthcare, North America, for GlaxoSmithKline, Merck’s new switch partner. “GlaxoSmithKline has a [proven] track record … for first-in-class switches,” Quesnelle noted, pointing to the company’s successful switch of complicated regimens like smoking cessation products and the diet aid alli. If switched, non-branded education to help raise awareness around statins will be launched into the marketplace, Quesnelle said, long before Mevacor Daily actually hits shelves.

GlaxoSmithKline’s marketing initiatives were submitted along with the application, Quesnelle said.

Some of the label revisions include a highlighted age-exclusion graphic on the front of the package and a stronger warning against the use of Mevacor Daily in women who are pregnant or could become pregnant.

Merck presented usage studies of two labels—one that asked consumers to evaluate whether or not they should take Mevacor Daily based in part on their knowledge of their total cholesterol scores and one that based that evaluation on a consumer’s low-density lipid levels. Merck concluded that consumers were more familiar with their total cholesterol levels.

Merck also proposed selling Mevacor Daily “on the open shelf but only in those stores with pharmacies.” Limiting distribution to stores-with-pharmacies affords the consumer convenient access to a healthcare professional—nurse practitioner, pharmacist—should they have questions.

However, the new studies have not alleviated all of FDA’s concerns over appropriate self-selection. In the usage study based on a consumer’s knowledge of their LDL levels, for example, 98 percent of consumers chose appropriately not to take the medicine, but only 16 percent of those who chose to take the medicine, did so appropriately.

In addition, more than 30 percent of participants who were already taking a lipid-lowering drug stated that they were appropriate to use an OTC statin. Of those, 55 percent would replace their current lipid therapy with the Mevacor Daily and 28 percent would take Mevacor Daily in conjunction with their current statin therapy.

Half of those already on a statin regimen would make the switch to Mevacor Daily based on cost concerns, with the assumption that an OTC medicine would be cheaper than their prescription-drug co-pays; 29 percent cited improved convenience in buying Mevacor over-the-counter; 15 percent said an OTC statin would mean they wouldn’t have to see their doctor as often; and 11.3 percent opined that OTC medicines present fewer side effects than their prescription-only counterparts.

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Britain’s pharmaceutical society supports U.K.’s decision on oral contraception

BY Michael Johnsen

LONDON The Royal Pharmaceutical Society of Great Britain supports the U.K. Department of Health’s recent decision to pilot the availability of oral contraception through Patient Group Directions, which are written instructions for dispensing of medicines to groups of patients without a prescription, the association announced Wednesday.

There is a direct correlation in the United States to how the emergency contraception Plan B was available to consumers, before it was switched to a dual OTC/Rx status by the U.S. Food and Drug Administration last year, in several states through a standing prescription, where pharmacists counseled patients and determined whether to dispense or not dispense the emergency contraceptive. The U.K. pilot may set the stage for consideration of oral contraceptives (not emergency contraceptives) in the U.S., especially as the FDA is currently researching the possible merits of a behind-the-counter system in this country.

“Pharmacists are experts in medicines and have a track record of supplying medicines such as emergency hormonal oral contraception via Patient Group Directions and also over-the-counter, stated David Pruce, director of practice and quality improvement at the Royal Pharmaceutical Society of Great Britain. “As such, they have clinical skills and expertise that will help them provide information and advice to women to ensure the appropriate use of oral contraception.”

In addition, the supply of oral contraception via PGDs would widen and improve patient choice, access and convenience, he said. “The necessary health checks such as blood pressure testing and healthy lifestyle checks are already a part of pharmacist’s extended role.”

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