On the eve of losing patent protection for its best-selling Lipitor cholesterol pill, Pfizer (PFE) is considering seeking FDA approval to sell an over-the-counter version. Whether the idea will pass regulatory muster, however, is questionable, given that the agency has previously nixed efforts by Merck (MRK) to sell an OTC version of the same type of cholesterol pill.
Why? An FDA spokeswoman tells The Wall Street Journal, which first reported the story, that earlier research on proposed OTC statins has not shown that most consumers will make correct decisions about taking the drugs. On the other hand, she says the FDA is open to discussing the possibility, but a drugmaker must be ready to demonstrate that consumers will make correct decisions.
In any event, an OTC version would allow Pfizer to capture some of the sales that will be lost when the Lipitor patent expires in November. In fact, Pfizer execs recently changed their mind about the possibility of selling the consumer healthcare unit, since the division allows them to market OTC versions of prescription meds and generates needed cash flow (read this).
The notion may also appeal to government agencies that would welcome the chance to pay much less for a prescription med that currently costs between $4 and $5 per pill. And as the paper notes, some docs argue that increasing access to statins could prevent heart attacks and strokes, which in turn would lower health care costs overall.
Of course, an OTC switch will not happen soon enough to blunt the patent expiration, since studies will need to be conducted to persuade the FDA. “The statin switch is a difficult one and the arguments against the switch ... have not and will not go away,” Patrick Ronan, a former chief of staff at the FDA who now provides regulatory consulting services to health-care companies, tells the Journal.
Indeed, although prescription allergy meds such as Zyrtec and Claritin are now sold over the counter, convincing the FDA to approve a statin may be difficult. In 2008, the FDA rejected a third effort by Merck to win approval of an OTC version of its Mevacor drug after an advisory panel expressed concerns about a study that failed to show consumers could make appropriate decisions about taking an OTC cholesterol pill. The panel also worried about patient monitoring by physicians (see here).
As the Journal points out, a study of an OTC Mevacor showed 30 percent of patients who thought they should take the drug actually had less than a 5 percent risk of a heart attack or other cardiovascular event in the next 10 years, and were therefore unlikely to benefit, according to a 2008 article in the New England Journal of Medicine written by the chair of the FDA advisory committee.
Moreover, many patients who thought they should take OTC Mevacor were outside the proposed target population of men over 45 and women over 55 who had high levels of bad cholesterol and met other criteria, the committee found. It is also worth noting that, unlike allergies, cholesterol does not generate symptoms that would prompt patients to make informed decisions about dosing or benefits.
“I do not think it would be wise,” Brian Strom, a professor of public health and preventive medicine at the University of Pennsylvania School of Medicine, tells the Journal. He adds that patients taking statins are supposed to undergo periodic blood tests to gauge the impact on cholesterol levels. He also frets that some may not follow instructions, because OTC may be perceived as less “serious.”
Merck, by the way, markets a non-prescription version of Zocor in the UK, but the pill is not sold OTC. Rather, pharmacists keep supplies behind the counter. And one consultant who specializes in Rx-to-OTC switches, Steve Francesco of Francesco International, believes new technologies, such as prescription cards, will make switches more viable. In fact, he believes Lipitor is a good candidate. “The attempted switch of a chronic therapy drug like Pfizer’s Lipitor would not be that surprising given the potential OTC sales,” he tells us;
“In fact, there are numerous chronic and recurrent therapy drugs that will seek to switch over the next five years that have great potential if the sponsor can prove that the drugs are safe in an OTC setting. That’s where new technology comes in to enable the switch. The interest in this new technology is, in part, why the FDA released its first guidance on the use of mobile phone applications.”
What do you think?