Statin Down the Hatches

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  • 03/07/2014

OTC Statins: More Questions than Answers

Much news lately about Pfizer’s desire to move Lipitor into the OTC category.

OTC statins. Not a new conversation, but certainly a timely one as we continue to face not just Hyperlipidemia – but medication adherence (and particularly for chronic, asymptomatic conditions).

Are statins “safe enough” to be available without a prescription? Well, with the appropriate caveat that no drug is 100% safe, it’s pretty fair to say that their safety profile is excellent – for Rx products. But is the same true if they were available OTC?

Here’s some history.

In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell lovastatin (Mevacor), without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase lovastatin from pharmacists much like the British are allowed to purchase simvastatin (Zocor), another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.

(Other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.)

Then, in 2007, another proposal to offer lovastatin over-the-counter was rejected by an FDA panel, primarily due to the fear consumers might not select the drug appropriately.

“It is not clear that the benefits to patients of lovastatin being over-the-counter outweigh the risks, although the risks are small,” Arthur Flatau, PhD, said during a joint meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee. “Clearly, there are a lot people who are not on statins and should be on statins; putting the drug over the counter will not increase the number of patients who take it.”

The vote was 10-2 against over the counter approval of lovastatin with one abstention. The majority of panel members who voted against lovastatin over the counter felt consumers were unable to make a decision regarding whether they should be taking a statin.

Can a patient self-diagnose and self-dose?  Do symptoms hide another, potentially more serious, underlying condition?  And what of safety concerns? 

Per a New England Journal of Medicine written by the chair of the FDA advisory committee, "Some docs argue that increasing access to statins could prevent heart attacks and strokes, which in turn would lower health care costs. Overall, a study of an OTC Mevacor (Merck's statin) 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."

Does this open the door for a so-called “behind the counter” (BTC) category? CDER Director Janet Woodcock has spoken out in favor of such strategies since they would allow switch candidates with greater self-selection obstacles to be available without a prescription.

This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.

Pfizer recently started a 1,200-patient clinical trial to test if consumers taking OTC Lipitor and getting their own blood tests improve their cholesterol levels and then make the right decisions based on the results of a second blood test. (These blood tests, in the real world, would be administered at the pharmacy.)

What additional questions should be asked when it comes to the OTC statin debate? Here are a few:

* Should any chronic medications be available OTC? (This is a very big “beyond statins” question that hasn’t been widely discussed … yet.) Most Rx-to-OTC switches have been for the treatment of acute, transient symptoms of allergies, heartburn, etc.

* Isn’t this a de facto BTC play? After all, the pharmacist will have to advise, test, and dispense. Isn’t that beyond the scope of FDA’s existing regulatory authority?

* Is an OTC “Drug Facts” label up to the task of properly communicating the most important benefit/risk information about statins (or, for that matter, about any OTC product)?

* Even at a 10mg dose?

* Per that second blood test, what does “success” look like?

* What if the patient doesn’t come back for a second blood test?

* What about the financial burden on the consumer? Rx products are reimbursed. OTC products are not.

* And, to that point, when there is an increased financial burden on the patient (i.e., raised co-pays) – adherence declines. Would OTC statins further exacerbate the problems with statin adherence?

* If, after the second pharmacist-implemented blood test, the patient is told to see their physician – why shouldn’t they just have gone to see their physician in the first place?

* If Pfizer is granted the OTC designation for Lipitor and then other statins follow suit (a pretty safe supposition), how are patients supposed to choose which statin is “best for them” minus a physician's “clinical experience?”

* What about prospective patient (aka “consumer”) education? Pfizer says it hopes to persuade regulators to approve OTC Lipitor by using "new and creative ways" to communicate instructions for use.

All this to say that it’ll make for an interesting and important conversation.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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