The Possibility of OTC Lipitor

The blockbuster drug Lipitor is about to go over-the-counter, which can lead to the loss of billions of dollars. Will converting save the brand?

The blogosphere was recently excited about the possibility of Pfizer aiming for an OTC version of Lipitor.

Class Effect

Lipitor belongs to a class of drugs called "statins". The primary issues associated with statins are (1) a heightened risk of rhabdomyolysis (breakdown of muscle) and (2) a change in the liver enzyme tests (LFTs). Both these issues are associated not just with a single member of the statin class, but are applicable, in general, to its members. Resultantly, this effect has been observed not only in the case of Lipitor, but also its competitors, including simvastatin and lovastatin.

Why an OTC switch?

Lipitor was the highest selling drug of all time. At its peak, Lipitor had annual sales of over $6 billion. Prescription Lipitor is about to go generic in November 2011. When a branded drug goes generic, it can lose a significant portion of its sales. In the case of Lipitor, it can mean the loss of several billion dollars.

Converting from a prescription drug to OTC allows Lipitor to extend its brand. It will allow Lipitor, the brand, to be sold over the counter, and allow for the profitable revenue stream to be maintained. Pfizer hence reached out to the FDA to request that it be allowed to convert its prescription Lipitor to an OTC product.

So what is an OTC drug?

An OTC drug is one that has been found to be both: safe and effective; and that may be appropriately used without the supervision of health care professionals. Resultantly, OTC products, unlike prescription products, may be purchased by consumers without a prescription.

Unfortunately, as by-product of the independence from medical supervision, healthcare professionals often fail to monitor OTC drugs as closely as they would, prescription products. Patients must hence take it on themselves to ensure that their healthcare practitioners monitor their use of prescription and OTC drugs.

Is Lipitor a bad OTC Candidate?

Several OTC drugs, according to some clinicians, exhibit a higher risks. Aspirin is associated with a risk of bleeding, Benadryl (diphenhydramine) can cause sleepiness and Sudafed (pseudaephedrine) can result in blood pressure and heart rate problems in specific patient populations. Comparatively, the risks of the OTC use of Lipitor is limited.

Additionally, simvastatin, from the same class as Lipitor was approved as an OTC product to be sold in the United Kingdom in 2004.

Likelihood of Approval

It is currently unlikely that an OTC version of Lipitor will be approved. Zocor (simvastatin), which was in the same product class, was not approved. Some commentators reported that repeated efforts by Merck to create an OTC Zocor failed because the FDA determined "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, [an FDA spokesman said that] the FDA is open to discussing the possibility, but a drugmaker must be ready to demonstrate that consumers will make correct decisions."