Blogs: For the Record

The Possibility of OTC Lipitor

Published Online: Thursday, November 3, 2011
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."
About
Darshan Kulkarni, Kulkarni Law firm
Blog Info
Darshan Kulkarni, a pharmacist and attorney based out of Kulkarni Law firm (Philadelphia, PA), will provide insights on the legal, regulatory, administrative, and ethical issues that can affect pharmacists in their everyday practice.
Author Bio
This blog will primarily focus on informing pharmacists about how the drugs that they dispense came to be in their hands—including the ethics, the arguments, the laws, and the drama. Among the topics covered are FDA regulations, drug development, clinical trial participation, compounding drugs, social media marketing, and pharmaceutical advertising. This blog will also discuss what pharmacists need to know about dispensing certain medications.

Dr. Kulkarni holds a Doctor of Pharmacy degree, a Master of Science in Quality Assurance/ Regulatory Affairs, and a Juris Doctorate degree. He works with and/or for research sites, clinical research organizations and a variety of small and large pharmaceutical and biopharmaceutical companies to assist them in meeting their clinical, legal, regulatory, and/or compliance needs.

Dr. Kulkarni has worked, and continues to work, as a pharmacist for more than 10 years. He currently serves as Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products–Regulatory Considerations.

You can follow him on twitter at @FDALawyers (http://www.twitter.com/FDALawyers) or visit the Kulkarni Law Firm's Web site (http://www.conformlaw.com/).

Disclaimer
The opinions stated in this blog are the sole and present opinions of Dr. Kulkarni as of the time of writing of the blog in question and do not necessarily represent the legal or medical opinions of Kulkarni, LLC and/or its other attorneys. Such opinion(s) may change over time. These blog postings do not constitute legal advice, and do not create an attorney–client relationship and should not be construed as such. These blog postings also do not constitute medical advice. Please contact your physician for medical advice, and your attorney for legal advice, that is appropriate for you.
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