Citing a person with knowledge of the matter, The Wall Street Journal reported Wednesday that Pfizer may introduce an over-the-counter version of Lipitor (atorvastatin). FDA spokeswoman Shelly Burgess said prior research on proposed over-the-counter statins hasn’t proven that most consumers will make correct decisions about taking the drugs, but she noted that the agency is open to discussing the topic with companies that are prepared to demonstrate that consumers will make the right decisions. The source noted that Pfizer has yet to conduct additional research to address the FDA’s concerns.
The Wall Street Journal noted that Pfizer recently decided to hold onto its consumer healthcare unit, despite pursuing divestitures of other divisions including animal health, in the hopes that the unit will afford it the opportunity to market over-the-counter versions of some drugs it currently sells as prescription-only. Currently, a nonprescription version of simvastatin is available for sale in UK pharmacies, although it is sold “behind the counter.”
“The statin switch is a difficult one and the arguments against the switch … have not and will not go away,” commented Patrick Ronan, a former chief of staff at the FDA. However, Miller Tabak analyst Les Funtleyder said “if you can keep some of that [market], that’s a win, especially a drug as big as Lipitor.”