Pharmaceutical giant, Pfizer, is making strides to sell a non-prescription version of its blockbuster cholesterol medication, Lipitor. The move is a clear indication that Pfizer intends to prolong the life of its top-selling product, especially considering Lipitor is on the verge of losing its U.S. patent protection, which would open the flood gates of competition from generic prescription forms of the same product.
Pfizer is likely to face a battle with federal regulators regarding safety concerns associated with the use of an OTC version of the drug. A spokesperson for the FDA told the Wall Street Journal that consumers are unlikely to make correct decisions about using anti-cholesterol drugs like Lipitor, which is obviously a huge cause for concern. Regardless, Pfizer remains hopeful that the U.S. Food and Drug Administration will allow an over-the-counter form of Lipitor to hit pharmacy shelves, which will help the company draw additional sales for the drug.
In the past, the FDA has rejected similar attempts to transition prescription medications to over-the-counter use, denying approval for drug maker, Merck & Co., to sell of an OTC version of the cholesterol drug, Mevacor. Like Mevacor, Lipitor is classified as a statin, which can lead to liver and muscle damage.