Cholesterol-lowering statin products may be the next class of drugs to go over the counter (OTC), according to "Cardiovascular Marketing," a new study by business intelligence firm Cutting Edge Information (report available at http://www.PharmaCardio.com ).
Critical challenges stand in the way. Patients taking statins must make regular doctor visits to monitor cholesterol levels throughout treatment. Since they could not address this need, Merck's Mevacor and Bristol-Myers Squibb's Pravachol applications for OTC status were initially rejected.
The FDA will stand firm on its decision until the industry proves that the public can safely self-medicate with statins. Statin drugs, which lower cholesterol levels, dominate the pharmaceutical industry.
The worldwide statins market approached $12.5 billion in 2003, and two drugs, Lipitor and Zocor, controlled nearly two thirds of the lucrative US market. With many blockbuster statin products approaching patent expiration, the industry is increasing its OTC efforts. The very size of the market provides further motivation for the FDA to grant certain statins OTC status.
More than 8 million patients in the US already take a statin, and federal guidelines released in 2001 estimate that as many as 36 million Americans may need to take a cholesterol-lowering agent to reduce the risk of heart attacks.
Currently, cardiovascular disease causes 950,000 deaths in the US each year. Companies continue to build on the FDA's 2000 decision to withhold OTC status for Mevacor and Pravachol. Merck and Johnson & Johnson are currently working together to re-petition the FDA for approval to sell Mevacor over the counter. Bristol-Myers Squibb is also considering another request for the approval of Pravachol. "Today, years of studies showing the safety of the drugs and years of use by millions of patients are boosting pharmaceutical companies' arguments in favor of OTC approval," said Elio Evangelista, senior analyst at Cutting Edge Information. "In addition, the FDA does encourage more over-the-counter switches to make sure consumers have access to safe, affordable drugs."
For more information on this report or to learn about other research being conducted by Cutting Edge Information, contact Jan Blanchette at [email protected] or 919-433-0218. For media inquiries call Tricia McGovern at 919-433-0217 or [email protected].