Could Statins Soon be Available Over-the-Counter in Texas?

This November, major pharmaceutical company Pfizer is set to lose patent protection on Lipitor, its blockbuster cholesterol-lowering drug. Each year, Pfizer makes an astounding $11 billion on sales of Lipitor, a number which is soon to be sharply cut by generic competition.

Rumors about Pfizer making Lipitor an over-the-counter (OTC) drug have been swirling, even though Pfizer has not yet confirmed whether this is true. The company does not want to lose its mega profits from the drug and is expected to make its own generic version of Lipitor. Come November, consumers could see as much as a 60 percent savings on the drug.

Other major pharmaceutical companies that have attempted to make their statins OTCs have failed in the past. Merck, for example, attempted to sell its Mevacor as an OTC, but the Food & Drug Administration (FDA) denied this request. According to the Wall Street Journal though, the FDA is now open to the idea of statin drugs becoming OTCs, as long as the drug manufacturers can prove that consumers would use them correctly.

Some medical experts think OTC statins would benefit Americans with high cholesterol, simply because the drugs would be more widely available, especially to those without insurance. But other experts are worried that the statins will do more harm than good.

Some doctors say patients need to have blood tests conducted to determine whether they have high cholesterol. And once on a statin medication, patients need to be periodically monitored to ensure the medication is working properly.

Currently, in the United Kingdom, statins like Lipitor are available without prescriptions. Doctors here worry that if OTC Lipitor hits Dallas' store shelves, patients will either over-medicate themselves, causing liver or muscle damage, or under-medicate themselves, making them vulnerable for a heart attack.

Another worry is that patients will not take the drug very seriously if it is available as an OTC. For example, Americans will continue to eat what they want, thinking they can "counteract" their bad eating by taking OTC Lipitor.

Before the FDA determines whether to allow Lipitor to be made available as an OTC drug, Pfizer will first have to prove that the drug would be easy for consumers of average intelligence to use by reading the instructions on the label.