Proposed FDA policy could provide route for OTC statin sales, expand pharmacist role

FDA to hold meeting on proposed policy on March 22

WHAT IT MEANS AND WHY IT'S IMPORTANT — One of the long-term goals of many drug companies has been to win Food and Drug Administration approval for cholesterol-lowering statins as over-the-counter drugs. But it's a goal that has long eluded them due to the agency's concerns about patient safety.

(THE NEWS: FDA mulls making some prescription drugs available over the counter. For the full story, click here.)

But the FDA's recently proposed policy for selling certain prescription drugs over the counter under special supervision from the pharmacist and physician could offer a way around the difficulty drug makers have had so far persuading the agency to allow an OTC switch for statins.

Granted, the conditions the FDA outlined for selling statins and other drugs over the counter wouldn't be the same as selling them at a lower dose directly from the store shelves like OTC proton-pump inhibitors or even behind-the-counter drugs — it still would require patients to have a diagnosis or to obtain an initial prescription from a physician, and regulations would be individually tailored to each drug.

At the same time, an important aspect of the proposed policy is that it would enhance the pharmacist's role as an extension of the physician, while also allowing a greater role for technology in self-diagnosis. For example, while a patient could use a kiosk or other device to self-diagnose for some medical conditions or check for drug interactions, the pharmacist still would step in to confirm the diagnosis before allowing the drug's purchase.

Physicians will always be needed to mend fractures or determine whether that mole is something to worry about, but allowing pharmacists to provide a greater share of services at the retail level with the aid of technology helps to take a lot of work off doctors' hands, thereby helping to reduce healthcare costs for patients and payers alike.

Login or Register to post a comment.