FDA weighs over-the-counter switch for key drugs

By MATTHEW PERRONE , AP Health Writer

Some of the most widely used prescription drugs, including those to treat cholesterol and high blood pressure, could be available over the counter under a new proposal being weighed by government regulators.

Food and Drug said Wednesday they are considering waiving prescription requirements for certain drugs used to treat ailments like diabetes, asthma and migraine. Driving the move is a wave of computer technology, including touch-screen kiosks found in pharmacies, designed to help patients self-diagnose .

FDA regulators told reporters that easing access to obtain certain medications could help address undertreated epidemics like diabetes. Of the more than 25 million Americans with diabetes, an estimated 7 million are not diagnosed and therefore do not receive treatment. Diabetes is a leading cause of and stroke.

"These are discussions that need to start happening as we think about people's health needs and how to improve access," said FDA Commissioner Dr. Margaret Hamburg.

The over-the-counter switch is one of several FDA proposals aimed at increasing access to established drugs or speeding up approval of experimental medications.

After years of high-profile drug-safety cases in which the FDA restricted access to certain medications, the agency is increasingly highlighting its efforts help drugmakers get new innovative drugs on the market. The shift comes as drug companies and their allies in Congress have pressured the agency to speed up approvals, complaining that U.S. requirements are more burdensome than those in Europe and elsewhere.

Some Republican-backed proposals in Congress would even change FDA's mission statement, requiring the agency to encourage medical innovation and . Since its creation, the FDA has traditionally evaluated solely on their safety and effectiveness.

"The world is changing and we have to change to with it," Hamburg said. "We're not talking about abandoning standards for safety and efficacy, we're talking about leveraging opportunities in science so we can do a more effective job as regulators and also improve the drug development process."

Over the years, the FDA has approved the switch of several high-profile to over-the-counter use. In 2003, the FDA cleared Prilosec, an over-the-counter version of the blockbuster AstraZeneca heartburn drug Nexium. The FDA only approves such changes if studies show that patients can safely take the drug after reading the package labeling. Under the industry-backed proposal, drugmakers could use electronic questionnaires, diagnostic devices like blood pressure monitors and other computer-assisted technology to guide patients.

In some cases, patients would still need to see a doctor to obtain an initial prescription before getting over-the-counter refills. In other cases, patients would need to speak with a pharmacist but would not need a prescription to receive medication.

The agency also predicts a number of benefits from decreasing doctor visits.

"Eliminating or reducing the number of routine visits could free up prescribers to spend time with more seriously ill patients, reduce the burdens on the already overburdened health care system and reduce health care costs," the agency states in recent federal notice about the proposal.

Drugmakers would have to request a switch for each drug individually, and the FDA would judge the safety of each proposal on a case-by-case basis.

FDA officials stress that the idea is still in the early stages and a public meeting is scheduled for later this month to gather comments.

"We're not talking about very specific drugs right now, we're talking about the concept," said Dr. Janet Woodcock, director of FDA's drug center.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA cracks down on untested cold medicines

Mar 02, 2011

(AP) -- The Food and Drug Administration says it will remove roughly 500 unapproved cold and allergy medications from the market as part of an ongoing campaign cracking down on ineffective prescription medications.

FDA stresses need to modernize its science

Oct 06, 2010

(AP) -- The Food and Drug Administration must update its scientific tools for reviewing prescription drugs, medical devices and tracking food safety, according to a list of priorities laid out Wednesday by agency leadership.

FDA panel backs Pfizer drug for kidney cancer

Dec 07, 2011

(AP) -- A panel of advisers to the Food and Drug Administration voted Wednesday that the benefits of a Pfizer kidney cancer drug outweigh its risks, according to a company spokeswoman.

Recommended for you

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

EU regulator: Morning-after pill OK for all women

Jul 24, 2014

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

Physicians warned about counterfeit medical devices

Jul 24, 2014

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in ...

User comments