WASHINGTON (AP) —
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 Administration officials 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 common diseases.
The FDA 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 heart disease 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 job creation. Since its
creation, the FDA has traditionally evaluated medical products 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
prescription drugs 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.
Copyright 2012 The Associated Press.