FDA mulls bringing key drugs over-the-counter and medications for high blood pressure, diabetes and migraine may be the first to make the switch.
It’s driven by many things: Drug companies seeking more profits, as well as the rapid developments in medical technologies that have led to touch-screen kiosks in pharmacies that patients can use to self-diagnose common diseases. It’s also motivated by a need to address undertreated epidemics like diabetes.
Overall, it means nothing less than a sea change in the United States drug regulation policy.
On March 8, the U.S. Food and Drug Administration announced it was considering waiving prescription requirements for the most widely used prescription drugs used to treat diabetes, asthma and migraines.
The over-the-counter (OTC) switch is aimed to increase access to established drugs. It’s also aimed to speed up approval of experimental medications.
The FDA also predicts that the shift will bring a decreasing number of visits to the doctor — and resulting benefits. “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.
But the proposal is still in the early stages, the FDA says, adding that it has scheduled a public meeting for later this month to gather comments.
“We’re not talking about very specific drugs right now, we’re talking about the concept,” says Janet Woodcock, director of FDA’s drug center.
Better access for needed drugs
The move’s first goal is to make certain medications more easily available to people. These medications are those that are needed to treat currently undertreated epidemics like diabetes and high blood pressure, the FDA claims.
According to health experts, the unwillingness of people to take certain drugs as prescribed undermines the effective treatment of certain conditions like high blood pressure. This, in turn, raises the cost of healthcare in the U.S. — high blood pressure cost American taxpayers US$76 billion in 2010, the Centers for Disease Control and Prevention says.
About one in three U.S. adults has high blood pressure — a main contributor to heart disease and stroke, the nation’s top killer. Contributing also to these top killer diseases is diabetes — and the FDA estimates that of more than 25 million Americans with diabetes, about seven million aren’t diagnosed and don’t receive treatment. About a third of those with high blood pressure stop taking their medication, the FDA also reveals.
The goal of the OTC switch is to ensure that patients take drugs as needed — but with a clear understanding of the drugs’ safety and risks.
But the main problem with making these drugs available without prescription is that this will require patients to understand complex issues — like exactly when to take a drug to ensure safe use, as well as complicated aspects of their disease.
Typically, over-the-counter drugs treat short-term conditions with easily recognized symptoms like headaches or runny noses. They also come with a fact box or pamphlet that are easy to understand. But prescription drugs — cholesterol lowering drugs called statins, for instance — require detailed knowledge about a person’s condition, in this case, elevated or abnormal levels of fat in the blood, known as lipids.
“These are discussions that need to start happening as we think about people’s health needs and how to improve access,” FDA commissioner Margaret Hamburg says.
Speeding drug approvals
For a long time, pharmaceutical companies have been complaining that U.S. requirements for drug approval are more burdensome than those in Europe or those in other parts of the world. Thus, or a long time too, drug companies and their allies in Congress have been pressuring the agency to speed up approvals.
Now, apparently, the FDA is giving in to the pressure.
Since its creation, the FDA has evaluated medical products solely on their safety and effectiveness. Now, after years of restricting access to certain drugs in many high-profile drug-safety cases, the FDA is highlighting its efforts help drug makers get new drugs on the market.
According to the Associated Press, some Republican-backed proposals in Congress would even change FDA’s mission statement, requiring the agency to encourage medical innovation and job creation.
“The world is changing and we have to change to with it,” Dr. Hamburg tells the AP. “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.”
Not the first time
It isn’t the first time that the FDA will bring prescription drugs over the counter, though.
Over the years, the switch of a number of high-profile prescription drugs to over-the-counter use has been approved by the federal regulator. In 2003, it cleared Prilosec — now an over-the-counter version of the bestselling AstraZeneca heartburn drug Nexium.
But the agency only approves such changes when the drug maker presents studies showing that patients can take the drug safely after reading the package labeling.
In 2008, the FDA rejected Merck & Co Inc’s bid to sell its Mevacor statin over-the-counter when FDA advisers ruled that patients wouldn’t be able to decide for themselves whether they were appropriate candidates for the medicine.
Janet Woodcock, head of the FDA’s drugs center also explains why statins — taken by millions of Americans — haven’t been cleared for over-the-counter sales.
“We’ve had several applications already to switch statins to over the counter, and they have failed because consumers can’t determine their lipid status,” Woodcock tells Reuters.
But new technologies are changing all that.
Under the pharmaceutical industry-backed proposal, drug makers say they will use electronic questionnaires, diagnostic devices such as blood pressure monitors and other computer-assisted technology to guide patients.
The FDA has met with the drug makers to discuss these ways to help people understand drug risks when they go to a pharmacy.
Under the plan, some patients would first need to obtain an initial prescription from a doctor before being able to get over-the-counter refills. In other cases, patients would have to speak first with a pharmacist to get information on the drug’s risks, benefits, dosage and other information, but wouldn’t need a prescription to buy the drugs.
A switch would have to be requested by drug makers for each drug individually, and then the FDA would judge the safety of each proposal on a case-by-case basis.