FDA May Let Patients Buy Drugs without Prescriptions

Daily News Article — Posted on May 2, 2012

(by Paige Winfield Cunningham, WashingtonTimes.com) – In a move that could help the government trim its burgeoning health care costs, the Food and Drug Administration (FDA) may soon permit Americans to obtain some drugs used to treat conditions such as high blood pressure and diabetes without obtaining a prescription.

The FDA says over-the-counter distribution would let patients get drugs for many common conditions without the time and expense of visiting a doctor, but medical providers call the change medically unsound and note that it also may mean that insurance no longer will pay for the drugs.

“The problem is medicine is just not that simple,” said Dr. Matthew Mintz, an internist at George Washington University Hospital. “You can’t just follow rules and weigh all the pros and cons. It needs to be individualized.”

Under the changes that the agency is considering, patients could diagnose their ailments by answering questions online or at a pharmacy kiosk in order to buy current prescription-only drugs for conditions such as high cholesterol, certain infections, migraine headaches, asthma or allergies.

By removing the prescription requirement from popular drugs, the Obama administration could ease financial pressures on the overburdened Medicare system by paying for fewer doctor visits and possibly opening the door to make seniors pay a larger share of the cost of their medications.

The change could have mixed results for non-Medicare patients. Although they may not have to visit a doctor as often, they could have to dish out more money for medications because most insurance companies don’t cover over-the-counter drugs.

“We would expect that out-of-pocket costs for insured individuals, including those covered by Medicare, would be increased for drugs that are switched from prescription to OTC status,” said Dr. Sandra Adamson Fryhofer, who testified last month on behalf of the American Medical Association in an FDA-held public hearing.

Pharmacists and doctors have lined up on opposite sides of the issue. Often trying to combat a public perception that downplays their medical training, pharmacists embrace the notion that they should be able to dole out medication for patients’ chronic conditions without making them go through a doctor.

“We think it’s a great development for everybody – for pharmacists, for patients and the whole health care system,” said Brian Gallagher, a lobbyist for the American Pharmacists Association. “The way we look at it is there are a lot of people out there with chronic conditions that are undertreated and this would enable the pharmacists to redirect these undertreated people back into the health care system.”

Medical providers urged caution, saying the government should not try to cut health care costs by cutting out doctors.

“What the government via the FDA has decided to do is just bypass the expensive doctor and to satisfy some safety concerns of letting people just pick out their medications is make sure they have to get counsel by the pharmacists,” Dr. Mintz said. “I believe there is value to using pharmacists, but not at the expense of primary care.”

Although the FDA says more patients will be likely to obtain the drugs they need under the proposed model, Dr. Fryhofer questioned whether the agency has sufficiently proved that.

“The FDA has not offered any evidence establishing that it is safe, or patient outcomes are improved, when patients with hypertension, [high cholesterol], asthma or migraine headaches self-diagnose and manage these (or other) serious chronic medical conditions on their own,” she said.

Comments on the proposal are due by May 7.

FDA spokeswoman Erica Jefferson said the agency will issue a decision sometime after that but didn’t offer a more specific time frame.

“The agency is still reviewing the public comments and will make a determination on the best path forward once this has been completed,” she said.

Background

The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets [etc.].

The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. The 21st and current Commissioner is Dr. Margaret A. Hamburg. She has served as Commissioner since February 2009.

The FDA has its headquarters in Maryland, and also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.