FDA May Allow Patients to Buy Drugs Without Prescriptions


medicineIn a move that could help the government trim its burgeoning health care costs, the Food and Drug Administration 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, theObama 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.

{The Washington Times/Matzav.com Newscenter}


  1. A few pharmacies already have clinics staffed by nurses to treat simple illnesses that cause people to miss work or school such as strep throat, eye infections, bladder infections, etc. Most health departments also offer vaccinations and health screenings for a lower price. I was in a drugstore yesterday and the loud speaker announced that the pharmacist could now test blood sugar. There is probably nothing wrong with having a pharmacist test blood pressure, blood sugar, and cholesterol. The patient, though, would need to keep his or her own health records because one function of doctors is to keep a record of the patient’s history. Pharmacists get paid less than doctors but most are very busy dispensing medications and patient care takes time as well. Those patients without insurance will welcome this new trend but those who pay for insurance will surely hate it.

  2. These “common” drugs all have side effects, which may not appear for some time. Currently people have to be under the care of a doctor, who hopefully will spot side effects before they kill or disable the patient. Also, as people age or their health status changes, their dosage may have to be readjusted. For that, you need the experience of a doctor.

    And who’s to say that only people that need them will take them? Someone may surf the web, decide they have a problem and self-medicate, with possibly tragic results. And…some of these meds have psychological / emotional side effects, which makes them open to abuse. We need more of that?

  3. This is insane-so everyone will be self-medicating and overdosing and then they’ll have a really serious problem on their hands! what are they thinking?!

  4. Soon after this patients will be able to obtain videos that will guide them on how to do simple surgery on themselves. This is such a stupid and dangerous idea. Many patients espcially elderly ones have problems taking their medications with their doctors’ guidance. Imagine how well they will do on their own. Pharmacists are busy filling perscriptions etc. See the line of confused elderly customers out the door. As for kiosks…

    If this passes watch the lawsuits burgeon as patients harm themselves.

  5. I would say this, that some common illnesses such as adult onset diabetes, is often caused by lifestyle choices. Smoking can aggravate asthma. Some high cholesterol can be controlled by diet but some of it appears in people who don’t eat too much dietary cholesterol. High blood pressure can be reduced in some cases with less salt in the diet but in other cases, it is not the result of lifestyle. Some people may be able to save money by changing their habits.