FDA Considering Letting Patients Purchase Drugs Without Prescriptions

The Washington Times reported on April 29, 2012 that 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." According to the FDA, such a move would allow patients to purchase drugs for a number of common medical conditions "without the time and expense of visiting a doctor".

According to the article, "medical providers call the change medically unsound and note that it also may mean that insurance no longer will pay for the drugs." An interesting part of the considered changes is that "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."

In this way, "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." It is significant to note that in theory on an economic level, the marketplace could readjust for any imbalances between drug costs and doctor visits. Per the Washington Times, such changes may have "mixed results for non-Medicare patients". Non-Medicare patients may have to pay more money for medications owing to the fact that "most insurance companies don't cover over-the-counter drugs".

According to Dr. Sandra Adamson Fryhofer, "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." Whereas pharmacists and doctors are divided on the issue of transitioning certain drugs from requiring a doctor's prescription to being over-the-counter, the article noted that "pharmacists embrace the notion that they should be able to dole out medication for patients' chronic conditions without making them go through a doctor."

Even so, "[m]edical providers urged caution, saying the government should not try to cut health care costs by cutting out doctors." Per George Washington University Hospital internist Dr. Matthew Mintz, "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." Mintz continued, "I believe there is value to using pharmacists, but not at the expense of primary care."

Per the Washington Times, "[c]omments 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."

Whereas in theory the proposed FDA changes suggest taking doctors out of the equation for obtaining medications, one has to wonder about the reliability of allowing patients to diagnose their own illnesses online or at a pharmacy kiosk. And even then, where we do we draw the line? Can loved ones go online to enter symptoms for a patient in need of prescriptions? Hypothetically, such changes may open the door for patients to allege legal wrongdoing on the part of pharmacists or online organizations for problems resulting from the adverse effects of various medications. One could contend that there is a strong public policy concern in making sure that trained physicians retain the ability to prescribe various medications.

On the other hand, there seems to be a growing Zeitgeist in American society avoiding regulation and bureaucratic procedures in the interest of cutting costs and preserving resources. In other words, tighter budgets portend looser rules. If a trend toward reducing regulations and bureaucratic procedures in American society continues, we may see more similar steps taken by the governmental agencies going forward. That being said, the proposed FDA move portends substantial changes in the way that Americans purchase medications. Might the proposed FDA changes spur an increase in the number of Americans that use such medications? Might the proposed changes spur more sales for pharmaceutical companies?

In terms of stocks to watch regarding the proposed FDA changes, traders may want to keep an eye on Pfizer Inc. PFE, GlaxoSmithKline GSK, Sanofi SA SNY, AstraZeneca AZN, Merck & Co. MRK, and Bristol Myers Squibb BMY. Traders can also check out Teva Pharmaceutical Industries TEVA and Eli Lilly LLY. In light of potential changes to the health care system owing to the Affordable Care Act, it will be interesting to see how both the medical field and the marketplace respond.