As Michael F. Cannon and I discuss in a new paper, ”Drug Reformation: End the Government’s Power to Require Prescriptions,” the FDCA’s authors emphasized that they respected the right of individuals to self‐medicate, seeking only to make self‐medication safer. The new law required drug makers to convince the Food and Drug Administration that new drugs were safe before being brought to market. It made manufactures provide detailed instructions on their labels comprehensible to people with a rudimentary education. The labeling requirement was waived if the drug maker decided to require a physician’s prescription before it could be sold to the public.
Respect for patient autonomy came to a complete end with the passage of the Durham‐Humphrey Amendment to the FDCA in 1951. This Amendment authorized the FDA to henceforth classify drugs as either prescription‐only or over‐the‐counter (OTC). It prohibits dispensing a prescription‐only drug unless the consumer presents a prescription from a government‐licensed health care practitioner.
Durham‐Humphrey disrespects patient autonomy and the right to self‐medicate. It increases the cost of obtaining medications by requiring visits to doctors’ offices and pharmacies and may contribute to higher drug prices. It also makes patients less safe.
Evidence shows patients tend to trust prescriptions from expert professionals, and don’t perform anything resembling the due diligence they perform when purchasing OTC medicines on their own. As a practicing surgeon, I frequently see patients who can’t tell me the names of the routine drugs their doctors prescribe to them — or the reasons they take them.
For example, a 2006 study of women in Seattle found they were more conservative than Ob‐Gyn specialists when self‐screening for use of oral contraceptives. Yet 95 percent of the victims of the sulfanilamide tragedy took the drug under their doctors’ prescription and supervision. And many of the doctors prescribed the drug to treat inappropriate conditions. Government‐licensed physicians prescribed thalidomide to 624 pregnant women, without informing them that the drug was experimental. The resulting horrific birth defects caused an international scandal in 1962.
Economist Sam Peltzman found enforcement of prescription regulation increased per capita consumption of these medicines, which tend to be more potent than OTC meds, and suggested there is a moral hazard in shifting consumption toward riskier drugs. Peltzman also found deaths from accidental or suicidal poisonings increased by 50 to 100 percent when the FDA began imposing prescription requirements.
When the government controls which drugs are prescription‐only, lobbying by special interests affects policy. Schering‐Plough, makers of the non‐sedating antihistamine Claritin, which was approved as a prescription drug in 1993, lobbied successfully for it to be sold OTC in Europe for several years, while simultaneously making the opposite argument to the FDA. It wasn’t until the drug’s patent expired in 2002 that the company changed its position, after which the FDA allowed Americans to buy it OTC. Until then, patients only had over‐the‐counter access to much more dangerous sedating antihistamines.
As we explain in our paper, prescription drugs tend to bring greater profits because drug makers can charge third‐party payers higher prices. We illustrate how drug prices usually drop after they are reclassified as OTC and become subject to comparison shopping and closer scrutiny by consumers. That helps explain why the makers of the opioid overdose antidote naloxone are reluctant to ask the FDA to end its prescription‐only status, despite the agency practically begging them to do so. The drug is OTC in Australia, Italy, France, and Canada.
Political considerations also play a role. That’s why it took twelve years and a court order before the emergency contraceptive Plan B became available OTC without age restrictions. It also has something to do with why oral contraceptives require a prescription in the U.S. while they are over‐the‐counter in more than 100 countries.
Ending the government’s power to require prescriptions would still see manufacturers requiring prescriptions for the great majority of today’s complex pharmaceuticals. They might require other drugs to be sold only to people who are screened by pharmacists. But the competition and efficiency of the market means more drugs will become OTC more quickly. This portends better choices and better prices for consumers — and respects patient autonomy.