The Future of Physician Prescribing: Part II – Prescription vs. Over-The-Counter (OTC) Drugs

Sen. Hubert Humphrey, pharmacist

Mike Magee

In FDR’s original New Deal legislation, there was ample room for significant health reform. But challenges to his early legislative victories in the courts and a bruising battle to pass and defend his Social Security Act pushed these reforms aside. They included much needed improvements in the original 1906 Pure Food and Drug Act which was primarily a “truth in labelling” initiative on pharmaceutical products that crossed state lines.

The much needed reforms were known early in FDR’s first term. But it was an event, late in his 2nd term in 1937, that triggered legislative action. The S. E. Massengill Co of Bristol, Tennessee, a middle man producer and distributor of pharmaceutical products, had their chief chemist prepare an elixir of sulfonamide. The company’s sales people had assured leadership there was a market for a liquid sulfur drug for children with sore throats. The chemist produced the elixir using diethylene glycol. It passed his smell and taste tests. But he missed the fact that the additive was known to be poisonous. Over 100 children died, and that number would have easily soared into the thousands had the government not moved swiftly to recover 95% of the batch that was already distributed to pharmacies nationwide.

Following the Massengill sulfonamide elixir tragedy, Congress developed the will to pass the Federal Food, Drug, and Cosmetic Act of 1938. This, for the first time, required manufacturers to demonstrate safety of a drug before marketing. In the same year, the Wheeler-Lea Act, for the first time, empowered the Federal Trade Commission to regulate advertising of products falling under FDA oversight. In the war years that followed, new drugs and therapies appeared signaling a new era in scientific discovery. By 1950, the drug labels were deemed inadequate. That year the Alberty Food Products v. U.S. ruling declared that the drug label must include the condition it is intended to treat.

One year later, in 1951, two chemists, Senator Hubert Humphrey (D-MN) and Congressman Carl Durham (D-NC) proposed and helped pass the Durham-Humphrey Amendment. The law required that any drug that was “habit forming or potentially harmful” be declared “legend”, and all others be declared “over-the-counter”(OTC). Legend drugs were subsequently called “prescription drugs” because the law required that their labels carry the message, “Caution: Federal law prohibits dispensing without a prescription.” From this day forward, any drug deemed potentially unsafe for self-medication would require a physician’s written permission, in the form of the prescription, to allow a pharmacist to provide the therapy. All others would be available “over-the-counter”.

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Part I: Controlling The Flow of Narcotics in the 19th Century

Part III: The “Learned Intermediary” and Direct-To-Consumer (DTC) advertising.