A Lengthier-Than-Expected History of the 1938 Food, Drug and Cosmetic Act: Part 6

In a way that only grand tragedy can instigate reform, the rising number of deaths due to Massengill's Elixir Sulfanilamide mobilized a formerly apathic press and public to demand revision of the 30-year-old Wiley statute. The principal House opponent of Copeland's first S. 5 bill, B. Carroll Reece (R-TN), was particularly stung by the fact that Massengill's company resided in his district, and reformists were only too happy to point out this fact.

But passage of S. 5, while facilitating the FDA's ability to seize bottles of Elixir Sulfanilamide, would not have prevented the disaster. The bill, unlike the original Tugwell measure (S. 1944), had no licensing provisions for new drugs entering the market, as the League of Women Voters was quick to note. This fact was verified by Representative Lea with Paul Dunbar of the FDA, and the California legislator requested an appropriate amendment to rectify the omission.

Copeland was way ahead; on December 1, he introduced S. 3073, which stated that any manufacturer who sought to market a new drug must submit the drug's components, testing records, an explanation of the manufacturing processes, labeling examples, and drug samples (if requested) to the Secretary of Agriculture. Five months later, the Senate passed S. 3073 unanimously, after a few minutes of half-hearted objections.

However, the old sticking point of the government's advertising purview remained, manifest in the Wheeler-Lea bill (S. 1077)—which was intended to expand the FTC's control over food, drug, and cosmetic advertising. After heated debate, the House had passed the measure in January of 1938, and the Senate had followed 2 months later. The bill was signed into law on March 21. The FDA was "apoplectic," given that the act not only stripped the agency of any marketing control over drugs but required proof of fraudulent intent after the fact (like the 1912 Sherley amendment).*

By the spring of 1938, Lea, after increasing pressure, finally brought S. 5 no. 2 out of House committee, but not before he had slipped in a section that allowed for numerous appeal reviews for alleged violators in any one of the 85 federal district courts. Lea's rationale was to provide a check on the Secretary of Agriculture's regulatory power, but reformists were having none of it. Consumer and national women's organizations were outraged and bombarded the President with pleas to intervene. FDR did so, although somewhat cryptically. Publicly he gave no indication that he would sign the Copeland-Chapman bill if Lea's appeal section was included; privately he informed the House committee of a forthcoming veto.

So in June, a legislative compromise was hammered out in conference: industry's appeals would be restricted by circumstance and court venue. And in a conciliatory mood, the conferees also accepted stronger language on the subjects of label disclosure, standard variations, and seizures. The conference report was quickly passed by the Senate and House, and FDR signed the new Food, Drug and Cosmetic Act on June 25, 1938—12 days after Massengill pleaded not guilty to federal charges of mislabeling and misbranding Elixir Sulfanilamide and 8 days after an exhausted Royal Copeland collapsed on the Senate floor and died later that evening. He was 69.

The Act that Copeland championed would become effective 1 year later.

* Regulation of prescription-drug advertising was finally transferred to the FDA after passage of the Kefauver-Harris Drug Amendments in 1962.

Chief source: Jackson Co. Food and Drug Legislation in the New Deal. Princeton, NJ: Princeton University Press; 1970.