Controlling “America’s Opium”: Barbiturate Abuse, Pharmaceutical Regulation, and the Politics of Public Health in the Early Postwar United States

In the United States and elsewhere, many medicines legally require prescriptions, and none is allowed on the market without substantial evidence of its safety and efficacy. This situation reflects two major changes that occurred in the mid-twentieth century: first, the medical profession gained control over distribution of many drugs, inserting the prescriber between manufacturer and user; second, government gained regulatory powers over what drugs were allowed on the market, inserting itself between manufacturer and doctor. These changes were nearly simultaneous in the United States, occurring quickly between 1938 and 1951, and, as we shall see, they were intimately connected. However, even though these changes were to a great extent mirrored in the regulatory regimes of other developed nations, they were hardly automatic and inevitable.¹ Rather, as I shall argue here, the politics of pharmaceuticals regulation were briefly linked to narcotics control in 1940s America in a manner that has been forgotten, along with potential regulatory strategies that were never tried.

The value of these market interventions has been contested in historical accounts. For example, in 1980 Peter Temin, in a book widely cited by deregulation advocates during the Reagan-Bush years, noted that the 1938 revisions to the federal statutes that gave the U.S. Food and Drug Administration (FDA) authority over drug safety did not mention restricting any drugs to prescription, even though this was the law behind FDA’s first prescription-only rules. Temin further argued that requiring prescriptions was unjustified, given pharmaceuticals at the time: informed consumers could easily and safely self-administer the few drugs with any potency (and the 1938 law was chiefly a consumer-protection measure).² Temin’s critique of prescription-only regulation belongs to a tradition alive today at think tanks such as the Heartland Institute, seeking to roll back the bureaucratic imperialism that later (in 1962) arrogated to government the power to decide which drugs were effective enough to market.³

Historian Harry Marks in the 1990s wrote a powerful counter-critique, showing that the first prescription-only regulations were actually drafted in consultation with industry and widely seen as justified when implemented in 1940. The later evolution of these rules, Marks argued, was provoked by industry abuses of the agreed labeling system, while the 1951 Durham-Humphrey law giving prescription-only regulation a statutory basis marks industry’s victory in a decade-long struggle against the FDA’s efforts to restrict drugs with a poor balance of medical benefit to risk.⁴ Political scientists have also discussed prescription-only regulation. In his massive recent study of the FDA, Daniel Carpenter treats it as a typical FDA success, a win for the public health and, with Temin, an industry defeat—in line with the agency’s self-image as a wise and independent market umpire using science to channel industry in the public interest.⁵ And Kathleen Frydl, in a well-regarded recent book mainly on narcotics control, treated prescription-only as an inevitably weak measure derived from the FDA rather than the Bureau of Narcotics authority over nonnarcotic drug abuse (thus a victory for both industry and consumer freedom to self-medicate, contra Temin and Carpenter).⁶

I shall argue here that Temin and Marks have both made important points: the New Deal/Fair Deal FDA did have what industry could fairly perceive as an expansionist agenda (as per Temin), and the drug industry did successfully play the red scare card to frustrate what to many seemed a timely intervention (as per Marks). However, I offer a novel account rather than a reconciliation of views. Scholars of regulation have somehow missed the main event as perceived by the public at the time, a crisis of drug addiction, without which one cannot understand why any major pharmaceutical legislation passed in 1951. In short, during the late 1940s the American public health community fanned the flames of spontaneous popular outrage over a certain class of medicine, the barbiturates, in an effort to win new authority for government over what we now...