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.^{Footnote 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).^{Footnote 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.^{Footnote 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.^{Footnote 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.^{Footnote 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).^{Footnote 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 would call “prescription drug abuse” (“misuse of medicines” would be less anachronistic) and addiction. The FDA may have helped provoke this agitation, and certainly used it for political leverage in an effort to gain new authority over how all drugs—not just psychoactive drugs—should be marketed and used. The Federal Bureau of Narcotics was called on from many quarters to intervene but, while acknowledging a socially corrosive problem of barbiturate overuse and misuse, deferred to the FDA. In this crisis atmosphere, the FDA used barbiturate-related enforcement under its (arguably) existing powers to pressure both drug firms and pharmacists, their main outlets, and the pharmacists mostly capitulated to the proposal that the FDA should have formal authority to regulate drug efficacy together with safety. An ambitious scheme was floated that would even have given the FDA some power over the prescribing of barbiturates and other “dangerous” drugs. But manufacturers frustrated these federal efforts by making common cause with physicians against government, helping to elevate the social authority of these allies while hiding in their skirts, so to speak. Prescription-only was the politically salable outcome, though an ineffective measure for solving the underlying problem of barbiturate abuse and addiction—according both to the public health community and to the defenders of morality with which they had allied. It should be viewed as one of the many setbacks that American public health suffered in the 1950s.

Crucial background to understanding this episode of prescription drug abuse and (failed) control in the United States lies in the distinctively strong and moralistic American reaction to the problem of addiction at the turn of the twentieth century, with its embodiment in the narcotics control regime until the 1970s. In a story well covered by historians including David Musto and David Courtwright and sociologists back to Alfred Lindesmith, between 1900 and 1920 the term “addiction” ceased to refer to a commonplace, merely inconvenient medical condition. Especially in the United States, addiction became a state of moral deviance and possibly contagious criminality associated with threatening racial groups such as the Chinese. Patent medicines containing drugs said to be addictive were suppressed. Medicine retreated. Opiates and cocaine were restricted to doctors’ orders, and those still prescribing these “narcotics” required special registration and recordkeeping, subjecting them to police surveillance and potential loss of license for noncompliance. The 1914 Harrison Narcotic Act thus created the category of prescription-only drugs, an unfortunate intrusion into physician authority for the AMA, but one fitting reform efforts within the profession. It also established the precedent of federal monitoring of the medicine supply chain, from the importer or manufacturer all the way through to the consumer—tracking prescriber, pharmacist, and distributor along the way.^{Footnote 7}

Supporting the narcotic-control system, science between the wars reinforced popular stigma around drug addiction. Psychiatrists attributed an individual’s initial attraction to pleasure-producing drugs to escapism and cowardice, a failure to face the challenges and responsibilities of economic citizenship. Those who become addicted “accidentally,” for example, by beginning morphine use on doctors’ orders, were spared this stigma. However, pharmacologists redoubled the character blemish by locating a physiological compulsion in the addict’s nervous system, which developed as it adapted to frequent use of an addictive drug, causing users to “degenerate” no matter how they started. According to the theory that was dominant from about 1930 through the 1950s, drugs like morphine that are truly addictive have this property because they exert a stimulant and a depressant or sedative action in combination. The stimulant action being longer-lasting, a little more of the drug must be taken each time to achieve the same relaxing and euphoric effects. In this way tolerance develops, and also an irresistible, agitated abstinence syndrome that can drive even the accidental addict to the same depraved drug-seeking behavior as the hedonistic addict. This property of “narcotics,” which enabled them to corrupt even the virtuous and gave addiction a quasi-contagious character, was what justified their extraordinary control measures.^{Footnote 8}

From 1930 the American narcotic control system was ruled by Federal Bureau of Narcotics (FBN) Commissioner Harry Anslinger, whose success in maintaining a national law-enforcement empire by stoking fears of addiction among self-appointed defenders of decency like the YMCA, Clubwomen, and the American Legion made him a paradigmatic “moral entrepreneur” for Howard S. Becker (coiner of the concept).^{Footnote 9} As recent work by a number of historians has shown, during the 1930s Anslinger employed intimidation much more than prosecution to manage the still-large trade in medical opiates with his bureau’s relatively small staff and budget. On one hand, he reined in pharmaceutical firms overstepping what he felt was propriety in pain medication marketing with threats to cut off their ability to vend opiates (as he could administratively, under Harrison powers), while on the other, he pressured state medical associations to suspend the licenses to practice of physicians who prescribed too loosely (because he could not administratively rescind a physician’s opiate prescribing license). The physicians, David Herzberg has argued, caused Anslinger particular grief since he often found medical associations far too lenient and forgiving. Still, he ruined many medical careers.^{Footnote 10} When in the mid-1940s a furor around the very widely consumed barbiturates again linked “dangerous pharmaceuticals” and “drug addiction” in a way that echoed the early Harrison Act era, drug firms and doctors had good reason to worry about a fresh wave of government intrusion into their business.

By the time the United States entered World War II, barbiturate overuse was already seen as problematic in some popular and medical quarters, though not yet a crisis. These synthetic sedatives became popular during the 1920s for insomnia, largely replacing the recently restricted opiate and chloral sleeping drafts. In the 1930s more than a dozen different barbiturate compounds were in common use, and annual consumption exceeded a billion one-grain sedating doses. The danger of overdose was well known. By the end of the decade twenty-six states had laws requiring prescriptions for barbiturate sales, several of which also covered amphetamines, newer drugs becoming popular nonmedically among the same dangerous classes as barbiturate “goofballs” (so-called by recreational users because of their inhibition-loosening effects). Of these twenty-six state laws, ten banned or limited refills, and twelve demanded that pharmacists or prescribers keep special records. In a 1940 study of “promiscuous” barbiturate use, an AMA expert commission not only proposed strict prescription-only regulation, but even “restrictions on prescribing”—largely because the drugs were overprescribed and produced an extremely “vicious” “addiction.” (By contrast, amphetamines were never classed as addictive by medical authorities, and no national measures to control prescription amphetamine misuse were seriously considered before the 1960s.)^{Footnote 11} As we will see, the American medical profession was not ready to accept this expert view about barbiturates. Still, regulators could reasonably expect some support from within medicine. Thus, before the FDA wrote its regulations restricting some drugs to prescription use, not only had a major class of modern pharmaceuticals attracted popular and medical concern but also had fallen under prescription-only regulation at state and local levels. Such regulation hardly came out of the blue by FDA fiat, as Temin would have it. Nor can it be cast as unnecessary, according to broad opinion at the time.

The 1938 Food and Drug act that finally gave FDA pre-market authority over drug safety, after the Elixir Sulfanilamide disaster that ensued when drugmaker Massengill sold one of the new sulfa antibiotics in a toxic solvent, also provided that barbiturates carry a warning label that they were “habit forming.”^{Footnote 12} This statutory detail clearly reflects mounting concerns. It reinforces the impression that restrictions were already growing, but it also supports the Temin view of an expansionist agenda in FDA’s post-1938 regulations that went beyond warning labels. The agency’s first set of new rules required all medicines either to carry detailed instructions or else to be labeled “Caution: use only by prescription.” As Marks pointed out, these regulations left the choice of labeling to drugmakers, and the FDA only required drug firms to give prescription-only labels to a select few medicines. By the beginning of 1940, these included the “potent but dangerous” sulfa drugs, barbiturates, and amphetamine. These were drugs with which the FDA could stand firmly on precedent—not just existing state laws and codes, but also the industry’s own recent practice. For example, Smith, Kline and French, the leading amphetamine maker, had spontaneously applied a prescription-only label to their new Benzedrine sulfate product between mid-1936 and late 1937 because the product had too many uses to specify.^{Footnote 13} So prescription-only labeling was no novel and alien imposition on industry. When the FDA’s power to require conformity with it was tested in court, this would be in a context offering more powerful arguments than mere precedent.

Popular outrage—perhaps even “moral panic”—over barbiturates had emerged by early 1945. Concern was certainly fueled by prominent media items such as a major Saturday Evening Post feature that February entitled “Sleeping Pills Aren’t Candy.” According to this piece, despite the fact that “we do not tattoo ourselves with hypodermics,” mainstream America was being silently made a nation of “drug fiends” by more than 6 million daily doses of “sleeping pills—‘barbiturates’ to the doctor, ‘goof balls’ or ‘red devils’ or ‘yellow jackets’ to the addict.”^{Footnote 14} That figure was nearly three times 1939 consumption levels. The pills presented a triple threat. First they caused overdoses and suicides, highlighted by a spate of celebrity deaths in 1944. These tragedies had drawn expert pronouncements that the drugs not only made it easy to kill oneself, but actually produced suicidal acts by making users depressed or forgetful of the number of pills taken. Second, they were a threat to public order as the pills, aptly called “goofballs” for the disinhibited behavior they can produce, had become popular for recreational use among wayward youth, “underworld characters,” and the dark elements signaled here as “the addict.”^{Footnote 15} Third, barbiturates carried a risk of harmful dependence even when used as prescribed, as many Americans learned for themselves when their regular sleeping-pill dose stopped working. While this article sought to represent the barbiturates as “addictive” (and freely used the term), the official status of the drugs as genuinely addictive was contentious at the time, as we will see; this danger in particular could justify the control of the drugs as “narcotics.” In any case, the misuse of these ubiquitous medicines now seemed to present a dire menace to public health and the social order.

Heightened anxieties about drug abuse and addiction owed much to the social dislocation produced by World War II. Millions of young men were drafted and moved to massive camps, with profound effects on nearby towns. There was a boom in war industries, abruptly ending the Depression and drawing millions to factory jobs far from their origins. There was unprecedented social mobility, with well-paying skilled jobs opened to women and normally unfavored racial and ethnic groups. As populations and social roles underwent dramatic shifts, old mores were greatly strained. Government concern about venereal disease escalated in some places into a witch-hunt, against not just prostitutes and teenage runaway “Victory girls,” but any woman straying from traditional gender roles. “The promiscuous girl, the khaki-wacky and the girl who has become unbalanced by wartime wages and freedom” demanded repressive action—according to volunteer defenders of public decency such as the businessman quoted here. As Marilyn Hegarty has shown, thousands of young women were arrested “on suspicion” of solicitation, for transgressions as slight as ordering a drink or waiting alone for a train. A related worry about wild youth, their fathers serving overseas and their mothers working in factories, fueled a wave of agitation over “juvenile delinquency.” “Promiscuous” use of barbiturate “goofballs” was a part of this same picture, popular recreationally with soldiers on leave, their female companions, and young people generally. They were also associated with the urban Mexican- and African-American youth counterculture, targeted with violent outrage by white servicemen in the mid-1943 “zoot suit riots.”^{Footnote 16} Thus, in the context of social unrest and hypervigilance to defend the established order, the wartime tripling of the consumption of pills linked with loose behavior (as well as addiction and poisoning) prompted emotive reactions along with well-justified worries for the public health.

By 1944, public health authorities in many states and cities were taking aggressive action against nonmedical barbiturate use. In Los Angeles, California authorities were investigating hundreds of pharmacies for violating the existing code requiring prescriptions and prosecuting dozens of druggists in connection with barbiturate misuse cases. Along with cases of disorderly servicemen, the investigators were assiduously accumulating evidence of personal decline and the corrosive social effects caused by taking barbiturates without medical supervision. For example, one absent sailor’s wife became addicted to Nembutal from an endlessly refilled prescription and “so grossly neglected her baby girl that neighbors had to take care of the baby”; a young woman munitions inspector was found passed out on the street after a night on the town, her pockets full of Nembutals prescribed to a friend; and a (quote) “sixteen year old Pachuca gang member” became “jagged up” on street goofballs with three friends, stole a late model Oldsmobile, committed a couple of armed robberies, and then fell into a squabble that ended in his own fatal shooting. Such cases show that, even for public health officials, the pills’ threat to decency and the public order was intimately linked to the health problems caused by their misuse (similar horror stories were collected by the FDA as a tactic in their efforts to obtain legislative action, as we shall later see). From mid-1944, California health officials began pushing for tighter state laws involving special licensing of druggists and stricter inventory control.^{Footnote 17} In New York City, similarly flooded with war workers, soldiers, and transient young people more generally, public health officials urged that the soaring barbiturate traffic and death rate demanded laws much stricter than the local health code requiring prescriptions. Soon the health department cracked down on nonprescription sales and announced new city codes banning refills. Refill restrictions were also multiplying among state laws during the war years. None of these regulatory changes did anything to reduce prescribing of the pills or their dispensing directly by physicians (a common practice).^{Footnote 18}

Late 1944 also saw a wave of heightened enforcement efforts by the FDA. Partly because drugmakers took to putting prescription-only labels on common household remedies, both to avoid detailed instructions and to imply their products’ great potency, the FDA issued revised regulations requiring prescription-only labeling for drugs unsafe for self-medication—as judged by the FDA—and for those drugs only. That same year the FDA launched a test of its power to enforce these new rules, prosecuting a Georgia pharmacist named Sullivan for selling packets of sulfa drugs to military personnel without either prescriptions or labels indicating that one was needed. The agency similarly prosecuted a Waco, Texas, druggist named Fadal for selling barbiturates to war workers and “vagrants,” again without either a prescription or prescription labeling. Like a long series of other barbiturate-peddling druggists prosecuted by the FDA, Fadal pled guilty. But the Sullivan case would go all the way to the Supreme Court, which in 1948 ruled in the FDA’s favor—stressing in its opinion that the 1938 Food and Drug law empowered the agency to do whatever was necessary to protect the public health with respect to drug labeling. This victory provided the FDA with firm legal grounds to enforce its 1944 regulations issued under that 1938 act.^{Footnote 19} That is, it could put druggists in prison for selling dangerous drugs without prescription, however labeled.

In its legal strategy, the FDA had focused its limited resources on drugs where precedent supported restrictions and whose misuse resonated with popular anxieties: the sulfa drugs were being used for venereal disease self-treatment. Barbiturates, of course, were linked to transgressive behavior, overdose deaths, and addiction. Both drugs presented hazards that were incontestable in the public’s eye (even if the Sulfa Elixir deaths were actually due to the solvent). Furthermore, given the wider implications of addiction and infectious disease, both drug classes presented mingled problems of consumer protection and public health. So the FDA’s enforcement and legal offensive drew on the morally overcharged wartime atmosphere, particularly the anxieties associated with sexual license and disinhibited “goofball”-fueled behavior, and the agency emerged from court with validation for an enlarged public health mission. In this, the FDA’s actions fit an activist agenda to expand its health powers based on statutory authority oriented toward consumer protection, as the drug industry then and critics since, like Temin, have charged (although protecting the public health by making drugs “pure” was always its foundational charter).^{Footnote 20}

There was a mounting public media furor over barbiturates at war’s end, and it may well have been cultivated by local and federal officials—not merely used as leverage. The early 1945 Saturday Evening Post’s feature, after its attention-grabbing foray into celebrity tragedy and lurid “goofball” escapades, drew on detailed cases and figures from New York, suggesting sources among public health professionals there. It blamed overprescribing doctors as well as unscrupulous druggists and manufacturers. It went on to discuss policy, suggesting that even restricting barbiturates to prescription-only sales nationally would not suffice—even though Surgeon General Parran was pictured with a quote calling for just that measure. Instead, the piece continued, “What many officials as well as some doctors and druggists would like to see are laws for the sale of barbiturates similar to those for the distribution of narcotics—that is with rigid recording of every grain.” Hinting at the identity of these “officials” seeking Harrison-style restrictions on barbiturates, Charles W. Crawford, FDA deputy and soon commissioner, was prominently quoted, assuring the public that the agency was doing what little it could—and it was already enforcing the prescription-only rules of which Parran spoke, as in the Fadal case.^{Footnote 21} Behind this mismatch between the FDA and the Surgeon General was the FDA’s understanding that prescribed drug use was a problem in itself. An agency study found that 100 of the 105 tainted Sulfa Elixir deaths in 1938 resulted from drugs bought on prescription, and that many of these prescriptions were for inappropriate uses, such as mercury poisoning and backache. That so many patients were needlessly exposed to the dangers that all active drugs can pose implied that the public health required not just prescription-only access, but responsible prescribing, at least for particularly dangerous drugs.^{Footnote 22}

As other major magazines and newspapers ran goofball stories echoing their concerns, barbiturate-burdened public health officers could not have been displeased, and neither with the burgeoning national outcry for action. For example, in November 1945 the Hearst papers—instrumental in drumming up sentiment against marijuana not long before—began a series of prominent features in the their national Sunday supplement under the theme that Americans were becoming “slaves” (and sometimes “victims”) of the “Devil’s Capsules.” The first of these articles recounted graphic tales of “murders, suicides, berserk joy-riding, juvenile delinquency, stunted mentalities . . . the results of the country’s barbiturate binge.” According to the piece, one “experienced public health official” refers to the pills as “America’s Opium,” while a “law enforcement officer” calls them a “national menace.”^{Footnote 23} The references to opium and slavery of course evoked not just problems of public order, but also addiction. The lurid details in such features could only have come from the casebooks of police and public health officers such as the Los Angeles inspectors described above. Echoing the national media, in local papers everywhere pillars of society like the PTA, women’s clubs, and church organizations demanded an end to the circulation, especially among youths, of the “addicting” pills. As one typical commentator from Schenectedy worried, “The physical and mental vitality of the American people can be sapped in much the same manner as that of the Chinese with their opium” if barbiturate overuse continued.^{Footnote 24}

The pills represented a moral threat even after the war receded, as illustrated by another Hearst Sunday feature in December 1947. This particular item in the “Devil’s Capsules” series discussed accidental barbiturate poisonings of children, but it also condemned greedy druggists who sold the pills to those seeking “cheap thrills.” Quoting the New York City health commissioner, the piece applauded the city’s new “rigid controls,” as well as a bill in Congress to tackle the problem federally.^{Footnote 25} This bill to curb barbiturates, on the grounds that they cause addiction, as well as suicide and sexual transgression (for instance, slipped into girls’ drinks at parties), was sponsored by Congresswoman Edith Nourse Rogers (R-Mass.) and drafted in consultation with both the FDA and the Narcotics Bureau—the latter reluctantly. It would formally extend the Harrison Narcotic Act to cover the pills, with physician registration and strict recordkeeping just as with opiates—and everything else that came with it, like the threat of stiff penalties for noncompliant druggists and doctors, and prison sentences for users without prescriptions. Other publications, for example, Colliers a year later (and not the first barbiturate feature in Colliers), endorsed Rogers’s bill. This piece contained extensive quotes from FDA chief Dr. Paul B. Dunbar explaining that such an amendment either to the FDA or the Narcotics Bureau authority was essential to control barbiturate misuse.^{Footnote 26} And as Dunbar knew, Narcotics did not want the job. Evidently the FDA was ready to take it.

Druggists and allied interests rallied in the hope of “heading off” the pending federal controls on distribution with less restrictive state controls.^{Footnote 27} Many pharmacists granted that some change would be required; as early as 1945 a feature in the American Druggist, entitled “The Barbiturate Time Bomb,” warned that denialism would only ensure harsh control of these pills as “ordinary dope.” Soon the main retail druggists’ association struck a deal with the FDA, and no wonder, since the brunt of the FDA and public health efforts to rein in the whole drug industry fell on druggists.^{Footnote 28} In 1948, when the New York Pharmaceutical Council brought suit against the city’s new recordkeeping and refill controls on barbiturates and heightened enforcement, one of their grounds was “severe financial loss” to pharmacists (the drugs accounted for 20 to 25 percent of their retail sales, according to estimates at the time). New York City public health officials replied by expressing satisfaction with the druggists’ plight.^{Footnote 29}

The response of manufacturers and distributors was fully predictable in terms of economic interest. Their trade associations especially opposed measures for tracking supply and sales. Of course, the same inventory-tracking measures that would make it easy for officials to identify rogue druggists would also make it easier to identify their suppliers, or distributors bypassing drugstores entirely.^{Footnote 30} The medical profession’s stance, taking the AMA as its voice, had grown similar to that of the drug industry and equally predictable. Naturally the AMA endorsed prescription-only laws, but no restraint or monitoring either of inventory (which would apply to dispensing physicians) or prescribing; thus it vigorously opposed the Rogers bill. The AMA focused its objections to surveillance on prescribing as a “continuation of a trend to confer more and more jurisdiction of the Federal Government over the practice of medicine.” If Anslinger’s enforcement of the Harrison Act was the basis of its expectations, then doctors could indeed anticipate being told how much of, and for what, the barbiturate drugs should be prescribed; perhaps losing their right to prescribe these popular medicines if they did not comply (depending on the exact provisions of the new legislation); and in some cases (for example, if they prescribed to an addict) being prosecuted and jailed or else having their medical license suspended through indirect pressure. The AMA also endorsed the drugmakers’ view that barbiturates were a tremendous boon to medicine, safe when used as directed, and as Winthrop-Sterling CEO Ted Klumpp explained in national media, habit-forming (not addictive) only in individuals lacking “normal self-control.” The victim was thus to blame, rather than the drug itself or its suppliers, according a time-honored logic—but one that could only be maintained so long as the drugs were not officially classed as addictive. Contrasted with the 1940 AMA expert commission’s report on barbiturates described above, this late 1940s dismissive stance toward public health signals the association’s postwar drift into an alliance with drugmakers, in contrast to its vigilance toward industry in the interwar era.^{Footnote 31}

In 1947 Rogers’s bill was introduced but, resisted by Narcotics chief Anslinger, was held up in committee. Why Anslinger did not take the opportunity to expand his Bureau of Narcotics domain, as one would expect of the power-hungry “entrepreneur” portrayed by Becker, is an intriguing question. According to Kathleen Frydl, in a speculative interpretation of off-record congressional discussion, Treasury had its hands full implementing the new income tax, and the Secretary of the Treasury wanted to reduce involvement in excise-based activities (which, technically, included narcotics).^{Footnote 32} That may well be, but it is hardly a complete answer given that Congress does not take orders from Treasury, and Anslinger had his own congressional supporters. While he expressed tentative interest in barbiturate control in 1941, by 1945 Anslinger had decided against it, telling a journalist that a fiasco resembling Prohibition might result should the government attempt to restrict such popular drugs. While this second explanation, which he would repeat before Congress and elsewhere, rings a little hollow because barbiturate synthesis is complex and therefore more easily controlled as compared with brewing alcoholic drinks, the popularity concern is plausible.^{Footnote 33}

Anslinger also gave a third reason. When in 1946 he let Rogers know that he did not welcome the barbiturates bill that his legal staff had recently (as a courtesy) drafted at her request, he told the congresswoman that the enforcement task would require at least a doubling of the FBN’s staff and budget. This he declared very unlikely, referring to the 1937 Marihuana Tax Act, with which Congress granted Anslinger the responsibility for controlling marijuana as a narcotic but gave no extra appropriation to enforce it. Not long after, he gave the same explanation to leaders of the Womens’ Christian Temperance Union, who were pressuring him to clamp down on the goofballs. Recent historical literature also suggests that he took on marijuana control reluctantly, anticipating the resource problem.^{Footnote 34} Perhaps all three explanations are partly true: given Treasury’s new focus on the federal income tax, coupled with resistance from manufacturers and doctors, Narcotics would be very unlikely to get enough money to regulate these prescription drugs effectively. It all amounted to a poor cost-benefit ratio for Anslinger and his fiefdom. As a closely involved congressman would put it a little later, “With all due respect to Mr Anslinger . . . it seems to me what he is thinking about is that he has a department which is functioning very well, and if he gets this one [responsibility for barbiturates], he has for himself a deluxe headache, which he apparently does not want to acquire.”^{Footnote 35}

For the FDA, 1948 was a watershed year. As noted, in the Sullivan sulfa case, the Supreme Court upheld the FDA’s prescription-only regulations for drugs too dangerous for self-medication. The win seems to have emboldened the agency: at a national druggists’ convention late that year, Commissioner Dunbar created “chaos” with a speech where he likened a prescription to a check written by the doctor, which lost its validity once cashed. Refilling without written specification would henceforth be treated as dispensing without a prescription, and the trade did not hear this threat as applying only to habit-forming drugs.^{Footnote 36} The FDA followed these words with deeds in 1949, cracking down on pharmacists refilling valid barbiturate prescriptions lacking written refill instructions. The agency also angered manufacturers and some doctors by barring certain hormones on the grounds that without demonstrable efficacy they could not be used safely.^{Footnote 37} Meanwhile, around the start of 1950, field inspectors nationally were ordered to gather evidence of injury not just from unauthorized refilling of barbiturates but also, specifically, from prescribed “dangerous drugs other than habit-forming drugs.”^{Footnote 38} Clearly, the FDA leadership sought to justify the need for stronger prescription controls on all medicines powerful enough to cause harm, rather than basing new powers only on the need to control addiction. But the investigations and prosecutions still focused on barbiturates. Anti-goofball enforcement can be viewed as the vice with which the FDA squeezed pharmacists to obtain federal legislation that would increase its power more broadly. Certainly it was perceived this way by many in the drug business: with the FDA “really bearing down” on unauthorized barbiturate refills, “pharmacists [were] up in arms” while their trade associations negotiated with the agency over new legislation in February 1950. And the time was ripe for FDA expansionism, for with Truman’s surprise victory in the 1948 election, his administration moved his bold national health insurance plan forward, along with a set of associated expansions in power for the federal agencies responsible for health. Notoriously, however, the AMA mounted a ferocious and effective counterattack on “socialized medicine” using professional publicity firms, funded by an unprecedented multimillion-dollar war chest.^{Footnote 39}

At the start of 1950, while the national health battle raged and the reproposed Rogers bill sat in limbo, still a menace to the drug industry with its backing from groups like the American Legion and Women’s Clubs, and while FDA inspectors gathered evidence on the harms of barbiturate misuse to put before Congress, the bill that would become the Durham-Humphrey prescription law was being drafted in negotiations between the FDA and retail druggists. The bill was introduced by Senator Hubert Humphrey (D-Minn.) and Carl Durham, a member of the House of Representatives from North Carolina (both pharmacists). Strengthening the FDA’s hand in April, barbiturates again made headlines with reports from leading addiction researchers at the federal narcotics prison in Lexington, who showed authoritatively that the drugs produced true physical withdrawal, the cardinal mark of narcotic addiction, and by this standard measure were worse than morphine.^{Footnote 40} This scientific affirmation came late, however, as the mounting atmosphere of Cold War fear and fervid anti-Communism in 1950 (which, for example, saw the arrest of the Rosenbergs and others as spies responsible for the USSR’s first atomic bomb blast of 1949, as well as the start of the Korean War), ably exploited by the AMA’s public relations campaign against “socialized medicine,” undercut the FDA’s political traction along with the Truman administration’s larger health-reform project. The ongoing wrangling over the Durham-Humphrey bill’s provisions through all of 1950 and most of 1951 among retail druggists, drugmakers, the AMA, and the FDA’s supporters reflected this decline in FDA momentum.^{Footnote 41}

At the same time that the Durham-Humphrey prescription bill was in House hearings (April–May 1951), in other hearings Anslinger’s ally Representative Hale Boggs (D-La.), exploiting concerns about renewed heroin imports from Europe by declaring a “war on narcotics” and proposing mandatory sentencing to fight the “moral leprosy” of addiction, saw a related problem—and perhaps political advantage—in barbiturate abuse and addiction. Rogers sought to roll barbiturates into Bogg’s narcotics bill, at first in alliance with Boggs. But Anslinger again resisted the new authority, giving both the Prohibition unpopularity and cost arguments before Congress. Furthermore, he might have continued, the measure would draw the ire of a now militant medical profession, which had just flexed impressive political muscle in the November 1950 election by helping the Republicans make serious inroads into Democratic control of Congress using their “socialized medicine” theme. Indeed, in the narcotics hearings the AMA made a submission against the Rogers modification of Boggs’s bill. Physician and voter retaliation would have concerned the congressmen more than the Secretary of the Treasury’s preferences, as invoked by Frydl, or Anslinger’s budgetary worries.^{Footnote 42}

Frustrated, Boggs’s subcommittee commanded Narcotics and the FDA to “get together” and devise a workable barbiturate control plan. Seizing the opportunity in July 1951, Dunbar’s boss, Federal Security Agency chief Oscar Ewing (the Truman administration’s health-reform leader), quietly offered a proposal, endorsed both by Treasury and Justice. Under the same commerce powers that already underpinned FDA authority, that agency could establish a licensing system for “all manufacturers, wholesalers and retailers (including hospitals and physicians who dispense the drugs),” making it a federal crime to sell these drugs without a license or possess them without license or prescription. Prescribing would be specially recorded, and possibly licensed also. Thus with some changes to the pending Durham-Humphrey bill to formalize prescription-only regulation, the agency could also acquire some power over prescribing, by giving it new authority to monitor prescriptions of barbiturates and to revoke dispensing privileges from doctors not conforming to the agency’s standards of therapeutic rationality. This idea appealed to many congressmen “hopped up” on barbiturate control, in the words of a drug industry newsletter. Boggs did not act on it quickly, perhaps (as the newsletter suggested) distracted by his state’s gubernatorial campaign. And when they learned of the proposal, the AMA savaged it.^{Footnote 43} The Boggs narcotics sentencing bill dropped barbiturates, and a licensing-augmented Durham-Humphrey bill seems never to have been drafted for formal discussion.

Even though it did nothing to extend FDA control over sales of barbiturates, the Durham-Humphrey Amendment would ultimately be presented as the answer to the problematic overuse of these drugs. To revisit Marks, Temin, and others, the bill was initially drafted by the National Association of Retail Druggists (NARD) together with the FDA. Pharmacists sought relief from the heavy toll of FDA barbiturate enforcement. They wanted oral and particularly telephone prescriptions and refills to be authorized. And they wanted the FDA to provide a definitive list of prescription-only drugs to end the uncertainty created by leaving labeling to manufacturers. Under the bill as introduced and advanced by NARD, druggists would get their certainty and their telephone prescribing, while the agency would gain statutory authority to do more of what it had already been doing administratively—determining what drugs must be sold only on prescription, based on its own judgment of safety and efficacy. But the drugmakers fiercely resisted ceding any further power to the FDA, particularly as entailed in new authority to regulate marketing channels on criteria involving efficacy. At the eleventh hour, industry managed to have the efficacy language struck, and the legislation as passed in October 1951 essentially gave statutory force to the FDA’s 1944 regulations. Manufacturers would continue to decide whether or not their products would bear the prescription-only label, keeping the legal onus on the FDA to show that their labeling was inconsistent with consumer safety. This outcome was, as Marks argued, a setback for the agency’s effort to make pharmaceutical usage more rational and “effective,” because it codified FDA’s power just where the courts had already affirmed it based on the 1938 laws. To the relief of pharmacists, however, drugmakers did cooperate with the FDA in agreeing to a large list of existing drugs that should only be labeled for over-the-counter sales.^{Footnote 44}

With neither the Boggs nor Durham-Humphrey laws as enacted addressing barbiturate overuse and misuse, late 1951 still found Congress in a mood to “do something,” as drug industry sources dryly put it, about the so-called “menace” or “problem” . . . [and] “particularly . . . alleged teen-age ‘addiction.’” “America’s opium,” would not quite so easily vanish as an issue.^{Footnote 45} Industry responded with efforts “to get good publicity for these drugs” so as to forestall new regulation, seeking friendly media outlets “to emphasize the beneficent effects of barbiturates.”^{Footnote 46} Meanwhile the FDA still sought to license physicians and/or monitor prescribing (e.g., through the type of registration system that the FBN used to trace narcotics distribution). Whether this ambition had been imposed by Ewing or had been initiated within the agency, it remained the FDA’s hope after Durham-Humphrey. In December 1951, as Rogers and allies once more pushed her stand-alone barbiturate control bill, the FDA’s Bureau of Field Operations again wrote to all its district chiefs with a new evidence-gathering project. “We anticipate that there may be introduced in Congress in the near future a bill designed to materially tighten federal control over the traffic in barbiturate drugs,” the directive read. “This legislation, as envisioned, would include a licensing or other provision” that would relieve the FDA of proving the interstate character of the drug traffic. “Strong opposition to such legislation is anticipated,” it continued, on the grounds that Durham-Humphrey had already dealt with the problem. To overcome that opposition, inspectors should gather cases of harmful barbiturate consumption where the interstate character of the drugs could not be established, complete with enough “background” to make the case “impressive,” and to forward a summary to the office of Deputy Commisioner George P. Larrick.^{Footnote 47}

But to no avail. Congress had turned “against almost anything that has to do with public health,” lamented Truman in late 1951 to his confidante on health matters, lobbyist Mary Lasker (about another topic). As the FDA had anticipated, opponents of barbiturate control pretended that prescription-only was enough: the AMA’s Committee on Legislation explained, in 1952, why the medical profession should oppose Rogers: “The recently enacted Durham-Humphrey amendment to the Federal Food, Drug, and Cosmetic Act should provide adequate safeguards” by requiring prescriptions and doctor authorization for refills. If controls go further, for instance, with “a federal licensing or registration system of control over the prescribing or dispensing of barbiturates by physicians . . . [the federal government] might ultimately attain the power to dictate . . . the practice of medicine in this country.” In the context of a generally resurgent big business in the 1950s and a medical profession now fully aligned with industry, the FDA was able to go no further in limiting “dangerous drugs” to scientifically justifiable indications and dosage regimes, even when those drugs were certifiably addictive.^{Footnote 48} Instead of gaining new powers, the FDA found its budget slashed punitively in the early Eisenhower years by Republicans leading the House Appropriations Committee, deliberately to impair its enforcement zeal (especially, it seems, in the foods arena). The energy with which the agency enforced prescription-only regulations greatly declined as compared with the late 1940s: only after receiving complaints did inspectors now investigate pharmacies for dispensing barbiturates and amphetamines without prescription—although there were still enough complaints to make this the FDA’s main enforcement task throughout the decade.^{Footnote 49}

Ewing departed office with Truman after 1952. Adapting to the times, through the rest of the 1950s Larrick, who became FDA commissioner in 1954, repeatedly stood before Congress retailing lurid goofball morality tales. Rather than blame respectable institutions like drug firms, Larrick tried to stir outrage by demonizing those already outcast, as when he told a 1953 Juvenile Delinquency subcommittee about “known homosexuals” cruising Seattle’s skid row proffering barbiturates, and “sex deviates preying on juveniles after influencing them to take drugs” at a New Orleans recreation center.^{Footnote 50} Other testimony featured once-solid citizens going “berserk under the influence,” neglecting their children, setting themselves on fire in a stupor, and so forth. The irresistible, addictive power of barbiturates to corrupt the previously virtuous or innocent was a constant and prominent theme. (Sometimes Larrick also linked the officially nonaddictive amphetamines to barbiturates, despite their diametrically opposite pharmacological action, under the shared label “thrill pills”—referring of course to their attractiveness to similar hedonists, their related social dangers, and their shared problematic regulatory status.) Briefly in 1955, the idea of giving the FDA new barbiturate-control powers through licensing and inventory tracking, much as Ewing had proposed, was advanced again by Senator Price Daniel (D-Tex.), who had taken up Boggs’s mission to punish addiction and support Anslinger (in this case, by protecting him from responsibility for barbiturate control and from being transferred from Treasury to Justice). From his testimony it is not clear that Larrick welcomed the responsibility at this point, perhaps wary of budgetary burdens and the hostility of organized medicine. The idea of requiring an emetic in all barbiturate capsules so that large doses would be vomited, floated first by Senator Estes Kefauver (D-Tenn.) in the late 1940s, reappeared at this time too. Harsher minimum sentencing and other measures against opiates were passed, but nothing came of new barbiturate controls.^{Footnote 51}

The sort of outcome Larrick sought in the later 1950s can be glimpsed in the Drug Abuse Control Amendments finally passed under Lyndon Johnson in 1965. These gave the FDA new enforcement powers, creating a fresh cadre of gun-toting G-men (as Rufus King so colorfully put it) in the agency’s Bureau of Drug Abuse Control.^{Footnote 52} Provisions included some inventory tracking requirements for both barbiturates and amphetamines and criminal penalties for possession without prescription. Nothing was done about prescribing per se, thus reducing the conflict with organized medicine. These measures were not enough to reduce the consumption rate or the mounting harm done by barbiturates and amphetamines. This failure was, a few years later, attributed to the legislation’s lack of restraints on manufacturers and on physician prescribing. Prescription drug abuse was much better managed by the Department of Justice after the 1970 Comprehensive Drug Abuse Prevention and Control Act, which enabled production quotas on medicines liable to abuse and required reporting of prescriptions for controlled substances.^{Footnote 53} But we should not leap to the conclusion that, because the FDA did not effectively control barbiturate abuse in the 1950s and 1960s, it could never have done so. The 1951 proposal that the FDA should control dangerous drugs by licensing and monitoring prescribers as well as manufacturers and dispensers, in the context of a more robust federal public health apparatus, represents another path not taken. It is one that would have made especially good sense within the coherent national health system that the Truman administration was attempting unsuccessfully to institute.^{Footnote 54}

To conclude, then, the FDA did have an expansionist agenda in the late 1940s, in which a cultivated panic over barbiturate overuse and addiction served as an opening wedge for stronger federal powers over physicians as well as drugmakers. But, while successful in court, in Congress these efforts were defeated by an alliance between the drug industry and the medical profession, amid the broader rollback of state intervention and the resurgence of business power associated with the 1950s. The prescription, imposed by government as a barrier between manufacturer and patient, became invested as a symbol of medicine’s autonomy and fortified by opponents of regulation as the boundary beyond which the state could not legitimately reach. Medically authorized drug use remained by definition unproblematic, and only unprescribed drug use problematic. The public health was a victim. U.S. barbiturate consumption continued at near-wartime levels, rising with population from about 5 billion sedating doses in 1950 to at least 6 billion by 1960—some thirty-three capsules for every man woman and child. It stayed this high for another decade, by which time amphetamine consumption, in 1960 about equal that figure, had nearly doubled it.^{Footnote 55} This outcome stands as another testimony to the toxicity of the medical profession’s growing intimacy with the drug industry in the period, and of the Cold War culture that both fostered it and stunted public health in the United States.