New data shows that the mass killers in the U.S. opioid epidemic are heroin and fentanyl, powerful substances that were involved in nearly 50,000 overdose deaths in 2017. Beyond these deaths, 12.5 million Americans abused prescription opioids, according to recent yearly data, and the estimated 2 million people addicted accounted for untold damage to individuals, families and communities.
But the federal government has a hard time more strongly regulating addictive and abused pharmaceuticals more strongly. This is why.
Here’s how I did my research
My research, detailed in a new article in Studies in American Political Development, examines how the Food and Drug Administration, Congress and the White House faced serious obstacles regulating pharmaceutical tranquilizers, sedatives and stimulants from the 1930s through the 1980s — even though the public and policymakers recognized that these drugs, like opioids, caused significant harm.
I extensively analyzed historical evidence, including congressional hearing transcripts, FDA reports, White House papers, interest-group memos, participants’ memoirs, magazine pieces, newspaper accounts, medical journal articles, drug ads and epidemiological data.
Here are the four broad factors that consistently hobbled national policymaking:
1. The FDA focuses on keeping unsafe drugs off the market, rather than regulating them after they are approved
The FDA, which regulates pharmaceutical drugs, is often called “the world’s most powerful regulatory agency.” But its powers are concentrated on evaluating whether drugs should be approved for public use to begin with. Companies spend considerable time and money getting products through the gate. Once drugs are approved, the FDA has much less influence.
That’s because the pharmaceutical regulatory process was designed to keep lethal products off the market, in response to drug scares such as the 1937 elixir-sulfanilamide disaster and 1962 thalidomide tragedy. Such episodes, and the political incentives that animate them, have reinforced a trade-off —preapproval regulatory strength paired with post-approval regulatory weakness.
2. The government lacks forceful tools for changing physician and consumer behavior
After the FDA approves a drug, its powers mostly address changing labeling and marketing.
To make changes in response to newly identified harms, the FDA must produce new data — which it generally lacks and which companies are reluctant to produce — and overcome procedural hurdles or negotiate with companies over compromises. And companies fight hard against attempts to change how they label and market approved drugs. For instance, in the 1970s, the FDA was concerned tranquilizers were being overprescribed. Doctors and pharmacists saw medication with labels said the drugs could be given for “stress” and in “stressful situations” — which could be interpreted very broadly. The FDA wanted to change these phrases to instruct practitioners to prescribe these drugs only during “transient situational disturbances.” To do that, it undertook a multiyear, high-profile effort involving FDA hearings, congressional hearings, extensive negotiations, and substantial pressure from the agency, legislators and the public.
In 1980, the FDA finally reached a landmark deal requiring companies to adopt labels reading, “Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.”
Meanwhile, courts have long protected other controversial marketing practices — including direct-to-consumer advertising, disease awareness campaigns and sponsored medical conferences and journal ads — under the First Amendment.
Accordingly, as FDA officials noted in the 1970s, regulating what information doctors and patients received was “unlikely to be a terribly effective strategy for altering physician behavior,” adding that “it is going to take a lot more than simply drug-labeling changes by us.” To make a difference, agencies would need greater post-approval powers — over prescription and adverse-event data collection, and over advertising, marketing, distribution, sale, prescribing and even consumption practices.
3. Organized interests fight stronger regulation
Congress and presidents have also tried to address addiction and abuse. Congress can pass, with the president’s approval, new restrictions on drugs or can move drugs into more-stringent regulatory categories.
But to do so, they have to battle two groups that resist such efforts — the medical profession and the pharmaceutical industry. Medical providers fiercely guard their autonomy; drug producers guard their profits. Both mobilize vigorously against new rules, using substantial resources, connections with lawmakers and policymaking expertise to avoid or delay controls, generally quite successfully.
For instance, in the 1970s a leading producer paid lobbyists three times the Senate regulatory committee’s annual budget to work against proposed regulations. One of those was future secretary of health, education and welfare Joseph Califano Jr., who successfully exploited connections, procedures and choke points to stymie regulation. Decades later, he regretted these efforts, writing, “To this day I wonder how many patients developed problems as a result of my lobbying to keep these tranquilizers free of stricter controls.”
4. Attacking illegal drugs is much easier than regulating legal ones
Policymakers are reluctant to regulate legal drugs that, while addictive and abused, are nonetheless also appropriately used by millions of their constituents. Policymakers also generally want to avoid policing Americans’ private medical habits, which would be cumbersome and unpopular. Policymakers have therefore historically targeted only egregiously and clearly overprescribing “pill mills.”
However, policymakers are happy to attack illegal drugs to diffuse the public’s concerns about drug abuse and addiction. These substances are usually seen as illegitimate and seldom have well-resourced, organized and mobilized defenders and are therefore far easier and more politically beneficial to attack. White House aides in the Kennedy, Johnson and Nixon administrations, as well as members of Congress, consistently recognized and followed this electoral calculus.
Ending the opioid epidemic
Of course we can’t draw exact parallels between what’s happened in the past and today’s opioid epidemic. But both are shaped by U.S. regulatory structures and political incentives. In the past and present, regulation has been hampered by weak regulatory tools, limited political incentives and organized interest groups’ opposition to regulation.
Given those challenges, advocates looking to end the opioid epidemic might seek other routes, such as state and local regulations and prevention efforts, or federal funding for treatment and recovery programs.
Herschel Nachlis is a research assistant professor of government and a policy fellow in the Nelson A. Rockefeller Center at Dartmouth College.