While the introduction of buprenorphine to treat opioid use disorder (OUD) was supposed to make treatment much more accessible, barriers put up by the company that created Suboxone (Reckitt, now Indivior) and the federal government limited its lifesaving potential, according to a new book.

The details:

The drug development: Before Suboxone was introduced, buprenorphine was an old drug with no patent protection, meaning it would not be profitable for a pharmaceutical company to develop. But in the mid-1990s, Reckitt signed an agreement with the National Institute on Drug Abuse (NIDA), which paid for the clinical research, and then received orphan-drug status designation from the Food and Drug Administration (FDA), barring generic competition for the first 7 years a drug is on the market. Even though OUD was not a rare disease, Reckitt claimed buprenorphine would attract few patients because doctors could not yet prescribe it for addiction treatment outside of methadone clinics.
The prescribing laws: At the same time, the company and some members of Congress were working to allow doctors to prescribe buprenorphine without special training or restrictions, using France as a model. But the Drug Enforcement Administration (DEA) was opposed to making the drug widely available due to diversion and misuse concerns, and methadone clinics did not want buprenorphine to cut into their business. The bill’s sponsors ended up making concessions, requiring doctors to go through training and apply for special permission to prescribe buprenorphine, subjecting prescribers to DEA oversight, and implementing patient limits. The Drug Addiction Treatment Act was signed into law in 2000, and two years later, FDA approved Suboxone.
The early prescribing and diversion: Lawmakers had wanted patients to be able to access treatment in primary care, but most doctors who prescribed Suboxone were addiction treatment providers. A small but growing number of clinics accounted for a large number of prescriptions and fueled the spread of the drug onto the black market. Reckitt sales reps soon started spending less time trying to persuade skeptical doctors to prescribe buprenorphine and more time targeting high-volume doctors to encourage them to prescribe more.
The enforcement: DEA officials instituted routine inspections of doctors who prescribed Suboxone, conducted by “diversion investigators” already overwhelmed by prescription opioid inspections. But most people who purchased Suboxone on the black market did so because they could not find a prescriber for treatment. The investigations and raids scared doctors away from prescribing Suboxone and pharmacies from filling prescriptions.
The reformulation: Beginning in 2006, three years before Suboxone’s orphan drug status expired, Reckitt developed a plan to replace the drug with a new product “on the grounds of superior safety.” In 2010, Reckitt introduced a strip that dissolved under the tongue and had no generic competition, claiming the new product was safer despite having no evidence to back the claim. FDA said the film actually appeared more dangerous because a child could not spit it out like a tablet.
The lawsuits: Whistle-blowers began to come forward about the company’s tactics, including the fabrication of data to support their safety claims. In 2014, Reckitt spun off its pharmaceutical business as an independent company, Indivior. In 2019, the Department of Justice announced criminal and civil investigations of the companies. Indivior’s chief executive and global medical director were charged in connection with false and misleading claims. Indivior pleaded guilty to a felony charge and, along with Reckitt, agreed to pay more a more than $2 billion penalty.
The elimination of prescribing limits: In 2022, Congress repealed the DATA waiver requirements, allowing any doctor to prescribe buprenorphine.

Why it’s important: Even without the limits on buprenorphine prescribing and with generic versions now on the market, too few people receive treatment.

The original regulations created a reticence around Suboxone that has been hard to overcome. Many doctors say they have little time and interest in treating patients with OUD and remain fearful of DEA, some pharmacies decline to fill prescriptions, and reimbursement rates remain low.