Shaheen Calls on FDA to Stop Drug Manufacturer from Abusing System Amid Opioid Epidemic & Allow More Affordable Options for Medication-Assisted Treatment

September 10, 2019

(Washington, DC) – U.S. Senator Jeanne Shaheen (D-NH) sent a letter to the Food and Drug Administration’s (FDA) Acting Commissioner Dr. Norman Sharpless, requesting that the FDA prevent the manufacturer of buprenorphine from abusing the FDA’s “Orphan Drug Designation” process to secure an additional seven years of market exclusivity. The new monthly injection version of buprenorphine – known as Sublocade – is used to treat those suffering from opioid-related substance use disorder in medication-assisted treatment (MAT). If the FDA provides the drug manufacturer with this market exclusivity, it would block competition from generic drug makers and other manufacturers of medication-assisted treatment drugs, preventing potential price cuts.

The Orphan Drug Act was enacted in 1983 to help provide incentives for drug manufacturers to pursue the development of drug therapies for rare diseases. Under the law, a drug manufacturer can receive an Orphan Drug Designation for their drug if the drug meets either of two requirements: that it treats a condition affecting fewer than 200,000 patients in the United States, or if it is a drug that would likely recover the costs of development and marketing (known as “cost recovery”). Under this designation, the FDA can provide the drug with seven years of market exclusivity, meaning that no generic or competitor version can be approved by the FDA for the first seven years that the orphan drug is on the market. A new injectable version of buprenorphine – Sublocade – has been developed, which could allow from the drug’s manufacturer to reapply for orphan drug exclusivity.

In her letter, Senator Shaheen explains that when the original brand name for this drug was approved in 1994, it was only used in methadone clinics, which limited the number of patients receiving the medication and the ability of the manufacturer to recover development and marketing costs. However, 25 years later, the opioid epidemic is a public health emergency and the drug that once would have been in limited use now has a significantly broader scope, particularly in states including New Hampshire that are on the frontlines of the opioid crisis. Not only would the drug likely not qualify under the Orphan Drug Act’s criteria, but blocking competitor drugs from coming to the market puts this life-saving medication out of reach for those in recovery who need it.

Shaheen underscored how critical this drug would be to treatment centers in New Hampshire that provide medication-assisted treatment, writing, “This monthly injection version could help to improve the administration of MAT and success of MAT for patients with opioid use disorder, as compared to versions of buprenorphine that require daily dosing. However, the product is priced at $1,580 per month by the drug manufacturer. Providing the monthly injection version of buprenorphine with orphan drug exclusivity could lock-in these high prices for seven years or even longer.”

Shaheen continued, “At a time when prescription drug costs are stretching household budgets and the opioid epidemic is still devastating communities across the country, I am concerned that granting orphan drug exclusivity for Sublocade could put access to promising developments in MAT out of reach for patients with opioid use disorder and limit treatment options.”

In her letter, Senator Shaheen explicitly states that drugs used to treat opioid-related substance use disorder should not be entitled to market exclusivity benefits that are intended for rare disease drugs under the Orphan Drug Act, and closes by requesting the FDA to answer specific questions about how it determines what drugs fit the criteria established by the law.

The letter can be read in full here.

Senator Shaheen is leading efforts in the Senate to reduce the cost of prescription drugs. The Senate Committee on Health, Education, Labor and Pensions (HELP) recently cleared package legislation that included her bipartisan bill to lower prescription drug prices by increasing competition through improved oversight of the Food and Drug Administration’s (FDA) citizen petition process. This bill would reduce federal spending of prescription drugs by approximately $253 million over the next ten years. She also introduced the Biologic Transparency Act of 2019, bipartisan legislation to encourage competition in the prescription drug marketplace and put an end to the harmful patent strategies that block new drugs from coming to market. 

Senator Shaheen has fought tirelessly to ensure that Granite State communities have the resources they need to battle the substance use disorder epidemic. Shaheen helped negotiate the bipartisan agreement in 2018 that outlined the two years of opioid response spending – totaling $6 billion to respond to the opioid crisis. Shaheen also helped negotiate the bipartisan agreement in 2018 that outlined the two years of opioid response spending – totaling $6 billion to respond to the opioid crisis. This included the set-aside funding for states with the highest mortality rates, like New Hampshire. This critical additional funding, which Shaheen helped broker, has been included by Congress over the last two fiscal years. As a result of the Delegation’s efforts, New Hampshire received a more than ten-fold increase in opioid treatment funding through the State Opioid Response grant program. Shaheen has also recently unveiled sweeping new substance use disorder legislation, the Turn the Tide Act, to help tackle the substance use epidemic and provide resources for Granite Staters struggling with substance misuse.  The Turn the Tide Act provides $63 billion in funding over ten years to deliver flexible treatment funding to providers, establish proven prevention programs and address the substantial workforce challenges in the treatment field.