Skip to content

Drug Manufacturer Prevented from Abusing System After Shaheen Calls on FDA to Act

**In September, Shaheen called on the agency to stop a manufacturer from securing market exclusivity for medication to treat opioid-related substance use disorders amid epidemic** 

(Washington, DC) – Yesterday, the Food and Drug Administration (FDA) stopped the manufacturer of medication to treat opioid-related substance use disorders from abusing the agency’s “Orphan Drug Designation” process to limit market competition. This effort to abuse the system was particularly concerning amid ongoing efforts to respond to the substance use disorder epidemic.  The FDA’s action – which follows Senator Shaheen’s letter to the agency in September – will allow potentially cheaper competitor drugs for the monthly injection version of buprenorphine, known as Sublocade, to come to market faster, which can help reduce the cost of the medication. Sublocade can currently cost as much as $1,580 per month. As a result of the FDA’s decision, competitor drugs for this medication could be available next year, rather than being barred from market entry until 2024. 

“The Food and Drug Administration made the right decision by heeding my call. As our communities fight to turn the tide of the substance use disorder epidemic, it is particularly egregious that this manufacturer tried to game the system and obstruct potentially cheaper competitor medications from coming to market that will help address this public health emergency in our state,” said Shaheen. “I’ll continue to work across the aisle to reduce prescription drug costs and increase market competition among manufacturers so Granite Staters and Americans across the country don’t have to choose between paying for their medication and putting food on the table.” 

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 be unlikely to 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.  Without FDA’s action in this case, Sublocade would have been provided seven years of market exclusivity as an orphan drug, despite the fact that opioid use disorder is not a rare disease and affects millions of Americans.

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 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. This included the set-aside funding for states with the highest mortality rates, like New Hampshire. This critical additional funding 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 a 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.