Senator Shaheen, Hassan Join Push to Make Naloxone Available Over the Counter

Press Release

Today, U.S. Senators Jeanne Shaheen (D-NH) and Maggie Hassan (D-NH) joined U.S. Senator Tammy Baldwin (D-WI), Representative Carolyn B. Maloney (D-NY), Senator Angus King (I-ME), and Representative Brian Fitzpatrick (R-PA) along with a bicameral, bipartisan group of colleagues in urging seven major manufacturers of naloxone -- the opioid overdose reversal medication -- to apply for over-the-counter (OTC) status for their products to help increase access and save lives. Despite the effectiveness of naloxone to reverse active opioid overdoses and the Food and Drug Administration's (FDA) public support for making the product available over the counter, the medication is not currently available over the counter because drug manufacturers have resisted applying. This step is expected to lower the cost of the medication and increase access both at the pharmacy counter and for community organizations working to distribute this life-saving tool.

"One of the most important actions that can be taken right now is for manufacturers to submit applications to make naloxone available over the counter without delay," wrote the members of Congress. "Further, a formal switch to OTC status will help reduce stigma and encourage the widespread use of this critical medication."

The members continued, "Now the responsibility lies with manufacturers to submit the paperwork needed to make this switch. By doing so, [the drug manufacturer] will be taking an important step in the ongoing effort to prevent deadly opioid overdoses."

The series of letters comes as the COVID-19 pandemic has dramatically exacerbated the opioid epidemic and substance use disorder crisis in this country, with the United States experiencing more than 100,000 overdose deaths in a 12-month period for the first-time ever last year. A study found that substantially increased access to naloxone reduced opioid overdose mortality rates by 46 percent.

The letters were sent to the CEOs of Pfizer, Emergent Biosolutions, Teva Pharmaceuticals, Hikma, Akorn, Adamis Pharmaceuticals, and Amphastar Pharmaceuticals.

Shaheen has led efforts in Congress to combat rising drug prices, prevent drug manufacturers from abusing the drug approval process to limit market competition and increase access to medication that those struggling with substance use disorder need for their recovery. She previously introduced the End Taxpayer Subsidies for Drug Ads Act, a bill that would prohibit pharmaceutical drug manufacturers from claiming tax deductions for expenses on advertising directly to consumers. Last year, Shaheen introduced bipartisan legislation that would increase the amount of time a physician can hold long-acting injectable (LAI) buprenorphine -- a form of medication for opioid use disorders -- from a specialty pharmacy. And following reports that the manufacturer of buprenorphine was attempting to use the orphan drug approval process to secure an additional seven years of exclusivity and block potentially cheaper generic versions of the medication from appearing on the market, Shaheen sent a letter to the FDA calling on the agency to prevent the manufacturer from abusing the system. As a result of Shaheen's actions, the FDA revoked buprenorphine's orphan drug status.

Full text of the letters can be found here or below:

Dear [CEO],

Given our nation's alarming opioid overdose rates, we write to urge [company name] to submit an application to the Food and Drug Administration (FDA) for over-the-counter (OTC) status for your naloxone product, a desperately needed step to ensure widespread and affordable access to this critical overdose reversal medication. We ask that you act quickly given the scale of need at this moment. Lives are at stake.

The COVID-19 pandemic has dramatically exacerbated the opioid and substance use disorder epidemic in this country, with reported overdoses and deaths spiking to historic levels. In fact, alarming data show that last year, the United States experienced a record 100,306 overdose deaths. These trends show no signs of abating as overdose deaths continue to rise.

Given the scale of need at this moment, it has never been more important to adopt opioid overdose prevention and reversal strategies on a wide scale. This includes steps to increase access to affordable naloxone, which is a proven, effective tool to reduce medical emergencies, drug overdoses, and deaths. A study conducted in Massachusetts found that substantially increased access to naloxone reduced opioid overdose mortality rates by 46 percent. With the support of naloxone manufacturers, we can significantly increase access to the medication and help mitigate the worsening crisis of drug overdose deaths.

One of the most important actions that can be taken right now is for manufacturers to submit applications to make naloxone available over the counter without delay. While many states have standing orders and workarounds that allow individuals to acquire naloxone without a prescription, regulatory hurdles continue to create unnecessary barriers. Further, a formal switch to OTC status will help reduce stigma and encourage the widespread use of this critical medication during emergencies. Additionally, market prices for naloxone remain prohibitively high, putting additional financial strain on community organizations working to reduce overdoses. Creating additional OTC naloxone options will help to reduce prices for those who need it, as well as for first responders and other good Samaritans, and increase the supply in at-risk communities.

The FDA strongly supports this change and has proactively created, tested, and validated the key labeling information and data needed to approve an OTC version of naloxone. As part of this effort to expedite the application process, the FDA has provided model OTC labels and usage instructions for the nasal spray and auto-injector versions of naloxone. Now the responsibility lies with manufacturers to submit the paperwork needed to make this switch. By doing so, [company name] will be taking an important step in the ongoing effort to prevent deadly opioid overdoses.

We strongly urge you to support the widespread access to naloxone, and request that you quickly apply to the FDA for OTC status.

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