Letter to the Hon. Brett Giroir, Acting Commissioner of the U.S. Food and Drug Administration - Following this year's heartbreaking, opioid-poisoning death of Rochester infant, Schumer stands with Maisie Gillan's parents & calls on FDA to use new powers granted in Schumer-backed law, requiring all drug companies to use safer blister packaging for opioids ASAP

Letter

Dear Acting Commissioner Giroir:

I write to urge you to strongly consider issuing a requirement that all types and doses of opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging. As the opioid epidemic continues to impact communities across the country, you have a responsibility as leader of the Food and Drug Administration (FDA) to protect public health. This requirement could potentially limit the number of accidental overdoses, while still preserving access to appropriate amounts of opioids for individuals that require them for pain management. Though I appreciate the FDA's consideration of this issue in recent months, the agency must now move swiftly to develop innovative solutions that can alleviate the detrimental health consequences of this crisis.

The need for FDA action is clear. According to the Centers for Disease Control and Prevention, opioids were involved in 47,600 overdose deaths in 2017, accounting for almost 70 percent of all drug overdose deaths. Furthermore, it is estimated that roughly 500 children die annually from opioid poisoning, and over the last 20 years, 605 children under five years old have died from opioid poisoning. Unfortunately, New Yorkers have also died as a result of unsafe opioid handling, including Maisie Gillan a nine-month old infant from Rochester, NY. Maisie accidentally ingested a legally prescribed 10 mg methadone pill that authorities believe had been dropped on the floor a few days earlier, underscoring the dire need for safer opioid handling. This senseless death demonstrates why the FDA has no time to waste in requiring blister packaging and why the agency should apply this requirement to all types of opioids, since even low-dose opioids can be fatal to children and infants.

I was pleased to vote to enact the SUPPORT Act, which became law on October 24, 2018, and specifically gave the FDA new authority to require special packaging for opioids and other drugs that pose a risk of abuse or overdose. Although the type of packaging is not specified, there is evidence supporting the benefits of blister packaging. For example, blister packaging has been found to support medical adherence, as well as increase the likelihood that patients refill their prescriptions on time. There is also evidence that demonstrates past FDA action related to blister packaging drastically improved health outcomes. In 1997, the agency required that iron pills be distributed in blister packaging in order to prevent poisoning deaths among children. Consequently, iron ingestion calls regarding children to poison control centers dropped by a third and the number of deaths related to iron poisoning decreased from 29 to 1 in the years following implementation. Given these findings, it is clear that blister packaging could be useful tool in efforts to combat the opioid crisis.

The FDA's decision to solicit public comment regarding a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that certain opioids be made available in fixed-quantity, unit-of-use blister packaging is timely and a step in the right direction. In order to prevent accidental overdoses, the FDA should issue a requirement that opioids be made available in fixed-quantity, blister packaging. Additionally, to reverse the alarming increase in unintentional ingestion of opioids by children age five and younger, I urge the agency to expand the scope of this requirement beyond immediate-release, commonly-prescribed opioids to cover all opioid medications, including more potent opioids that are responsible for the majority of opioid-related morbidity and mortality. This expansion is recommended by the American Academy of Pediatrics and could help better address the threat posed by unintentional opioid ingestion.

Given that it has now been over a year since the FDA was granted new authority by Congress in the SUPPORT Act, it is imperative that the FDA move swiftly to reduce unnecessary exposure to opioids. By requiring companies to manufacture blister packaging for opioid products, the agency would strengthen public health protections and help prevent misuse and accidental poisonings of opioids. The health and safety of communities across the country depend on your continued efforts.

Thank you in advance for your attention to this matter.

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