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

In January, Rochester 9-Month-Old Passed Away After Unintentionally Ingesting A Methadone Pill; Roughly 500 Kids Die Annually From Accidental Opioid Poisonings 

Blister Packs Could Prevent Accidental Overdoses & Stop Increase In Children’s Unintentional Opioid Deaths; Schumer Calls On FDA To Use New Powers—In SUPPORT Act Passed Last Year—To Require Opioid Companies To Offer Blister Packs 

Schumer To FDA: Honor Baby Maisie Gillan By Requiring Blister Packaging To Keep Lethal Opioids Away From Our Children

Standing in Rochester with Adam and MaryBeth Gillan, parents of Maisie Gillan, U.S. Senator Charles E. Schumer today launched a major new effort to increase the safety of opioid packaging for residents of the Rochester-Finger Lakes Region and all Americans. Schumer’s push comes in the wake of a devastating incident in Brighton, in which nine-month-old infant Maisie Gillan passed away earlier this year after ingesting a methadone pill. Schumer pointed to this heartbreaking death as a means of demonstrating the need for safer opioid packaging that could decrease the likelihood of potentially lethal pills falling into the wrong hands—especially vulnerable children and infants. Specifically, Schumer called on the Food and Drug Administration (FDA) to issue a requirement that all types and doses of opioid-based drugs be made available in fixed-quantity, unit-of-use blister packaging. As the opioid epidemic continues to ravage communities across the country, Schumer said the FDA’s responsibility to protect public health is more urgent than ever. The requirement of blister packaging, Schumer argued, could potentially limit accidental overdoses and opioid poisonings, while still preserving access to appropriate amounts of opioids for individuals that require them for pain management.

“This year’s heartbreaking incident in Rochester, when Maisie Gillan passed away after accidentally swallowing a methadone pill, shows us that there is no step too far when it comes to protecting our children from potentially lethal opioids. With roughly 500 children dying from opioid poisoning each year, the need for the FDA to act swiftly and decisively to stop these preventable deaths is clear,” said Senator Schumer. “That’s why today, I’m urging the FDA to protect children from accidental opioid poisonings, by issuing a requirement that all types and doses of opioid-based drugs be made available in fixed-quantity, unit-of-use blister packaging. While I appreciate the FDA’s hard work in combatting the opioid crisis, we must not allow Maisie’s death to go in vain, and instead must finalize this critical regulation as soon as possible.”

“We applaud and support Senator Schumer for his demand for action at the FDA around packaging improvements with legal opioids, specifically blister packaging. To our family, this is a matter of life and death. We love and miss our daughter Maisie, who died in January from a lethal methadone overdose. This November, we will welcome a son. Two of our three children will never meet each other, as our family is an unneeded victim of the opioid epidemic in the United States. These needed safeguards in opioid packaging will protect everyone from negligent handling and dramatically reduce the opportunity for endangerment to children like Maisie,” said Adam Gillan.

According to the Centers for Disease Control and Prevention (CDC), opioids were involved in 47,600 overdose deaths nationwide in 2017, accounting for almost 70 percent of all drug overdose deaths. Over 3,000 of these deaths occurred in New York State alone. 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.

The Schumer-backed Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT) Act, which became law on October 24, 2018, 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 under this law, there is substantial evidence supporting the benefits of blister packaging. For example, blister packaging has been found to help avoid misuse of drugs, as well as increase the likelihood that patients refill their prescriptions on time. Furthermore, Schumer explained, blister packs are an important way to limit the amount of unused opioids that are dangerous to keep around in medicine cabinets, as well as limit over-prescribing of opioid-based medication. There is also evidence that demonstrates past FDA action related to blister packaging dramatically reduced accidental child poisonings.  In 1997, FDA 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. Schumer argued that for these reasons, health care providers should have the option to prescribe 5-, 10-, or 15-count unit-of-use blister packs, but currently, drug companies are not required to offer these types of configurations.

Now that it has been over a year since the FDA was granted new authority under the SUPPORT Act, Schumer urged the FDA to act swiftly to reduce unnecessary exposure to opioids. Schumer supported the steps taken by the FDA solicit public comments regarding a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require certain opioids be made available in fixed-quantity, unit-of-use blister packaging. However, Schumer urged the agency to expand the scope of the requirement to cover all opioid medications, including more potent opioids that are responsible for the majority of opioid-related morbidity and mortality. This expansion is also recommended by the American Academy of Pediatrics.

Schumer concluded that in order to prevent accidental overdoses and reverse the alarming increase in unintentional ingestion of opioids by children, the FDA must issue a requirement that opioids be made available in fixed-quantity, blister packaging as soon as possible.

A copy of Schumer’s letter to the FDA appears below.

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.

Sincerely,

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