Legislation, Associations Demand Action on ADHD Medication Shortage
A new legislative proposal aims to “tear down regulatory barriers that are preventing families from accessing” generic versions of ADHD medications such as Adderall and Vyvanse at the same time associations demand U.S. government action.
May 21, 2024
The ongoing shortages of generic ADHD medications and chemotherapy drugs are addressed in new draft legislative proposal released on May 3 by Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Chair Ron Wyden (D-Oregon), who said the proposed legislation would “tear down regulatory barriers that are preventing families from accessing critical drugs like those needed to combat ADHD.”
The draft legislation was announced on the same day the American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry (AACAP), and Children’s Hospital Association (CHA) sent a letter to the U.S. Department of Health and Human Services and Drug Enforcement Administration expressing their continued concern about the ongoing stimulant medication shortages.
“Families that rely on generic stimulant medications have been disproportionately affected by the ongoing stimulant shortages,” the letter said. “This situation only exacerbates existing health disparities among economically disadvantaged families who are enrolled in Medicaid and CHIP.”
The proposed legislation establishes a Medicare Drug Shortage Prevention and Mitigation Program, wherein hospitals, healthcare providers, group purchasing organizations, drug manufacturers, and others could earn payment incentives for improving their purchasing and contracting practices across the supply chain for generic drugs, including generic versions of ADHD medications such as Adderall and Vyvanse. The proposed legislation would also limit inflationary rebates under the Medicaid Drug Rebate Program (MDRP) for certain generic drugs susceptible to shortages.
“It is unacceptable that America is consistently running out of affordable and essential generic medicines,” Wyden said in a press release. “Once again, monopolistic middlemen have put market power and profit over families’ healthcare.”
Associations Urge Government to Address ADHD Medication Shortage
In their letter on ADHD medication shortages, the AAP, AACAP, and CHA call on the federal government to “convene all relevant stakeholders for a forum to discuss the impact these shortages are having on patients, families, and their providers and identify actionable solutions that will alleviate these shortages.”
“Pediatric providers, including child and adolescent psychiatrists, pediatricians, and children’s hospitals, along with the patients and families they serve, face an insurmountable struggle with stimulant medication shortages,” the letter said. “Untreated ADHD can contribute to worsening mental and behavioral health disorders, including mood and substance-use disorders, unintended injuries resulting from ADHD-related impulsivity and long-term impacts on relationships-building, educational achievement, and professional success. Parents and families may also be negatively impacted by the disruption that untreated ADHD can cause in the home, school, and work environments.”
According to the American Society of Health-System Pharmacists (ASHP), 323 medicines are currently in short supply, the highest number of ongoing and active drug shortages since the organization began tracking data in 2021.
ASHP reported that “new DEA quota changes, along with allocation practices established after opioid legal settlements, are exacerbating shortages of controlled substances (12% of all active shortages).” The Drug Enforcement Agency (DEA) classifies stimulant ADHD medications, such as Adderall and Vyvanse, as “Schedule I,” which indicates drugs with a high potential for abuse.
FTC, HHS Seeks Public Input on ADHD Medication Shortage
The Federal Trade Commission (FTC) and U.S. Department of Health and Human Services (HHS) are seeking public input to understand how the practices of pharmaceutical middlemen contribute to drug shortages and impact patients, hospitals, healthcare providers (including small healthcare providers and rural hospitals), pharmacies, generic manufacturers, and other suppliers.
Sixty-three percent of the more than 6,200 public comments already submitted mention ADHD.
The deadline to submit public comments is May 30, 2024. Add your testimony at Regulations.gov.
The public can also demand an end to the ADHD medication shortage by writing letters to representatives, the DEA, and the FDA using templates provided by ADDitude.
