As the ADHD medication shortage drags on, the Federal Trade Commission and U.S. Department of Health and Human Services seek public input on how pharmaceutical intermediaries may influence drug prices and availability.
ADDittude Magazine
February 21, 2024
To what degree are ongoing nationwide ADHD drug shortages worsened by the role of pharmaceutical middlemen? This is the subject of a public inquiry recently launched by the Federal Trade Commission (FTC) and U.S. Department of Health and Human Services (HHS), which issued a joint Request for Information (RFI) on February 14.
The public has until April 15 to publicly submit comments at Regulations.gov.
The RFI asks patients to submit comments, documents, and data regarding how the practices of two types of pharmaceutical drug intermediaries — group purchasing organizations (GPOs) and drug wholesalers — may contribute to generic drug shortages, including how both entities may influence the pricing and availability of pharmaceutical drugs.
“When you’re prescribed an important medication by your doctor, and you learn the drug is out of stock, your heart sinks,” HHS Secretary Xavier Becerra said in a press release. “This devastating reality is the case for too many Americans who need generic drugs for ADHD, cancer, and other conditions. Today’s announcement is part of the Biden-Harris Administration’s work to tackle healthcare monopolies and lessen the impact on vulnerable patients who bear the brunt of this lack of competition.”
More specifically, the federal agencies say they aim to learn:
Whether and to what extent manufacturers, GPOs, and drug wholesalers are complying with their legal obligations under Section 3 of the Clayton Act and the Robinson-Patman Act.
Whether and to what extent the available protections for GPOs under the Federal Anti-Kickback Statute affect market concentration and contracting practices by GPOs, as well as drug shortages.
Whether and to what extent market concentration among GPOs and drug wholesalers has impacted smaller healthcare providers and rural hospitals.
Whether and to what extent concentration among GPOs and drug wholesalers has disincentivized suppliers from competing in generic drug markets.
What is the impact of the prevailing GPO compensation model, which may rely on rebates, chargebacks, and administrative fees from manufacturers and suppliers in exchange for favorable treatment, on generic manufacturers and other suppliers?
Since the U.S. Food and Drug Administration (FDA) first reported a shortage of Adderall in October 2022, millions of patients and caregivers have struggled to fill prescriptions with no end in sight.
According to a December 2023 report published in USA TODAY, the average price paid by small to mid-sized independent and chain pharmacies nearly doubled from late 2022 to December 2023 for specific dosages of methylphenidate (i.e., Ritalin and Concerta); the average cost of certain versions of dexmethylphenidate (Focalin) more than doubled during that period.
According to an ADDitude survey of 11,013 adults and caregivers, at least 20% of ADHD patients continued to be impacted by the stimulant shortage in the summer of 2023.
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.