EXCLUSIVE — House Republicans are escalating their investigation into the Drug Enforcement Administration’s handling of the shortage of stimulant medications used to treat attention-deficit/hyperactivity disorder, or ADHD, hinting at a subpoena should the agency not respond.
On Friday, House Oversight Committee Chairman James Comer (R-KY) and Healthcare and Financial Services Subcommittee Chairwoman Lisa McClain (R-MI) sent a letter obtained by the Washington Examiner to DEA Administrator Anne Milgram requesting information regarding the agency’s lack of action to increase the manufacturing limit on amphetamines necessary to treat ADHD, including Adderall, Vyvanse, Concerta, and Ritalin.
Comer and McClain sent their initial request to the DEA in May, but they said the agency has largely not cooperated with the committee this summer.
“In the three months since the initial request, DEA has only responded to one of the four requests,” wrote Comer and McClain to Milgram. “The Committee has been patient, but DEA is failing to provide a sufficient meaningful response to the outstanding requests.”
For nearly two years, patients and caregivers have faced difficulties finding medications like Adderall since the Food and Drug Administration first announced a shortage of the amphetamine compounds used to make the brand name drugs in October 2022.
This week, the DEA announced approval for U.S. manufacturers to increase the production of lisdexamfetamine, the amphetamine compound for Vyvanse, by 24% to meet the demand in the U.S. and abroad.
Last year, the agency also increased the production limit for methylphenidate, used to make Ritalin and Concerta, by 27%. Although this improved shortage conditions for most prescriptions, the supply of extended release formulation of the drugs still does not match demand.
According to the Centers for Disease Control and Prevention, approximately 7 million children between 3 and 17 years old, or about 11.4%, have a formal ADHD diagnosis.
Estimates on the share of adults with ADHD in the U.S. vary between 2.6% and 3.1%, but experts agree that individuals diagnosed with the disorder in childhood will likely continue to have symptoms as adults.
Comer and McClain note in their letter to Milgram the potential for illicit actors to abuse market shortages with illegal substances, which could be laced with fentanyl or other potentially lethal drugs.
“In times of prolonged shortage, patients in desperation may turn to sourcing their prescriptions outside of the regulated healthcare system,” wrote McClain and Comer.
The DEA highlighted in December that stimulants like Adderall are often mass produced by criminal drug networks and are easily marketed as legitimate prescriptions.
DEA lab testing found that 60% of illegal pills seized by the agency in 2023 contained potentially lethal doses of fentanyl. More than 50.6 million fake prescription pills were seized by the DEA in 2022, more than double those seized by the agency in 2021.
The House Oversight Committee has pressed the Biden administration on the broader issue of drug shortages for several months, including demanding information from the FDA on shortages of other drugs as well as stimulants.
In April, Republicans on the committee pressed FDA Commissioner Robert Califf regarding inspection of foreign pharmaceutical manufacturing plants necessary to meet increasing demand. At that time, foreign plant inspections from the FDA had not yet returned to pre-pandemic levels.
The House Republicans leaders requested a response from Milgram before the end of September to address the continued concerns about stimulant production or else the committee will begin to consider the compulsory process.