United States Food and Drug Administration Increases Production of Vyvanese in Response to ADHD Drug Shortage

Reuters reported on September 4th that the United States Food and Drug Administration approved to increase production of the stimulant medication known as Vyanese made by Takeda Pharmaceuticals.   Vyvanse is commonly prescribed as a stimulant  for treating attention deficit hyperactivity disorder (ADHD).

ADHD medication shortages have been documented since 2022 when Teva Pharmaceuticals announced a shortage due to manufacturing problems.  Medications like Vyvanse are a class II controlled substance classified by the Drug Enforcement Authority (DEA).

The issue of ADHD medication shortages received broader attention after the United States Department of Justice (DOJ) announced sweeping indictments against the founders of the online pharmacy Done Global on June 13, 2024.  The United States Attorney’s Office for the Northern District of California alleged that clinical director David Brody and founder Ruthia He by alleging using telemedicine to improperly prescribe Adderall and using deceptive marketing tactics.

AFAA Foundation recommends the following policy solutions in helping prevent another ADHD medication shortage crisis:

1. Reaffirm that only licensed pharmacists can dispense medications and stimulants used for treating attention deficit hyperactivity disorder (ADHD).

2. Requiring any online pharmacy that dispenses stimulants or equivalent medications to be accredited by both the Food and Drug Administration (FDA) and related state agencies.

3. Congress should introduce legislation to make it easier for the FDA to approve non-stimulant medications for ADHD and similar coincidental conditions.

4. Congress should use its subpoena power to make pharmaceutical executives answer on what led to the ADHD medication shortage and to ensure another shortage never happens again.

5. Congress should work on future reauthorization bills tied to The Autism CARES Act that more research should be funded Autism and coincidental conditions like ADHD.  This research can help bring new non-stimulant medications that can prevent another shortage.