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Medical Professionals Reference (MPR)DEA, FDA Address Prescription Stimulant Shortage in Joint Letter

The FDA and DEA provide an update on the efforts being taken to alleviate the shortages in a joint letter.


Amidst a shortage of prescription stimulant medications, the FDA and DEA have issued a joint letter, urging stakeholders to collaborate and ensure patient access to these crucial drugs.

Key Points:

  • The shortage began last fall due to a manufacturing delay from a single pharmaceutical company.
  • This issue was exacerbated by record-high prescription rates for stimulant medications.
  • The DEA sets annual production quotas for these controlled substances.
  • Manufacturers did not produce their full quota in 2022, and 2023 shows a similar trend.
  • DEA is urging manufacturers to either increase production to meet their quota or relinquish it for redistribution.

Additional Points:

  • The FDA suggests reviewing the appropriateness of stimulant prescriptions and considering alternative treatments.
  • Alternatives include an FDA-cleared game-based digital therapeutic for children with ADHD and nonstimulant medications.
  • The FDA mandated updates to prescription stimulant labels to address concerns of misuse, addiction, and overdose.
  • Medical literature indicates that family and friends are the primary sources of prescription stimulants for nonmedical use.

Conclusion:

  • Both the FDA and DEA emphasize the importance of ensuring access to stimulant medications while also promoting thoughtful and responsible prescribing.

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“We want to make sure those who need stimulant medications have access. However, it is also an appropriate time to take a closer look at how we can best ensure these drugs are being prescribed thoughtfully and responsibly.”

FDA Commissioner Robert M. Califf, MD
DEA Administrator Anne Milgram
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