About the Author(s)
Recent Developments
Attention Deficit Hyperactivity Disorder Drug Shortages
Kimberly Sue N. Barrientos


Abstract: There is alarming concern in recent reports about the shortages of generic drugs used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Keywords: ADHD, drug shortages, generic drugs, mental health

Published: 10 January 2013 Cite as: Barrientos KSN. Attention Deficit Hyperactivity Disorder Drug Shortages. Bull Health L Policy. 2012;1(2).

Introduction In recent months, widespread shortage of generic ADHD drugs has caused difficulties for patients with ADHD. Those who require the medications are being forced to purchase expensive brand name drugs because generic versions are unavailable.1 The FDA, drug-manufacturing companies, and patients are blaming shortages on the Drug Enforcement Administration (DEA).2 Many manufacturers have reported that certain ADHD medications are in short supply, specifically generic versions of Adderall and Ritalin.3 The DEA has refused to acknowledge the shortage; they have placed blame for this shortage on the drug manufacturers’ decision to divide their manufacturing quota between generic and brand name drugs.4

Reports provided to Congressional leaders indicate drug manufacturers may be manipulating the market to create an artificial shortage of generic drugs, thereby forcing patients to purchase more expensive brand-name drugs.
5 These reports have indicated DEA policies regarding ADHD drug quotas may be exacerbating the shortages.6 On January 17, 2012, House Democrats sent letters to the DEA, the CEOs of Shire Pharmaceuticals (manufacturer of both the brand and generic version of Adderrall XR), and Novartis (manufacturer of both the brand and generic versions of Ritalin) in which they demanded answers regarding the shortages.7

Issue: Action Must Be Taken to Prevent and Reduce Prescription Drug Shortages
The cost of prescription ADHD medication is rising and the shortage of generic versions is extremely disconcerning for patients. However, there does not seem to be a clear answer as to what is causing this shortage.8 Drug manufacturers claim the shortage of generic drugs results from both an increase in demand from consumers and shortages of essential ingredients for the medication, such as amphetamine salts.9 The DEA believes there is an adequate supply of materials and the shortage problem comes from within the manufacturing process itself, therefore shifting blame to the manufacturers.10

Many clinicians have recognized this problem and are currently attempting to create solutions to help diagnosed patients fill their prescriptions at a low cost.
11 However, many parents still are forced to contact multiple pharmacies in order to get the necessary medication for their children.12 One DEA representative has reported that the DEA sets manufacturer quotas in order to help prevent abuse by individuals who do not have ADHD and who are seeking the drugs solely for recreational purposes.13 It is argued by many, this fear of potential abuse should not affect the DEA and manufacturers’ decision to limit the production of the medication because of its imperative importance for those diagnosed with ADHD.14

In October 2011, President Obama signed an executive order directing the FDA to take action against these supply shortages.
15 As established by this order, it is clear the FDA, DEA, and drug manufacturers need to start holding each other accountable in order to keep generic versions of ADHD medication available and accessible. However, details and disagreements on the root causes of the shortage and relationships to ADHD drugs in particular cloud the potential for solutions to this concern in the near future.

Conclusion

It is necessary for the legislature to ensure that the generic medication shortage is addressed and that patient access to generic forms of ADHD medication is not severely impacted. Additionally, drug manufactures’, the DEA and the FDA must come to a resolution of how to increase availability of generic medication while ensuring lower costs. Most importantly, it is essential that these entities ensure ADHD patients have access to affordable versions of medication.

Competing Interests: None reported
Acknowledgments: None reported

Author(s)
Kimberly Sue N. Barrientos is a second year student at California Western School of Law, Vice President of the Health Law Society, and a member of the Pro Bono Honors Society. Ms. Barrientos received her undergraduate degree in Biology from the University of California, Los Angeles.

References (Bluebook)
1. Carolyn Drake, DEA, Drug Companies Trade Blame for Generic ADHD Drug Shortage, hcp live (Feb. 28, 2012), http://www.hcplive.com/articles/DEA-Drug-Companies-Trade-Blame-for-Generic-ADHD-Drug-Shortage/.
2. Id.
3. Id.
4. Id.
5. Id.
6. B. Mixter, House Democrats Seek Answers On Shortages of Generic ADD Drugs, bloomburg bna (Feb. 29. 2012), http://healthlawrc.bna.com/hlrc/4225/split_display.adp?fedfid=24335549&vname=hcenotallissues&fn=24335549&split=0#24335549/.
7. Id.
8. Id.
9. D. Brauser, ADHD Drug Shortages a Major Problem for US Physicians, medscapemed.news (Feb. 29, 2012), available at http://www.medscape.com/viewarticle/757164/.
10. Id.
11. Id.
12. Id.

13. Id.
14. Id.
15. Id.

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