Regulatory Focus™ > News Articles > ADHD Drugs Remain in Short Supply

ADHD Drugs Remain in Short Supply

Posted 03 January 2012 | By Alexander Gaffney, RAC 

A shortage of a medication used to treat attention deficit hyperactive disorder (ADHD) shows little sign of abating as the US Drug Enforcement Administration (DEA) continues to regulate the amphetamine salts that act as the drug's active pharmaceutical ingredient (API).

The DEA controls the supply of the amphetamine salts via a manufacturing quota system, and authorizes certain amounts of the amphetamine salts to be distributed based on what the agency determines to be the actual medical need for the drug.

Critics maintain that the quota system has led to a shortage of the drug that has had an outsized effect on generic versions of the drug as manufacturers opt to use their limited supplies of the amphetamine salts to make pricier, brand-name products instead.

US Food and Drug Administration (FDA) officials have called for the DEA to recognize the issue of shortages, which according to the New York Times has led to a "rare open disagreement between two federal agencies." The FDA, however, has no say in how the DEA manages its quota system.

The DEA has responded to the FDA by stating that they believe the shortage issue is a result of marketing decisions made by industry, and that the quota system as it currently exists is adequate.

Said DEA spokeswoman Barbara Carreno, "Any shortage of these products is therefore a result of decisions made by industry regarding manufacturing or distribution."  Carreno further noted that the DEA believes that the same issues causing other drug supply issues are likely to blame.

Industry, however, has deflected blame back to the DEA, calling the quota system the root of the issues-not manufacturers.



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