A recent shortage of a drug for attention-deficit/hyperactivity disorder in the U.S. has sparked a round of finger-pointing between Shire PLC (SHPGY) and the Drug Enforcement Agency.

Shire blames the shortage of branded and generic versions of its Adderall XR product on DEA limits on the amount of product Shire can manufacture. The Ireland-based company didn't get DEA clearance on boosting supply until December, which has caused "spotty availability" in some regions of the country this year, said Shire spokesman Matt Cabrey.

The DEA, however, is deflecting the blame. Spokesman Lawrence Payne said the agency approved a sufficient amount of the drug's active ingredient to allow for uninterrupted supplies.

The shortage has generated controversy. Sen. Amy Klobuchar (D., Minn.), sent a letter to Shire last week saying patients and pharmacies were having difficulty getting access to generic versions of ADHD drugs, forcing some to switch to more expensive branded drugs. She urged Shire to take immediate action to resolve the problem.

Klobuchar has introduced legislation that would give the Food and Drug Administration more tools to help address and prevent drug shortages. A rash of shortages have hit the drug industry, including the cancer chemotherapy cytarabine.

Adderall generated $361 million in sales for Shire in 2010, down 42% from 2009 because of the availability of cheap generic versions of the drug.

Shire also supplies generic versions of Adderall that are marketed by Teva Pharmaceutical Industries Ltd. (TEVA) and Impax Laboratories Inc. (IPXL).

The drug's active ingredient, derived from amphetamine, is on the DEA's schedule of controlled substances because of its potential for abuse. The DEA determines an annual quota for each class of controlled substance. Manufacturers submit applications to DEA for a portion of the quota.

The DEA, however, says it doesn't set quotas for specific products or set limits on the amount of brand-name or generic products companies can produce.

"Based upon all of the data that DEA has at this time, manufacturers have sufficient amphetamine quota to provide an uninterrupted supply of products," the DEA said in a statement. "Manufacturers can request additional quota at any time during the year. DEA will review their request and provide additional quota, if warranted."

In November, Impax filed a lawsuit accusing Shire of being in breach of its supply contract for generic Adderall, Shire said in a recent regulatory filing. Shire cited the DEA restrictions and said it is defending itself against the suit.

"We're not getting the supply we're ordering to meet our strong customer demand," said Impax spokesman Mark Donohue. The suit is still pending.

Shire's Cabrey said the company is working with the office of Klobuchar to try to resolve the situation.

-By Peter Loftus, Dow Jones Newswires; 215-982-5581; peter.loftus@dowjones.com

--Jennifer Corbett Dooren contributed to this article.
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