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FDA, DEA Lock Horns Over ADHD Drug Shortage

January 2, 2012

Patients suffering from attention deficit hyperactivity disorder (ADHD) can expect continued difficulty obtaining medicine to treat the ailment, recent published reports suggest.

According to Toni Clarke of Reuters, shortages of medications like Adderall, a stimulant used to control ADHD symptoms, are due in part because they are regulated by the Drug Enforcement Agency (DEA) as a controlled substance. In other words, because the drug is addictive, the DEA can place strict regulations on how much of its active ingredient is distributed annually to manufacturers.

That ingredient, API, is described by Clarke as “mixed amphetamine salts,” and is sometimes misused by students seeking to improve their test scores. As a result, she says, the DEA “authorizes a certain amount” of API “to be released to drugmakers each year based on what the agency considers to be the country’s legitimate medical need.”

New York Times reporter Gardiner Harris puts it more bluntly, saying that the shortages “are a result of a troubled partnership between drug manufacturers and the [DEA], with companies trying to maximize their profits and drug enforcement agents trying to minimize abuse by people, many of them college students, who use the medications to get high or to stay up all night.”

“Caught in between are millions of children and adults who rely on the pills to help them stay focused and calm. Shortages, particularly of cheaper generics, have become so endemic that some patients say they worry almost constantly about availability,” Harris added.

Contributing to the lack of available Adderall and similar medications is the increasing number of prescriptions being written for them. Clarke, citing IMS Health statistics, says that more than 18 million Adderall prescriptions were written in 2010 — an increase of 13.4% over the previous year.

“Concerns are now rising among patient groups and doctors that the shortages seen in 2011 will continue into this year. Many orders remain unfilled, manufacturers say, and it may take several months before ingredient authorized under the new 2012 quota can be turned into new product,” the Reuters reporter wrote on Sunday.

The situation has resulted in what the New York Times has called “for a rare open disagreement” between the FDA and the DEA, with FDA representatives saying they have informed the DEA of the shortages and officials with the enforcement agency insisting that there is “plenty” of supply and questioning whether or not pharmaceutical companies are opting to make more of the expensive, name-brand versions of the drugs and less of the cheaper generic version.

“Some high-priced pills are indeed readily available, and DEA officials said that so long as that is the case, they believe that ADHD drug supplies are adequate,” Harris said. “But those who rely on the drugs can react very differently to apparently similar medicines, so an adequate supply of one drug does them no good when their preferred medicine is unavailable, patients and their doctors say. And prices can vary so much that some patients say they cannot afford to switch.”

“Right now patients are trying to scrape by, either by traveling long distances to fill prescriptions or switching to other products even if they don’t work as well or are more expensive. But these are temporary workarounds and without a structural change manufacturers and advocate groups fear the problem will linger or even worsen,” added Clarke.

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Source: RedOrbit Staff & Wire Reports