| Adderall has been in short supply since August, causing chaos for the millions of people in the US who need the medicine to treat attention-deficit/hyperactivity disorder or narcolepsy. It's easy to point a finger at the government agency whose job it is to make sure there's enough raw ingredients available for companies to meet the medical need for the drug. That's just what Teva Pharmaceutical Industries, the largest manufacturer of generic Adderall did last year when a spokesman for the company said the shortage was partially caused by limits set by the the US Drug Enforcement Administration. But as a DEA spokesperson told me earlier this month, companies had at least 34,980 kilograms (77,000 pounds) of Adderall's raw ingredient – amphetamine – on hand at the end of last year, suggesting there was plenty to go around. So does the DEA deserve the blame? Every year, the DEA sets a quota — a limit on the amount of raw materials for many controlled substances, like Adderall. This is based in part on the Food and Drug Administration's estimate of need for the drug. Controlled substances can be abused, and the DEA wants to make sure there isn't more than the necessary amount out there. The DEA divides the quota up, giving each manufacturer an allotment. But the agency doesn't need to assign all of the quota immediately. If manufacturers want more, they can ask the government for it. In 2020, 2021 and 2022, the agency didn't allot the entirety of the quota, said the DEA spokesperson, who didn't want their name printed, citing department policy. The spokesperson provided some numbers to show how this works: For 2023, the FDA estimated just over 38,000 kilograms of amphetamine would be sufficient to meet the demand for Adderall and its generics – and the DEA set the quota at 42,400 kilograms. But the agency doesn't say which companies get which portion of that pie. And the DEA has also declined to share when companies have requested increases to their quotas from last year. Major manufacturers also won't share that detailed information. Some manufactures said that DEA quotas contributed to the shortage or made it harder to alleviate. But we don't have the data to know whether manufacturers actually ran out out of their individual quotas during the recent shortage. According to federal law, if a company requests a quota increase for a drug in shortage and the request is denied, the Attorney General is supposed to provide a written denial, which the Secretary of the Department of Health and Human Services is supposed to post on the FDA website. A spokesperson for Sandoz, Novartis AG's generic drug unit, the second-largest manufacturer of generic Adderall, said that the company requested quota increases, some of which were granted, some of which were denied. But there aren't any notices posted on FDA's website. An HHS spokesperson referred us to the FDA, where a spokesperson said that the agency "is not aware" of any quota increase denials. The DEA and Department of Justice didn't respond to requests for comment. All of that makes it challenging to say how the government is responding to the quota increase requests. As a result, it's also difficult to know to what extent shortages of this common medication rests with the government or the companies it oversees. — Ike Swetlitz | 
No comments:
Post a Comment