“A U.S. shortage of the new generic version of Vyvanse, an ADHD medication, is due in part to federal limits on production, according to an industry group representing generic drug makers,” Ike Swetlitz writes over at Bloomberg. “Manufacturers haven’t been able to secure enough raw material ‘to launch their products at full commercial scale,’ according to a letter from the Association for Accessible Medicines addressed to the Drug Enforcement Administration, which sets the limits on production that the industry must follow. These restrictions on obtaining the drug’s active ingredients have curbed generic manufacturing, and people and insurers are paying more for the branded drug as a result, the letter says. The D.E.A. didn’t immediately provide a comment…. The agency is generally reevaluating aspects of the quota process for controlled substances, according to a notice published earlier this month. Production of many drugs used to treat attention-deficit/hyperactivity disorder, including Adderall and Vyvanse, is limited by the government since the medications are designated as controlled substances and they’re seen as prone to addiction and abuse. Caps on production set by the DEA are meant to ensure legitimate demand is met while also preventing an excess of supply that could leak into the black market. Vyvanse was available only as a branded drug sold by Takeda Pharmaceutical Co. until late August, when the market opened up to generic competition. Drugmakers haven’t received permission to manufacture enough generic Vyvanse because of two chicken-and-egg situations, according to the letter, which is dated Nov. 14. The D.E.A. sets limits in part based on past production and future sales commitments, the A.A.M. says, but companies making a new generic drug haven’t sold any amounts at all in the past. At the same time, the companies are reluctant to sign new sales contracts without knowing whether they’ll get government permission to make enough of the drug. If they fail to get the green light, they’ll have to pay customers’ fees for not fulfilling the contracts.” Ike Swetlitz, “U.S. limit on a key ADHD drug is worsening shortages, group says,” Bloomberg.
