House Democrats have called on the Drug Enforcement Administration and two manufacturers of drugs to treat attention-deficit/hyperactivity disorder to explain shortages of medicines to treat the disorder, especially generic versions of the drugs.
The request comes amid reports that the drug makers may be manipulating the market to force consumers to purchase brand-name products.
Rep. Henry Waxman (D-Calif.), ranking member of the House Energy and Commerce Committee, joined Reps. Diana DeGette (D-Colo.), Frank Pallone, Jr. (D-N.J.), and Chris Van Hollen (D-Md.) to question the DEA as well as Shire Pharmaceuticals and Novartis regarding recent reports of shortages of generic ADHD drugs.
The FDA is reporting current shortages of three drugs that are prescribed to treat ADHD: amphetamine mixed salts immediate-release tablets, dextroamphetamine tablets, and methylphenidate HCI tablets.
"Reports indicate that drug manufacturers may be manipulating the market to create an artificial shortage of the generic ADD drugs and force patients to purchase the more expensive brand-name drugs," the lawmakers said in a statement. "Reports have also indicated that DEA policies regarding ADD drug quotas may be exacerbating these shortages."
In a letter dated Jan. 17, the lawmakers asked the DEA for details on how the agency sets the quotas for the drugs involved and how it develops quotas for drugs with rapidly increasing sales, such as amphetamine mixed salts immediate-release tablets. They also asked the DEA to describe any changes in the process it plans to make to address the reported shortages.
Meanwhile, the lawmakers sent separate letters asking Novartis, which produces both branded and generic methylphenidate (Ritalin), and Shire Pharmaceuticals, which makes both branded and generic amphetamine mixed salts immediate-release tablets (Adderall), to provide details on their production of both brand name and generic versions of their ADHD drugs.