On Thursday, May 10, 2012, the House Energy and Commerce Committee considered and unanimously approved H.R. 5651, the Prescription Drug User Fee Act (PDUFA) Reauthorization legislation. This bill is tentatively titled "to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes." The reauthorization package would extend the operations of the FDA user fee program for an additional 5 years. The package also contains provisions seeking to address the national shortage of anesthetic and other drugs. Among the key sections of Title IX of the legislation are provisions that would enhance FDA notification requirements on manufacturers whose production of certain drugs is discontinued or interrupted. Such notification would enable FDA to use its existing authority to respond to the reduced production of key drugs in a timely fashion.
Under the current modest voluntary notification requirement, FDA has been able to prevent more than 32 drug shortages in 2012 alone. Other provisions in the title would require the Drug Enforcement Agency (DEA) to provide timely approval or denial to quota changes when it could help address shortages, require the FDA to expedite the approval of manufacturing adjustments that could help prevent or limit drug shortages, authorize GAO to conduct a comprehensive survey about the causes of drug shortages and issue recommendations, and develop interim rules to allow for repackaging of drugs into smaller units by hospitals until the FDA is able to issue guidance on this practice.
Thanks to a concerted lobbying effort by ASA and others, we are pleased that language was included in Title IX that includes manufacturers of anesthetic drugs as part of the enhanced notification provisions. Specifically, the language would require FDA notification for manufacturers of drugs that are "intended for use in the prevention or treatment of a debilitating disease or condition," an important distinction that ASA believes covers drugs used in anesthesia and pain medicine.
As part of the ASA 2012 Legislative Conference May 2 "Lobbying Day," more than 500 anesthesiologists visited Capitol Hill to urge support for drug shortage relief and to highlight the significant impact drug shortages have on the practice of anesthesia, in particular, noting that anesthetic and central nervous systems are the drugs experiencing the highest frequency in shortage.
The legislation is expected to face consideration by the full House of Representatives later this month.
Review the legislation.