NCPA, NACDS support, recommend revisions for PDUFA

May 1, 2012

The National Community Pharmacists Association and the National Association of Chain Drug Stores expressed their support and made recommendations for Congress's reauthorization of the Prescription Drug User Fee Act.

The National Community Pharmacists Association (NCPA) and the National Association of Chain Drug Stores (NACDS) expressed their support and made recommendations for Congress’s reauthorization of the Prescription Drug User Fee Act (PDUFA).

The U.S. Senate Committee on Health, Education, Labor & Pensions is currently working on a draft proposal to revise PDUFA, which was originally enacted in 1992.

Among the goals of the reauthorization are to address drug shortages, enhance the safety and integrity of the prescription drug manufacturing process, deter prescription drug counterfeiting, and assist those who are blind or visually impaired in accessing prescription label information.

Several changes are needed to help combat the problem of drug shortages, according to NCPA CEO B. Douglas Hoey, RPh. Most drug shortages have occurred in hospitals but community pharmacies are also experiencing shortages, primarily of drugs that treat ADHD, Hoey said.

“The effects of these shortages could be mitigated by reforming the Drug Enforcement Administration’s quota system and by ensuring that pharmacy reimbursement rates are updated more frequently to reflect price spikes and keep pharmacies whole,” Hoey said.

Congress should include provisions requiring DEA to act more favorably and expeditiously on manufacturer requests to increase quotas for certain controlled substances that are in short supply, according to NCPA.

Meanwhile, NACDS supports PDUFA’s provision giving FDA authority to destroy any drug refused admission into the United States if the drug has a “reasonable probability of causing serious adverse health consequences or death,” along with other drug manufacturing provisions.

“These important enhancements include increased oversight, inspections, and audit of both domestic and foreign facilities involved in drug manufacturing, as well as those facilities that prepare active and inactive ingredients used in drug products,” NACDS stated in a letter to the Senate committee.