Congress Finalizing Drug User Fee Bill; NCPA Provides Pharmacist’s Perspective

Congress is actively working to reconcile Senate and House-passed versions of the Prescription Drug User Fee Act (PDUFA) and the National Community Pharmacists Association (NCPA) recently wrote to lawmakers to offer the pharmacist’s view.

NCPA’s letter (available here) provides lawmakers with the community pharmacist perspective on several issues addressed in the bill, including:

  • Supply chain integrity / track-and-trace—While the nation’s pharmaceutical supply is safe, NCPA also supports measures to further enhance its safety. The RxTEC framework included in the Senate bill would create a practical tracking program for all prescription drugs. (To read more on RxTEC, see NCPA’s March 8th testimony before the House Energy and Commerce Committee.)
  • Drug shortages—NCPA supports separate provisions in both the Senate and House bills to help address drug shortages. In particular at community pharmacies, medications to treat ADD and ADHD have been subject to shortages, which may have been exacerbated by government actions, such as Drug Enforcement Administration (DEA) limits on the production by manufacturers of certain medications. The legislation could result in greater study in this area.

The June 7 NCPA letter also addresses the proposed re-classification of common, hydrocodone-containing pain relief products from Schedule III to the more-restrictive Schedule II under the Controlled Substances Act. It echoes the concerns expressed in an earlier letter to lawmakers from NCPA, the letter from the American Pharmacists Association, Food Marketing Institute, International Academy of Compounding Pharmacists and the National Association of Chain Drug Stores.

“We understand the concerns about diversion and abuse of these products and we share these concerns,” the groups wrote in that letter. “Nevertheless, moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products and it will result in adding to the nation’s health care costs with no assurance of a reduction in diversion and abuse.”

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