ALEXANDRIA, Va. — The Food and Drug Administration this week got a heads-up on key pharmacy industry priorities over the next five years from the National Association of Chain Drug Stores.
NACDS said it sent a letter dated Nov. 1 to FDA commissioner Margaret Hamburg in which the association discussed its support for the agency’s strategic priorities, "especially FDA’s objectives to enhance the safety and integrity of the foreign supply chain and to improve patient-targeted written medication information. However, we urge FDA to raise the priority of issues related to generic drugs and biogenerics."
In the letter, NACDS pointed to the pharmacy sector’s support of state-level legislation requiring enhanced wholesale distributor licensure requirements and chain-of-custody "pedigrees" for drug distributions outside the safe and recognized "normal distribution channel."
"NACDS strongly supports FDA’s commitment to strengthening the safety and integrity of the global supply chain, as outlined in the agency’s Strategic Priorities document for 2011-2015," the letter stated.
The association also recognized the FDA’s recent public hearings to review ways in which patient medication information can be consolidated into a concise and standardized one-document solution to help reduce confusion.
"Ensuring patient understanding of their prescription medication should be viewed as the final link in the prescription supply chain and is perhaps the most difficult to improve," NACDS said in the letter.
In addition, NACDS urged the FDA to implement an expedited approval process for biological products that are interchangeable with FDA-licensed products. "Biogenerics hold great promise to deliver critical cost savings to the health care system, just as generic drugs have," the letter said.
"As integral members of health care delivery teams and the face of neighborhood health care, pharmacies’ key priorities include preserving and enhancing the safety and quality of life-saving medications that we provide our patients. We are pleased that our priorities align with those of FDA," the letter added.
