The Senate Committee on Health, Education, Labor and Pensions held a markup of 11 health care-related bills on Wednesday, two of which deal directly with the pharmaceutical supply chain.
S. 3788, the "CLEAR LABELS Act," would add country of origin labeling requirements to the prescription drug supply chain. Sens. Maggie Hassan (D-N.H.) and Rand Paul (R-Ky.) both spoke on the legislation, with Hassan expressing national security concerns about publishing the locations of drug manufacturing facilities. Paul asserted that additional labeling requirements would not meaningfully change consumer behavior or choice, noting that patients often have little choice between products due to insurance plans and worries that labeling requirements would increase cost and complexity without changing end results. No amendments were made; S. 3788 was batched with several other bills under consideration and passed unanimously out of committee.
S. 3794, the "SAFE Drugs Act," would, as drafted, have imperiled pharmacy compounding by dramatically altering the current regulatory framework at the FDA, and would threaten to severely disrupt the drug supply chain, exacerbate ongoing drug shortages, and block patient access to essential, customized medications. NCPA and our partners at the Alliance for Pharmacy Compounding worked closely with staff on the bill, however, and the version considered in markup was greatly improved. Sen. Jim Banks (R-Ind.), sponsor of S. 3794, spoke on his bill, thanking pharmacy groups for working with his office to improve the legislation.
Sen. Jon Husted (R-Ohio) offered an amendment to create an expedited approval pathway at the FDA for over-the-counter drugs. He then withdrew his amendment for further work. The committee voted 18-4 to report S. 3794.
Watch a recording of the markup here.
