Senate committee moves FDA User Fee bill with 5 NACDS-backed provisions

The diverse NACDS-backed provisions would enhance patients’ access to OTC hearing aids, as well as to biosimilar and generic medications.

Sandra Levy

6/17/2022

The National Association of Chain Drug Stores lauded the advancement of five supported provisions as part of the U.S. Senate Health, Education, Labor and Pensions Committee’s consideration of a legislation to reauthorize Food and Drug Administration user fees. Meanwhile, the association maintained its caution against personal drug importation — which also is included in the bill — due to safety concerns.

The committee passed the legislation on Tuesday, June 14, by a vote of 13-9.

“This bill contains three provisions supporting improved patient access to biosimilar and generic medications. It also would expedite the FDA’s finalization of the OTC hearing aids rule and maintain consistency with a flexible approach to drug disposal options,” said NACDS president and CEO Steve Anderson.

Anderson continued, “These provisions are consistent with NACDS policy recommendations, which have been crafted with the benefit of pharmacies’ insights and trusted role on the front lines of health and wellness delivery. We appreciate the Senate Health, Education, Labor, and Pensions Committee’s progress on these issues.”

Specifically, NACDS backs the following provisions:

Section 502. Safer disposal of opioids. If the FDA uses its authority to require manufacturers to provide drug disposal packaging or systems with opioid prescriptions, this provision allows more flexibility in the disposal options. With more options for drug disposal, we can expect to have higher patient participation which can help to reduce improper use of opioids. NACDS lauds lawmakers for recognizing this, especially as FDA is in the process of determining if and how to exercise their existing authorities to support drug disposal;
Section 503. Clarifications to exclusivity provisions for first interchangeable biosimilar biological products. Provisions in this section would speed approval of biosimilars — helping to enhance the affordability and accessibility of these medications for the American public;
Section 504. Improvements to the Purple Book. The reference that lists biological products licensed by the FDA would be updated more efficiently — which is important given references to this resource in state substitution laws;
Section 505. Therapeutic equivalence evaluations. Provisions in this section would serve to speed the approval of certain generic drugs thereby making these medications available to Americans sooner; and
Section 903. OTC hearing aids final rule. FDA would be required to publish the final OTC hearings aids rule 30 days after the legislation’s enactment. NACDS has commented to FDA in support of swift finalization of the rule.

The U.S. House of Representatives passed its version of the legislation last week. The full U.S. Senate will need to pass its legislation, and then House and Senate negotiators will need to work out differences so both chambers can pass the bill in identical form and send it to President Biden for consideration, NACDS noted.

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