Priority nonprescription drugs

(a)

In general

The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506L (21 U.S.C. 356l) the following:

506M.

Priority nonprescription drugs

(a)

In general

(1)

Designation

The Secretary may, at the request of the sponsor of a nonprescription drug, designate as a priority nonprescription drug under this section a drug intended for nonprescription use that is subject to an application submitted (or to be submitted) under section 505(b), if the Secretary determines that the drug meets the criteria specified in subsection (d). (2)

Nonprescription defined

In this section, the term nonprescription means, with respect to a drug, that such drug is not subject to section 503(b)(1). (b)

Request for designation

The sponsor of a drug subject to a pending application under section 505(b) for nonprescription use may request that the Secretary designate the drug as a priority nonprescription drug. (c)

Designation

Not later than 60 calendar days after the receipt of a request under subsection (b), the Secretary shall determine whether a drug meets the criteria for designation as a priority nonprescription drug under this section, and if so, make such designation. (d)

Criteria

(1)

Eligibility

Except as provided in paragraph (2), a drug described in subsection (a) is eligible for designation as a priority nonprescription drug if— (A)the drug is intended for a novel nonprescription indication that could provide a meaningful public health benefit; (B)the drug is a new molecular entity; or (C)the drug contains an active ingredient that has never been available in a nonprescription drug. (2)

Exclusion

A drug is not eligible for designation as a priority nonprescription drug if the drug is subject to a risk evaluation and mitigation strategy under section 505–1 or if the drug is a controlled substance (as defined in section 102 of the Controlled Substances Act). (e)

Actions

If the Secretary designates a drug as a priority nonprescription drug, the Secretary shall take such actions as are appropriate to facilitate the development of, and expedite the review of, an application or supplement to an application for such drug, which may include— (1)holding meetings with the sponsor and the review team throughout the development of the drug; (2)providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary to demonstrate the inapplicability of the criteria described in section 503(b)(1) is as efficient as practicable; (3)involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review; (4)assigning a cross-disciplinary project lead for the Food and Drug Administration team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the sponsor; and (5)taking steps to ensure that the design of any necessary nonclinical or clinical trials is as efficient as practicable, when scientifically appropriate, including reliance on real world evidence. (f)

List of conditions

(1)

Establishment

Not later than 18 months after the date of enactment of this section, the Secretary shall publish in the Federal Register a list of conditions for which a nonprescription drug, if developed for the condition, could provide meaningful public health benefit. (2)

Public comment

The Secretary shall provide a period of not less than 30 days for public comment on— (A)the list under paragraph (1); and (B)any updates to such list.

(b)

Rule of construction

The amendment made by subsection (a) shall not be construed to alter the evidentiary standards or the information required for approval of a nonprescription drug under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355). (c)

Report to Congress

Not later than 4 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report containing— (1)the number of nonprescription drugs for which a sponsor requested that the Secretary designate such a drug as a priority nonprescription drug under section 506M of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); (2)the number of nonprescription drugs for which the Secretary approved such request; (3)the number of priority nonprescription drugs (as designated under such section) for which the Secretary approved an application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); (4)an overview of the resources used to implement such section; and (5)any recommendation on further improvement on increasing over-the-counter drug approvals using a framework similar to the designation framework established in such section. (d)

Sunset date

The authority provided to the Secretary of Health and Human Services under section 506M of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall cease to be effective September 30, 2032.