Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing (2024)

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Food and Drug Administration, HHS.

Notice.

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Submit written comments (including recommendations) on the collection of information by July 8, 2024.

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0435. Also include the FDA docket number found in brackets in the heading of this document.

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Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.

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In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Prescription Drug Marketing

OMB Control Number 0910-0435—Extension

This information collection helps support FDA regulations and statutory requirements that govern prescription drug marketing. Specifically, the Federal Food, Drug, and Cosmetic Act, as amended by the Prescription Drug Marketing Act of 1987 (Pub. L. 100-293) (PDMA) and Prescription Drug Amendments of 1992, establishes requirements for the: (1) reimportation and wholesale distribution of prescription drugs; (2) sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs that were purchased by hospitals or healthcare entities or donated to charitable organizations; and (3) distribution of prescription drug samples. Because insufficient safeguards existed over the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs, and that a wholesale drug diversion submarket had developed that prevented effective control over the true sources of drugs, PDMA was enacted. PDMA is intended to ensure that drug products purchased by consumers are safe and effective and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold. Agency regulations implementing PDMA requirements are codified in part 203 Start Printed Page 48432 (21 CFR part 203), Prescription Drug Marketing.

The regulations in part 203 include reporting and recordkeeping requirements intended to help achieve the following goals to: (1) ban the reimportation of prescription drugs produced in the United States, except when reimported by the manufacturer or under FDA authorization for emergency medical care; (2) ban the sale, purchase, or trade, or the offer to sell, purchase, or trade, of any prescription drug sample; (3) limit the distribution of drug samples to practitioners licensed or authorized to prescribe such drugs or to pharmacies of hospitals or other healthcare entities at the request of a licensed or authorized practitioner; (4) require licensed or authorized practitioners to request prescription drug samples in writing; (5) mandate storage, handling, and recordkeeping requirements for prescription drug samples; and (6) prohibit, with certain exceptions, the sale, purchase, or trade, or the offer to sell, purchase, or trade, of prescription drugs that were purchased by hospitals or other healthcare entities or that were donated or supplied at a reduced price to a charitable organization.

Respondents: Respondents to the information collection are persons or entities engaged in prescription drug marketing.

In the Federal Register of January 22, 2024 (89 FR 3928), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four information collection topics solicited in our 60-day notice.

FDA estimates the burden of this collection of information as follows:

Based on a review of Agency data, since our last request for OMB approval, cumulatively our estimate reflects an increase of 6,492,354 responses and 516,028 hours annually. The estimates in table 1 reflect an assessment of the volume of loss/theft/falsification reports received by the Agency under § 203.37 over the past 18 months. While the requirements have not changed, we believe the current figures more accurately reflect the number of reports estimated to be submitted to FDA under this section. Our adjustments to table 2 are attributable to a more accurate reflection of the number of drug sample requests received by manufacturers and authorized distributors of record. The PDMA does not require manufacturers and distributors to report the number of drug sample requests they receive to FDA. However, section 6004 of the Patient Protection and Affordable Care Act (Pub. L. 111-148) requires that manufacturers and authorized distributors submit to FDA annually the identity and quantity of drug samples requested, among other information.

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