Drug and Device Corner March 2022 - EAS Consulting Group

FDA announced the fiscal year 2022 OTC-Monograph Drug User Fee rates in the Federal Register Vol 87, No 51 published today 16 March 2022. These fees cover FDA’s FY2022 which runs from October 2021 through September 2022. The facility fees for FY 2022 are due on 1 June 2022

Regarding fee specifics,

Owners of manufacturing and processing facilities of finished OTC-drug dosage forms will pay a full facility fee: $24,178
Owners of a contract manufacturing facility will pay 2/3 of the full fee: $16,119
Submitters of OTC monograph order requests (OMOR) will pay tier-based user fees, (with the exception of those submitting certain safety-related changes). Tier 1 OMOR user fees are assessed at $507,021, Tier 2 OMOR user fees are assessed at $101,404

The facility fees are assessed on any facility that identified the business process of OTC monograph drug facility in their establishment registration during the fee-liable period of 1 January 2021 through 31 December 2021.

Entities that ended any OTC monograph drug activities, and updated their drug facility registration accordingly by 31 December 2020 will not be included in the FY2022 fee assessment.

As with FY2021, any OTC monograph drug facility that registered with the FDA during the COVID-19 pandemic, whose only OTC monograph drug activities are / were manufacturing of OTC hand sanitizer products, are not subject to FY2022 OMUFA facility fees.

Again, the fees are due on 1 June 2022. Payments must be made in U.S. currency by electronic check or wire transfer, with FDA’s preference being an online payment via e-check. If using a wire transfer, include the PIN assigned to your cover sheet, and do factor in any bank fees to ensure the full amount reaches the FDA.

The FDA has finalized a product recall guidance document that is applicable to all companies involved in the distribution chain of an FDA regulated product. The agency is urging manufacturers, and downstream distribution outlets to have a recall plan in place in order to expeditiously and effectively respond to a violative product’s correction, or removal from the market. Guidance is offered on processes to implement, including the essential communication piece. Preparing, maintaining, and documenting these procedures, as well as training identified personnel, are highlighted. The goal, of course, is to reduce the public’s exposure to any potentially harmful products as quickly as possible. The guidance document Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, has recommendations on how to put a recall plan in place. EAS, as your regulatory compliance partner, is here to assist with development of such a plan.

Guidance Documents of Interest

Pre-Launch Activities Importation Requests (PLAIR)

This guidance finalizes the July 2013 draft guidance Pre-Launch Activities Importation Requests, which describes the FDA’s policy regarding requests for the importation of unapproved finished dosage form drug products by an applicant preparing the product for U.S. market launch based on anticipated approval of a pending new drug application or abbreviated new drug application.

Patient-Focused Drug Development: Methods to Identify What Is Important to Patients

This guidance (Guidance 2) is the second in a series of four methodological patient-focused drug development guidance documents that describe how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.

The methods described in this document can be used to elicit what is important to patients, which may in turn help inform understanding of disease/condition and clinical trial design. It may also help the generation and use of patient experience data, including clinical outcome assessments and patient preference information, to inform benefit-risk assessment.

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

This revised draft guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the FD&C Act, as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, this draft guidance covers the statutory verification system requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate.

All Guidance Documents can be searched on the FDA’s website.