Drug and Device Corner April 2021 - EAS Consulting Group

After regrouping in January, the FDA has published their finalized FY2021 OTC Monograph User Fees in the Federal Register Vol 86, No. 57.

This is the official announcement industry has been expecting from the agency which gives the required amount and due date for OTC drug manufacturing facility user fees. The announcement also reiterates previously shared information for OTC Monograph Order Requests, although the FDA does not yet have a system in place to process such an order. For the time being, interested parties can send a meeting request to the agency at Monograph-Meeting-Requests@fda.hhs.gov.

For OMUFA purposes:

An OTC monograph drug is a nonprescription drug without an approved new drug application which is governed by the provisions of section 505G of the FD&C Act
An OTC monograph drug facility (MDF) is a foreign or domestic business or other entity that, in addition to meeting other criteria, is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug
A contract manufacturing organization (CMO) facility is an OTC monograph drug facility where neither the owner nor any affiliate of the owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States, and
An OTC Monograph Order Request (OMOR) is a request for an administrative order, with respect to an OTC monograph drug, which is submitted under section 505G(b)(5) of the FD&C Act

Each registered facility that is identified as an OTC monograph drug facility during the period from January 2020-December 2020 will be responsible for these fees. MDF facility fees are $20,322 and CMO facility fees are $13,548. These fees are for the period from 1 October 2020 through 30 September 2021.

OTC monograph drug facilities are exempt from FY 2021 facility fees if they had ceased OTC monograph drug activities, and updated their registration with FDA to that effect, prior to December 31, 2019.
Entities that registered with FDA during the Coronavirus Disease 2019 (COVID-19) pandemic whose sole activity with respect to OTC monograph drugs during the pandemic consists (or had consisted) of manufacturing OTC hand sanitizer products are not identified as OTC monograph drug facilities subject to OMUFA facility fees.

OTC Monograph Order Request user fees remain the same as previously stated for FY2021, Tier 1 OMOR rate is $500,000 and Tier 2 OMOR rate is $100,000.

Do note, OMUFA fees are not applicable to API manufacturing facilities.

Payment of OMUFA facility fees are due 45 days after the date of the Federal Register notice publication (26 March 2021) which would be 10 May 2021, and will be processed through the FDA User Fee system.

See the Federal Register notice for further details.

The FDA’s GDUFA Self-ID period begins 1 May 2021. As you know, the FDA uses this database for metrics to determine annual facility fee amounts as well as targeting inspections.

The following types of generic industry facilities, sites, and organizations are required to self-identify with FDA:

Facilities that manufacture, or intend to manufacture, human generic drug APIs or FDFs, or both.
Sites and organizations that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system.
Sites that are identified in a generic drug submission and pursuant to a contract with the applicant remove the drug from a primary container/closure system and subdivide the contents into a different primary container/closure system.
Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing.
Sites that are identified in a generic drug submission and perform testing of one or more attributes or characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a current good manufacturing practice (CGMP) testing requirement (excludes sites that are testing for research purposes only).

Do note, sites and organizations that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system are considered to be manufacturers, whether or not that packaging is done pursuant to a contract or by the applicant itself.

Not all facilities that self-identify will be required to pay the GDUFA facility fee. Only facilities that manufacture, or intend to manufacture, generic drug APIs or FDFs, or both, are required to pay facility fees. Sites and organizations that only perform testing, repackaging, or relabeling are not required to pay a user fee.

If you would like EAS to handle this process for you, please contact Victoria Pankovich. As your regulatory support partner, EAS is happy to answer any questions you have about this program.

In a reversal of the notification in FR Vol. 86, No. 10, the FDA has determined that prior findings were ‘flawed’, and are retracting the announcement of the exemption of seven Type I medical devices from premarket notification. A full explanation of the agency’s current view can be read in the Federal Register Vol 86, No. 72. Comments to this notice may be submitted by 17 May 2021.

FDA generic drug outreach

The FDA is holding a free Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs meeting 5 May 2021, from 9 am – 12:30 pm EDT. The agency will share information with prospective and current generic drug applicants on uses of PSGs, as well as their process of developing and revising these guidance documents. Interested parties can register here.

A meeting will be hosted by FDA to cover Common Labeling Deficiencies and Tips for Generic Drug Applications on 7 May 2021, from 1 – 2 pm EDT. The agency will discuss the most common labeling mistakes and how to avoid them, as well as offer labeling tips. FDA will also answer commonly asked questions. Register online for this event.

Product-Specific Guidances for Generic Drug Development (FR Vol 86, No. 56)

Today’s batch of 36 PSGs includes:

22 new and 14 revised PSGs
New PSGs for products used as treatments for diseases or conditions such as:
- Prostate Cancer
- Hepatitis C
- Multiple Sclerosis
- Acromegaly
30 PSGs for products with no approved ANDAs (including 8 PSGs for complex products with no approved ANDAs)
8 PSGs for complex products (4 new and 4 revised PSGs)
- 5 of these PSGs were developed based on research data generated by the Generic Drug User Fee Amendments (GDUFA)-funded Science and Research program

Recently published Guidance Documents

CDER

Development of Abbreviated New Drug Applications During the COVID-19 Pandemic

FDA is issuing this guidance to provide general recommendations to prospective applicants and applicants of abbreviated new drug applications related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by FDA during the COVID-19 public health emergency.

CDER & CBER

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency

FDA is issuing this guidance to describe how the agency will request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA’s bioresearch monitoring (BIMO) program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the duration of the COVID-19 public health emergency.

Federal Register notices of interest

FR Vol 86, No. 73 Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act
FR Vol 86, No. 72 Medical Devices; Class I Surgeon’s and Patient Examination Gloves
FR Vol 86, No. 55 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

FDA websites of interest

GDUFA III Reauthorization Negotiation Sessions, containing minutes from meetings with industry on the reauthorization of the GDUFA program.
FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief
PDUFA VII: Fiscal Years 2023 – 2027 Public meeting 23 July 2020
CDRH recently published a website regarding their workload and anticipated delays in MDUFA timelines. They are seeing the heaviest impact, understandably, in IVD submissions. The agency is prioritizing submission reviews of COVID-19 related devices. IVD Medical Devices that are not companion diagnostics, a breakthrough designation request, or considered to have a significant public health impact have unfortunately languished in the system. As a result, FDA is currently declining IVD pre-submission requests that don’t fall into these categories. Submissions already in the system are experiencing delays in initiation of reviews and longer than typical review timelines. The agency is doing a bit better in non-IVD product area reviews, however these submissions are also seeing extended review timelines.
Catalog of Regulatory Science Tools to Help Assess New Medical Devices

COVID-19 specific FDA webpages

Posted in Drug and Device Corner, Drugs, Medical Devices.