The fall agenda for proposed and final rulemakings for the US Food and Drug Administration (FDA) was released on Wednesday and includes dozens of proposed and finalized rulemakings that will affect drug and device companies.
Below is a rundown of the rulemakings with brief descriptions of what’s in FDA’s plans for the near future and what drugmakers and device firms should be ready for, in addition to those that are being withdrawn.
October and November
On the drug side, and beginning with proposals expected this month, FDA is planning a rulemaking
that would permit an Institutional Review Board (IRB) to waive or alter the informed consent requirements under certain conditions for minimal risk clinical investigations.
“This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat disease and would harmonize with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies,” FDA says.
The so-called “deemed to be a license” for biologics proposed rulemaking
is also expected this month. FDA says biologics license applications (BLAs) “generally may not rely on drug substance, drug substance intermediate, or drug product information contained in master files. The proposed rule would permit the contained use of DMFs [drug master files] for NDAs subject to the BPCI Act transition.”
Also this month, FDA is planning to propose a rulemaking
to amend its regulation that defines biological products to conform to the statutory definition (21 U.S.C. 262) adopted in the Biologics Price Competition and Innovation Act
(BPCI Act) of 2009.
In addition to adding rulemakings, FDA also plans to pull a rulemaking
from 2010 this month. This proposed rule would have required sponsors of certain clinical and nonclinical studies “to promptly report to FDA information indicating that any person has or may have engaged in the falsification of data in the course of proposing, designing, performing, recording, supervising, or reviewing research, or in the course of reporting research results.”
On the device side this month, FDA plans to propose a rulemaking
on De Novo classification. “By clarifying the requirements for the De Novo classification process, FDA expects that the rule would reduce the time and costs associated with preparing and reviewing De Novo requests, and would generate net benefits in the form of cost savings for both private and government sectors,” the proposal says.
The agency also looks to pull a proposal
from 2016 that would have required medical device firms listing certain home-use medical devices to submit, in electronic format, the label and package insert of such medical devices listed with FDA.
expected this month would amend FDA regulations to remove requirements to submit multiple paper copies of device regulatory pre-submissions and submissions, and replace them with one copy in an electronic format.
In November, FDA plans to finalize a proposal from 2014 that implements Section 608 of the Food and Drug Administration Safety and Innovation Act
(FDASIA) “requiring FDA to use administrative orders to announce or to change the classification of devices, instead of taking action by regulation.”
Also in November, FDA plans to propose
to amend the regulations at 21 CFR 203 to remove provisions no longer in effect and incorporate conforming changes following enactment of the Drug Supply Chain Security Act
(DSCSA). FDA is looking to clarify provisions and avoid causing confusion with the new standards for wholesale distribution established by DSCSA.
In March 2019, FDA is planning to propose a new rulemaking
on post approval changes to approved applications. The proposal would update the existing regulations governing supplements and other changes to approved new drug applications (NDAs) abbreviated new drug applications (ANDAs) and biologics license applications (BLAs), as well as regulations regarding certain post-approval reports.
In April 2019, FDA is proposing to add
requirements for the content of initial pediatric study plans required to be submitted under the Pediatric Research Equity Act
(PREA). Although plans for pediatric development are required to be submitted based on the statutory provision, FDA says, “A regulation is required and will provide clarity, specificity, and direction to sponsors, as well as assist FDA in ensuring compliance, and ultimately help to better advance the study of drugs in pediatric populations to support advancing pediatric indications.”
In May 2019, the agency is planning to finalize a rule
that would better align postmarket safety reporting requirements with the International Council on Harmonisation (ICH).
On the medical device front in June 2019, FDA is planning to propose a rulemaking
to discontinue publishing in the Federal Register after each quarter a list of premarket approval application (PMA) and humanitarian device exemption application (HDE) approvals announced that quarter. Also in June, FDA plans to issue a proposed rule
to classify Human Leukocyte Antigen (HLA), Human Platelet Antigen (HPA), and Human Neutrophil Antigen (HNA) devices as a group of devices with each device having its own product code.
In July 2019, FDA plans to finalize a proposed rulemaking
from 2010 on major risk statements in direct-to-consumer advertisements. “The rule would require that the major statement in DTC television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug be presented in a clear, conspicuous, and neutral manner,” FDA says.
In addition in July 2019, FDA expects to put out a proposed rulemaking
to better protect the rights, safety and welfare of clinical trial subjects by updating the agency’s investigational new drug application (IND) regulations to “define and clarify the roles and responsibilities of the various persons engaged in the initiation, conduct, and oversight of clinical investigations subject to IND requirements.”
Also in July 2019, FDA is planning to update
its biologics regulations “to clarify existing requirements and procedures related to Biologic License Applications and to promote the goals associated with FDA’s implementation of the abbreviated licensure pathway created by the Biologics Price Competition and Innovation Act of 2009.”