Regulatory Radar: FDA Regulatory Initiatives: What’s Ahead Based on the Spring 2018 Unified Agenda

The U.S. General Services Administration’s Spring Unified Agenda, released in May 2018, provides insight into upcoming FDA regulatory actions.

Federal agencies including the FDA are required to publish an Agenda of Regulatory and Deregulatory Actions in the spring and fall of each year, commonly referred to as the Unified Agenda. It is through this Unified Agenda that FDA announces future rulemaking activities to update the public on pending and completed regulatory actions. Proposed rules are open for public comment and once finalized final rules are published in the Federal Register where agencies must publish additions, deletions or revisions to the Code of Federal Regulations (CFR) based on the final rule.

Some of the significant FDA rule making initiatives coming out of the Spring Agenda include:

Quality Oversight of Devices - Proposed Rule (RIN 0910-AH99)

In the continued effort to modernize and harmonize medical device regulations, FDA’s newly proposed rule seeks to replace the existing requirements with the quality specifications of ISO 13485:2016, an international consensus standard for medical device manufacture. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. Once finalized, this rule should it make it more efficient for manufacturers to sell their products globally.

Enhancing Clinical Trial Processes – Proposed Rule (RIN 0910-A108)

FDA is seeking to streamline clinical trial conduct by a new proposed rule that would replace current FDA requirements for cooperative research so that any institution located in the United States and participating in multi-site cooperative research would need to rely on approval by a single Institutional Review Board (IRB) for the portion of the research conducted in the U.S., with some exceptions. This rule would also establish an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution.

The use of a central IRB should speed up multi-site clinical trials where some institutional site IRBs have extended timelines in approving clinical protocols.

IND Requirement and Clarity of Roles – Proposed Rule (RIN 0910-AH07 and A109)

FDA is seeking to broaden the regulatory criteria for studies exempt from investigational new drug (IND) requirements and provide clarity and consistency regarding when studies evaluating drug uses of lawfully marketed products -- such as conventional foods, dietary supplements or cosmetics -- are subject to IND review. Reducing the IND requirement does not relieve the sponsor from informed consent and IRB approval obligations but would reduce the burden of submitting and maintaining an IND.

Another proposed new rule updates FDA’s 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. The proposed changes would better protect the rights, safety and welfare of subjects and help ensure the integrity of clinical trial data, reduce study misconduct and ensure the integrity of clinical trial data while requiring additional documenting, reporting and recordkeeping for clinical investigators. The conduct of the majority of clinical trials involves multiple parties including the sponsor, CROs and clinical investigators where a clearer designation of responsibilities will improve the quality of the trial data and protection of subjects participating in these studies.

FDA Seeking Input for New Regulations of Tobacco- and Nicotine-Containing Products (E-Cigarettes) – Prerule Stage (0910-AH60 and RIN 0910-AH86)

As part of FDA’s enhanced effort to protect the public from health-related issues resulting from tobacco and nicotine products, it has issued two advance notices of proposed rule makings (ANPRMs). As of 2017 the annual number of cigarettes sold in the U.S. is estimated at 249 billion with smoking-related health care costs estimated at nearly $170 billion annually. FDA is specifically concerned about exposure of young people to tobacco products and resulting nicotine addiction. It estimates that about 4.7 million middle and high school students use at least one tobacco product, with a big uptake in use of e-cigarettes among youth.

One ANPRM seeks information on how FDA might regulate flavors in tobacco products to limit appeal to youth while taking into account the potential role that some flavors may help some users to transition away from combusted tobacco products. Certain flavors are generally recognized as appealing to youth (e.g. gummy bears and cotton candy), while others (e.g. coffee and cinnamon) may not be as obvious.

In another ANPRM, the FDA seeks public input on the appropriateness of developing a product standard that would set a maximum nicotine level in certain combusted tobacco products so that they are minimally addictive. It is thought that such a standard, if ultimately promulgated, could help limit the addictiveness of the most toxic and widely-used tobacco products, with significant public health and economic benefits. The ANPRM requests comments, data, research results and other information that could inform regulatory actions FDA might take with respect to the nicotine level of certain combusted tobacco products.

Further, FDA is proposing regulations to establish tobacco product standards for nicotine, propylene glycol and vegetable glycerin purity in e-liquids. This rule, if finalized, would establish limits on the level of toxicants and impurities found in nicotine, propylene glycol and vegetable glycerin, which are known to cause death or other adverse health effects.

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