By: Ned Sharpless, M.D., Acting Commissioner
Earlier this week, the federal government published the 2019 “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda). This semiannual compilation of information about regulations under development by federal agencies across the government provides the public with a concise accounting of our government’s recent regulatory actions and future priorities that can have a profound impact on the lives of all Americans.
The FDA’s work reflected in the Unified Agenda offers a number of key actions already taken this year, as well as several planned actions spanning the broad range of the agency’s oversight responsibilities in protecting and promoting the health of consumers and patients.
These actions are designed to advance the FDA’s policy priorities and build on the enormously busy and successful year just completed. The FDA intends to maintain this current course of action, while advancing innovation and staying committed to the FDA’s science-based decision-making. This will help ensure the policies we enact, developed with public comment and participation, achieve the maximum benefit for consumers and patients in furtherance of the FDA’s mission to protect and promote public health, when they are implemented.
The Spring 2019 Unified Agenda cuts across the landscape of the FDA. What follows is a brief highlight of some of these important new FDA contributions to the Spring Unified Agenda.
Medical Product Safety
A cornerstone of the FDA’s work involves making the development of new treatments and cures more efficient, while maintaining the FDA’s gold standard of safety and effectiveness. Our work in this area involves both premarket and postmarket, and the upcoming regulatory actions reflect our continuing efforts of robust oversight.
New items added to the Agenda in the drug and devices space include our intent to propose a rule that would amend our requirements concerning the annual reports submitted by sponsors to investigational new drug (IND) applications. This would replace our current annual reporting requirement with a new requirement for a development safety update report (DSUR), making them less burdensome and consistent with the format and content of the International Council for Harmonisation (ICH).
On the postmarket front, we intend to propose to amend the Adverse Event Reporting regulations for marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application. This amendment will provide greater clarity to industry regarding when adverse event reports should be submitted.
We are also proposing several actions on individual device types. The first will classify spinal spheres, a product used in intervertebral fusion procedures, and which is currently an unclassified pre-amendment device, into class III, subject to premarket approval. We believe that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device type, and that this device type presents a potential unreasonable risk of illness or injury. Similarly, we intend to propose to classify more than minimally manipulated (MMM) allograft heart valves, currently an unclassified pre-amendment device, into class III, based on the recommendations of the Circulatory System Devices Panel.
Improving Oversight of Compounded Drugs
Some patients require medications that can’t be met by FDA-approved drugs. In these cases, pharmacy compounding can help meet the need. Compounded medicines are not approved by the FDA, and therefore, the FDA does not evaluate these medicines for safety, effectiveness and quality before they reach patients. Following the tragic fungal meningitis outbreak in 2012 associated with contaminated compounded medicines, Congress enacted the Drug Quality and Security Act (DQSA) to address the need for improved compounding oversight.
To advance and support the work in this area, we are developing a proposed rule to establish criteria to evaluate whether drug products and categories of drug products are demonstrably difficult to compound under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Additionally, based on the results of the FDA’s evaluation of nominated drug products and categories of drug products to date, as well as its consultation with the Pharmacy Compounding Advisory Committee, the proposed rule would also propose to identify certain categories of drug products as being demonstrably difficult to compound. Drug products and categories of drug products identified as presenting demonstrable difficulties for compounding would be ineligible for the statutory exemptions under sections 503A and 503B of the FD&C Act.
Veterinary Medicine and Animal Health
In addition to regulating drugs intended for use in humans, the FDA also protects both human and animal health by ensuring the safety and effectiveness of animal drugs.
The FDA is proposing to amend its animal drug regulations to require applications for new animal drugs, abbreviated applications for new animal drugs, and applications for conditional approval of new animal drugs be submitted to us in an electronic format. This proposed change will conform with other recent legislative changes designed to help increase uniformity and speed up processing of applications. rule changes. Just like human generic drugs, animal generic drugs help increase competition, lower costs, and make critical medications more available.
Modernizing Food Standards
Part of the FDA’s important work regarding foods is focused on ensuring that food standards keep up with advances in science and technology. This includes modernizing standards of identity, which specify the composition and manufacturing of certain foods.
In support of this, the FDA is planning to issue a final rule to amend the standard of identity for yogurt and revoking the standards of identity for low fat yogurt and nonfat yogurt. This will allow for technological advances in food processing, reflect industry practices, and align the standards with products in the marketplace. The final rule will define safe and suitable ingredients for yogurt, including cultures, flavoring, color additives, stabilizers, emulsifiers, and preservatives. This rule will also help remove barriers to innovation while preserving the basic nature and essential characteristics of yogurt expected by consumers.
Continuing to Reduce Disease from Tobacco Use
Over the last several years the agency has been focused on reducing the use of tobacco products, reducing the harm to those who use tobacco products, and preventing kids from ever starting down this path, including through pursuing measures to address the addictiveness, appeal and toxicity of tobacco products. These efforts also have included groundbreaking public education campaigns designed to inform the public, and particularly children and young people, about the dangers posed by tobacco products. In an effort to address what still remains the leading cause of preventable death and disease, we will continue to advance this agenda.
To this end, we are proposing two new rules in 2019. The first concerns Required Warnings for Cigarette Packages and Advertisements. This rule proposes to require color graphics depicting the negative health consequences of smoking to accompany textual warning statements on cigarette packages and in cigarette advertisements. This rule will propose new cigarette health warnings as directed by Congress in the Tobacco Control Act, which amended the Federal Cigarette Labeling and Advertising Act.
A second rule in this area would propose to establish content and format requirements to ensure that modified risk tobacco product applications contain sufficient information for the FDA to determine whether it should permit the marketing of a modified risk tobacco product. The proposed rule would set forth the basic procedures for modified risk tobacco product application review and require applicants receiving authorization to market a modified risk tobacco product to establish and maintain records, conduct postmarket surveillance and studies, and submit annual reports to the FDA.
Ensuring Consumer and Patient Safety
These are just some of the important upcoming proposed regulatory changes by the FDA. Separately and collectively, they are designed to support our robust, consumer and patient-focused policy agenda, which in turn is driven by our public health mission. We will continue to update our stakeholders as we develop these further and continue to strengthen and reform our regulations in support of protecting patients and consumers.