Thursday, May 19, 2022


FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain

Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s efforts have contributed to fewer new drug shortages and reduced the time to resolve existing drug shortages. This is due, in part, to authorities the agency now has, including those added by the Food and Drug Administration Safety and Innovation Act

But despite mitigating or preventing hundreds of new drug shortages, disruptions in the U.S. drug supply continue to occur due to drug quality problems, vulnerabilities in the global supply chain, unanticipated increases in demand, market withdrawals of drugs or natural disasters.  

In 2019, in an effort to address the national drug shortage problem, the federal Drug Shortages Task Force released a report that called for the adoption of risk management plans to proactively assess risk and to predict and prevent supply disruptions that could potentially lead to a drug shortage. Then in 2020, Congress passed the CARES Act to require certain manufacturers to develop, maintain, and implement, as appropriate, risk management plans that identify and evaluate risks to a drug’s supply.

To further assist manufacturers with these requirements, we are issuing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, intended to help with the development, maintenance and implementation of risk management plans.

The draft guidance describes a framework for stakeholders to consider when developing risk management plans that aligns with principles stated in the International Council for Harmonisation guidance for industry, Q9 Quality Risk Management, and identifies risk factors to consider when developing the content of risk management plans. The steps needed to reduce risks of a disruption in drug supply may vary among the different manufacturers in the supply chain for a given drug. 

Today’s draft guidance is an important step in what the nation needs to achieve an increasingly secure and resilient drug supply. For Americans to have access to an uninterrupted supply of safe, effective and high-quality drugs, all entities involved in the manufacture of a drug should take every step available to reduce risks and threats to the drug supply chain. Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages.


FDA's “All-in” Approach to Enterprise Transformation

The U.S. Food and Drug Administration's responsibilities to protect the public health are broad, complex, and necessary because the products we regulate are in every home and used every day across the U.S. As we witnessed during the pandemic, the FDA plays a critical role in enabling access to safe and effective medical products, such as vaccines, therapeutics, and accurate diagnostic testing. The agency also monitors and supports the supply chains for critical components of these products, while continuing to ensure the safety of our food supply, all in an increasingly complex and interconnected environment.

In meeting our public health mission, the FDA must have more effective and efficient business processes, increased capabilities to better use the data that we review, and a more coordinated development of the IT systems designed to support these activities. In the past, the FDA has taken an organization-based approach to process development and IT investments, resulting in siloed solutions and a fragmented data environment. To achieve new efficiencies, the FDA is advancing an agency-wide enterprise approach to business process, data, and technology management that will allow us to work more efficiently and optimize the use of the vast amount of data that is the foundation of our work.

Today we are introducing the Enterprise Modernization Action Plan, which is the next phase of the FDA’s stronger data and technology foundational approach.

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New FDA Draft Guidance Aims to Increase Safety Information About Dietary Supplement Marketplace

Today, the U.S. Food and Drug Administration announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications.

The FDA wants consumers who use dietary supplements to know that today’s draft guidance, if finalized, will advise the dietary supplement industry that the agency intends to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage manufacturers and distributors to correct any past failures to submit a required NDI notification. By providing industry with an opportunity to correct past failures to submit required safety information, the FDA can gain more safety information about the dietary supplement marketplace and better protect public health. 

“We remain committed to a flexible framework for dietary supplements that ensures the safety of these products for consumers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). “The resulting notifications the agency receives through this period of enforcement discretion will help increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace.” 

The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires manufacturers and distributors who wish to market a dietary supplement containing an NDI to notify the FDA before marketing, unless a legal exception applies. The notification must contain the safety information that a manufacturer relied upon to conclude the dietary supplement containing the NDI is reasonably expected to be safe.  The NDI notification process is the FDA’s only chance to evaluate the safety of a dietary supplement before it becomes available to consumers.  For dietary supplements that do not contain an NDI, the law does not require manufacturers to submit safety information to the FDA before marketing.  The FDA is aware that in the more than 27 years since the requirement was established, some dietary supplement firms have marketed products for which a premarket NDI notification was required, but never submitted.

The enforcement discretion policy proposed in this draft guidance relates solely to the failure to submit an NDI notification. For example, it would not extend to NDI-containing dietary supplements that are adulterated for safety reasons or that violate any other regulatory requirements that pertain to dietary supplements. This temporary policy also should help facilitate enforcement actions against those that remain out of compliance with the NDI notification requirements after the enforcement discretion period ends.

In a February 2019 statement about new efforts to strengthen the regulation of dietary supplements through modernization and reform, the FDA emphasized the need to ensure that our regulatory framework is flexible yet comprehensive enough to effectively evaluate product safety, while promoting innovation. The FDA also stated that fostering the submission of NDI notifications would be key to this effort. This draft guidance is a critical first step toward encouraging those submissions.

If the draft guidance is finalized without change, the enforcement discretion period to submit a late notification would start when the guidance is published, would last 180 days, and would apply only to products on the market when the Federal Register notice announcing the draft guidance was published. Along with this draft guidance, the FDA is also developing a new submission type through the CFSAN Online Submission Module to provide a dedicated pathway for stakeholders to electronically submit their late notifications. 

Tuesday, May 17, 2022


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