Welcome to the inaugural issue of FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal and regulatory world.

FDA Warning Letter focuses on GMP failures at 503B compounding outsourcing facility. After a brief hiatus from the string of Warning Letters sent to 503B outsourcing facilities in mid- to late 2021, on June 7, 2022, FDA issued a Warning Letter to Hybrid Pharma, LLC based on an inspection ending in September 2021. FDA appears to be coming back with a vengeance, as the same Hybrid Pharma facility received a previous Warning Letter in November 2018. Read more.

Guidance coming to supplements industry on new dietary ingredients. The FDA intends to release multiple draft guidance documents to the dietary supplements industry in the form of relatively small, discrete topics related to New Dietary Ingredients, an FDA executive said on May 26. Betsy Jean Yakes, acting director of the agencys Division of Research & Evaluation, made those comments at the IPA World Congress + Probiota Americas conference in Washington, DC. An FDA spokesperson elaborated that the agency has announced its intent to finalize the NDI Notification Procedures and Timeframes sections of its guidance in its Foods Program Guidance Under Development. Under the law governing NDIs, a manufacturer that wishes to introduce a new ingredient in a supplement must file a notification with the FDA 75 days before marketing the ingredient.

FDA says it now has the staff to review pre-submissions for non-COVID-19 products. The FDA said in a May 31 blog post that it now has the staff it needs to review pre-submissions for medical devices that arent related to the COVID-19 pandemic. In the post, Jeff Shuren, director of the agencys Center for Devices and Radiological Health (CDRH), and William Maisel, director of its Office of Product Evaluation and Quality (OPEQ), noted that since the beginning of the pandemic, the demand for medical devices has far exceeded the demand in any previous public health emergency. This, they said, had significantly overloaded the agencys ability to review requests for Emergency Use Authorization (EUAs) as well as conventional requests. The post also noted that in December 2021, the agency had highlighted that it was prioritizing work in this area that is related to COVID-19 and that it had a limited ability at that time to accept non-COVID pre-submissions. In the May 31 post, the agency said that things have changed and that it is pleased to announce that, as of June 1, 2022, CDRH plans to accept all non-COVID IVD pre-submissions and that due to the continued elevated workload related to COVID, its likely these IVD pre-submissions will initially be reviewed under an extended timeline.

FDA withdraws COVID-era guidance on marketing submissions and applications. On June 7, the FDA announced it is withdrawing a guidance document entitled Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical DevicesQuestions and Answers (Revised). This document was originally issued in June 2020 and updated in December 2020, during the height of the COVID-19 pandemic. The agency said it is withdrawing this guidance document because it recognizes that the conditions that created the need for these policies have evolved and that they are no longer needed essentially, that the pandemic has decreased in scope and severity. The effective date of the withdrawal of the guidance is July 7, 2022. A key aspect of the withdrawal is that the agency said it has determined it is in the interest of the public health to return to pre-pandemic policies regarding hold times for marketing submissions and applications to the FDA. Reverting to policies regarding hold times described in the preexisting guidance documents should facilitate more timely premarket review of innovative and potentially lifesaving devices, the agency said.

FDA issues industry guidance on tropical disease priority review vouchers. On June 13, the FDA issued a guidance for industry entitled Tropical Disease Priority Review Vouchers. The guidance explains how the agency implements provisions of section 524 of the Food, Drug, and Cosmetic Act and how sponsors may qualify for a priority review voucher based on eligibility criteria set forth in the statute. It also discusses how to use priority review vouchers and how priority review vouchers may be transferred to other sponsors. The idea behind section 524 is to stimulate research into possible drugs for certain tropical diseases that affect millions of people and to create a way to give priority review vouchers to sponsors of diseases that can treat those diseases. Priority review means that applications for those drugs take priority over any other type of drug application.

Ex-Eli Lilly employee files suit claiming she was fired for making allegations about the manufacture of Trulicity. Amrit Mula, a former senior human resources employee at Eli Lilly & Co., filed a federal lawsuit on June 6 claiming that she was fired after reporting manufacturing and data falsification issues related to the pharmaceutical companys products, including its blockbuster diabetes drug Trulicity. The suit was filed in the US District Court for the District of New Jersey. Mula, who was an associate director of employee relations at Eli Lilly in Branchburg, New Jersey, contends in the lawsuit that she repeatedly asked her superiors, starting in 2018, to remedy manufacturing violations involving several biologic drugs, including Trulicity. Lilly executives responded by marginalizing, harassing and eventually terminating her position under false pretenses, she said in the lawsuit. The US Department of Justice last year launched a criminal investigation into alleged manufacturing irregularities at the plant.

Guidance for small businesses on importation rule. On May 25, the FDA issued a nonbinding Industry Guidance document concerning the implementation of its 2020 rule on the importation of prescription drugs from Canada. The guidance document is specifically designed, the FDA said, to aid small businesses in their efforts to comply with the rule. The document reviews the structure of the importation program. It points out that the program, under section 804 of the Food, Drug and Cosmetic Act, will be implemented through time-limited Section 804 Importation Programs (SIPs), which will be reviewed and authorized by the agency and managed by states or Indian tribes, or in certain future circumstances by pharmacists or wholesale distributors. The purpose of the final rule, the guidance notes, is to achieve a significant reduction in the cost of covered products to the American consumer while posing no additional risk to public health and safety.

FDA rescinds approval for a drug being used against lymphoma. On June 1, the FDA withdrew for safety and health reasons -- its February 5, 2021 accelerated approval for a new cancer drug, Ukoniq or umbralisib. Ukoniq had been approved to treat two types of lymphoma, marginal zone lymphoma and follicular lymphoma. However, findings from a post-market clinical trial continued to show a possible increased risk of death in patients receiving the drug, leading the agency to determine that the risks of treatment with Ukoniq outweigh its benefits. Based on this determination, the drugs manufacturer, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq from the market for the approved uses in these two types of lymphoma. The FDA told doctors to stop prescribing Ukoniq and to switch to alternative treatments for patients who were taking it. The drug had been approved in February 2021. The pending user fee legislative proposals contains additional authorities for FDA to require additional clinical studies for accelerated approvals and take enforcement action based on those results.

Appeals court rejects challenge to FDA ban on sale of raw butter. On June 10, the US Court of Appeals for the DC Circuit, affirming the ruling of a US district judge, found against a farmer who had asserted that the FDAs regulation banning the interstate sale of raw butter violates the federal Food, Drug, and Cosmetic Act. The appeals court found that the FDA acted reasonably when it concluded that raw butter was too dangerous to be sold interstate. The court pointed out that when Congress set a standard of identity for butter, it explicitly prevented the FDA from altering that definition. The plaintiff in the case, the court noted, contended that the pasteurization requirement for butter does alter that definition in violation of the law. But, the court concluded, That is incorrect: The pasteurization rule did not amend the statutory standard of identity for butter, either formally or functionally. Raw-cream butter, though unpasteurized, is still butter, notwithstanding the FDAs determination that its interstate sale would threaten public health.

FDA provides guidance on risk management for the pharma industry. On June 14, the FDA released a new guidance document titled Quality Risk Management that is intended to offer to pharmaceutical companies a systematic approach to quality risk management for better, more informed, and timely decisions. The agency, recognizing that the manufacture and use of pharmaceuticals necessarily entails some risk, said that the document specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle. The FDA noted that the guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products.

Program to help device makers find new ways to sterilize their devices. On June 7, the FDA announced it is considering a master file pilot program for premarket approval holders whose approved medical devices are sterilized using radiation. The FDA is doing this because of global supply chain constraints and the need to support sterilization supply chain resiliency. If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources. The FDA is working with sterilization experts, medical device manufacturers, and other government agencies to advance alternative ways to sterilize medical devices while maintaining device safety and effectiveness. Sterilization master file pilot programs are often used to encourage new ways to sterilize medical devices that reduce the potential impact of ethylene oxide on the environment and on public health. Ethylene oxide is used to sterilize about 50 percent of all sterilized medical devices, but long-term exposure to it is linked to certain cancers.

New FDA guidance points to priority in finding drugs to treat serious bacterial diseases. On May 24, the FDA issued a nonbinding Industry Guidance document titled Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases Questions and Answers (Revision 1). A major purpose of the guidance document is to emphasize that since many serious cases of bacterial disease persist in hospitals and other settings especially cases that cannot be treated by currently available drugs it is important to prioritize efforts to find new appropriate drugs. The guidance quotes a previous FDA statement noting that it is appropriate to exercise the broadest flexibility in applying the statutory standards, while preserving appropriate guarantees for safety and effectiveness. These procedures reflect the recognition that physicians and patients are generally willing to accept greater risks or side effects from products that treat life-threatening and severely debilitating illnesses, than they would accept from products that treat less serious illnesses. These procedures also reflect the recognition that the benefits of the drug need to be evaluated in light of the severity of the disease being treated.

Warning Letter sent to maker of hand-sanitizing products. On May 23, the FDA sent a Warning Letter to Missouri-based Aire-Master of America, telling the company that it is engaging in significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. Because of these violations, the agency said, its drug products are to be considered adulterated under federal law. The company manufactures hand-sanitizing products. The FDA also noted several other violations and told the company that its products are unapproved new drugs because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from the FDA, the agency said in the Warning Letter. The FDA also strongly recommended that the company hire a consultant to help it meet the requirements of CGMP.

The future of diagnostic regulation. DLA Piper Partner Bethany J. Hills joined Dr. Timothy Stenzel, Director, Office of In Vitro Diagnostics and Radiological Health, CDRH, William G. Morice, Chair, Department of Laboratory Medicine and Pathology, Mayo Clinic and Mike Dobias, Officer, Health Care Products, The Pew Charitable Trusts to discuss important trends in diagnostic regulation at the Food Drug Law Institute Annual conference in Washington, DC on June 15, 2022. Dr. Stenzel provided a deep overview of the lessons learned by CDRH from the COVID pandemic, touching on important innovations in over-the-counter and home testing technologies. A key takeaway is that technologies that are well understood by the FDA can benefit from more efficient regulatory authorization review, while novel technologies take longer and Dr. Stenzel encouraged continued development of novel technologies. Dr. Morice spoke on topics of addressing health access disparities and the infrastructure issues that require updating and restructuring for the future success of deploying diagnostic technologies rapidly. Dr. Stenzel described a number of programs where government supported test validation was very effective and allowed for rapid deployment of tests that would have otherwise been inaccessible. Finally, Mike Dobias and Dr. Morice discussed in depth the pending legislation, the VALID Act, embedded in the proposed user fee bills, that will fundamentally change the way diagnostics are categories and regulated. Mr. Dobias provided an overview of the classification framework, the technology certification program for testing modifications and the available exemptions from pre-market authorization, while Dr. Morice focused on the need for clarity and predictability in the delivery and innovation of diagnostics and the ways the legislation could address those concerns. Key other topics included addressing cost barriers to diagnostic testing and dealing with large data and delivery gaps as tests become more available to consumers directly in their homes.

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