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FDA in Flux — July 2025 Newsletter

July 9, 2025 | Article | By Joanne Hawana , Benjamin Zegarelli

The July 2025 edition of FDA in Flux highlights five significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

A Texas Federal Court Sides with Laboratories, But There May Be Unintended Consequences for FDA

April 10, 2025 | Blog | By Benjamin Zegarelli, Joanne Hawana

The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology, in the Eastern District of Texas to determine whether the Federal Food, Drug, and Cosmetic Act (FD&C Act) permits the agency to regulate laboratory developed tests (LDTs) is a complete victory for clinical laboratories. The U.S. district judge’s decision, issued on March 31, 2025, vacated the May 2024 final rule through which FDA sought to specify that LDTs are agency-regulated in vitro diagnostic products (IVDs) and to describe a plan for phasing-in enforcement of existing medical device regulations for such products over four years (see our previous posts on the LDT final rule here and here). In adopting the plaintiffs’ arguments wholesale, however, the judge created some incongruities in the relevant regulatory frameworks, as well as several quandaries for FDA and the clinical laboratory industry going forward. These inconsistencies could have greater consequences down the road if the Trump administration decides not to appeal the ruling.

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

March 13, 2025 | Blog | By Benjamin Zegarelli, Joanne Hawana

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase out the agency’s historical approach of enforcement discretion towards such tests (see here, here, here, and here). However, one infrequently considered regulatory compliance issue for LDTs is their reliance on separate specimen collection devices or convenience kits. All LDTs require the use of some form of biological specimen, such as blood or saliva, which may be collected by health care professionals in a clinical setting or by consumers in their homes before being submitted to a laboratory for testing.

Bipartisan VALID Act Re-Introduced in Congress: Is Diagnostics Reform on the Horizon?

July 13, 2021 | Blog | By Joanne Hawana , Benjamin Zegarelli

In our most recent year-end blog post on devices and diagnostic products at the Food and Drug Administration (FDA), we summarized the tumultuous events of 2020 with respect to laboratory developed tests (LDTs) and clinical laboratory testing in general during the COVID-19 public health emergency. We highlighted at the time an August 2020 Trump Administration order barring FDA from requiring premarket review for any LDT unless the agency goes through formal rulemaking procedures. We also speculated that although “the regulatory framework and policies surrounding LDTs will be a prominent topic of debate in 2021…there will be no quick resolution of these issues, either at a legislative or agency policy level, in the short term and that LDTs will likely remain in a gray area of FDA regulation and policy for the foreseeable future.”

Webinar Recording: FDA in 2021: A Look Ahead

February 18, 2021 | Webinar | By Joanne Hawana , Anthony DeMaio

In this fireside discussion, Mintz attorney Joanne Hawana and Aaron Josephson and Anthony DeMaio from ML Strategies explored policy activities that will likely have the greatest impact on stakeholders in 2021, and how the new Administration may impact the FDA in the year ahead and beyond.

Looking Ahead: FDA in 2021

January 8, 2021 | Blog

Politics will have an effect on FDA policies in 2021, including with respect to the ongoing COVID-19 response, manufacturing, compliance, digital health, laboratories, user fees, device servicing, and more.

FDA in 2020: What a Year!

December 15, 2020 | Blog | By Benjamin Zegarelli

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some ways to political pressure, and that effectively ensuring the public health requires a balance between safety and effectiveness and patient access to medical products. As we look ahead, we eagerly anticipate how FDA will protect and promote public health in a Biden administration. In this post we’ll explore the FDA’s device law and policy activities from 2020.

An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

November 5, 2020 | Blog | By Joanne Hawana

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the quality of different subsets of tests. Since then, there have been some important policy developments affecting diagnostic and antibody testing. There also has been significant growth in the number of tests authorized by the Food and Drug Administration for point-of-care uses in various patient settings such as clinics, emergency departments, and physician offices. Read on for an update about these developments.

Rough Seas for COVID-19 Serology Tests Lead to Course Correction by FDA

May 5, 2020 | Blog | By Joanne Hawana , Hope Foster

Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020 the Food and Drug Administration (FDA) announced a revised policy aimed at reducing the risks associated with such tests.

FDA’s Ongoing Response to the COVID-19 (Coronavirus) Outbreak

March 18, 2020 | Blog | By Joanne Hawana , Benjamin Zegarelli

As we write this update on the actions of the Food and Drug Administration (FDA), more state and local governments (along with private businesses and employers) are taking sweeping actions to protect the public from the continued spread of COVID-19. The federal response to what is now a pandemic of COVID-19 started off slowly, but we are now seeing frequent and promising announcements from FDA and other agencies within the Department of Health and Human Services.

We published our first installment highlighting FDA’s role in this public health emergency on March 4, 2020 (see our prior post here). In the two weeks that have elapsed since then, FDA has taken several actions related to COVID-19 testing and other important public health protections which are explained below. One of the most striking things about the list of actions included in this post may be how diverse and broad FDA’s authorities are and what a substantial role the agency plays in protecting Americans from a variety of different types of harm.

FDA User Fee Agreements

February 14, 2020 | Video

In this video, Aaron Josephson discusses FDA user fee agreements, the timeline for the reauthorization process, and why it is important for companies with FDA-regulated products to be paying attention now.

FDA Regulatory Due Diligence

February 7, 2020 | Video | By Joanne Hawana

Joanne Hawana explains how FDA regulatory due diligence fits into the broader diligence that is done when a transaction involves an FDA-regulated entity as well as what the team is looking for when conducting an FDA regulatory diligence project.

FDA’s Approach to Direct-to-Consumer Genetic Testing

February 7, 2020 | Video | By Joanne Hawana

Joanne Hawana talks about the rise in direct-to-consumer genetic testing and how FDA has adapted its regulatory approach to such tests over the past few years as it has become more comfortable with genetic testing and sequencing technologies.

New Government Action Aims to Increase Competition among Biological Products: FDA and FTC Step Up Industry Pressure

February 4, 2020 | Blog | By Joanne Hawana

Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018 (see our prior post here), the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020. These recent moves make clear that FDA Commissioner Stephen Hahn, who was confirmed and sworn in to his new role at the tail end of 2019, is continuing to focus agency resources on the Biosimilars and Drug Competition Action Plans developed under the leadership of his predecessor, Dr. Scott Gottlieb.

FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round

February 3, 2020 | Blog

As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight some changes made to the programs when they were last reauthorized through the 2017 Food and Drug Administration Reauthorization Act (FDARA) (P.L. 115-52) and consider what could be included in the upcoming user fee reauthorization package.

FDA User Fees: How Do They Work?

January 28, 2020 | Blog

A history of FDA human medical product user fee programs, including those for prescription drugs (PDUFA), generic drugs (GDUFA), biosimilars (BsUFA), and medical devices (MDUFA), their negotiation and reauthorization, and how manufacturers and patients can participate and get involved in the negotiations.

Regulatory Agencies Launch Unified Website for Biotechnology Regulation

January 16, 2020 | Blog

In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020. The website serves to streamline information regarding agriculture biotechnology products, which are regulated by FDA, USDA, and EPA. The implementation of the website is in response to the June 2019 Executive Order issued by President Donald Trump on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The Unified Website for Biotechnology Regulation complements prior joint actions such as the Coordinated Framework for the Regulation of Biotechnology, an Obama administration effort to reform the biotechnology regulatory process by enhancing transparency, predictability, and efficacy.

Health Care: A Clearer Vision in 2020? Don’t Bet On It

January 15, 2020 | Blog | By Tara E. Dwyer

As we noted in our previous blog post, there are several legislative priorities in the health care space that could see action this year. There are also a variety of activities beginning this year that could set the stage for later action. Here’s what we’re tracking for a 2020 health care legislative package.

Cures Act Developments: FDA Publishes CFR Amendments Exempting Class II Devices with an Interesting Addition

January 13, 2020 | Blog | By Benjamin Zegarelli

Since the 21st Century Cures Act became law in December 2016, we have been keeping track of the Food and Drug Administration’s actions to carry out its obligations under the relatively new law. One particular provision of the Act: (i) emphasized the agency's responsibility to identify class II devices that may be exempted from premarket notification (or 510(k)) requirements, and (ii) required the agency to publish a list of each type of class II device that the Food and Drug Administration (FDA) determines no longer requires a 510(k) submission to provide reasonable assurance of safety and effectiveness at least every five years, or as appropriate. On December 30, 2019, FDA published a final notice of its amendments to each classification regulation for the newly exempted devices.

Health Care Provisions in 2020 Spending Package

January 9, 2020 | Blog

On December 20, 2019, the President signed into law a bill to fund the federal government through September 30, 2020. The bill included several important health care provisions but left some longstanding policy challenges unresolved. Most notable changes to law are the elimination of three Affordable Care Act taxes and the passage of the CREATES Act. Noticeably absent is legislation related to surprise billing and prescription drug pricing. A summary of key health care provisions included in the 2020 Consolidated Appropriations Act (P.L. 116-94) follows. We will address the legislative outlook for 2020 in a separate ML Strategies blog post next week.

Administration Finally Releases Proposed Drug Importation Policies for Stakeholder and Public Comments

December 27, 2019 | Blog | By Joanne Hawana , Tara E. Dwyer

At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part plan to allow foreign prescription drugs to be imported into the United States in an effort to reduce drug prices. We wrote about the release of the Safe Importation Action Plan here, and the detailed proposals made public by the Administration on December 18, 2019, follow the framework that the agencies sketched out earlier this year. Specifically, HHS and FDA have proposed two different pathways: one that is being implemented via notice-and-comment rulemaking, and one that is being implemented via an FDA guidance document. HHS Secretary Alex Azar touted the two pathways together in a same-day FDA press release as “historic actions…[that] represent the bold nature of President Trump’s agenda for lowering drug costs.”

Consumer Product Regulatory Priorities in 2019: An Ever-Shifting Landscape for FDA

December 19, 2019 | Blog | By Joanne Hawana

This is our third year-end post for 2019 related to the Food and Drug Administration (FDA), focusing on the agency’s activities in the widely divergent area of “consumer products.” (You can find our two prior posts on medical devices and prescription therapeutic products here and here, respectively.) In taking a wide-lens view of the past year, we see it as having presented a huge number of opportunities for the FDA to educate the public about its role in regulating non-prescription products sold directly to consumers. Most of the educational opportunities we highlight below came in concert with some other agency actions, like the issuance of Warning Letters to specific firms, but we’ve decided to cover only the key issues in the interest of keeping this post from turning into a long list of hyperlinks given the post’s already broad scope. Consumer products that fall within FDA’s jurisdiction include over-the-counter (OTC) drugs and OTC homeopathic drug products; tobacco and other nicotine delivery products; dietary supplements; foods and beverages for both humans and animals (technically, there is no such thing as an animal “dietary supplement”); cosmetics (sort of); and a wide variety of cannabis-derived consumer products that exploded onto the national landscape during 2019 and essentially cross into all of the aforementioned product categories.

Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020

December 13, 2019 | Blog | By Joanne Hawana

In many ways, the past year could be called a “business as usual” year for the FDA’s drugs and biologics centers in that they continued to make progress all of large-scale programs and priorities initiated by former-Commissioner Scott Gottlieb, who left the agency in April. At the same time, however, the final months of 2019 have exposed several challenges for various FDA programs that operate under the extensive drug and biologic authorities contained in the Food Drug & Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act), respectively.

Evolution & Revolution: Device Policy Priorities at FDA in 2019

December 5, 2019 | Blog | By Joanne Hawana , Benjamin Zegarelli

This post is the first in a series of three in which we recap the Food and Drug Administration’s somewhat difficult year, having spent the majority of it without a permanent Commissioner and facing a slew of political and practical challenges. Today our topic is “medical devices” writ large, which is a product class that is becoming more complex by the day as it grows to encompass software, diagnostics, laboratory tests, and new medical technologies that resemble nothing that Congress had in mind when it first gave FDA authority to regulate medical devices in 1976. In the coming days, we’ll also take a broad look at FDA’s year from the standpoint of therapeutic medical products, including drugs and biologics, as well as the more commonly used category of consumer products.

Key Vote in FDA Commissioner Confirmation Process Set for December 3rd

December 2, 2019 | Blog

The Health, Education, Labor and Pensions (HELP) Committee is set to vote on Dr. Stephen Hahn, the Trump administration’s nominee to head the Food and Drug Administration (FDA), on December 3, 2019. Hahn faced a flurry of questions at the confirmation hearing before the Senate Health Committee on Wednesday, November 20, 2019, most of which spoke to the youth vaping crisis with little emphasis on other hot topics such as prescription drug shortages or drug pricing. Despite the barrage of questions, many of his responses were non-specific in nature and avoided committing to any set platform. Instead, Hahn focused on his pledge as a doctor to put patient care first and rely on science and data as a basis for decision-making.

First Indicators of FDA’s Policy Decision on CBD and Cannabis-Derived Ingredients: “Only Limited Data” and “Real Risks”

November 26, 2019 | Blog | By Joanne Hawana

We have previously blogged about the Food and Drug Administration’s year of listening and information-gathering related to products containing cannabis or cannabis-derived compounds since the 2018 Farm Bill removed “hemp” from the federal Controlled Substances Act. Among other things, the Agency issued a call for scientific information on a variety of topics identified in this April 3, 2019 notice; opened a public docket to receive written comments in response to those questions (docket no. FDA-2019-N-1482); and convened a public hearing in May 2019 to hear from stakeholders directly. Our summary of that May 31st hearing, which also provides an overview of the legal and regulatory landscape post-2018 Farm Bill, is available here. This intensive period of evaluation was led by an internal working group charged with making recommendations for the open scientific, technical, and policy questions created by the new legal status of hemp.

FDA Issues Drug Shortage Report Identifying Root Causes and Potential Solutions

November 7, 2019 | Blog

Despite congressional attention, Food and Drug Administration (FDA) action, public and private sector efforts, and ongoing media coverage, drug shortages remain a significant public health crisis in the United States. In response to that crisis (and at Congress’s urging), the FDA formed the interagency Drug Shortages Task Force (Task Force) to study the issue. FDA has now released the report resulting from the Task Force’s activities: “Drug Shortages: Root Causes and Potential Solutions.” The report, issued on October 29, 2019, concludes that drug shortages are primarily the consequence of economic factors driven by private and public business practices. Those practices, according to the report, disrupt the supply chain availability of marketed pharmaceuticals. The report offers recommendations to provide a framework for stakeholders to address the underlying economic factors leading to drug shortages.

The Other Shoe Drops: FDA Withdraws 30-Year-Old Homeopathic Drug Enforcement Policy and Puts Industry on Notice of Further Regulatory Pressure

October 25, 2019 | Blog | By Joanne Hawana , Benjamin Zegarelli

To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA) announcement on October 24, 2019 likely came as no surprise. But to stakeholders in this industry, it was certainly unwelcome news and may portend a coming wave of unapproved drug enforcement actions by the FDA.

FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

October 9, 2019 | Blog | By Benjamin Zegarelli

On September 26, 2019, FDA released a six revised digital health guidances. The primary objective of these revisions was to bring the guidances into alignment with the software function exemptions described in Section 3060 of the 21st Century Cures Act (the “Cures Act”). The medical device community has anticipated these changes since Congress passed the Cures Act almost three years ago in December 2016.

HHS Files Brief in D.C. Circuit Supporting Drug Pricing Transparency Rule

September 30, 2019 | Blog

As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court’s holding that the Secretary lacked the authority to compel drug manufacturers from disclosing drug prices in direct-to-consumers television advertisements (DTC rule). On September 23, 2019, HHS filed its appeal in the D.C. Circuit against plaintiffs Merck & Co., Eli Lilly and Co., and Amgen Inc. The brief argues that the district court erred in holding that HHS lacks the statutory authority through the Social Security Act (SSA) to force the DTC rule upon drug manufacturers because they are not direct participants in the Medicare and Medicaid programs.

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July 9, 2025 | Article | By Joanne Hawana , Benjamin Zegarelli

April 10, 2025 | Blog | By Benjamin Zegarelli, Joanne Hawana

March 13, 2025 | Blog | By Benjamin Zegarelli, Joanne Hawana

July 13, 2021 | Blog | By Joanne Hawana , Benjamin Zegarelli

February 18, 2021 | Webinar | By Joanne Hawana , Anthony DeMaio

January 8, 2021 | Blog

December 15, 2020 | Blog | By Benjamin Zegarelli

November 5, 2020 | Blog | By Joanne Hawana

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