Skip to main content

Joanne S. Hawana

(she/her/hers)

Member

[email protected]

+ 1.202.434.7349

Follow:
Share:

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized, including with respect to advertising and promotion. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, biologics, regenerative medicine products, foods, cosmetics, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications.

Her strategic counseling and compliance support work reaches into all aspects of FDA-regulated companies’ operations, including:

  • Determining regulatory status of novel products;
  • Pre-market and post-market requirements for various regulated products;
  • Restrictions on advertising and product sampling;
  • State licensing schemes for prescription drug manufacturers and distributors;
  • Compliance with prescription drug compounding regulations;
  • Review and approval of various types of policies and procedures for facilities that manufacture or distribute regulated products;
  • Advising on or preparing clients’ written submissions to FDA requests for comments or rulemaking activities;
  • Requirements for importing and exporting regulated products; and
  • Food safety and labeling advice for food, including dietary supplements and functional foods.

Joanne frequently works with clients to develop and implement their responses to common FDA actions, such as warning letters and inspectional reports (the “Form 483”). She has also been involved in advising and helping clients respond to Federal Trade Commission investigations related to product advertising and requests for substantiation of certain promotional claims.

As an FDA regulatory specialist, Joanne assists the Mintz corporate team by performing regulatory due diligence as part of potential mergers and acquisitions that involve regulated companies, and she often works in conjunction with the Firm’s intellectual property attorneys to ensure that patent and regulatory activities are strategically aligned. She also collaborates regularly with Mintz attorneys who negotiate royalty monetization transactions and who defend false advertising or product liability litigation brought against FDA-regulated businesses. Although the day-to-day work for clients may be different, the common thread that she enjoys most is helping companies (both start-up and established) bring their products to market – without heightened risks of enforcement actions as a result of non-compliance with sometimes-opaque regulatory requirements.

Prior to joining Mintz, Joanne was an attorney in the food and drug practice in the DC office of another law firm. 

Joanne is an editor of and frequent contributor to the firm's Health Care Viewpoints. 

Experience

  • Represented a diagnostic developer during an FDA investigation into its alleged distribution of an unauthorized test for COVID-19 and subsequent recall activities.
  • Supported Mintz Corporate Team in negotiating and executing the sale of a client’s FDA Priority Review Voucher to another party for over $100 million.
  • Negotiated the release of consumer goods by FDA on behalf of a retailer client following the agency’s erroneous conclusion that the shipments contained laser components that did not comply with U.S. law, thereby leading to their detention at the port of entry.
  • Counseled a nationally recognized health system regarding the construction of advertising claims for various services involving regenerative medicine-based therapeutic procedures.
  • Served as FDA specialist and regulatory team leader on a client’s complex bid for a bankrupt pharmaceutical company’s U.S. and European drug-related assets, including marketing authorizations and distribution permits.
  • Handled regulatory due diligence and related contractual negotiations for two acquisitions of independent testing laboratories by a global client.
  • Worked with several Mintz clients operating in non-FDA regulated industries to determine how to manufacture and distribute face shields, face masks, and alcohol-based hand sanitizers in compliance with FDA’s enforcement discretion policies during the COVID-19 pandemic, including by providing promotion and labeling advice.
  • Guided clients developing COVID-19 diagnostic or serological tests on various promotional risks and regulatory obligations both before and after they secured Emergency Use Authorizations from FDA that allowed the test to be distributed and used in the United States.
  • Prepared a Breakthrough Designation Request on behalf of a therapeutic developer client and helped another client secure Orphan Drug Designation for its innovative drug product.
  • Participates in the Medical, Legal, and Regulatory (“MLR”) Committees that are engaged in promotional review activities on behalf of multiple clients with recently approved new drugs and biologics. Also assists various companies that market non-prescription consumer products in structuring and implementing their Advertising Compliance Programs and ensuring ongoing risk mitigation in new promotional activities or when launching new products.
  • Assisted multiple pharmacy clients in determining whether to register with FDA as an Outsourcing Facility and advised them regarding the compliance obligations associated with this form of compounding business, including with respect to applicable COVID-19 enforcement discretion policies.
  • Negotiated with FDA on behalf of a cosmetic client when a large shipment of imported products was detained by Customs and Border Protection due to non-compliant labeling and assisted company in developing plans for reconditioning the products.
  • Counseled a cosmetic company on its response to an FDA Warning Letter related to the use of drug claims to promote cosmetic products and then assisted in the company’s implementation of internal processes and procedures to avoid similar issues in the future.
  • Represented an innovative beverage company with a national profile on FDA compliance issues, labeling, promotional activities, and distribution agreements.
Read less

viewpoints

Agencies across the federal government continue to grapple with how to respond to the directives in President Biden’s October 2023 executive order on artificial intelligence, including the Food and Drug Administration (FDA) and its parent agency the Department of Health and Human Services (DHHS). As summarized in this handy Mintz/ML Strategies timeline of the actions set forth in President Biden’s AI executive order, DHHS has a mandate to “develop a strategy for regulating the use of AI in the drug development process” and a deadline of October 29, 2024 to meet that obligation. Notably, earlier this year DHHS announced a functional reorganization within the department that included creating the position of Chief AI Officer in response to the presidential order.

Read more

Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders. An announcement on August 7, 2024 by the Centers for Medicare and Medicaid Services (CMS) of a final notice for the Transitional Coverage for Emerging Technologies (TCET) pathway was therefore a welcome development. However, digging under the surface of the TCET pathway uncovers some less than thrilling details. CMS’s failure to address stakeholder proposals to modify the TCET program has increased interest and advocacy around Congress’s consideration of the Ensuring Patient Access to Critical Breakthrough Products Act. We explore both the shortcomings of the TCET pathway and the possible legislative solutions to its perceived gaps below.

Read more

Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and breakthrough therapy/breakthrough device designation programs. These designation programs follow a typical paradigm – (1) a product developer demonstrates to FDA that its candidate meets certain qualifying criteria; (2) FDA grants the relevant designation to the product candidate in question; and (3) the product developer then benefits from an increased frequency of interactions with the agency during continued development of the product and/or a valuable advantage that’s secured upon the product’s future marketing authorization (e.g., orphan exclusivity or a priority review voucher). 

Read more

Read about the Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) joint workshop in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

Read more

The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade-plus-long journey toward winding down its historical enforcement discretion posture for LDTs. But FDA’s crusade is far from over. It will have much to do to implement the four-year phase-out period described in the final rule and those efforts may be delayed by litigation seeking to enjoin implementation of the rule altogether. While we wait for the litigation shoe to drop, let’s take a look at what the final rule says and the changes FDA made in these highly significant policy decisions since the Notice of Proposed Rulemaking was published on October 3, 2023 (see our previous posts on the NPRM here and here).

Read more

In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates on behalf of the U.S. public. IVDs are classified as medical devices and include “reagents, instruments, and systems intended for use in diagnosis, including determining the state of health, through the collection, preparation, and examination of specimens taken from the human body.” Unlike human drug and non-IVD device products, which generally must be authorized for a specific medical use prior to commercialization, IVD products may be sold for certain scientific research studies without FDA authorization, but such IVD products may not be sold for clinical diagnostic use. 

Read more

In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory developed tests (LDTs).

Read more

The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump. What the majority may not know quite as well, however, is how many important regulatory programs the Food and Drug Administration (FDA) has tasked itself with completing sometime this year. Given the centrality of much of FDA’s work to the average American consumer and all users of health care services, not to mention the various business stakeholders whose operations can be shaped in part by policy decisions executed by the agency, this blog post will preview upcoming milestones that FDA is expected to meet in 2024.

Read more

White House Launches Initiative on Women’s Health Research

January 3, 2024 | Blog | By Joanne Hawana , Maya Lytje, Rachel Wang

An important new initiative focused on women’s health research – defined as “the study of health across a woman’s lifespan in order to preserve wellness and to prevent, diagnose, and treat disease” – was recently kicked off in the United States. On November 13, 2023 the White House announced the Initiative on Women’s Health Research, to be led by First Lady Jill Biden and the Gender Policy Council. The Initiative aims to recognize and address the historic and persisting gaps in women’s health research and, by extension, in our collective knowledge about women’s health as well as how women experience certain conditions or respond to certain treatments differently than men. 

Read more

A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation efforts steadily increased throughout the calendar year, as the December 29, 2023 compliance date for most MoCRA provisions approached, FDA’s release of information and deployment of new systems for the industry came to a climax. Several recent MoCRA-related developments will influence how cosmetic industry stakeholders, consumers, and even the FDA will approach and navigate the law’s requirements over the next year. In this blog post, we will discuss each of these developments and forecast the law’s future as we move into 2024.

Read more
Read less

News & Press

Press Release Thumbnail Mintz

A Mintz team led by Richard Gervase, Member and Chair of the firm’s Royalty & Revenue Interest Financing Transactions Group, advised global investment firm Sixth Street in a non-dilutive, senior secured credit facility of up to $475 million for Apellis Pharmaceuticals. Apellis received $375 million in funding at close, with ability to access an additional $100 million under the facility at the Company’s option prior to September 2025, subject to the satisfaction of certain conditions.

News Thumbnail Mintz

Bloomberg Law spoke to Member Joanne Hawana in an article seeking clarity on the FDA’s authority over social media influencers promoting prescription drugs without clear warning risks.

News Thumbnail Mintz

Member Joanne Hawana was quoted in a Bloomberg Law article discussing how TikTokers put consumers at risk of misinformation as drug ads go unchecked by the FDA. Joanne comments on the Office of Prescription Drug Promotion’s efforts to conduct research projects to better comprehend how viewers understand information presented in direct-to-consumer advertising.

Press Release Thumbnail Mintz

Mintz is pleased to announce that Member Joanne Hawana has been awarded the Pro Bono Advocate of the Year Award by Kids In Need of Defense (KIND) for her exceptional contributions to her clients’ cases. The annual awards “recognize outstanding attorneys and volunteers who have gone above and beyond in their assistance to unaccompanied children.”

Press Release Thumbnail Mintz

Mintz’s new Women’s Health and Technology Practice brings together attorneys from our transactional, intellectual property, health care, FDA regulatory, and litigation teams to serve FemTech and other life sciences clients. The practice advises companies, entrepreneurs, and investors focused on addressing unmet needs in women’s health.

News Thumbnail Mintz

Law360 featured the launch of the firm's Women's Health and Technology practice and highlighted founding Members Ellen JanosJoanne HawanaKaren Lovitch, and Melanie Levy.

News Thumbnail Mintz

Mintz Member Joanne Hawana and Associate Jean Krebs were interviewed by CosmeticDesign about legal reform in the U.S. Food and Drug Administration.

News Thumbnail Mintz

Mintz Member Joanne Hawana was quoted in the National Journal discussing Congress' plan to reauthorize key user-fee programs that fund the Food and Drug Administration.

News Thumbnail Mintz
Mintz Member Joanne S. Hawana was quoted in an analysis article published by Law360 on the biggest COVID-19 product scams and actions taken by the U.S. Food and Drug Administration (FDA) to tackle fraudsters during the ongoing crisis.
News Thumbnail Mintz
Mintz Members Brian P. Dunphy, Joanne S. Hawana, and Jennifer B. Rubin co-authored a Bloomberg Law insights column examining potential legal liabilities for employers implementing Covid-19 workplace vaccination programs, explaining that immunity under the federal Public Readiness and Emergency Preparedness Act (PREP Act) is not absolute.
News Thumbnail Mintz
An article published by Inside Health Policy featured extensive commentary from Senior Director of ML Strategies Aaron Josephson on priorities for the Senate Health, Education, Labor and Pensions (HELP) Committee following the 2020 Presidential election. Mintz Member Joanne Hawana was also quoted in the article.
News Thumbnail Mintz
Mintz Member Joanne Hawana was quoted extensively in an article published by the International Bar Association on how consumer protection bodies, including the U.S. Food and Drug Administration, are dealing with the proliferation of fake products and treatments related to COVID-19.
Press Release Thumbnail Mintz
In the latest guide, Mintz garnered rankings as a top national firm in eight practice areas, and 32 firm attorneys were individually recognized.
News Thumbnail Mintz
Mintz Member Joanne Hawana is quoted in an article published by MedCity News discussing the latest decision by the U.S. Food and Drug Administration (FDA) granting an emergency use authorization for hydroxychloroquine and chloroquine for COVID-19, and the balance the agency is taking with the current pandemic.
News Thumbnail Mintz
Mintz Member Joanne Hawana, Senior Director of ML Strategies Aaron Josephson, and Mintz Associate Benjamin Zegarelli co-authored an article published in Law360 discussing the latest actions from the U.S. Food and Drug Administration (FDA) in response to COVID-19.
This Law360 analysis piece looks at how the U.S. Food and Drug Administration (FDA) is easing concerns about off-label marketing restrictions without antagonizing the plaintiffs bar or public health advocates. FDA attorney Joanne Hawana is quoted providing third-party commentary in the piece.
This piece looks at what could make the proposed Making Objective Drug Evidence Revisions for New Modern Labeling (MODERN) Act stronger - primarily liability protection for generics. Joanne Hawana is among the FDA industry sources quoted providing commentary in the piece.
Arameh O’Boyle, a Member and Nada Shamonki, Of Counsel in the Mintz Los Angeles office, and Joanne Hawana, Of Counsel in the firm’s Washington, DC office collaborated on an article published in Law360 on regulatory changes to the cosmetics and personal care products industries.
Mintz attorney Joanne Hawana authored an article published by ICIX assessing the performance of FDA Commissioner Scott Gottlieb’s first four months on the job.
The Food and Drug Administration quietly announced and enacted significant organizational changes. FDA and Health Law attorney Joanne Hawana is quoted in this article discussing the potential impacts of these changes could include faster FDA factory inspections and audits.
Joanne Hawana, an attorney in Mintz’s FDA and Fraud & Abuse, Compliance & Regulatory Counseling Practices, is included in this piece which discusses changes the Trump administration could make to Food Safety Compliance and the dangers of lawsuits against the government amid deregulatory efforts.
Health Law and FDA attorneys Bethany Hills and Joanne Hawana are among the industry sources quoted in this piece analyzing new statistics from the U.S. Food and Drug Administration showing a relatively quiet 2016, but a busier year for enforcement in 2017.   
In this Law360 feature article, Joanne Hawana and Dan Herling discuss the release of data regarding adverse events received by the FDA’s Center for Food Safety and Applied Nutrition, whether the timing of the release matters, and what greater AER transparency means for litigations risks.
This article, published in Medical Marketing & Media, addresses the FDA’s new approach to regulating drugmakers’ advertising and promotion. Mintz FDA team members Bethany Hills and Joanne Hawana offer insight. 
News Thumbnail Mintz
This Bloomberg BNA Health Law article discusses the FDA's controversial guidance on the naming of biological products, designed to prevent inadvertent substitution and support safety monitoring when they are on the market.
Three attorneys from Mintz authored the initial installment of a four-part series recapping key government policies, regulations, and enforcement actions from 2016 and discussing their potential impacts on 2017.
FDA and Health Law attorney Joanne Hawana is quoted in this Medical Marketing & Media article on the FDA off-label hearing. The article discusses possible results from the hearing which could facilitate a regulatory resolution to the off-label pharmaceutical promotion issue.
Joanne S. Hawana, Of Counsel for Mintz's Health Law Practice, is participating in two sessions at the 2016 TEDCO Entrepreneur Expo. The event will bring together entrepreneurs, business executives, investors, economic development officials, and legislators.
FDA and Health Law attorney Joanne Hawana is quoted in this Refrigerated and Frozen Foods article on why frozen food manufacturers and grocery retails must remain diligent about checking that their safety procedures and policies still comply with best practices.
FDA and Health Law attorney Joanne Hawana is quoted in this Bloomberg BNA Health Care Policy Report article on how pharmacists and medical providers are calling upon the FDA for quick guidance on biosimilars.  
Dan Herling, a Litigation Member in the Mintz San Francisco office, and FDA attorney Joanne Hawana authored this San Francisco Daily Journal article covering the predicted impact of the FDA's food safety regulations on California tort law.  
Health Law attorney Joanne Hawana and Associate Benjamin Zegarelli authored a Law360 column on how the Senate Appropriations Committee’s approval of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies 2017 appropriations bill sets the stage for GMO legislation. 
FDA and Health Law attorney Joanne Hawana and New York Associate Benjamin Zegarelli authored this Law360 column discussing the growing public support for genetically modified organism and genetic engineering labeling on appropriate food products across the board.
The Parental Drug Association (PDA) has published a book by Washington, D.C. FDA and Health Law attorney Joanne Hawana. According to the PDA, the book “presents a condensed overview of the regulatory systems and processes for marketing a drug product in the three major global regions.”  
FDA and Health Law attorney Joanne Hawana is quoted in this Medical Marketing and Media article on how despite calls for change from pharmaceutical marketers, it is not likely that limitations on direct-to-consumer practices will become a reality.
Read less

Events & Speaking

Speaker
Mar
20
2024
Conference Reference Image
Speaker
Panelist
Dec
13
2022

IP Considerations for Medical Device Companies

Boston Bar Association

Online Event

Webinar Reference Image
Panelist
Nov
10
2022
Webinar Reference Image
Speaker
Speaker
May
26
2022
Conference Reference Image
Moderator
Mar
8
2022

DIA Advertising and Promotion Regulatory Affairs Conference

Drug Information Association (DIA)

Arlington, VA

Conference Reference Image
Speaker
Jan
26
2022
Webinar Reference Image
Speaker
Sep
23
2021
Webinar Reference Image
Speaker
Jun
17
2021

US Regulation of Advertising, Promotion and Labeling for Medical Devices

Regulatory Affairs Professional Society (RAPS)

Online Event

Conference Reference Image
Moderator
Speaker
Feb
18
2021

FDA in 2021: A Look Ahead

Mintz & ML Strategies

Webinar

Webinar Reference Image
Oct
8
2020

Food and Drug Law Institute Annual Conference

FDA’s Amended Intended Use Regulation – Has It Finally Hit the Sweet Spot?

Online Event

Seminar Reference Image
May
18
2020

DIA Advertising and Promotion Regulatory Affairs Conference

Engaging with Patients to Diversify Advertising and Promotional Activities

Online Event

Conference Reference Image
Apr
14
2020

FDA in the Time of COVID-19

View the Webinar Recording

Webinar Reference Image
Mar
31
2020
Jan
15
2020

ELabs NYC

Planning for Success: Integrating Product Development with Intellectual Property and Regulatory Strategies

New York, NY

Panelist
Sep
24
2019

Six-Month Assessment: The Impact of Gottlieb’s Departure on FDA Priorities

Mintz, 3580 Carmel Mountain Road | Suite 300, San Diego, CA

Speaker
Jun
20
2019

RAPS Virtual Program: US Regulation of Advertising, Promotion, and Labeling for Medical Devices (2-Part Series)

Navigating Federal Trade Commission (FTC) Requirements for Medical Products

Moderator
May
3
2019

Food and Drug Law Institute Annual Conference

Regenerative Medicine, Gene Therapies, and FDA Regulation

Washington, DC

Speaker
Feb
6
2019

FDLI's Introduction to Drug Law and Regulation Course

Regulation of Over-the-Counter OTC Drugs

Lake County, Illinois

Speaker
Jan
16
2019

ELabs NYC

Planning for Success: Integrating Product Development with Intellectual Property and Regulatory Strategies

New York, NY

Moderator
Nov
13
2018
Seminar Reference Image
Speaker
Nov
6
2018

The 9th Annual Advertising and Promotion of Medical Devices Conference

FTC’s Authority Applied to the Regulation of Medical Devices

The Madison Hotel, Washington, D.C.

Moderator
May
4
2018

Emerging Issues for Drug Compounders

Food and Drug Law Institute

Washington, DC

Speaker
Faculty
Moderator
Speaker
Jan
24
2017
Panelist
Nov
14
2016

Entrepreneur Expo 2016

TEDCO

Hilton Baltimore 401 W. Pratt Street Baltimore, MD 21201

Speaker
Read less

Recognition & Awards

  • William P. Cunningham Award for Achievement and Service to the School of Law, University of Maryland (2007)

  • Manuscripts Editor, The Journal of Health Care Law and Policy (Vol. 10)

  • Recognized by The Legal 500 United States for Healthcare: Service Providers (2020)

  • Recognized by The Legal 500 United States for Healthcare: Life Sciences (2021)

  • JD Supra: Top Author, Readers' Choice Awards – Life Sciences (2021)

  • Pro Bono Advocate of the Year Award, Kids In Need of Defense (KIND) (2023)

Read less

Involvement

  • Member, Food and Drug Law Institute (FDLI)
  • Member, FDLI Publications and Academic Programs Committee
  • Member, Drug Information Association (DIA)
  • Member, American Bar Association (ABA), and ABA Health Law Section
  • Member, American Health Lawyers Association (AHLA), and AHLA Life Sciences Practice Group
  • Member, FDLI Audit Committee
  • Member, Mintz Pro Bono Committee
  • Past Chair, FDLI Publications Committee
  • Past Chair, FDLI Primer Committee
  • Past Chair, FDLI Update Magazine Editorial Advisory Board
Read less