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.
viewpoints
Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs
March 7, 2024| Podcast|
FDA Faces Critical Deadlines in 2024, Even Without an Election Looming
March 6, 2024| Blog|
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
Looking Back and Moving Forward: MoCRA Regulatory Developments Ring in the New Year
January 2, 2024 | Blog | By Madison Castle, Joanne Hawana, Jean D. Mancheno
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
2023: Another Year Chock Full of Challenges for FDA
December 20, 2023| Blog|
Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers, that Employ “Pharmaceutical Sales Representatives”
November 9, 2023 | Blog | By Joanne Hawana, Jean D. Mancheno
Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs pharmaceutical sales representatives (PSRs) is required to register with the Connecticut Department of Consumer Protection (Department) as a so-called “pharmaceutical marketing firm” (PMF). As discussed in our previous blog post, there are few jurisdictions in the United States that require registration or licensure of PSRs, and up until now, these obligations were placed on PSRs at the individual level. However, this new Connecticut law deviates from the typical regulatory scheme. In this post, we will provide an overview of the affirmative obligations that the Act imposes on PMs, PMFs, and PSRs and compare them to the laws, regulations, and ordinances of other United States jurisdictions.
Read more
Guidance from FDA Clarifies a Key Issue for Industry: Non-Promotional Presentations About Unapproved Uses of Medical Products Can Be Produced by the Products’ Sponsors Without Violating Off-Label Rules
October 30, 2023 | Blog | By Joanne Hawana
U.S. health care attorneys, investors, and industry stakeholders are very familiar with the well-worn mantra that prescription drug and medical device companies are not allowed to “market” or “promote” their otherwise-authorized medical products for unapproved uses, also known as “off-label” uses. Over the past decade or so, this strict rule has been the subject of significant litigation and administrative proceedings seeking to disrupt and ultimately soften the government’s position in this long-standing, complex balancing of competing interests. What has been emerging is a more nuanced modern regime in which a drug or device sponsor’s First Amendment rights to speak responsibly and in a non-promotional way about its own products – as well as health care providers’ interests in gaining access to such information directly from the product sponsor to enhance patient care – are gaining greater recognition than ever before.
Read more
Five Topline Takeaways from FDA’s Proposed Rulemaking on Lab-Developed Tests
October 2, 2023| Blog|
FDA Warns “Natural” Birth Control Company: Three Takeaways from the NOV Letter
August 1, 2023 | Blog | By Joanne Hawana, Lara Compton
A little over a year after the Dobbs v. Jackson Women’s Health Organization decision, the Food and Drug Administration (FDA) continues to be at the forefront of addressing reproductive health concerns. An example of this activity came just a few days after the FDA approved the first nonprescription daily oral contraceptive for marketing in the U.S. when the agency sent a warning letter to Wise Women’s Choice (WISE) in connection with the marketing and sale of its “birth control cream.” Among other things, this warning letter highlights for consumers the importance of confirming that birth control methods are safe, effective, and FDA-approved for their intended uses.
Read more
News & Press
TikToker Drug Ads Spark Demands for FDA to Clarify Its Authority
February 16, 2024
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.
Digging Into The Debate On FDA's Proposed Lab Test Rule
January 3, 2024
TikTokers Put Consumers at Risk as Drug Ads Go Unchecked by FDA
December 14, 2023
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.
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.”
Mintz Forms Pioneering Women’s Health & Technology Practice
March 09, 2023
BOSTON – Mintz has launched a Women’s Health and Technology practice, bringing together attorneys from across the firm’s transactional, intellectual property, health care and FDA regulatory, and litigation teams with a focus on serving clients in life sciences, specifically FemTech.
Mintz Debuts 'Femtech' Practice For Life Science Clients
March 9, 2023
Law360 featured the launch of the firm's Women's Health and Technology practice and highlighted founding Members Ellen Janos, Joanne Hawana, Karen Lovitch, and Melanie Levy.
MoCRA- Industry Must Prepare For Mandatory Adverse Event Reporting And Safety Substantiation Now: Expert
January 11, 2023
Mintz Member Joanne Hawana and Associate Jean Krebs were interviewed by CosmeticDesign about legal reform in the U.S. Food and Drug Administration.
Pared-Down FDA-Fee Bill Moving With CR
September 28, 2022
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.
Charting A Year Of The Biggest COVID Scams Cited By FDA
March 15, 2021
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.
Mintz Advises NexImmune in its Upsized $126.5 Million IPO
February 17, 2021
Legal Risks of Employer-Sponsored Covid-19 Workplace Vaccination Clinics
February 12, 2021
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.
User Fees Will Be A Focus For Senate HELP, No Matter Who’s In Charge
November 5, 2020
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.
COVID-19: Regulators Confronted with Scourge of ‘Fake Cures’
September 29, 2020
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.
Introduction to the Due Diligence Process
July 27, 2020
Mintz Practice Groups and Attorneys Garner Top Rankings in 2020 Edition of The Legal 500 United States
June 12, 2020
In the latest guide, Mintz garnered rankings as a top national firm in eight practice areas, and 32 firm attorneys were individually recognized.
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.
What FDA Has Done So Far In Response To COVID-19
April 1, 2020
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.
Mintz Promotes Eleven Attorneys to Member
May 10, 2019
FDA Finally Hitting Sweet Spot With Off-Label Oversight
November 21, 2018
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.
MODERN Labeling Act Needs Liability Protection for Generics
November 14, 2018
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.
Cosmetic Companies Must Plan For New Regulation
December 14, 2017
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.
But What About Food? FDA Director Scott Gottlieb’s 4-month Scorecard
September 14, 2017
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.
Mintz Attorney Says New FDA Organizational Changes Could Have Big Food Industry Effects
July 5, 2017
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.
5 Ways Trump Could Change Food Safety Compliance
April 26, 2017
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.
New FDA Enforcement Stats Show Shifting Targets
February 13, 2017
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.
Will FDA Adverse Event Data Release Mean More Lawsuits?
January 18, 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.
The FDA targeted DTC, video, unapproved drug promotion in 2016
January 18, 2017
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.
FDA Sticks to Its Naming Plan for Biologics and Biosimilars
January 13, 2017
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.
Health Care Enforcement Review And 2017 Outlook: Part 1
January 13, 2017
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.
Mintz Attorney Joanne S. Hawana to Speak at 2016 TEDCO Entrepreneur Expo
November 02, 2016
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.
Why FSMA collaboration is the new normal in food transportation
November 1, 2016
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.
Providers, Pharmacists Call for Earlier FDA Guidance on Biosimilars
October 24, 2016
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.
Food Safety Regulations Will Affect California Tort Law
July 13, 2016
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.
GE Salmon Sets Stage For Future GMO Labeling Regime
June 27, 2016
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.
Food Companies Are Hedging Their Bets With GMO Labeling
April 25, 2016
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.
Events & Speaking
Speaker
Speaker
Mar
12
2024
Drug Information Association (DIA): Advertising and Promotion Regulatory Affairs Conference
Sheraton Pentagon City Hotel Arlington, VA
Panelist
Panelist
Nov
10
2022
Guide to Advertising for Life Sciences Companies: Insights from Legal and Business Perspectives
Association of Corporate Counsel San Francisco
Online Event
Speaker
Sep
27
2022
The Food and Drug Administration (FDA): Series Spanning Key Topics
Regulation of Foods & Cosmetics
Speaker
May
26
2022
US Regulation of Advertising, Promotion and Labeling for Medical Devices
Regulatory Affairs Professionals Society (RAPS)
Moderator
Mar
8
2022
DIA Advertising and Promotion Regulatory Affairs Conference
Drug Information Association (DIA)
Arlington, VA
Speaker
Speaker
Oct
25
2021
Pro Bono in a Virtual Age: A conversation with KIND, Legal Aid Society, and Bread for the City
Kids In Need Of Defense (KIND)
Online Event
Speaker
Jun
17
2021
US Regulation of Advertising, Promotion and Labeling for Medical Devices
Regulatory Affairs Professional Society (RAPS)
Online Event
Panelist
Jun
8
2021
Regenerative Medicine: Regulatory, Legal, and Compliance Challenges for Cell and Gene Therapies
Food and Drug Law Institute
Online Event
Moderator
Speaker
Jan
15
2021
Mandatory or Voluntary Workplace Vaccination – Guidance for Employers
This is an online event.
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
May
18
2020
DIA Advertising and Promotion Regulatory Affairs Conference
Engaging with Patients to Diversify Advertising and Promotional Activities
Online Event
Speaker
Apr
7
2020
Everything Life Sciences Companies Need to Know to Navigate the COVID-19 Pandemic
View the Webinar Recording
Mar
31
2020
Introduction to Biologics and Biosimilars Law and Regulation Course Presented by FDLI
Regenerative Medicine Advanced Therapies (RMATs)
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
Speaker
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
Drug Compounding Post-DQSA: Emerging Regulatory Challenges & Business Opportunities
Mintz, One Financial Center, 38A, Boston, MA 02111
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
Speaker
Faculty
Moderator
Speaker
Panelist
Speaker
Nov
10
2016
Speaker
Aug
9
2016
Compounding Under Sections 503A and 503B: Distinctions, Limitation, Liabilities, and Compliance
FDANEWS
Webinar
Speaker
Panelist
Read less
Aug
5
2015
Publications
- Co-author, The Grocer Will Fill Your Order Now: Modernizing Online Food Shopping Becomes a Priority for Federal Agencies, Update Magazine (Fall 2023).
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)
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
- Past Chair, FDLI Publications Committee
- Past Chair, FDLI Primer Committee
- Past Chair, FDLI Update Magazine Editorial Advisory Board
Recent Insights
Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs
March 7, 2024| Podcast|
FDA Faces Critical Deadlines in 2024, Even Without an Election Looming
March 6, 2024| Blog|
