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Joanne S. Hawana

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[email protected]

+ 1.202.434.7349

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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. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. In recent years she has been advising clients in different industries regarding FDA’s approaches to precision medicine and the impact of the agency’s policies on product development and marketing plans.  

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

  • Determining regulatory status of novel products like mobile health systems and point-of-care diagnostics;
  • Pre-market and post-market requirements for various regulated products;
  • Restrictions on advertising and sampling, including for controlled substances;
  • State licensing schemes for prescription drug manufacturers and distributors;
  • Federal track-and-trace obligations for all members of the prescription drug supply chain, from manufacturers to pharmacies;
  • Compliance with drug compounding regulations, both State and Federal;
  • Review and approval of various types of policies and procedures for facilities that manufacture or distribute regulated products;
  • Advising on clients’ written submissions to FDA requests for comments or rulemaking activities, and in some cases preparing those submissions on behalf of private companies or patient advocacy groups;
  • Requirements for importing and exporting regulated products; and
  • Food safety and labeling advice for human and animal food, including dietary supplements and “functional foods,” as well as alcoholic beverage products.

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.

Joanne also 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 has developed a distinctive relationship with Mintz attorneys who negotiate royalty monetization transactions and works closely with them in developing the terms for these unique transactions. 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. She had internship experiences during law school at the Biotechnology Industry Organization and as a National Institutes of Health Fellow. Before attending law school, Joanne was assistant managing editor of a biomedical research trade publication, and prior to that she was a lab scientist studying the regulation of gene expression and the molecular basis of cancer, all valuable experiences that make her more attuned to the technical, business, and policy pressures facing companies on the cutting edge of the biotech and med-tech fields.

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

Education

  • University of Maryland School of Law (JD, cum laude)
  • University of Medicine and Dentistry of New Jersey, Graduate School of Biomedical Sciences (MS, Molecular Genetics & Microbiology)
  • College of William & Mary (BS, Biology)

Experience

  • 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 secure Emergency Use Authorizations from FDA that allow 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. 

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)

Involvement

  • Member, Food and Drug Law Institute (FDLI)
  • Chair, FDLI Publications 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 Primer Committee
  • Past Chair, FDLI Update Magazine Editorial Advisory Board

Recent Insights

News & Press

Events

Viewpoints

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Yesterday, we blogged on how scammers are trying to monetize on the COVID-19 health crisis for their personal gain. Though the U.S. Food & Drug Administration (FDA) issued a consumer update yesterday saying that there is still no approved vaccine or drug to prevent or treat this disease, companies have continued to market products that claim to prevent, treat, or even cure COVID-19 in an attempt to “help” or profit from distressed, vulnerable Americans. While the FDA is working tirelessly to review possible vaccines, treatments, and cures, Americans should avoid endangering their health or lives by self-medicating. Per the FDA, self-medicating with any new product on the shelf (real or virtual) could not only lead to adverse effects but also could interfere with crucial medications. We are closely monitoring whether Congress will take specific actions on these increasingly prevalent issues in the context of the COVID-19 pandemic.
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Tackling False Claims Being Made for COVID-19 Treatments and Products

March 24, 2020 | Blog | By Christian Tamotsu Fjeld, Joanne Hawana, Karen Lovitch, Joseph MIller, Aaron Josephson

Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to treat Coronavirus Disease 2019 (COVID-19).  The agencies warned the companies that their health claims lacked credible supporting evidence and emphasized the FDA does not recognize a vaccine, drug, or treatment for the disease.  
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FDA’s Ongoing Response to the COVID-19 (Coronavirus) Outbreak

March 18, 2020 | Blog | By Joanne Hawana, Aaron Josephson, 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.
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Following years of discussion, on March 5, 2020, U.S. Representatives Larry Buchson (R-IN) and Diana DeGette (D-CO) and U.S. Senators Richard Burr (R-NC) and Michael Bennet (D-CO) introduced identical versions of the Verifying Accurate and Leading-edge IVCT Development (VALID) Act in both chambers of Congress. The bipartisan legislation closely tracks existing medical device laws, with some notable exceptions, discussed below and in a prior post. If enacted, many regulatory elements familiar to in vitro diagnostic (IVD) and other medical device manufacturers would be applied to clinical laboratories that develop their own tests, commonly known as laboratory developed tests (LDTs). The bill also includes elements that are priorities for the Food and Drug Administration (FDA), including a program conceptually similar to pre-certification, third-party review, and Collaborative Communities. Unlike previously-circulated discussion drafts, the introduced bills include specific language designed to address public health emergencies, including COVID-19.
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Some clinical trial sponsors and principal investigators will be digging through their archives soon as a result of a recent ruling in the case of Seife v. U.S. Department of Health and Human Services, case number 1:18-cv-11462 (S.D.N.Y. 2018). In Seife, the plaintiffs – an investigative journalist and a former Associate Commissioner at the Food and Drug Administration (FDA) – challenged a Department of Health and Human Services (HHS) final rule that implemented clinical trial reporting requirements mandated by the Food and Drug Administration Amendments Act (FDAAA).
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FDA’s Evolving Response to the COVID-19 (Coronavirus) Outbreak

March 4, 2020 | Blog | By Aaron Josephson, Joanne Hawana

Within the U.S. Department of Health and Human Services (HHS), many agencies have responsibility for responding to public health emergencies. The Centers for Disease Control and Prevention (CDC), as its name implies, is at the forefront of the COVID-19 (coronavirus) outbreak as the government seeks to control and prevent the spread of the virus in the United States. The National Institutes of Health (NIH), particularly the National Institute of Allergy and Infectious Diseases, are also involved, primarily conducting research into the sources, cause, and means of transmission of the new virus and coordinating vaccine development efforts. The Food and Drug Administration (FDA) is responsible for assuring the safety and effectiveness of medical products and therefore has oversight over any clinical trials for promising coronavirus treatments (drugs, vaccines, devices), as well as authority to authorize the marketing of any such product. The agency oversees the drug supply chain and monitors drug and device shortages. This blog post covers steps that FDA has taken to mitigate potential drug and device shortages related to coronavirus and to otherwise respond to the coronavirus situation.
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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.
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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.
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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.
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Recap of Our Health Law and Policy Year-in-Review Posts for 2019

January 27, 2020 | Blog | By Joanne Hawana

Over the past month or so, our Health Care Team has published a number of posts examining important developments and trends in health law and policy during 2019, as well as providing some thoughts on what we expect to see in 2020. Our posts cover a range of topics, including health care enforcement trends, HIPAA updates, priorities from the Food and Drug Administration (FDA), and drug pricing initiatives. In case you missed one, below are links to all of our annual review posts (plus a few extras).
Read more

News & Press

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In the latest guide, Mintz garnered rankings as a top national firm in eight practice areas, and 32 firm attorneys were individually recognized.
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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.
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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.   
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. 
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.
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.
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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.
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.

Events

May
18
2020

DIA Advertising and Promotion Regulatory Affairs Conference

Engaging with Patients to Diversify Advertising and Promotional Activities

Online Event

Apr
14
2020

FDA in the Time of COVID-19

View the Webinar Recording

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
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