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Joanne S. Hawana

(she/her/hers)

Member

[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 so-called 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.

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. 

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

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. 
  • 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.
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viewpoints

Regulatory Roundup: Important FDA Developments at the End of September 2022

October 10, 2022 | Blog | By Joanne Hawana, Benjamin Zegarelli

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary roundup for our readers!
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FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence

September 28, 2022 | Blog | By Benjamin Zegarelli, Joanne Hawana

The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human Service’s declaration of a public health emergency under Section 564 of the Food, Drug and Cosmetic Act on August 9, 2022. Subsequently, the Secretary declared on September 7 that in vitro diagnostics for monkeypox were needed to respond to the public health emergency, and the FDA released its guidance on the same day. The monkeypox test guidance describes the agency’s general expectations and approach for test development and validation, as well as the EUA request process.
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On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of over-the-counter (OTC) drugs to Medicare Part D in violation of the False Claims Act (FCA).  Because Medicare Part D only covers prescription drugs, the pertinent drugs were not eligible for Medicare reimbursement. The conduct at issue under this settlement is a relatively novel basis for FCA liability, but we may see similar government enforcement actions in the future as the federal government actively encourages drug manufacturers to “switch” prescription drugs to OTC status in order to enhance their accessibility and reduce costs. This blog post provides an overview and analysis of the settlement. 
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The head of the Food and Drug Administration (FDA), Dr. Robert Califf, announced on August 30, 2022 that, in addition to an extensive review of opioid regulations, the agency is launching a framework aimed at preventing overdose-related deaths.  Commissioner Califf previously committed to leading a review of opioid regulations during his December 2021 confirmation hearing, in response to repeated questions from Senators regarding FDA’s response to the ongoing opioid epidemic and broader public criticism of the agency’s historical actions in the space.  The commitment to regulatory review also follows criticism FDA has received over the years for approving OxyContin in 1995 and many other addictive opioid drugs since then without requiring more thorough warning labels and other protections that could help combat misuse and over-prescribing.
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Receiving a warning letter from the U.S. Food and Drug Administration (FDA) means that the agency has identified what it calls “violations of regulatory significance” and that you (as the recipient) need to take corrective actions or risk inviting some actual enforcement under the Food, Drug, and Cosmetic Act (FD&C Act), which could include injunctions, seizures, and criminal penalties. This post highlights what an FDA warning letter means for Amazon.com as well as potential implications for the retail giant. 
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Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts. Those looking ahead have raised concerns about women’s continued access to the wide array of birth control options that have been approved for use in the United States by the Food and Drug Administration (FDA). This post provides a brief historical background on how OTC birth control pills have been regulated under the Federal Food, Drug, and Cosmetic Act and reviews the FDA's Additional Conditions for Nonprescription Use (ACNU) Proposed Rule.
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Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and Drug Administration (FDA). Mintz previously published this wonderful explanation of the process complete with an estimated timeline for how this year’s reauthorization was likely to go. As a reminder, the current authorization for FDA’s various human product user fee programs – with the exception of the over-the-counter drug program that was freshly created in 2020 – will expire on September 30, 2022 with the end of the federal government’s fiscal year, unless they are renewed by Congress before that time.
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On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC).  FDA has previously sent warning letters to other companies illegally selling unapproved and misbranded cannabidiol, or CBD, products that claimed to treat illness in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as we have discussed in prior posts (one example here).  In a separate recent slew of CBD-related actions, it issued warning letters jointly with the Federal Trade Commission (FTC) to seven companies for selling CBD products with claims that they will treat or prevent COVID-19. This blog post will define delta-8 THC and analyze the FDA's warning letters. 
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Removing Barriers to Second Chances

January 24, 2022 | Article

Mintz initiated many pro bono projects to combat systemic racism after the murder of George Floyd, including organizing Massachusetts Criminal Offender Record Information sealing clinics with the Lawyers Clearinghouse and conducting research for a Boston-based nonprofit into how housing authorities around the country evaluate applicants with open criminal charges.
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On January 12, 2022, the co-owner of a clinical research site in Miami, Florida pleaded guilty to one count of obstruction of justice after she knowingly lied to a United States Food and Drug Administration (FDA) investigator during a 2017 regulatory inspection. Olga Torres co-owned the clinical research site, Unlimited Medical Research (UMR). During its years of operation, UMR was engaged as a clinical trial site by a number of pharmaceutical companies. The conduct that led to the obstruction of justice charge stemmed from a clinical trial conducted at UMR to evaluate the safety and efficacy of a pediatric asthma drug.
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News & Press

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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.
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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.
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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.
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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.
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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.
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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.   
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. 
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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.
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.
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Events & Speaking

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Nov
10
2022
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May
26
2022
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Moderator
Mar
8
2022

DIA Advertising and Promotion Regulatory Affairs Conference

Drug Information Association (DIA)

Arlington, VA

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Jan
26
2022
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Sep
23
2021
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Jun
17
2021

US Regulation of Advertising, Promotion and Labeling for Medical Devices

Regulatory Affairs Professional Society (RAPS)

Online Event

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Moderator
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Feb
18
2021

FDA in 2021: A Look Ahead

Mintz & ML Strategies

Webinar

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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

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May
18
2020

DIA Advertising and Promotion Regulatory Affairs Conference

Engaging with Patients to Diversify Advertising and Promotional Activities

Online Event

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Apr
14
2020

FDA in the Time of COVID-19

View the Webinar Recording

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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
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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

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Faculty
Moderator
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Jan
24
2017
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Nov
14
2016

Entrepreneur Expo 2016

TEDCO

Hilton Baltimore 401 W. Pratt Street Baltimore, MD 21201

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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)
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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
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Joanne S. Hawana

(she/her/hers)

Member

Washington, DC