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Joanne S. Hawana

Of Counsel

[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.

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”). In recent years, she has been providing ongoing counseling to clients on the impact of sweeping changes to the U.S. food safety system that are being ushered in by the FDA Food Safety Modernization Act, including foreign supplier verification requirements and preventive controls for registered food facilities.

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. 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 the business incubator-focused Maryland Intellectual Property Legal Resource Center. She also spent a summer 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.

Joanne is a contributor to the Mintz Health Law & Policy Matters blog and an editor of the Consumer Product Matters blog.

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

  • Negotiated with FDA on behalf of a cosmetic client when a large shipment of imported products were 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 assisted in the company’s implementation of internal processes and procedures to avoid similar issues in the future.
  • Represent an innovative beverage company with a national profile regarding on FDA compliance issues, labeling, promotional activities, and distribution agreements.
  • Assisted multiple pharmacy clients in determining whether to register with FDA as an Outsourcing Facility and advised them regarding the establishment of such operations.

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)

Involvement

  • Member, Food and Drug Law Institute (FDLI)
  • Chair, FDLI Update Magazine Editorial Advisory Board
  • Member, American Bar Association (ABA), and ABA Health Law Section
  • Member, American Health Lawyers Association (AHLA), and AHLA Life Sciences Practice Group
  • Member, National Association of Professional Women
  • Past Chair, FDLI Primer Committee

Recent Insights

News & Press

Events

Viewpoints

Viewpoint
In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and biological products, the Agency is recommending that companies take additional steps to ensure that quantitative efficacy or risk information does not convey inaccurate information and does not have the potential to confuse consumers. The draft guidance defines quantitative efficacy and risk information as “information that numerically addresses the likelihood or magnitude of a drug’s effectiveness or risks.” FDA’s advice on how to most clearly share this type of information should be considered by companies when developing any form of DTC promotional media, whether they are digital, broadcast, in traditional print format, or otherwise.
As an immediate follow-up to last week’s release of the FDA’s Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018 to gather stakeholder input on “FDA’s approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.”
On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for stimulating and improving the marketplace for biosimilars in the U.S.
In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval of gene therapy products on July 11, 2018.
A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory program for biosimilar products and the abbreviated BLA (aBLA) review process.
Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a roller coaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago.
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation's abbreviated marketing pathway for biosimilar products.
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years.
Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement priorities for over-the-counter homeopathic drug products.
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space.  Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug competition issues, with the end goal of affecting drug prices, as well as current figures related to this year's new drug and biologic approvals.

News & Press

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. 
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.
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

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