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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.

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

  • Assisted a medical device client in structuring and implementing an Advertising Compliance Program.
  • Prepared a Breakthrough Designation Request on behalf of a therapeutic developer client.
  • Sit on the Medical, Legal, and Regulatory (“MLR”) Committees engaged in promotional review activities on behalf of multiple start-up company clients developing new drugs and biologics.
  • Worked with a medical device trade association on 2018 updates to its direct-to-consumer advertising guidelines for member companies.
  • 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.
  • 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.

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 Publications Committee
  • 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

Viewpoints

Viewpoint General
Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials, according to the General Accountability Office (GAO). Of those 23 company policies, GAO reports that nineteen of them stated that the manufacturer would consider individual requests for expanded access to their drug candidates, while the remaining four companies stated that such requests would not be considered at the present time. Moreover, approximately half of those companies who would be open to meeting a patient’s request for expanded access also noted expressly in their policies that additional procedures would need to be followed, including review of the request by the Food and Drug Administration (FDA) and an institutional review board (IRB). The GAO study – released on September 9, 2019 – was conducted in response to a congressional mandate (included in the FDA Reauthorization Act of 2017) for the investigative body GAO to review the agency’s actions to facilitate patient access to investigational drugs.
Viewpoint General
Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court. On August 21, 2019, the U.S. Department of Health and Human Services (HHS) filed a notice of appeal against a federal judge’s decision to block an HHS final rule that would require drugmakers to disclose product list prices within consumer-directed television advertisements for certain prescription drugs.
Viewpoint General
On July 29, 2019, the Food and Drug Administration (FDA) published a notice to the Federal Register (84 Fed. Reg. 36609). The notice invites comments on information collected in connection with FDA research by obtaining information from pharmacists and other management at outsourcing facilities as well as related compounding businesses. The collected information will support a comprehensive analysis of the outsourcing facility sector with hopes to inform future FDA work in this area.
Viewpoint General

Pharmaceutical Companies Object to HHS Drug Pricing Disclosure Rule

July 1, 2019 | Blog | By Joanne Hawana, Elizabeth Conti

Several parties from the pharmaceutical industry have teamed up with an advertising association to file a lawsuit against the Department of Health and Human Services (HHS) to prevent a new drug pricing disclosure rule from going into effect. The legal challenge was filed on June 14, 2019 and takes issue with a final rule adopted by HHS on May 8, 2019 (which we previously blogged about here) that purports to provide consumers with information regarding the price of prescription drugs. However, opponents to the HHS rule counter that the opposite will occur and that it will actually mislead patients about the price of prescription drugs. This point may not be difficult for the plaintiffs to demonstrate in support of their request for a declaratory judgment that the rule is unlawful, since even HHS has admitted in the final rule preamble that the new requirement may “discourage patients from using beneficial medications, reduce access, and potentially increase total cost of care.”
Viewpoint General
On June 6, 2019, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a report that found among a sample U.S. hospitals that obtained non-patient-specific (NPS) compounded drugs from outside compounders, 89% of hospitals obtained them only from compounders that were registered with the U.S. Food and Drug Administration (FDA) as outsourcing facilities. The OIG study was conducted to provide the FDA with insights to improve its oversight of compounders and enhance patient safety. According to the study, “factors associated with quality, including registration with FDA as an outsourcing facility, are among the most important factors considered when hospitals decide where to obtain their non-patient-specific compounded drugs.” Although use of compounded drugs is widespread in hospitals, the OIG also found that it is rare for hospitals to consider registering their own pharmacies as outsourcing facilities.
Viewpoint General
As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a public hearing “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” Stakeholders who attended the hearing presented many diverse viewpoints and the FDA panelists – who were in listening mode – received extensive information from across that spectrum of perspective.
On May 10, 2019, the Food and Drug Administration issued highly anticipated final guidance that gives drug-makers more clarity on how to demonstrate that a proposed biosimilar product meets the statutory interchangeability standard under the Public Health Service Act (PHS Act or the Act). According to the Act, an interchangeable biosimilar may be substituted for the original biological product without the involvement of a prescriber, similar to the way generic drugs are routinely substituted for brand name drugs at the pharmacy level. The Final Guidance, entitled “Considerations in Demonstrating Interchangeability with a Reference Product,” is shorter than the draft version released over two years ago, in response to industry feedback, but generally tracks the original policy positions proposed in the draft, with a few notable exceptions summarized below.
Viewpoint General
FDA's Comprehensive Regenerative Medicine Policy Framework is nearing the halfway mark of the “grace period” the Agency extended for certain regenerative medicine product developers to come into compliance by obtaining investigational new drug applications (INDs) and working towards premarket approval of their products.
Viewpoint General

FDA 2018 Year in Review (and a Few Thoughts on 2019)

December 27, 2018 | Blog | By Joanne Hawana, Aaron Josephson, Benjamin Zegarelli

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs point to yes” that everything on the list below will continue to be major areas of focus for both FDA and the U.S. Congress next year and into the foreseeable future.
Viewpoint General
In his typical forceful style on December 11, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced several big pieces of policy news affecting the nascent biosimilar market. The Commissioner’s statement broadly relates to FDA’s “actions to advance the biosimilars policy framework” and is a well-articulated hodgepodge of FDA regulatory, drug pricing, industry competition, and patent thicket complaints, which Dr. Gottlieb is becoming famous for in his written and oral presentations. 

News & Press

Supplement Lobbies Support Incentives But First Want More Enforcement

April 18, 2019 | https://insidehealthpolicy.com/daily-news/supplement-lobbies-support-incentives-first-want-more-enforcement https://insidehealthpolicy.com/daily-news/supplement-lobbies-support-incentives…

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 | Inside Health Policy

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. 

FDA Sticks to Its Naming Plan for Biologics and Biosimilars

January 13, 2017 | http://healthlawrc.bna.com/hlrc/4255/split_display.adp?fedfid=103314364&vname=plirnotallissues&fn=103314364&split=0#103314364 Bloomberg BNA Health Law Resource Center

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.

Will drugmakers get what they're looking for at this week's FDA off-label hearing?

November 7, 2016 | http://www.mmm-online.com/legalregulatory/will-drugmakers-get-what-theyre-looking-for-at-this-weeks-fda-off-label-hearing/article/570637/ Medical Marketing & Media

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.

Why FSMA collaboration is the new normal in food transportation

November 1, 2016 | http://www.refrigeratedfrozenfood.com/articles/91707-why-fsma-collaboration-is-the-new-normal-in-food-transportation Refridgerated and Frozen Foods

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

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