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Bethany J. Hills

Member / Chair, FDA Practice

[email protected]

+1.212.692.6239

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Bethany is nationally recognized for her experience and insight on FDA matters and advises businesses on both pre- and post-market issues, including everything from FDA submissions and communications strategies to post-approval compliance. Bethany also helps international and US companies enter and navigate the US health care market. She’s adept at helping clients identify technologies that are likely to complement the health care delivery system, clear FDA regulatory hurdles, and provide a healthy return on investment. She also has an exceptional understanding of health care reimbursement issues.

Bethany is Chair of the firm's FDA practice and leverages deep FDA regulatory experience and exceptional knowledge of the health care delivery system to help international and domestic health technology companies enter and navigate the US health care market. Bethany helps companies manage the full range of FDA regulation issues, from inspections and investigations through complex regulatory challenges affecting everything from product approvals and product labeling to collaborative research, supply, and distribution agreements. She focuses on mission critical strategic engagements, including all aspects of FDA communications. Her client engagements regularly span the full scope of pre-market and post-market issues, from devising unique regulatory strategies that are then implemented through FDA submissions and complex interactions with the FDA, including post-approval compliance and enforcement. Bethany’s representative clients include medical device, drug, combination product, diagnostic, biologic and regenerative medicine, cosmetic, dietary supplement and food industry companies.

Through her extensive representation of health care provider businesses, she has developed an understanding of compliance issues and of the US health care reimbursement system that far surpasses that of most FDA lawyers. She uses her strengths in these areas to provide clients with insight on regulatory policy, reimbursement issues, and pricing to shape innovation, and helps them use that knowledge to develop viable value propositions within the constraints of the evolving health care delivery system. She advises clients on laws applying to referral relationships, clinical trial compliance, licensure, and security and privacy issues as well as on the ins and outs of government and third-party reimbursement. Clients rely on Bethany’s practical guidance to help them invest and collaborate strategically, by identifying technologies that are likely to complement the health care delivery system, clear FDA regulatory hurdles, and provide a healthy return on investment.

Before joining Mintz, Bethany served as the co-leader of the FDA and medical technology services team in the New York office of another law firm. She works with academic centers to educate future business leaders on relevant health care regulatory issues, and is frequently invited to speak on issues concerning FDA regulations, health care reimbursement, and pricing.

Education

  • State University of New York - Buffalo (MPH)
  • State University of New York - Buffalo (JD, cum laude)
  • State University of New York - Geneseo (BA, summa cum laude)

Experience

  • Provided strategic counsel to a start-up medical application company that has devised a method to detect mild cognitive impairment as a precursor to more significant cognitive diseases.
  • Represent a national IVF clinic and management provider in drug delivery, pharmacy relationships, and delivery of care issues.
  • 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.
  • Assisted multiple pharmacy clients in determining whether to register with FDA as an Outsourcing Facility and advised them regarding the establishment of such operations.
  • Advise innovative drug development client on regulatory strategy following Phase II clinical study data analysis.
  • Advise a food manufacturing company on multiple product line contract manufacturing arrangements and negotiated supply and quality agreements.
  • Analyzed the impact of proposed Medicare National Coverage Decision on an integrated FDA and reimbursement strategy for a next generation sequencing cancer test and drafted comments to CMS.
  • Guided a medical device manufacturer through multiple FDA inspections and developed effective and sustainable corrective actions to address deficiencies and avoid focused FDA enforcement.
  • Participated in marketing and labeling pre-launch team, working side by side with biological client team to craft marketing messages and product labeling for product launch.
  • Provided legal and regulatory advice to consumer app software collecting symptoms and providing guidance on possible next steps, including commercial agreements and new feature development.
  • Conducted a regulatory assessment and classification of software product used to support monitoring and management of patients with chronic obstructive pulmonary disorder.
  • Advised on legal and regulatory issues surrounding market launch of a software solution to gather patient data from peripheral devices and coordinate a communication and management platform with their physician, including licensing arrangements, clinical study agreements, and quality and supply agreements.

Recognition & Awards

  • Lexology and the ILO: Client Choice Award
  • Included on the New York Super Lawyers Rising Star: Food & Drugs, Health Care, and Technology Transactions lists (2015 - 2018)
  • Chambers USA: “Up-and-Coming” lawyer, New York Healthcare category (2012 ‒ 2014)
  • American Bar Association and Bureau of National Affairs: Excellence in Health Law (2005)
  • Recognized by The Legal 500 United States for Healthcare: Service Providers (2017)
  • Environment and Society Institute, Lester Milbrath fellowship

Involvement

  • Member, executive committee, Food, Drug, and Cosmetic Law Section, New York State Bar Association
  • Member, Editorial Advisory Board, BNA Medical Devices Law & Industry Report
  • Member, Regulatory Affairs Professional Society
  • Member, American Health Lawyers Association
  • Appointed Member, New York State Bar’s Committee on Cannabis Law
  • Executive committee, Kevin Guest House for Patient Families, Buffalo, NY (until 2012)
  • Board of directors, MedTech (2014 ‒ 2015)
  • Board of directors, NY Data Protection Review Board (2010 ‒ 2013)

Recent Insights

News & Press

Viewpoints

Viewpoint
Regulatory compliance is often treated as completely independent from development or enforcement of patent rights. This situation is not helped by the absence of coordination between the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO). Still, companies must understand and appreciate the impact regulatory submissions may have on their patent portfolio.
The pharmaceutical industry is facing new limits on payments to prescribers in New Jersey. Earlier this month the state's Division of Consumer Affairs finalized sweeping new rules prohibiting some types of payments and capping others. New Jersey now joins the ranks of other states, like California and Massachusetts, with specific payment prohibitions between manufacturers and prescribers.
As we enter a new era in which executive agencies are headed by President Trump, we are also faced with many other transformative changes that will affect FDA-regulated entities in a significant and lasting way. This post will outline some of our thoughts related to what could face FDA and its various stakeholders as we go forward into the great unknown.
Next Tuesday, January 12th, Mintz and ML Strategies will host the first installment of our three-part series focusing on the 21st Century Cures Act (“Cures Act”).  The Cures Act represents significant legislation that will have overarching implications on medical research, product development, and drug and biologic manufacturing.
Over the past year, clear trends have emerged in FDA’s enforcement activities. Enforcement arising from alleged violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) can take many forms, including FDA advisory actions such as warning letters, adverse inspectional observations that can lead to specific administrative action.
As you have seen in our recent coverage, the 21st Century Cures Act is a major legislative undertaking, and it will have a great impact the medical device industry. Join my Mintz Levin and ML Strategies colleagues Tom Crane, Bethany Hills, and Rodney Whitlock on January 18th for a MassMEDIC webinar, “Impact of the Cures Act on the Medical Device Industry.”
As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support approvals of new indications for previously approved drugs, and to support or fulfill post-approval study requirements.
On Wednesday, the U.S. Senate overwhelmingly passed the 21st Century Cures Act (the “Act”) by a vote of 94 to 5.  Spearheaded by Michigan Representative Frank Upton, the bill now heads to President Obama who has promised to sign it. The Act is ambitious, and will impact a wide swath of the U.S. health care system.
Based on recent FDA statements, it looks as though the FDA would like to integrate hospital medical device reporting obligations into the National Evaluation System for health Technology (NEST) framework.
This week, a high-profile FDA hearing sought to receive broad stakeholder input on four draft guidance documents from 2014 and early 2015 that further explain the agency’s views on some of the criteria for the regulation level of Human Cell and Tissue Products (HCT/P) as well as on the scope of the “same surgical procedure” exception under 21 CFR § 1271.15.

News & Press

This in-depth Washington Post piece looks at Apple’s latest venture into health care - a new Apple Watch technology to detect atrial fibrillation. The piece notes, however, that the technology is not intended for people who have atrial fibrillation. The Post delves into questions raised by the introduction of a mass-market monitoring tool for the heart. Bethany Hills, Member and Chair of Mintz's FDA practice, is among the industry sources quoted providing commentary in the piece.
This article notes the pushback the Food & Drug Administration (FDA) and Commissioner Gottlieb are facing after introducing a new plan to overhaul FDA’s clearance process for certain low­ and moderate ­risk medical devices. Mintz Member and Chair of the FDA practice Bethany Hills is among the industry sources quoted providing commentary in the piece.

This in-depth Q&A with Member and Chair of the firm’s FDA practice Bethany Hills details a wide-ranging conversation with Law360’s senior health care and life sciences reporter. Among the topics covered in the Q&A, Bethany notes that she is seeing an uptick in “cosmeceutical” class actions and a new trend of drawn-out FDA inspections.
This feature article notes the medical device industry’s reaction to a draft guidance released by FDA aimed at expanding the use of a faster premarket review program could, if finalized, be particularly useful for software companies. The piece further notes that this could help the FDA achieve its goal of reducing its average 510(k) review times. FDA Practice Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are among the industry sources providing commentary.
Member and Chair of Mintz’s FDA practice Bethany Hills provides commentary in this “Device Lawyer” feature article. The piece looks at the new FDA guidance, "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions," which some industry sources say illustrates the FDA’s willingness to accept greater premarket risk in the device development process. This openness comes as long as postmarket controls and data collection procedures are in place.
Member and Chair of the firm’s FDA Practice Bethany Hills provides commentary in this article on the latest draft of the FDA’s device pre-certification model. The program will allow firms that meet certain criteria to submit medical software products through a streamlined process.
The medical industry is rapidly embracing the use of artificial intelligence and as new products are being developed, the Food and Drug Administration (FDA) is trying to keep up with the technology.
Member and Chair of the firm’s FDA practice Bethany Hills provides commentary in this feature article discussing record-high medical device recalls seen in the first quarter of 2018.
Member and Chair of Mintz’s FDA Practice Bethany Hills provides commentary in this feature article on the Food & Drug Administration’s (FDA) new draft guidance expanding the abbreviated 510(k) pathway.
Bethany Hills, Chair of the Mintz’s FDA practice, is quoted in a Reuters article regarding the FDA’s proposal to create a fast-track path for medical devices.
Bethany Hills, the Chair of the firm’s FDA practice, was featured in a STAT News article that discussed the Food and Drug Administration’s streamlining of the regulation of health software and the remaining question of how artificial intelligence-reliant products will be treated.
Bethany Hills, Member and Chair of the firm’s FDA practice, was quoted in a FierceHealthcare article discussing the reaction from industry experts to the Food and Drug Administration’s developed guidance for clinical decision support software.
Fourteen Mintz attorneys have been named New York Super Lawyers for 2017 and thirteen have been named New York Rising Stars. New York Super Lawyers recognizes the top lawyers with the highest degree of peer recognition and professional achievements.  
Bethany Hills, Chair of the Mintz’s FDA practice, was quoted in a FierceHealthcare article on the FDA’s overhaul of its approach to regulating health technology. She notes the shift from product to enterprise will “require a fairly monumental shift in the way the agency approaches oversight.”
Bethany Hills, Chair of the Mintz’s FDA practice, was quoted in a FierceHealthcare article on the Food and Drug Administration’s new precertification pilot program, a part of the overhaul of its approach to digital health designed to keep up with health IT innovation.
Bethany Hills, Chair of Mintz’s FDA practice, is quoted in a Bloomberg BNA article discussing the “de novo” classification pathway’s increasingly used by medical device companies to get innovative products to market faster, and how user fees may impact this approach.
Bethany Hills, Chair of the Mintz’s FDA practice, is quoted in a FierceHealthcare article discussing the provision in the Trump administration’s budget proposal that would add $313 million to medical device user fees.
This article discusses positions Scott Gottlieb, M.D. is likely to take as leader of the Food & Drug Administration (FDA). Highlighted within the piece are issues with the potential deregulation of the drug industry and digital health.
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.   
Bethany Hills and Benjamin Zegarelli co-author this piece reviewing the 21st Century Cures Act that requires the FDA to develop a framework for evaluating evidence in the context of drug regulation and predicting how the FDA will implement the policy.
Mintz Member Bethany Hills and an Executive Committee member of the New York State Bar Association’s Food, Drug and Cosmetic Law Section provides commentary on what to expect from the FDA under the Trump administration and how the Section can help prepare its members accordingly. 
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.
Bethany Hills, Chair of the Mintz’s FDA practice, is quoted in this Inside Health Policy article covering the FDA’s challenges with combination products, and the 21st Century Cures law’s calling for the creation of disease-specific intercenter institutes.
Member and Chair of the FDA Practice Bethany Hills is quoted in this Inside Health Policy article discussing the 21st Century Cures Act, and the criticism of the FDA’s language lacking clarity as it applies to the regulation of standalone medical software.
Bethany Hills, Chair of Mintz’s FDA practice, is quoted in a STAT News covering the long-awaited passage by Congress of the 21st Century Cures Act.
Sixteen Mintz attorneys have been named New York Super Lawyers for 2016 and twelve have been named New York Rising Stars. The list will be published in a special advertising supplement in The New York Times Magazine and in a stand-alone magazine, New York Super Lawyers - Metro Edition.
Bethany Hills, Chair of Mintz’s FDA Practice, and New York Associate Benjamin Zegarelli authored this Law360 column discussing the Eighth Circuit’s upholding the prison sentences for two food establishment executives.
The arrival of Health Law and FDA Member Bethany Hills and associate; and Member Rebecca Lee, former Boston Redevelopment Authority chief of staff, are highlighted in this American Lawyer column noting major moves among the AmLaw 200.  
The arrival of Health Law and FDA Member Practice Bethany Hills and New York Associate Ben Zegarelli is featured in The Deal’s “Movers & Shakers” column highlighting executive level moves and promotions.

Events

Panelist
Dec
5
2018

AI World Conference and Expo

AI and Advanced Algorithms in Healthcare from the Investors Perspective

Boston, MA

Speaker
Jul
18
2018

Rare Disease Symposium

Westchester Biotech Project

New York, NY

Moderator
Jun
1
2018

6th Annual World Life Sciences Conference

International Bar Association

InterContinental Boston 510 Atlantic Avenue Boston, MA 02210

Moderator
Mar
29
2018
Panelist
Mar
11
2018

BPIP 6th Annual Conference

Best Practices in Intellectual Property

Sheraton Tel Aviv Tel Aviv, Israel

Speaker
Moderator
Panelist
Moderator
Panelist
May
24
2017
Panelist
May
11
2017
Speaker
Jan
26
2017

Food, Drug & Cosmetic Law Section Meeting

New York State Bar Association

New York, NY

Speaker
Jan
24
2017
Panelist
Speaker
Oct
21
2016

Critical Path Life Sciences Accelerator Program

University at Buffalo Technology Incubator

Speaker
Sep
29
2016
Panelist