Emily L. Hussey

Emily leverages more than a decade of experience in healthcare and life sciences law to provide strategic business and regulatory advice to a diverse range of clients. She is passionate about helping healthcare platforms, drug distributors, pharmacies, hospital systems, and outsourcing facilities, among others, navigate the complex and evolving Food and Drug Administration (“FDA”), Drug Enforcement Administration, and state regulations that govern their operations and transactions.

Emily’s extensive experience in life sciences and healthcare transactions includes assisting clients with mergers and acquisitions. She advises on due diligence, change of ownership, regulatory approvals, and related issues in connection with these transactions. Her goal is to help clients achieve their business objectives while ensuring compliance and quality in healthcare services.

Emily also has a deep understanding of life sciences-related issues, with a particular focus on the regulation of compounded drugs across both the human and animal health spheres. She is a recognized industry advocate and thought leader who actively engages with regulators, legislators, and stakeholders to advance the interests of companies in the life sciences, including compounding pharmacies and outsourcing facilities.

Transactions

• Provided regulatory counsel to a telehealth platform in its strategic acquisition of an active-pharmaceutical ingredient (“API”) manufacturing facility.
• Provided regulatory counsel to an FDA-registered 503B outsourcing facility in its sale to private equity investors, which involved significant change of ownership work surrounding licensure transfers. While investor’s counsel is typically retained to strategize and implement licensure transfers (since licenses are the most fundamental aspects of these businesses), the investors and the client both agreed that our regulatory team should strategize and implement the licensure transfer process given our experience and past successes.
• Providing regulatory counsel to a compounding pharmacy in its acquisition of the assets of a retail pharmacy in Arizona; we handled regulatory diligence, drafting of regulatory provisions for the purchase agreement, and the transfer of all licenses.
• Provided regulatory counsel to a private-equity-backed dental supply company in connection with its subsidiary’s acquisition of several dental supply and product companies. Emily provided regulatory due diligence and advised on aspects of the purchase agreement and licensing transfers.
• Provided regulatory due diligence and counsel for a private debt and private equity firm in its acquisition of a full-service small animal veterinary hospital; our work included creating a strategy for and handling the change of ownership processes for many of the hospital’s most important state licenses to ensure it did not experience a single day of business interruption post-closing.
• Provided a national network of compounding pharmacies with regulatory due diligence and counsel in its acquisition of four pharmacies. This included developing and implementing strategies for license transfer.
• Retained by a private-equity-backed provider of veterinary health technology, pharmacy services, and care coordination solutions to provide regulatory due diligence and counsel—including developing and implementing a strategy for license transfer—in its acquisition of a number of veterinary compounding pharmacies and in its merger with the nation’s largest veterinary compounding pharmacy.
• Represented a private equity firm’s portfolio company in a significant number of acquisitions of nationally recognized pharmacies, outsourcing facilities, and active pharmaceutical ingredient manufacturers. We provided regulatory due diligence and counsel on these transactions, including implementing change of ownership strategies, which have involved up to 50 different licenses, registrations, and accreditations in many of these transactions.
• Provided regulatory due diligence and counsel to a private-equity-backed healthcare company in its acquisition of a prominent compounding pharmacy. Our work included developing and implementing the strategy for a complex change of ownership process for the target, which involved more than 50 different licenses, registrations, and accreditations, including specialty licenses required for compounded sterile medicines.
• Advised a veterinary compounding pharmacy in relation to its acquisition of one of its chief competitors, in one of the most significant transactions for animal compounding pharmacies to date. Our regulatory team evaluated business synergies, performed due diligence, and performed the change of ownership process, involving 160 different state and federal licenses.
• Represented a specialty pharmaceutical products company in connection with its agreement to merge with a leading national provider of infusion and home care management solutions to create one of the nation’s largest providers of home infusion services.

Regulatory

• Represented an FDA-registered outsourcing facility in response to an FDA Warning Letter.
• Represented an outsourcing facility with respect to an FDA inspection, including handling all written submissions to FDA and representing the facility in its most recent compliance conference with FDA. With our guidance, the client has maintained ongoing operations and worked efficiently and cooperatively with FDA to ensure compliance with applicable standards.
• Represented an FDA-registered compounding pharmacy in an FDA inspection, including fielding inquiries from FDA investigators and preparing comprehensive responses to Form 483 and subsequent inquiries.
• Counseled a nationally recognized FDA-registered compounding pharmacy on its arrangement with major telemedicine providers and platforms, including providing advice and counsel on all manner of telehealth compliance issues including the latest telehealth regulatory changes at the state level.
• Handled the legal review of an international pharmaceutical company’s U.S.-based drug advertising and marketing initiatives for a new product. Emily continues to advise the client on advertising and marketing matters.
• Provided regulatory review of a publicly traded healthcare company’s marketing and advertising plans to ensure compliance with FDA regulations and guidelines, including performing a comprehensive review of the client’s website, direct to consumer advertising, physician marketing programs, pamphlets, labels, and other potentially patient-facing materials. Additionally, the team provided regulatory counsel in preparation for the company’s initial public offering.
• Advised a publicly traded dietary supplement company on its introduction to the dietary supplement and drug space with its innovative new drug product. The work of introducing the new product into drug space included advising on the process for executing drug studies; crafting outsourcing fulfilment agreements; reviewing and commenting on proposed marketing initiatives; advising on anti-kickback and fraud and abuse issues; and assessing planned foreign marketing initiatives.

Industry Advocacy

• Retained by several industry stakeholders to spearhead comments to the July 2023 FDA draft guidance on Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act and advise on its implications.
• Represented a coalition of compounding pharmacies in a suit brought against the FDA challenging its memoranda of understanding (“MOU”) issued under Section 503A of the Drug Quality and Security Act, where FDA was proposing a volume limitation on interstate dispensing of compounds. The MOU is one of the most critical issues facing compounding pharmacies. Secured summary judgment in favor of our clients; the matter was remanded back to the FDA for the agency to comply with the Regulatory Flexibility Act. FDA ultimately decided to suspend its MOU and engage in a formal rulemaking process to promulgate regulations implementing the statutory requirements in question, which was relief sought by the coalition’s lawsuit.
• Successfully obtained a remand to the United States Pharmacopeia (“USP”) Expert Committee of the revised beyond use dating requirements set forth in revised USP Chapters <795> and <797> on behalf of compounding industry members. Navigating a novel and nearly uncharted USP appeals process, this was a significant result for the industry as it ensures hundreds of thousands of patients continued access to critical compounded medications.
• Represented a coalition of compounding pharmacies, outsourcing facilities, and medical companies in front of the National Association of Science Engineering and Medicine regarding their study of bioidentical hormones.
• Represented a coalition of veterinary pharmacies in commenting to both the 2015 draft guidance for industry (GFI) #230 (withdrawn by FDA), and the 2019 GFI # 256, where FDA is exerting authority over regulating animal compounding. FDA authority over animal compounding is one of the most critical issues facing animal compounders.
• Successfully obtained a revision by the Illinois Department of Financial and Professional Regulation to a proposed Illinois regulation threatening to limit the compounded medications veterinary compounders can provide for office administration to animal patients. Representing a coalition of veterinary compounding pharmacies and in conjunction with Illinois Veterinary Medical Association, the revision obtained in this matter allows all animal compounding pharmacies nationwide to provide medications for Illinois veterinarians to administer in the office, to allow proper treatment of animal patients, especially those who present with urgent medical needs.
• Represented a coalition of outsourcing facilities in commenting to an FDA draft guidance setting out FDA’s proposed framework for evaluating the bulk substances outsourcing facilities can use to compound, one of the most significant issues facing outsourcing facilities.

Healthcare Litigation

• Represented a compounding pharmacy before a state board of pharmacy seeking to bring a fine and reportable discipline action against our client, which would have adversely affected our client’s licensure in other states. We convinced the board to move to no fine and a non-disciplinary instrument that was not reportable.
• Successfully argued that a state board of pharmacy was exceeding its jurisdiction by seeking to enforce drug-related provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) against a compounding pharmacy. Our team was victorious for our client at the administrative level and, after the board nevertheless took adverse action against our client, the state’s superior court ruled in our client’s favor. This is the first ruling in the nation that has found a state board of pharmacy cannot enforce the FDCA through its disciplinary authority. Leveraging this success, we have settled some of the pending California matters and prevented other state boards from restricting compounding by enforcing the FDCA.
• Successfully represented a healthcare company against a state board of pharmacy seeking to levy a large fine against our client, which would have been reportable to the national practitioner database and likely resulted in similar actions in other states. We demonstrated to the board that it was unlawfully attempting to enforce drug-related provisions of the Food, Drug, and Cosmetic Act in violation of the prohibition against non-federal enforcement and moved the board to instead issue a non-disciplinary instrument and no fine.
• Represented an FDA-registered outsourcing facility in two separate investigations by a state board of pharmacy that had the potential to lead to a significant fine or restriction on its licensure—which could have had the domino effect of damaging administrative penalties in other states. Our team convinced the board to dismiss both matters in their entirety.
• Secured dismissal of the Pennsylvania Board of Pharmacy’s disciplinary action against our client stemming from our client’s licensure surrender in another state. We convinced the board to instead issue a confidential letter of warning and no fine, avoiding the sort of reportable discipline that would have created a domino effect of damaging administrative penalties across the country for our client.
• Obtained dismissal of an administrative matter initiated by a board of pharmacy against our outsourcing facility client, in which the board was attempting to discipline our client based on a non-disciplinary settlement our client had previously reached with a different state board of pharmacy. Our team convinced the board of the impropriety of trying to convert another state’s non-disciplinary matter into disciplinary action.
• Represented a healthcare company based in Texas in investigations and proceedings brought by two different state boards of pharmacy. In both cases, no action was taken against our client’s licenses, resulting in a complete close out.
• Represented an FDA-registered outsourcing facility in the aftermath of an FDA inspection that resulted in a high-stakes FDA conference. Our team led negotiations with the FDA and state regulators and ensured continuity of operations to safeguard the client’s licensure and business goals.
• Represented an FDA-registered outsourcing facility in the aftermath of an FDA inspection that resulted in a series of voluntary recalls, administrative actions, and an FDA conference. Our team led negotiations with the FDA and state regulators and ensured continuity of operations to safeguard the client’s licensure and business goals.

• Speaking Engagement

  Noteworthy Speaking Engagements

  Through to 2025

  Emily L. Hussey

• Press Release

  Blank Rome Welcomes Trio of Leading Regulatory and Litigation Partners in Chicago and Philadelphia

  February 4, 2025

  Rachael G. Pontikes, Emily L. Hussey, Shannon E. McClure

• Article

  Noteworthy Publication

  Through to 2025

  Emily L. Hussey

See all News and Views

• 2023, “Rising Star,” listed in in the LMG Life Sciences Guide for FDA Pharmaceutical
• 2022–2024, Healthcare: Pharmaceutical/Medical Products Regulatory, listed in Chambers USA
• 2011, Leadership and Service Award, by Loyola University Chicago School of Law
• 2011, National Jesuit Honors Society

Admissions

• Illinois
• New York
• U.S. District Court - Northern District of Illinois

Education

• University of Michigan, BA
• Loyola University Chicago School of Law, JD, cum laude