Interacting with governmental agencies: best practices around the world

With more than 27 years of experience in private practice and government, Ms. Walsh advises clients in M&A transactions requiring FDA expertise. She leads teams of attorneys to conduct comprehensive FDA-related diligence, and to advise clients on making determinations concerning the deal and its valuation. She also regularly counsels clients on managing FDA inspections, responding to warning letters, and deciding when to submit mandatory reports or conduct recalls. She has specific expertise in matters involving alleged FDC Act violations, such as off-label promotion or inadequate manufacturing practices. Prior to joining HPM, Ms. Walsh served as Associate Chief Counsel with FDA’s Office of Chief Counsel.

Sonia has deep experience in matters involving the Food and Drug Administration (FDA). Her practice encompasses investigations, litigation and regulatory counseling, as well as advising on transactional matters. Having served for almost 12 years at the FDA’s Office of the Chief Counsel as a litigation and enforcement attorney, Sonia helps clients prepare for and respond to interactions with the FDA, including FDA enforcement actions, Warning Letters and inspections. Sonia’s practice also focuses on conducting internal investigations and representing clients in criminal matters involving the FDA and FDA-regulated products. She also advises and represents clients in civil litigation involving FDA regulatory issues. Sonia routinely counsels clients on FDA regulatory compliance matters, including developing go-to-market strategies for companies – particularly in the medical device space – and representing companies at pre- submission meetings; reviewing labeling, advertising and promotional materials for drugs, devices, biological products, food and dietary supplements; and working hand-in-hand with business leaders to ensure the chosen regulatory pathways align with overall business strategy, including plans for developing and protecting intellectual property. Sonia has experience working across all FDA-regulated product areas, with a particular emphasis on the biotech and medtech industries. The transactional side to Sonia’s practice involves advising investors, underwriters, and public and private businesses in buy-side and sell-side transactions, as well as in financings involving FDA-regulated products. During her FDA tenure, Sonia gained subject matter experience across the gamut of FDA-regulated products, including prescription and over-the-counter drugs, medical devices, biologics, foods, cosmetics, dietary supplements and animal drugs. Sonia negotiated dozens of civil consent decrees for the government, defended the FDA in lawsuits brought under the Administrative Procedure Act and the Freedom of Information Act and handled False Claims Act litigation for the agency. Sonia also handled criminal investigations and prosecutions involving FDA-regulated products in her appointed role as a Special Assistant United States Attorney (SAUSA) with the US Attorney’s Office for the Central District of California. Sonia received numerous accolades for her government service – including the FDA’s Award of Merit (the agency’s highest recognition), the FDA Commissioner’s Award and the Department of Justice’s John Marshall Award (the DOJ’s highest award offered to attorneys). Sonia began her legal career as a law clerk to Judge Roger W. Titus of the US District Court for the District of Maryland and worked at a large international law firm for several years before joining the FDA. Before attending law school, Sonia was a management consultant for PwC and IBM, where she developed and implemented solutions for complex business problems.

Every year since 2008, Alison has been selected by her peers for inclusion on the Best Lawyers list for Australia in the practice area of Health and Aged Care. She has also been listed in the Doyles Guide. With over 20 years of corporate, commercial and regulatory experience, Alison has specialised in advising clients in the health, aged care and life sciences sectors. Her clients include public and private hospital operators and health care providers, private health insurers, biotechnology, pharmaceutical and aged care / retirement living and not-for-profit and government clients. Alison was previously General Counsel of one of Australia's largest private hospital operators and a major ASX listed company. She is the company secretary of the National Foundation for Medical Research and Innovation.