FDA & Healthcare Regulatory

To support companies and investors, our team delivers forward-looking solutions for regulatory compliance and deal execution at the U.S. federal and state levels. We help disruptors scale, develop strategic partnerships, protect IP and navigate a plethora of new regulation. The team is a key part of our multi-dimensional approach to supporting the life sciences, healthtech and healthcare ecosystem.

• FDA Regulation
• Healthcare Regulation

FDA Regulation

Orrick’s FDA team, which is based in Washington, D.C., brings years of experience helping hundreds of innovative U.S. and international life sciences and healthtech companies navigate the complex regulatory and enforcement landscape related to the U.S. Food and Drug Administration (FDA). The team is fluent in the laws, regulations and policies affecting FDA-regulated industries including pharmaceuticals, medical devices, wearables, cosmetics, biologics, foods, agtech, dietary supplements, digital health products, software as a medical device (SaMD), and health and wellness products. We also focus on helping our clients benchmark across verticals and see around corners to understand how the regulatory framework is likely to evolve.

FDA Approvals and Premarket Clearance. In collaboration with Orrick’s healthcare regulatory team, the FDA team provides holistic, strategic counseling to guide clients from “bench to bedside” throughout the entire product lifecycle. Our clients include some of the world’s largest and most sophisticated pharma and device companies to small, yet highly innovative start-ups utilizing machine learning (ML), artificial intelligence (AI) and other cutting-edge, novel technologies. The team works closely with life sciences and healthtech companies of all sizes on determining the optimal regulatory strategy for obtaining product approvals or premarket clearance, as well as determining instances when premarket approval or clearance may not be necessary.

Advertising, Marketing, and Promotions. Advertising, marketing and promotions are critical for any successful product launch, so the team is particularly focused on helping companies craft robust, compliant labeling and advertising to maximize U.S. marketplace opportunities. We also provide targeted advice to companies in a post-market environment should questions of safety, efficacy, product liability, or legal/regulatory compliance arise.

Corporate Transactions and Risk Assessments. The FDA team conducts regulatory due diligence reviews for the full range of corporate transactions, including venture financings, licensing & strategic arrangements, mergers & acquisitions, IPOs and follow-on offerings. We also conduct investment risk assessments that can inform our private equity clients’ strategic decision-making.

Consumer Product Safety. The firm also provides targeted counseling to life sciences and healthtech companies in FDA-adjacent spaces such as those governed by the Consumer Product Safety Commission (CPSC), the U.S. Department of Agriculture (USDA), and the Federal Trade Commission (FTC).

In short, Orrick’s FDA team offers a full range of critical services that life sciences and healthtech companies need to scale and thrive – corporate transactional support and regulatory due diligence reviews; advertising, marketing and promotion counseling and defense; FDA enforcement and litigation representation; pre-market strategic counseling; Good Manufacturing Practices (GMP) review and enforcement assistance; FDA Import Detention release; compliance plan design; product recall and crisis management navigation.

Healthcare Regulation

Orrick’s healthcare regulatory team is well-versed in structuring business models and advising on operational compliance questions throughout the lifecycle of an organization in ways that help advance innovation amidst an ever-changing regulatory landscape at both the state and national level.

We represent stakeholders across the healthcare industry, including digital health startups, emerging companies scaling nationally, venture capital and private equity investors fueling healthcare innovation, publicly traded healthtech companies, nationally recognized health systems and companies utilizing “click and mortar” models that leverage technology to transform the patient care experience. The breadth and depth of that experience informs a broad, sophisticated, and nuanced market perspective when advising companies shaping the future of healthcare.

Digital Health and Artificial Intelligence. In virtual care delivery, innovation is significantly outpacing regulation. Leveraging experience to “see around the corner” is therefore critical. Our expertise involving state corporate practice of medicine, psychology, nursing, and other professional services doctrines is drawn from our experience establishing and scaling dozens of “PC-MSO” arrangements across all fifty states (and negotiating the agreements establishing those arrangements). Having guided 100+ digital health companies on the full scope of regulatory issues impacting healthcare providers, we have a deep understanding of state laws addressing telehealth modalities, practitioner licensure, consent, virtual prescribing, and controlled substances prescribing. Together with the firm’s industry-leading Artificial Intelligence and FDA practices, we advise healthcare stakeholders on cutting edge artificial intelligence issues. From “chatbot” solutions utilizing generative AI to imaging solutions, clinical decision support, diagnostic and patient navigation tools, our understanding of state regulatory frameworks enables us to counsel innovators leveraging artificial intelligence in a rapidly evolving space.

Fraud and Abuse. Structuring financial arrangements with referral sources in compliance with fraud and abuse laws is a critical component of healthcare regulatory compliance. We assist clients in proactively assessing compliance with state and federal anti-kickback laws, physician self-referral prohibitions, beneficiary inducement laws, and related fraud and abuse authorities, as well as assessing potential overpayment and self-disclosure obligations as necessary.

Health Information Privacy. In collaboration with Orrick’s top-tier Cyber, Privacy & Data Innovation Practice, we counsel clients on patient privacy and security laws at the state and federal level, including the Health Insurance Portability and Accountability Act (HIPAA), the federal confidentiality of substance use disorder patient records regulations (42 CFR Part 2), and state-specific laws applicable to sensitive information, including in the behavioral health context.

Compliance Infrastructures. Having an effective compliance program is a hallmark of a compliance-minded healthcare organization and can help significantly mitigate regulatory risk. Our team advises on establishing compliance frameworks, and periodic assessments of how such frameworks are implemented, tailored to the client’s needs. Such support includes drafting or reviewing key policies and procedures, assisting with compliance audits and internal investigations, and advising key organizational leaders and compliance teams on corporate compliance considerations.

Strategic Affiliations and Other Contractual Relationships. Innovation in healthcare is often achieved through strategic affiliations as healthcare stakeholders seek opportunities to collaborate to improve quality, reduce costs, and expand access to care. We regularly assist with the establishment of value-based care arrangements, joint ventures, and other strategic affiliations intended to drive change in healthcare delivery.