Practice Areas

Life Sciences Regulatory

When life sciences organizations need comprehensive, end-to-end regulatory support, they turn to Paul Hastings. With decades of experience at and across from the FDA, DEA, and other federal and state agencies, our Life Sciences Regulatory team provides creative, practical and strategic advice that leverages our deep understanding of the law, the science, the agencies and our clients’ business goals.

We solve critical regulatory issues throughout the entire product life cycle, from the earliest phases of product development through approval and post-approval compliance. We have helped clients obtain product approvals and regulatory exclusivities for drugs and biologics across a range of therapeutic areas, including numerous novel molecules, controlled substances and unconventional data packages. In each instance, our goal is to help companies make the case on the science and clinical data within the framework established by the law, precedent and FDA’s public health mission.

Our clients run from early stage companies still identifying compounds to global corporations with scores of approved products and everyone in between, as well as investors, inventors and research universities. Our lawyers have decades of invaluable experience — at FDA, in private practice and in-house — giving us an informed and current sense of agency views, industry practices and what works.

We are laser-focused on helping our clients operate successfully in a highly regulated environment to achieve their business objectives. We understand the timing and precision imperatives of running a life sciences business and collaborate with a client’s in-house medical, science, commercial, compliance and legal teams, as well as outside consultants. Working hand-in-glove with our Paul Hastings life sciences colleagues in corporate, IP, litigation and other practices, our legal and regulatory group provides comprehensive support in matters such as:

Advertising and promotion
Agency meeting requests, briefing materials, presentation preparation
Breakthrough
cGMP compliance
Citizen petitions
Clinical trial compliance
Controlled substance scheduling and compliance issues
Fast track
FOIA issues
Formal and informal dispute resolution
Hatch Waxman/BPCIA/regulatory exclusivities
Orphan drug designation and exclusivity
Patent listing
Pediatric issues
Pharmacovigilance obligations
PMRs
Post-market studies
Product applications
Product approvals
Product development
Product labeling
Product reviews
Product safety
Rare disease studies and approvals
REMS negotiations and implementation
Securities law disclosures
Strategic agency interactions
Transactional due diligence

Representations

Depomed at FDA and in court to obtain orphan exclusivity for Gralise.
Multiple companies in FDA dispute resolution and the Administrative Hearing process after FDA refusal to approve an NDA or BLA.
Strategic advisor to sponsors of products for rare diseases or high unmet need in the development of the data package for application submission and engagement with FDA before and during the review.
Multiple innovator companies in the negotiation, development and implementation of REMS.
Pharmaceutical clients in FDA pharmacovigilance inspections throughout the process, from preparation to successful closeout.
A client in developing FDA legal and regulatory strategy for obtaining approval and three-year exclusivity that was essential to commercial success.
A company in developing and implementing a strategy that convinced FDA to reverse its denial of orphan drug designation for the company’s sole product and moved the product to approval and orphan drug exclusivity.
A senior executive in negotiating and operating under an FDA consent decree and subsequent Department of Justice investigation.
A client in authoring a successful FDA petition ensuring patent certification and opportunity for litigation and 30-month stay with competitor’s 505(b)(2) NDA.
A client in successfully advocating to the FDA Exclusivity Board for favorable decision on the scope of three-year exclusivity.
Multiple pharmaceutical clients throughout the controlled substances scheduling process, leading to the successful marketing of the product.
Multiple clients on controlled substances compliance obligations, import/export provisions and quotas.
Multiple clients in DEA enforcement actions, including response to an order to show cause and negotiation of settlements.