FDA: Drug & Device

Compliance and Enforcement

• Represented a device manufacturer in a criminal investigation, resulting in a nonprosecution agreement.
• Represented a dietary supplement manufacturer in a criminal investigation.
• Represented a device manufacturer in a civil enforcement action challenging Quality System Regulation compliance.
• Assisted a large national clinical research organization with an internal investigation of application integrity fraud and negotiated a resolution with the FDA Office of Scientific Integrity.
• Negotiated a consent decree for a generic drug manufacturer.
• Represented compounding pharmacies in a civil enforcement action.
• Represented a major pharmaceutical company in the resolution of issues related to establishment inspections and warning letters.
• Developed a medical device company’s compliance plan and remediation strategy in response to a recidivist warning letter.
• Defended a generic drug company in litigation regarding current good manufacturing practice (CGMP) regulation.
• Defended a targeted medical device executive in a criminal referral.
• Negotiated an FDA consent decree in a case involving the mass seizure of a generic drug company’s inventory.
• Assisted clients with the initiation, management, and closure of significant drug, device, supplement, and packaged food recalls. This work has included preparation of FDA recall evaluations, strategy, submissions, development of related communications materials, effectiveness checks, reporting, and crisis management.
• Defended class and individual claims asserting that food and dietary supplement products violate state and federal regulations, including:
• Unauthorized nutrient content claims.
• Violation of state and federal “slack fill” regulations.
• Presence of unauthorized dietary ingredients and food additives.
• False or misleading claims regarding ingredients and efficacy.
• Improper or misleading statements of identity.
• Unauthorized health claims.
• Represented a national retailer in an enforcement action by district attorneys of several California counties alleging the sale of an unapproved medical device.
• Won dismissal of a complaint alleging that organic infant formula did not comply with USDA or California organic standards.
• Defeated a motion for class certification and won a motion to dismiss a putative class action alleging the sale of dietary supplements violated controlled substance statutes.
• Defended manufacturers and retailers in several cases alleging that “natural” labeling was false and misleading.
• Obtained summary judgment and dismissal of a manufacturer and retailers of an over-the-counter cold remedy against claims that efficacy claims were false and misleading.
• Defended a manufacturer against allegations that labeling regarding trans fats violated California law.

Corporate

Conducted FDA regulatory due diligence reviews of food, drug, device, in vitro diagnostic, dietary supplement, and cosmetic companies and provided advice to major clients on the regulatory risk profiles of companies subject to pending acquisitions. This work has included:

• Negotiation of a clinical collaboration and licensing deal between a major biotechnology company and a startup biotechnology company for an immunotherapy product.
• Regulatory due diligence related to the acquisition of two contract packagers on behalf of a repackager of drug products.
• Regulatory due diligence related to the potential acquisition of multiple consumer health care brands of a major pharmaceutical and medical device company.
• Counsel to a specialty pharmaceutical company in its initial public offering and follow-on public offerings.
• Counsel to a private equity firm in its investment in an orthopedic medical device company.
• Counsel to a specialty pharmaceutical company in its acquisition of an established and well-known family of products and brands.
• Preparation of related regulatory due diligence memoranda and regulatory legal opinions.

Legislative & Public Policy

• Drafted and helped advocate legislation on many topics, including regenerative medicine, orphan drug designation, access to branded REMS drugs, drug user fees, and expansion of agency–industry collaborations.
• Assisted a client in the negotiation and preparation of testimony before congressional committees on multiple topics, including drug pricing.
• Prepared testimony and provided technical assistance to congressional staff on draft legislation regarding drug shortages.
• Assisted a client in drafting a legislative proposal on pedigree requirements.
• Assisted a client a with drug reimbursement issue at CMS.
• Advocated and secured policy solutions to various issues impacting orphan products.
• Secured an exemption from the ACA’s medical device industry fee for certain medical devices.

Affirmative Litigation

• Represented a generic drug manufacturer in an Administrative Procedure Act (APA) challenge to a therapeutic equivalence determination.
• Represented an international produce company in an APA challenge to an import alert.
• Represented a generic drug manufacturer in an APA challenge to ANDA rescission.
• Represented a device manufacturer in an APA challenge to an import alert.