Both established brands and innovative startups turn to Alston & Bird’s FDA attorneys for counsel on various FDA regulatory and compliance matters affecting prescription and OTC drugs, biologics, medical devices, in vitro diagnostics, food ingredients, supplements, cosmetics, and tobacco products. Our experience includes highly visible litigation, as well as discreet resolution of potentially serious charges. We have extensive experience with issues occurring throughout the product life cycle, including those related to clinical trials, product applications, market entry, product promotion, current good manufacturing practices (CGMPs), quality system regulations (QSRs), and product recalls. We also provide regulatory advice and FDA due diligence support for corporate financing and mergers and acquisitions. On legislative matters, we assist in the development of policy and implementation strategies, help draft legislation and testimony, prepare clients for interviews with congressional committee staff, assist with agency oversight, and provide advice on pending legislation.
Clients in the food, drug, device, cosmetic, supplement, and tobacco industries come to us for creative and business-minded solutions to the regulatory challenges they face. Our technical prowess and comprehensive understanding of the industry and regulatory bodies—where our lawyers have actually served—coupled with our responsiveness, effectiveness, and seamless access to practitioners in other legal areas affecting food, drug, device, and other industry clients regulated by FDA, CMS, HHS, FTC, TTB, USDA, and other federal and state government agencies sets our team well ahead of the competition.
We have been recognized by the American Health Lawyers Association, Chambers USA, and other ranking organizations as one of the nation’s top health care law firms. We are also recognized in The Best Lawyers in America in both biotechnology and health care and by U.S. News-Best Lawyers® “Best Law Firms” in FDA Law.
FDA/Food, Drug & Device
FDA regulatory, compliance, and litigation matters require experienced counsel who regularly interact with the FDA. We analyze risks, help maintain compliance, handle crisis management, and litigate throughout the life cycle of FDA-regulated products and services. We spot opportunities and help lower legal/regulatory hurdles so you can focus on the important commercial needs of your business.
- Drafted comments on a wide variety of proposed guidance documents for pharmaceutical, medical device, and biologics clients.
- Prepared citizen petitions on issues of importance to branded and generic drug manufacturers.
- Advised the internal promotional review committees of major prescription drug and biologic companies.
- Assisted a $2 billion privately held company in seeking new indications for its medical-imaging contrast agents and exploring regulatory pathways for combining drug-device products.
- Prepared substantial equivalence reports for full lines of tobacco products and obtained FDA approval orders.
- Represented a startup orthopedic device manufacturer in obtaining premarket clearance for a fixation device employing innovative technology.
- Advised a clinical-stage biotechnology company on the resolution of a clinical hold imposed following the death of a patient.
- Reviewed a health care provider’s device tracking policy and procedures for compliance with FDA’s tracking and recordkeeping requirements.
- Submitted complaints to FDA on behalf of a major maker of OTC cough and cold remedies regarding misleading competitor promotional activities.
- Counseled a university clinic on adverse event and medical device reporting requirements for user facilities.
- Obtained favorable designation of a tissue-based product as a tissue rather than a medical device based on FDA’s minimal manipulation rules.
- Represented a drug company petitioning FDA to expand the scope of an OTC drug monograph.
- Worked with the National Organic Program at the USDA to resolve organic certification eligibility issues for a major food manufacturer.
- Reviewed and drafted GRAS certifications and customer guaranties for food-contact substance manufacturers.
- Worked with FDA on behalf of a beverage manufacturer to resolve import detentions and demonstrate that lead concentrations fell within a permissible range under regulatory standards.
- Counseled an in vitro diagnostic developer on the regulatory premarket notification requirements for bringing an OTC blood-based pregnancy test to market.
- Reviewed a mobile app developer’s app functionality to assess application of FDA’s regulatory authorities.
- Advised a health care provider on DEA diversion reporting obligations for losses of controlled substances.
- Obtained an increased DEA quota for controlled drug manufacturer.
- Assisted a beverage and tortilla manufacturer with new product launches, including review of labeling and marketing claims.
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.
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.
- 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.
Digital Transformation of Health Care
Alston & Bird works with clients on the forefront of the digital transformation of health care.
Alston & Bird Adds Former FDA Associate Chief Counsel Alexandra Marzelli as Counsel in Washington, D.C.
Alston & Bird has expanded its health care and life sciences regulatory and compliance capabilities with the addition of counsel Alexandra Marzelli, former associate chief counsel at the U.S. Food and Drug Administration (FDA). Based in the firm’s Washington, D.C. office, Marzelli joins Alston & Bird’s Health Care and FDA/Food, Drug & Device Groups, where she will advise clients on the FDA’s complex approval process and regulatory compliance for prescription and over-the-counter drugs, biologics, medical devices, food ingredients, and other products regulated by the agency.
Matt Mamak | Crossroads of Biopharma and Securities: Navigating Competing Regulatory Agency Needs
Corporate transactions partner, Matt Mamak, gives life sciences companies a peek into capital raising and securities disclosure issues specific to their industry.