Food, Drug & Device/FDA
Alston & Bird’s Food, Drug and Device Group offers a completely integrated food, drug, biologic and medical device practice, serving both domestic and foreign clients handling products regulated by the United States Food and Drug Administration (FDA). Our FDA practice is led by a former FDA associate commissioner for legislative affairs and a former FDA associate chief counsel. Our practice is complemented by Alston & Bird’s expertise in our health care regulatory/reimbursement, intellectual property, corporate, product liability defense, import-export and legislation/public policy practices. The multidisciplinary core of expertise in the life sciences area is the basis for seamless, customized client teams that evolve based on client needs and regulatory and legal developments. The attorneys in our national health care practice and ancillary groups combine government and in-house experience with advanced degrees in biochemistry, medicine, biomedical engineering, medical technology, public health, biology, pharmacy and biostatistics.
OUR SERVICES
We understand the complex regulatory environment to which product manufacturers, distributors and user/provider facilities are subject and the interplay of the FDA, the U.S. Department of Agriculture (USDA), the Federal Trade Commission (FTC), the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services Office of Inspector General (HHS/OIG) and the states in regulating these entities. We offer core legal and regulatory services to the makers, marketers and users of drugs (prescription, over-the-counter, generic and animal), biologics, medical devices and in vitro diagnostics (IVDs), foods (and dietary supplements), cosmetics, tobacco products and any of their components. We guide clients through each phase of product development, marketing and distribution, from invention to clinical review and through post-market surveillance activities. We also offer legal services to vendors, institutions and consultants partnering with makers, marketers and users of FDA-regulated products.
Those services include:
- Counseling on compliance with FDA, USDA, FTC, CMS, HHS/OIG or relevant state processes, policies and procedures (including, among others, GMP/QSR recordkeeping, reporting and notification requirements).
- Strategizing and counseling on responses to inquiries, meeting requests or enforcement actions by FDA, USDA, FTC, CMS, HHS/OIG or relevant state authorities (related to, among others, inspections, warning letters, recalls, marketing activities, litigation, etc.).
- Drafting, submitting and reviewing documents necessary to obtain FDA approval or clearance of new drugs, biologics and devices (including preparation of and assisting in interactions with FDA regarding INDs, IDEs, NDAs, ANDAs, BLAs, PMAs, 510(k)s, supplements and any other required premarketing filings).
- Advising on orphan drug designation, fast-track designation, priority review and pediatric exclusivity.
- Preparing food additive, GRAS affirmation and threshold of regulation petitions.
- Reviewing and providing guidance on labeling and advertising copy for compliance with the provisions of the Federal Food, Drug, and Cosmetic Act and Lanham Act.
- Reviewing and providing guidance on interactions with health care professionals under relevant federal and state laws and industry codes (PhRMA and AdvaMed).
- Resolving import and export issues, including detentions.
- Preparing and strategizing for the filing of citizens’ petitions, advisory opinion requests, dispute resolution requests and FOIA requests.
- Negotiating, drafting and advising on all pertinent corporate documentation including licensing, registration and listing, along with drafting and counseling regarding co-development, co-marketing, supply and distribution agreements.
- Counseling IRBs, and clinical trial compliance and management.
- Providing regulatory support for commercial or enforcement litigation involving FDA-regulated products in federal and state courts.
- Preparing and filing regulatory comments in related administrative rulemaking.
- Reviewing continuing medical education (CME) programming and funding to ensure compliance with agency and industry guidelines.
- Arranging meetings with key decision-makers within the FDA, CMS, HHS, FTC, the Office of Management and Budget (OMB) and the Small Business Administration (SBA), when appropriate.
- Working with members of Congress and state legislatures to impact agency action or shape coming policy or regulatory changes.
OUR CLIENTS
As stated above, our clients span the product distribution chain and include many cutting-edge and well-known domestic and foreign manufacturers, ingredient suppliers and distributors of drugs, biologics, devices/IVDs, foods, dietary supplements, cosmetics and tobacco products. They range from large Fortune® 50 corporations to small start-up enterprises, including nonprofits. Beyond the makers of FDA-regulated products, we also provide regulatory counsel to trade associations and industry organizations, academic and research institutions, investors, wholesalers, retailers, continuing medical education providers and healthcare providers, as well as to individual researchers and physicians.
BRINGING VALUE TO OUR CLIENTS
Alston & Bird’s attorneys assist clients in the food, drug, device, cosmetic and supplement industries by developing creative and successful solutions to the regulatory challenges that they face. Our technical expertise and comprehensive understanding of the industry and regulatory bodies, in which our lawyers have actually served, coupled with our responsiveness, effectiveness and seamless access to experts in other legal areas affecting food, drug and device industry clients sets our team well ahead of the competition.