Regulatory Counseling: Product Development, Manufacturing, Marketing & Surveillance
Alston & Bird understands the complex regulatory environment in which product manufacturers, distributors and user/provider-facilities operate. We guide clients through each phase of the product life cycle, from invention to clinical review, product approval, manufacturing, distribution, promotion and surveillance.
These services include:
- counseling sponsors, institutional review boards (IRBs) and contract research organizations (CROs) on compliance with regulatory requirements for human subject research, good clinical practices (GCPs), and clinical trial management;
- drafting, submitting and reviewing documents necessary to obtain FDA approval or clearance of new drugs and new devices, including INDs, IDEs, NDAs, ANDAs, BLAs, PMAs, 510(k)s, supplements and all required premarketing filings;
- providing advice on orphan drug designation, fast-track review and pediatric exclusivity;
- preparing citizens’ petitions and FOIA requests, food additive petitions, GRAS affirmation and threshold of regulation petitions;
- preparing regulatory comments in administrative rulemaking;
- providing advice on import and export compliance;
- reviewing labeling and advertising copy for compliance with the Federal Food, Drug and Cosmetic Act, the Lanham Act and the National Advertising Division of the Council of Better Business Bureaus; and
- counsel on product labeling, review of marketing and promotional materials and strategies.
Compliance and Enforcement
Our practice also includes strategic counseling on FDA compliance and enforcement matters regarding product manufacturing. We assist our clients in responding confidently to FDA concerns in a manner that strengthens client processes, while restoring credibility with FDA. Our team focuses on resolving FDA compliance and enforcement matters and provides the following services:
- advising and counseling regarding inspection management, responding to Form FDA 483 Inspectional Observations and Warning Letters, product recalls, import holds and detentions;
- conducting independent internal investigations/audits of compliance with CGMPs and QSRs.
- developing compliance and remediation plans;
- representing FDA regulated clients at the agency level and in federal court on compliance and enforcement matters; and
- negotiating consent decrees and providing strategic advice regarding seizures, injunctions, application integrity matters and import alerts.
We also assist food, drug, biologic and medical device manufacturers, distributors and CROs with negotiating and entering into the various contracts necessary to carry out their operations in compliance with FDA regulations, including:
- drafting and negotiating product supply, development, manufacturing and quality control agreements;
- drafting and negotiating expanded access program and named patient program development and service agreements;
- formation and negotiation of joint ventures and contractual agreements related to development, manufacturing and distribution; and
- drafting standard terms and conditions and policies related to shipping and distribution.
Legislative and Public Policy
Our team includes numerous former administration and congressional officials and staffers with a wealth of knowledge regarding recent and anticipated changes to laws affecting manufacturers, distributors and users of FDA-regulated products. Our services include the following:
- analysis of proposed legislation and emerging policies affecting FDA regulated clients;
- developing legislative strategies and advocacy materials;
- drafting testimony and preparing witnesses for congressional hearings regarding legislation affecting the federal Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Prescription Drug User Fee Amendments (PDUFA) and the Social Security Act (SSA);
- assisting pharmaceutical, biologics and medical device clients in responding to all aspects of congressional inquiries and investigations;
- tracking state initiatives on issues of importance to FDA regulated entities; and
- monitoring activities of key House and Senate Committees.
Our FDA regulatory team members include a former associate FDA commissioner, a former FDA associate chief counsel for enforcement and a former associate general counsel for the American Red Cross. On litigation matters, our team includes a former U.S. attorney and several former assistant U.S. attorneys, a former counsel to the deputy attorney general and a former assistant deputy attorney general in the U.S. Department of Justice. Our Legislative & Public Policy team includes former U.S. Senate Majority Leader Bob Dole and former Chairman of the U.S. House of Representatives’ Committee on Energy and Commerce, as well as former president and CEO of PhRMA, Billy Tauzin. We work closely with other members of our health care team, which includes a former member of the U.S. House of Representatives, a former CMS administrator and a former deputy general counsel and acting general counsel of the U.S. Department of Health and Human Services (HHS). Our health care team also includes a member of the National Advocacy Council for the CDC Foundation, Inc., a vice-chair of the American Health Lawyers Association Hospitals and Health System Practice Group and a board member of the Southeast BIO Organization.
The firm has been recognized by the American Health Lawyer’s Association as one of the nation’s top health care law firms. We are listed in The Best Lawyers in America in both Biotechnology and Healthcare.
Bringing Value to Our Clients
Our clients span the product distribution chain and include many cutting-edge and well-known domestic and foreign manufacturers, component 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 manufacturers 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 health care providers, as well as to individual researchers and physicians.
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.