Pharmaceuticals & Biologics

We work with pharmaceutical and biotechnology companies to identify and overcome potential regulatory and business obstacles and to maximize commercial opportunities.

Overview

Our clients include pharmaceutical and biotechnology companies of all sizes, from start-up to multinational businesses, many of which are traded on NYSE, NASDAQ, and foreign-trading exchanges. We work with innovator and generic companies that manufacture both prescription and over-the-counter pharmaceuticals, representing all therapeutic areas.

With a client base of more than 100 pharmaceutical and biotechnology companies throughout the United States and a number based outside of the U.S., we’re known for our pragmatic, creative, and cost-efficient approach to client work. In addition, with lawyers on our team who previously worked at the Food and Drug Administration, we are able to provide clients with an insiders’ view of the regulatory process. We pride ourselves on balancing regulatory objectives with each client’s real-world business considerations to identify and implement the best holistic solution possible.

We help pharmaceutical and biotechnology companies navigate the FDA regulatory process from initial clinical trial development to product approval, product promotion, post-approval requirements, and management. Merely as examples, our lawyers work on orphan drug matters, Breakthrough Therapy Designation requests, clinical trial agreements, quality agreement reviews, import/export issues, Citizen Petition inquiries or market exclusivity and patent certification questions, pharmacy compounding issues, combination product jurisdictional questions, and Good Manufacturing Practice-compliance matters.

AGG lawyers help clients on corporate transactions involving FDA-regulated products. We prepare Regulatory Opinion Letters for securities filing and those regulatory sections involving FDA regulation and regulatory risks. We also conduct due diligence on potential investments, product or company acquisitions, co-promotion, licensing and distribution agreements, and other commercial transactions.

We advise clients with federal and state compliance and enforcement issues, and we counsel on related issues that affect the industry, such as privacy, fraud and abuse, state gift reporting, and trademarks and copyright laws. Clients also trust our advice on regulatory matters involving the Drug Enforcement Administration, the Federal Trade Commission, as well as State Boards of Pharmacy and other state regulatory bodies.

We have decades-long strong relationships with the pharmaceutical and biotechnology industries and we’re committed to maintaining these relationships for decades to come. We currently serve as General Counsel to the Sharing Alliance, Inc. (formerly the PDMA Alliance) and our attorneys are founding members of Georgia Bio (Georgia’s Life Science trade association), teachers of food and drug law at Emory University School of Law, and lecturers at programs sponsored by the Food and Drug Law Institute and the Regulatory Affairs Professionals Society. Our attorneys also serve on the editorial boards of three national FDA and regulatory periodicals, and on the Board of the National Health Museum. We are also recognized by leading rankings institutions including Chambers USA, Who’s Who in Legal Life Science and Best Lawyers.

Experience

Our Food and Drug team provides daily counseling on a wide variety of regulatory issues. AGG is unique in that it can provide a number of services to our pharmaceutical and biotechnology clients beyond merely the FDA-related work. Therefore, rather than list representative “experiences” that any reputable food and drug practice can provide, which we do daily, the following is merely some recent examples where our Food and Drug team and other AGG practice groups assisted our clients.

 

  • Serve on a dozen Promotional Review Committees for companies with either FDA-approved products or products in the investigational stage; we serve as the legal representative to ensure compliance with FDA requirements, but lawyers in our Healthcare, Data Privacy, and Trademark practices often assist, as needed.
  • Draft a number of agreements, such as Product Development and Collaboration, Manufacturing and Supply, Distribution, Intellectual Property License, Website Development, Website Terms and Conditions, and E-commerce for a contract manufacturer of over-the-counter pharmaceutical and dietary supplement products. AGG’s Food and Drug and Corporate practices jointly counsel this client.
  • Represented PL Developments in its acquisition of Teva Pharmaceuticals’ U.S. over-the-counter drug store-brand portfolio and a manufacturing facility. The deal involved lawyers from AGG’s Food and Drug, Corporate, and Tax practices.
  • Provided regulatory assistance to HealthEdge Investment Partners in its acquisition of WraSer Pharmaceuticals and Xspire Pharma to consolidate into a new company. Members of AGG’s Food and Drug and Healthcare practices assisted in the transaction.
  • Served as regulatory counsel to Sebela Pharmaceuticals in its acquisition of Braintree Laboratories, a leader in the gastroenterology pharmaceutical market. Members of AGG’s Food and Drug and Healthcare practices assisted in the transaction.
  • Advised in the formulation of a strategic alliance between a large pharmaceutical company and our client, an emerging drug company, to develop license and market a generic product for the treatment of pediatric epilepsy. AGG’s Food and Drug and Corporate practices were involved in this project.

    Food & Drug Newsletter

    The Food & Drug practice is pleased to bring you these timely updates on the issues currently affecting industries regulated by the U.S. Food and Drug Administration (FDA). We hope you find the information in these recent publications and the upcoming events useful.