Overview
Good Manufacturing Practices (GMPs) / Quality System Regulation
We regularly counsel global pharmaceutical and device companies on manufacturing-related regulatory issues, advise clients on FDA inspections, help clients draft “483” and Warning Letter responses and when necessary, respond to FDA enforcement actions such as product seizures and injunction actions. Our team has negotiated GMP consent decrees with the FDA and the U.S. Department of Justice and advised clients on implementing consent decree requirements. We also have experience advising global pharmaceutical companies on how to establish proper supply chain controls and how to respond to FDA import detentions and import alerts relating to alleged GMP deficiencies.
Drug and device safety surveillance and risk management are critical to the long-term success of a product. Our team has extensive experience counseling clients on compliance with pharmacovigilance requirements, negotiating and implementing risk evaluation and mitigation strategies (REMS) for global pharmaceutical brands, and advising drug and device clients on post-approval labeling changes, product recalls and safety inquiries.
Experience
Examples of our post approval compliance representations include:
Compliance
- Advised an animal health business in addressing and responding to certain alleged product quality problems.
- Prepared a comprehensive legal compliance policy manual for a major pharmaceutical manufacturer, outlining standards and describing company policy for use by their compliance team, employees, and sales force.
- Assisted various pharmaceutical manufacturers in developing or updating compliance policies and procedures on topics such as marketing interactions with physicians and other providers, grants, publications, privacy, charitable donations, and physician consultants.
- Conducted a promotional compliance assessment for a major medical device company to identify high risk products and provided recommendations for mitigating identified risks.
Good Manufacturing Practices (GMPs) / Quality System Regulation
- Represented a medical device manufacturer in responding to an FDA Warning Letter alleging violations of the QSR and negotiating a path forward to permit continued release of the company’s products.
- Investigated alleged Good Manufacturing Practice (GMP) violations at a pharmaceutical manufacturer’s overseas plants and drafted responses to FDA that avoided the threatened imposition of an import alert on a blockbuster product.
- Assisted a pharmaceutical manufacturer in the negotiation, drafting, and implementation of a consent decree of permanent injunction relating to alleged violations of GMPs.
- Prepared responses for the FDA and Congress on high-profile allegations of GMP violations on behalf of a client and worked with public relations professionals to handle related crisis management matters.
Safety Surveillance and Risk Management
- Assisted a multinational pharmaceutical company in crafting worldwide regulatory and risk management strategies with respect to clinical trial results involving one of its drugs.
- Assisted a pharmaceutical company in the preparation of a REMS under the FDA’s FDAAA authorities.