Ropes & Gray’s FDA regulatory team assists many of the world’s leading multinational pharmaceutical manufacturers, as well as mid-size and start-up drug companies, in navigating FDA requirements across the product life cycle.
Knowledge of FDA regulations is critical when developing an initial regulatory strategy, seeking product approvals, developing an effective lifecycle management strategy, and assuring that products are manufactured and marketed in compliance with applicable requirements. We routinely advise established and development-stage pharmaceutical clients on legal and regulatory matters relating to:
- Nonclinical and clinical trials
- Product approvals, including Rx-to-OTC switches, Advisory Committee meeting preparation, and appeals from adverse approval decisions
- Risk management and drug safety
- Data and marketing exclusivity, including Hatch-Waxman and Orphan Drug issues
- Advertising and promotion
- Adverse event reporting (pharmacovigilance)
- Current Good Manufacturing Practices / Quality System Regulation
- FDA inspections
- FDA Warning Letters and enforcement actions
We frequently represent pharmaceutical companies in disputes with the FDA and each other involving FDA regulatory matters and assist companies in conducting internal investigations of possible violations of FDA rules. We also advise companies on the policies, procedures, training, and other compliance measures that can help mitigate or avoid the risk of violating FDA requirements.
Examples of our regulatory pharmaceutical representations include:
- Assisted a multinational pharmaceutical company in crafting worldwide regulatory and risk management strategies with respect to clinical trial results involving one of its drugs.
- Advised a biopharmaceutical company during FDA approval process for its first drug to be marketed in the U.S., including issues related to FDA approval concerns, development of an initial sales and marketing compliance program, clinical trial matters and distribution/reimbursement concerns.
- Counseled a multinational pharmaceutical company on a variety of issues involving the sale of over-the-counter (OTC) drug products and switching prescription pharmaceuticals to OTC status.
- Provide ongoing advice on the Hatch-Waxman Act, and the appropriateness of listing various patents at FDA in connection with a client’s patent litigation on its contraceptive drug products.
- Assisted a leading pharmaceutical company in preparing submissions, including citizen petitions, to the FDA on issues surrounding bioequivalence of generic versions of the Company’s products including assisting in the development of comments on regulatory requirements governing bioequivalence of other products.
- Assisted in the development of a pharmaceutical client’s policies related to activities of medical science liaisons; and interactions of sales and marketing personnel with health care professionals.
- Represented a major multinational pharmaceutical company in two internal investigations involving allegations of off-label promotion, fraud & abuse violations, manufacturing violations, and failure to comply with internal company policies.
- Conducted a compliance risk assessment of the sales and marketing practices for a major pharmaceutical company’s drug. The assessment had two phases, which required a review of promotional and sales training materials, employee interviews, substantial document and email review.
- Represented a major pharmaceutical company as it worked with FDA to develop new policies for accelerated approval of drugs to treat life-threatening and serious conditions.
- 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.
- Provided regulatory counseling in connection with a “paragraph IV” lawsuit a leading global pharmaceutical company initiated against generic manufacturers who may be infringing the company’s patents.
- Provided regulatory due diligence advice and counsel to a leading global pharmaceutical company regarding the potential purchase of a pharmaceutical drug.