Food and Drug Regulation

We tackle complex regulatory problems by understanding how to devise practical solutions that account for the substantial relational capital and complex business realities that our clients face. Our portfolio is heavily weighted toward fully integrated, multinational pharmaceutical and biotechnology companies. Some of the regulatory issues recently handled by our lawyers include:

Days before the PDUFA action date, a sponsor learned that no established (generic) name had been obtained for its new oncology drug. We ensured the drug was approved on schedule anyway.
A medical device manufacturer received a 483 for QSR violations at its principal establishment. We made sure the affected devices stayed on the market and devised an aggressive but achievable remediation strategy to bring the company into compliance - without an FDA warning letter.
The leading manufacturer of a particular kind of medical device learned that a non-innovator aspiring competitor was seeking a change in regulatory status for the product to obviate the need for vital clinical testing. We worked as part of a coalition of innovator manufacturers to make sure that FDA and the relevant advisory panel understood the public health implications of the requested change. Soon after, FDA signaled its intention to reject the request and the petitioner withdrew.
Facing numerous products liability lawsuits, a large pharmaceutical manufacturer needed to devise competitive promotional communications that would distinguish the product from others in a crowded therapeutic class. We worked with an interdisciplinary team of medical, regulatory and legal professionals to develop advertising that advanced the business objectives, without creating a record of FDA correspondence that could be used against our client by plaintiffs’ lawyers.
A medical device manufacturer acquired a small start-up developer of an innovative orthopedic device. The sellers failed to disclose certain FDA documents that were material to the transaction. A team of Sidley regulatory, litigation and transactional lawyers worked with the client’s legal, regulatory affairs and business people to bring a claim against the sellers based on a sophisticated review of the regulatory record.
The manufacturer of a blockbuster primary care product faced generic competition for the first time. We developed a strategy to achieve the company’s objective of maintaining tier 2 formulary status that relied on a nuanced, but highly credible statutory and regulatory analysis of the FDCA.
A well-established bio-oncology company received a subpoena for documents relating to the marketing of one of its cancer drugs. We worked with in-house counsel and our colleagues in the Healthcare practice to develop sound statutory and regulatory arguments identifying the weaknesses in the government’s proposed interpretation of the FDCA. To improve the regulatory and enforcement environment generally, we formed a coalition of medical product companies to press FDA to clarify its policies in this area.