FDA & BIOTECHNOLOGY

As a firm that includes a focused Food & Drug Administration (FDA) practice, we fully understand both the business and the science of developing and marketing FDA-regulated products.

We are uniquely qualified to assist manufacturers and sellers of FDA-regulated products.

If you are engaged in pharmaceuticals, medical devices, foods and medical foods, laboratory tests, tobacco products or dietary supplements, you know how important it is to be successful in your relations with the FDA. Few firms can match the level of knowledge, scientific understanding and FDA experience we offer. Our team includes a former associate chief counsel for FDA, a Ph.D. in molecular biology and former in-house counsel to a pharmaceutical company. We have appeared before most of the drug reviewing divisions at CDER and CBER and pursued matters with most district offices.

When it comes to navigating the FDA, we’ve got you covered.

Regulatory

Unlike the FDA practices in other firms where a lawyer may work on only one aspect of the regulatory process, our team will guide you every step of the way, including creating rapid, sophisticated legal/scientific rebuttals to FDA actions when necessary. We keep our finger on the pulse of trends in FDA regulatory activity, to help with future planning and problem solving. 

Prescription Drugs

We offer pharmaceutical companies a wide spectrum of FDA-related services, including:

  • Reviewing prescription drug company policies and procedures.
  • Assessing company practices against PhRMA code, as well as state-specific codes of conduct.
  • Providing training in every aspect of compliance.
  • Challenging FDA administrative actions through correspondence, citizen petitions and litigation.
  • Reviewing and revising the labeling of drugs in light of FDA requirements and product liability considerations.
  • Participating in sessions with marketing, HEOR, managed markets, medical, and regulatory representatives to review product, company and disease-focused materials.
  • Working with the FDA on issues cited in FDA warning letters.
  • Negotiating with the FDA and assisting in planning and implementing product recalls.

Medical Devices

We provide a similar range of services for developers and marketers of medical devices. We have represented manufacturers of medical devices in matters such as assessing whether to pursue PMA or 510k filing, assisting with preparation of such filings and guiding on lawful marketing and sales practices. Our attorneys counsel medical device companies on federal and state regulatory issues and negotiate agreements at every step of the product cycle.

The Regulatory Path for Food Industry Clients

In the food industry, your specific regulatory framework is largely determined by the claims you make about your products in labeling and promotional materials. Very few firms have the experience we can provide to steer you through the regulatory complexities, no matter in which category your food products reside. Our team includes a former associate chief counsel for foods at the FDA, a former biologist with the National Center for Food Safety and Technology, and others with deep industry knowledge and experience.

The New Frontier of Cell and Tissue Therapy Regulation

The FDA has created a complex series of regulations that address human cells, tissues, and cellular and tissue-based products (HCT/Ps). We can assist you with all aspects of these regulations. Our attorneys are fully conversant about cell and tissue regulation, including product jurisdiction issues, possible FDA regulatory pathways to market, legal challenges and payment, and insurance coverage matters.

The FDA and Animal Health

Our team is highly experienced in the area of animal health and veterinary pharmaceuticals, including devices. A member of our team served as associate chief counsel for veterinary medicine at the FDA and was responsible for spearheading the creation and inception of the Generic Animal Drug Alliance (GADA) and the enactment of the Generic Animal Drug Amendments of 1988. We help to make certain that clients are well-positioned to manufacture, label and advertise their products in accordance with all FDA requirements. 

Helping You in Washington

Our fully integrated federal lobbying and health policy team is qualified to provide lobbying services for manufacturers of pharmaceuticals, medical devices, foods, medical foods, dietary supplements (including so-called “nutraceuticals”) and laboratory developed tests.

Litigation

The impact of FDA delay has become ever more costly and damaging to companies. We know how to help you minimize the risk of delays, as well as represent you in lawsuits or disputes. We have represented clients in administrative litigation in federal district court on allegations of marketing illegal products, unfair competitive advantages and Lanham Act violations, consumer fraud and other violations. We have also handled disputes between brand and generic drug manufacturers.

Transactions

Throughout the entire processes of development, testing, approval, production and marketing, our attorneys can assist you with all aspects of these transactions. We are adept at managing inconsistencies and smoothing the process at every step. Among the many ways we can accomplish this are:

  • Working closely with our corporate attorneys to assist you with even the most complex pharmaceutical, medical device and biotech mergers and acquisitions.
  • Negotiating and drafting clinical trial agreements as well as informed consent forms with clinical trial subjects.
  • Negotiating and drafting agreements to support all aspects of the business.
  • Guiding on employment matters (g., recruitment, employment handbooks, training, discipline, hot line call management).
  • Assisting with market access-related contracts and strategies.
  • Negotiating and drafting agreements with healthcare providers and vendors that support the commercialization of FDA-regulated products.
  • Helping you work with listing and paying agencies, including becoming listed on insurers’ formularies.