Health & Life Sciences

FDA Regulatory Practice

Pharmaceuticals/Biologics | Medical Devices | Clinical Trials | Dietary Supplements | Advertising and Promotion | Regulatory Compliance and Enforcement | Distribution of Drugs, Biologics, and Controlled Substances | Drug Compounding

Quarles & Brady's FDA attorneys provide counsel on pharmaceuticals, medical device development, dietary supplements, biotechnology, food and beverage, cosmetics, and other regulatory matters that are subject to the jurisdiction of the Food and Drug Administration (FDA). We frequently represent clients before related regulatory agencies, including the Center for Medicare and Medicaid Services (CMS), the Consumer Product Safety Commission (CPSC), the Drug Enforcement Administration (DEA), the Environmental Protection Agency (EPA), and the Federal Trade Commission (FTC). Our goal is to provide specialized, strategic service to clients through every stage of the development and approval process.

Pharmaceuticals/Biologics

Our attorneys assist clients in determining whether there is a need to submit investigational new drug applications (INDs) and provide regulatory requirements related to INDs, new drug applications (NDAs) for initial approval of drug products in the U.S., and abbreviated new drug applications (ANDAs) for approval of so-called "generic” drugs in the U.S. We assist in determining the status of over-the-counter (OTC) drugs and compliance with applicable monographs, or as competitors to "old" drugs that are currently marketed.

We have assisted clients whose new drug product approval comes with distribution restrictions in the form of a Risk Evaluation and Mitigation Strategy (REMS). In this regard, we have also advised clients regarding the implications of refusal to deal positions that some innovator drug companies have taken for their REMS drug products for requests by generic companies to acquire the REMS drug for bioequivalence testing and ANDA approval. In these instances, we have not only advised the innovator or generic drug manufacturer, but also the specialty pharmacies that distribute and oversee the drug use by the patients.

Our attorneys advise clients seeking NDAs on certain benefits in the form of exclusivities and/or Patent Term Restoration they may receive with the approval of the drug product. These include the requirements for orphan drug designation and exclusivity, NDA market and data exclusivities, and pediatric exclusivities. We also advise clients on the possibilities of priority review vouchers for various rare pediatric disease or tropical diseases that they may be pursuing. For approved products, we advise both foreign and domestic clients on the requirements for drug establishment registration and drug listing whether they may be making for themselves or by contract for others.

We advise clients on compliance issues, including current good manufacturing practice requirements; labeling and advertising issues; conducting product recalls; U.S. FDA inspection practices; providing guidance on compliance programs, policies, and implementation; and defending against government enforcement actions. Members of our FDA practice have assisted clients in defending against competitor challenges in court and other forums. Our team routinely provides advice to drug manufacturers, distributors, reverse distributors, and third-party logistics (3PLs) related to compliance with the Drug Supply Chain Security Act of 2013 requirements. Our FDA litigation attorneys regularly provide counseling on product liability issues for drug manufacturers and defend clients on such issues in court. We have forged relationships with various non-legal FDA consultants who assist clients in preparing premarket new drug applications, INDs, and other regulatory matters in the U.S.

Medical Devices

We work closely with our medical device clients to advise the proper classification of devices, and have assisted clients in obtaining market authorization through the premarket approval application (PMA) and premarket notification (510[k]) process. We have assisted clients with a wide variety of compliance and enforcements issues, including good manufacturing practice/quality system (QS) regulation matters; establishment registration and device listing; product recalls or market withdrawals; U.S. FDA inspection practices; responding to Warning Letters and other actual or threatened enforcement actions; and advising on device promotion and advertising boundaries. Our attorneys have experience with a wide variety of medical devices, including traditional products as well as with in-vitro diagnostics, software devices and mobile medical apps, and combination drug/device products.

Our FDA litigation attorneys regularly provide counseling on product liability issues for finished device manufacturers and component suppliers and defending related court cases. We have forged relationships with various non-legal FDA consultants who assist clients to prepare premarket notifications (510[k]s) and applications for premarket approval (PMAs) in the U.S.

Clinical Trials

Quarles & Brady attorneys counsel clients on a wide array of complex issues relating to clinical trials. We regularly advise clients on both the FDA regulatory and healthcare issues presented by clinical investigations of new drugs and medical devices (including biological products regulated as drugs and medical devices). Our attorneys also have expertise in federally funded research regulations involving human subjects.

We routinely advise on such essential FDA regulatory matters as to whether an investigational new drug exemption (IND) or investigational device exemption (IDE) is required. Our counsel includes providing guidance with respect to FDA inspections of clinical investigations at academic medical centers and community based medical centers. Our attorneys assist clients in developing and implementing FDA compliance programs that include Good Clinical Practice guidelines, federal-wide assurances, research protocols, informed consent, conflicts of interest, adverse event reporting, and research policies and procedures. We advise institutional review boards (IRBs) (community-based and commercial) on compliance with FDA and other applicable regulations.

We have experience structuring collaborative clinical research arrangements among multiple institutions, IRBs, contract research organizations, site management organizations, sponsors and investigators, drafting and negotiating joint development agreements, and clinical trial contracts.

Our attorneys are experienced in compliance requirements and with federal and state statutes governing fraud and abuse in this area as well as disclosure laws required under federal and state “Sunshine Laws.” Our goal is to help clients work through the complex regulatory issues presented by the investigational studies and development of new medical technologies.

Dietary Supplements

We provide strategic counsel to the dietary supplement industry on the regulations issues under the Dietary Supplement Health and Education Act (DSHEA) which includes dietary supplement marketing, labeling, manufacturing, and advertising compliance, as well as represent clients in enforcement actions by the FDA for adulterated or misbranded products. We also review and counsel dietary supplement companies regarding compliance with DSHEA substantiation of claims requirements and assist clients in responding to FTC enforcement actions regarding false or misleading advertising. Our goal is to provide advice that will help our clients minimize regulatory challenges and maximize the speed at which they can begin marketing their products to consumers. We regularly work hand-in-hand with relevant industry groups and individual companies on important dietary supplement policy issues to ensure products receive impartial treatment by regulatory agencies.

Our attorneys assist clients on all aspects of dietary supplement development, production, and marketing:

  • Labeling and advertising review and counseling to ensure that proper dietary supplement claims are made by our clients.
  • The appropriateness of product ingredients to meet the statutory definition of dietary supplement. We also help clients determine if any of their products contain New Dietary Ingredients (NDI) and, if so, we assist in the submission of these ingredients to the FDA for review.
  • Assistance with compliance with dietary supplement current Good Manufacturing Practices (cGMPs).
  • Enforcement-related issues regarding product labeling, promotion, or adulteration violations. We represent clients for making proper responses to Form 483 inspection observations and citations for perceived cGMP violations, Warning Letters, Untitled Letters, recalls, product seizures, consent decrees, and civil or criminal violations under the Food, Drug and Cosmetic Act (FDCA). We also represent clients before the FTC regarding claim substantiation in the context of promotion and advertising that may result in a cease and desist order, consent decree, or civil penalties.
  • Drafting manufacturing, quality, distribution, and supply agreements, and evaluating investment needs for new dietary supplement product development.

Advertising and Promotion

We work closely with our FDA-regulated clients on strategic and compliance issues related to promotional communications and activities. Our regulatory attorneys routinely advise clients on specific promotional pieces as well as overall promotional campaigns, including review of proposed promotional labeling, advertising, infomercials, direct-to-consumer marketing, and other forms of promotion to consumers, as well as health professionals for compliance with FDA and FTC requirements, as applicable.

Our knowledge and experience in this area covers a broad range of FDA-regulated products from prescription and over-the-counter drugs or biologics to dietary supplements, medical devices, and traditional and functional food products. We assist clients in responding to the Office of Prescription Drug Promotion (OPDP) Warning and Untitled letters, as well as enforcement actions by the FTC as well as state and local enforcement agencies with similar missions to protect consumers from misleading or deceptive advertising, investigations by state attorneys general, Lanham Act lawsuits, and challenges brought before the National Advertising Division (NAD) of the Better Business Bureau. Our attorneys deal with complex issues related to off-label dissemination, the relationship of promotional activities to fraud and abuse cases, and First Amendment Protection applicable to commercial speech.

Regulatory Compliance and Enforcement

We regularly represent businesses in FDA compliance and enforcement matters. Our attorneys have experience with FDA inspections and in providing assistance in responding to observations and/or warning letters, and we help craft responses and corrective action programs. If your FDA regulatory compliance and enforcement matters are more complex, we can assist in injunction actions and seizures, and litigate or negotiate consent decrees so you can continue or resume product distributions. In addition to FDA compliance, drug manufacturers are required to comply with a myriad of state laws and regulations. We have a long history of successfully representing drug and device manufacturers in connection with licensure, compliance, and enforcement matters in all 50 states, the District of Columbia, and all U.S. territories.

Distribution of Drugs, Biologics, and Controlled Substances

After drugs and devices have appropriate FDA marketing authorizations, the FDA regulated products enter a complex distribution chain. Our attorneys are especially knowledgeable about the pharmaceutical distribution chain. We provide a wide variety of legal advice concerning the wholesale distribution of drug products, including controlled substances and biologics; drug importation and re-importation; "pedigree" issues arising under the Prescription Drug Marketing Act of 1987 (PDMA) at the federal and state levels; additional state requirements; the secondary market; repackaging; and combating counterfeiting, diversion, and other avenues by which drugs become unsaleable.

Drug Compounding

Our attorneys have considerable experience with both human and veterinary drug compounding. We have assisted with FDA and state enforcement actions against pharmacies, appeals to third-party payers, and have provided advice to both pharmaceutical manufacturers and pharmacies on the appropriate limits of pharmacy compounding. In addition to traditional pharmacy compounding practice, we have experience with the Drug Quality and Security Act (DQSA), enacted in November 2013, which created a new type of compounding establishment under section 503B to the Food Drug & Cosmetics Act (FDCA). 503B established a new type of registration known as an “Outsourcing Facility.” Outsourcing Facilities are compounding establishments that, due to the nature of the compounding activity, are regulated by the FDA and required to adhere to requirements imposed on FDA-licensed manufacturers rather than as traditional state licensed pharmacies. Our FDA attorneys counsel clients on a wide array of legal issues related to FDA compliance, including Current Good Manufacturing Practices (CGMP) requirements, audits and inspections, FDA registration, recalls and responding to 483 inspectional observations, Warning Letters, and Untitled Letters.