The Pharmaceutical Regulatory & Compliance practice at Drinker Biddle & Reath counsels individual companies on regulatory requirements and science and policy issues across a broad range of areas. Our expertise includes:
Representing companies and associations in rulemaking proceedings before medicines agencies, including the U.S. Food and Drug Administration (FDA), Health Canada, and the European Medicines Agency (EMEA), and before standard-setting bodies such as the U.S. and other pharmacopeias, the International Organization for Standardization (ISO), and ASTM International.
Monitoring and influencing domestic legislation and international treaties and guidance documents.
Forming coalitions with patient and physician groups to address pharmaceutical policy issues in the U.S. and internationally.
Providing regulatory advice on issues related to clinical research, sales and marketing, Medicaid and Medicare reimbursement, and fraud and abuse.
Developing strategies to secure product approvals and improve marketing efforts within regulatory guidelines.
Managing common test method development and testing for a given sector of industry.
Areas of Focus
We advise clients on compliance with FDA’s human subject protections and requirements issued by HHS’s Office for Human Research Protections. We have assisted with the formation and education of in-house task forces devoted to clinical research compliance; drafted and negotiated clinical research agreements; prepared informed consent documents; drafted contracts between major research institutions and various service organizations to support the implementation of research protocols; drafted consortia agreements among research institutions; developed policies and procedures for institutional review boards; provided advice to academic medical centers on FDA compliance issues; and communicated with policymakers on legislative and regulatory developments related to clinical research both in North America and the European Union.
We provide specialized expertise in a number of areas, including: filing formal comments with the FDA, EMEA, Health Canada and other regulatory authorities relating to guidance on chemistry, manufacturing and control documentation, and bioequivalence and bioavailability; managing industry-wide toxicological and quality-assurance testing programs; and preparing and filing Drug Master Files that set forth quality specifications and acceptance testing methods. We also help clients understand current regulatory requirements in the U.S. and other regions of the world with regard to pharmaceutical, biotechnology and combination products and medical devices. We have experience with developing risk management plans and arranging benchmark testing as part of assuring drug safety.
Anti-Kickback Statute/False Claims Act/OIG Compliance Guidance/PhRMA Code
We review clients’ proposed research and marketing programs for compliance with the Anti-Kickback Statute (AKS), including compliance with the discount safe harbor, managed care safe harbor and personal services safe harbor, and False Claims Act. For those programs that cannot meet the exacting safe harbor requirements, we routinely assess them on a facts and circumstances basis to determine risk of a finding of AKS violation. We are well versed in the OIG Compliance Guidance for Pharmaceutical Manufacturers as well as with the PhRMA Code and FDA and American Academy of Continuing Medical Education (AACME) guidance with respect to research and grants, compliance with which also assist in putting clients’ proposed outreach programs in the most defensible position.
FDA’s Regulation of Promotion of Medical Products
We counsel pharmaceutical companies on the FDA’s labeling, advertising and promotional policies to ensure that all promotional materials and statements meet FDA’s requirements for truthfulness, fair balance and full disclosure. We understand the regulatory enforcement climate with respect to promotional activities for off-label use and can provide clear and unambiguous advice on best sales practices, regardless of the mode of communication. In addition, in light of evolving policies in this area of the law, we routinely review FDA warning letters and public statements as part of assessing regulatory enforcement trends.
FDA Prescription Drug Marketing Act (PDMA)
We have counseled companies and participated in industry conferences on compliance with the PDMA. We are well-versed in all aspects of the PDMA and can develop best practices for successful PDMA compliance.
Consumer/Prescriber Privacy Laws
We work with pharmaceutical manufacturers and other health care providers with respect to compliance with privacy and data security laws in North America, the European Union, Asia, and Latin America. We serve as privacy counsel to several global pharmaceutical companies and a number of national and regional health systems. DBR also serves as legal counsel and secretariat to the International Pharmaceutical Privacy Consortium, an association of 15 research-based pharmaceutical companies formed in 2002 for the purpose of addressing privacy issues in the pharmaceutical industry.
State Consumer Protection and Pharmaceutical Sales and Marketing Laws
We regularly track the evolving state laws impacting pharmaceutical sales and marketing activities. The divergent state laws present a unique challenge to national and global companies and we can propose best practices to meet these evolving challenges.
We counsel research institutions on ensuring compliance with requirements for documentation and accountability with respect to federal grant funds.