Our firm helps life sciences companies including pharmaceutical, medical device, biological product, tissue, and combination product manufacturers navigate U.S. Food and Drug Administration ("FDA") approvals and regulatory issues. We are problem solvers with experience addressing all kinds of situations throughout the lifecycle of a product – from the earliest stages of development through the approval or clearance process and into the product's post-market life. The depth and breadth of our FDA team's experience allows us to tailor approaches to meet the needs of clients that differ in size, therapeutic or diagnostic area, and culture. We counsel large and small companies, including major global corporations, start-ups, and R&D firms.
We also counsel several trade associations and coalitions in the industry regarding mHealth, clinical decision support software, combination products, other emerging technologies.
To provide our clients with the best possible outcomes, we often take a multidisciplinary approach to complex FDA problems, looking at not only the law but also the science at issue. We work regularly with a team of engineers, scientists, and technology experts to bring clients comprehensive and practical solutions.
Services/Scope of Practice
Early Product Development and the Investigational Phases
- Advising on investigational new drug and investigational device exemption regulatory submissions
- Advising and developing regulatory strategy
- Developing and negotiating a variety of research-related agreements, including site and investigator agreements; master services agreements; and co-development, co-promotion, outsourcing, and other strategic research, development, and collaboration agreements
- Advising on Good Clinical Practice requirements, both domestically and internationally
- Providing counsel on clinical trial registries and databases
- Developing clinical research compliance programs for manufacturers, clinical research organizations, and site management organizations
- Helping solve clinical trial problems, such as clinical holds and disputes with FDA regarding trial design and endpoint selection
- Advising clients on relationships with physicians, investigators, and research institutions
The FDA Approval Process
- Assisting in preparing marketing applications for medical devices (premarket approval applications ("PMA") and 510(k) submissions); drugs ((505(b)(1) and 505(b)(2) applications, and abbreviated new drug applications ("ANDA")); and biological products (biological license applications ("BLA"))
- Advising on FDA approval pathways (e.g., standard and accelerated approval paths for drugs and biological products), combination drug policy issues, product formulation and chemistry manufacturing and controls ("CMC") associated with drugs and biological products, and pediatric study requirements
- Helping resolve disputes with FDA by developing strategies, preparing responses to adverse FDA decisions (e.g., "complete response" letters for drugs, "not substantially equivalent" determinations for medical devices), and pursuing administrative appeals
Post-Approval Compliance and Enforcement
- Advising on current good manufacturing practice ("cGMP") and Quality System issues
- Developing policies, procedures, and strategy pertaining to FDA compliance, including product recalls (e.g., standards and processes for initiating recalls) and promotional practices (e.g., permissible claims and off-label promotion issues)
- Drafting responses to FDA-483s, Untitled Letters, and Warning Letters as they relate to various compliance issues (e.g., alleged cGMP or Quality System deficiencies, challenges to advertising, and promotion)
- Conducting Prescription Drug Marketing Act and Drug Enforcement Administration compliance reviews
- Reviewing proposed product market strategies, including the analysis of promotional claims and strategies, such as the use of social media and mobile applications
Regulatory Opportunities and Other Issues
- Preparing PDUFA user fee waiver requests for application, product, and establishment user fees
- Advising on Hatch-Waxman exclusivities and patent term extensions
- Assisting in pursuing pediatric market exclusivity for pharmaceuticals
- Advising clients on Emergency Use Authorizations for products in development
- Preparing Citizen Petitions to advocate on product-specific standards for clearance or approval, and for broad-based regulatory and policy reforms
- Assisting with import and export issues for FDA-regulated products
- Advising on research use only ("RUO") and investigational use only ("IUO") products
- Advising on the development of companion diagnostics for novel therapeutics
- Providing counsel on the standards for regulation of human cells, tissues, and cellular and tissue-based products ("HCT/P")
- Developing and implementing all aspects of corporate compliance programs for manufacturers and their direct and indirect customers
- Conducting corporate effectiveness reviews of corporate compliance programs
- Developing training programs on corporate compliance for marketing and sales forces, and assisting with the development of reporting systems and the development of compliance audit list priorities
- Developing clinical trial research corporate compliance programs for manufacturers, clinical research organizations, and site management organizations, including compliance with Good Clinical Practices, human subject protection compliance procedures, and procedures regarding investigator-initiated research
- Developing research compliance programs addressing relationships with research sites, researchers, vendors, professional organizations, independent foundations, and other participants in the clinical research process
Policy and Legislation
- Monitoring and analyzing pending federal and state legislation, rulemaking, regulations, and guidance
- Providing assistance with the submission of comments in connection with pending legislation and the preparation of testimony
- Providing counsel regarding state marketing, sales, gift, compliance program, pricing, clinical trials, pedigree, and related reporting requirements
- Providing legislative industry updates and analyses
In the mid-1990s, on behalf of the Indiana Medical Device Manufacturers Council and about a dozen large trade associations representing virtually every industry the FDA regulates, EBG attorneys advocated that FDA should improve its guidance development process to enhance the quality and reliability of guidance, as well as to better ensure public participation. EBG's advocacy resulted in the so-called FDA Good Guidance Practices, now embraced by other federal agencies as well.
On behalf of the coalition of trade associations and individual companies, EBG attorneys successfully sought to have responsibility for administering the Clinical Laboratory Improvement Amendments of 1988 moved from the Centers for Disease Control and Prevention to the FDA, and to have legislative amendments designed to clarify the waived category passed.
For a large medical device manufacturer, EBG attorneys conducted a series of internal investigations that identified areas of noncompliance and guided the company toward practical remediations.