For decades, Venable attorneys have helped clients successfully develop and market drugs, biologics, and medical devices that are regulated by the FDA. Members of our team have served as FDA officials and other government agencies with deep knowledge of the regulatory paradigm and medical product development and approval process.
We recognize that each product encounters unique regulatory challenges, and we offer advice that is practical, strategic, and customized to meet the needs of our clients. Venable attorneys help clients at every step of the product life cycle—from product development and regulatory approval/clearance to marketing, advertising, and reimbursement. Our "bench to bedside" capability across product categories makes the Venable team the to-go law firm for product developers.
Getting to Market
Sponsors face a challenging path as they develop drugs, biologics, and medical devices that are regulated by the FDA. To navigate a complex environment that often involves multiple players, each seeking a competitive advantage, you need sophisticated legal and regulatory skills. The Venable team offers strategic advice to help clients evaluate regulatory pathways and build partnerships that are necessary to ensure success. We have experience guiding sponsors through pre-clinical development and clinical trials, engaging with the FDA through informal and formal meetings, building effective manufacturing and quality systems, and preparing IND, NDA, ANDA, BLA, PMA, 510(k), and associated regulatory submissions. We also help take full advantage of any expedited approval mechanisms and marketing incentives (marketing exclusivity, priority review vouchers (PRVs), patent term restoration) that may be available. Our approach ensures that clients are never alone when facing difficult medical product development questions.
Protecting and Challenging Intellectual Property
Protecting your intellectual property (patents, trade secrets, trademarks, and copyrights) is critical throughout the research, development, and commercialization process. Our attorneys are leaders in these areas. We structure and negotiate licenses, research contracts, and technology transfer agreements to create "win-win" collaborations for our clients' long-term market success. And we know how to protect your product and preserve your ability to market and profit from it in a competitive environment. The Venable team excels at helping companies align their FDA regulatory and intellectual property strategies for success.
Marketing Your Product
Once a medical product makes it to market, it becomes one of the most closely regulated products in the world. The FDA continues to oversee manufacturing, distribution, and labeling, and closely reviews post-approval submissions to ensure products remain safe and effective. Venable attorneys help their clients navigate post-approval requirements, with an emphasis on quickly resolving any compliance actions to ensure their products remain on the market.
Advertising is regulated by both the FDA and the Federal Trade Commission (FTC), which regulates advertising for medical devices and over-the-counter (OTC) drugs. Our substantial practice involving the FDA and FTC draws upon the experience of Venable attorneys who have served in high positions at each agency. Our attorneys are also leaders in litigation against competitors under the Lanham Act and other state and federal statutes under which marketing claims may be challenged.
Getting Reimbursed
Venable attorneys are experienced in federal and state reimbursement issues and can help you secure and maintain reimbursement under Medicare, Medicaid, and other state and federal programs. We also provide critical advice regarding the False Claims Act and anti-kickback laws and have negotiated corporate integrity agreements on behalf of clients.
Help When Trouble Strikes
We're well equipped to protect you when challenges come your way. We also help to assert your interests aggressively—by challenging the regulators or your competitors. We are leaders in advocacy before the FDA and the FTC, and in bringing them to court. We have years of experience in dealing with:
- Seizures, injunctions, and other enforcement actions brought by the FDA and FTC
- FDA warning letters, inspections (negative 483s), product recalls, and import detentions
- Government challenges before the FDA, FTC, and state attorneys general
- Competitor challenges to advertising in proceedings before the National Advertising Division (NAD) and Electronic Retailing Self-Regulation Program (ERSP)
- Patent, trademark, and copyright litigation
- False advertising (Lanham Act) litigation
- Investigations and inquiries by Congress, federal agencies, and state attorneys general
- Other challenges faced by companies bringing medical products to market
Practice Focus
- Abbreviated new drug applications (ANDAs)
- Advertising and Promotion
- Anti-kickback laws
- APA challenges
- Biologics Price Competition and Innovation Act
- Biosimilars
- BLA licensing
- Blood and blood products
- Cell and gene therapies
- Citizen petitions
- Class action lawsuits
- Clinical studies
- Combination products
- Corporate integrity agreements
- Drug Supply Chain Security Act
- Expanded access INDs
- Expedited approval mechanisms
- False Claims Act
- FDA inspections
- Generic drugs
- GxP compliance
- Good clinical practice guidelines (GCPs)
- Hatch-Waxman Act
- Human subject protections in clinical research
- Human tissues and tissue-based products (HTTPs)
- Imports and Exports
- International regulatory strategy
- Investigational device exemptions (IDEs)
- Investigational new drug applications (INDs)
- Lanham Act lawsuits
- Manufacturing
- Marketing exclusivity
- Medicare and Medicaid
- Medical devices (510(k)s and pre-market approval applications)
- Monoclinal antibodies (mAbs)
- NAD challenges
- NDAs (505(b)(1), 505(b)(2) NDAs)
- Non-clinical research
- Off-label use and promotion
- OTC drug advertising
- OTC drug monographs
- OTC switches
- Patent certifications
- Patent infringement lawsuits
- Patent listings
- PMA approval and 510(k) clearances
- Pricing, reporting, and compliance
- Priority review vouchers
- Recalls
- Risk evaluation and mitigation strategies
- Seizures, injunctions, and criminal prosecutions
- Vaccines