Venable attorneys have decades of regulatory experience with therapeutic products. We help clients at every step of the product life cycle—from product development and regulatory approval/clearance to marketing, advertising, and reimbursement.
Getting to Market
Drugs (human and veterinary), devices, and biologics are strictly regulated by the Food and Drug Administration (FDA). The requirements for market entry can be complex and onerous. Over-the-counter (OTC) drug monographs, NDAs, ANDAs, PMAs, 510(k)s, BLAs—all can pose significant challenges. To navigate in a complex environment that often involves multiple players, each seeking a competitive advantage, you need sophisticated legal and regulatory skills.
Protecting and Challenging Intellectual Property
Protecting your patents, trade secrets, trademarks, and copyrights is critical throughout the process. Our attorneys are leaders in these areas. We structure and negotiate licenses, research contracts, and technology transfer agreements. And we know how to protect your product and preserve your ability to market and profit from it in a competitive environment.
Marketing Your Product
Once a therapeutic product makes it to market, it becomes one of the most closely regulated products in the world—subject to a diverse set of regulatory concerns. The FDA regulates the manufacture, distribution, and labeling of therapeutics and monitors prescription drug advertising. The Federal Trade Commission (FTC) regulates advertising for medical devices and OTC drugs.
We practice before those agencies and draw upon the experience of Venable attorneys who have served in high positions at each agency. We are also leaders in litigation against competitors under the Lanham Act and other state and federal statutes under which marketing claims may be challenged.
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.
You may need 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 also know how to address bad behavior on the part of your competitors through challenges to false advertising under the Lanham Act and other state and federal statutes.
Help When Trouble Strikes
We're well equipped to protect you when the challenges come your way. We have years of experience in dealing with:
- Seizures, injunctions, and other enforcement actions brought by the FDA and FTC
- FDA warning letters, inspections, recalls, and import detentions
- Government challenges before the FDA, FTC, and state attorneys general
- Competitor challenges to advertising in proceedings before the NAD and ERSP
- Patent, trademark, and copyright litigation
- False advertising (Lanham Act) litigation
- Inquiries by state attorneys general
- Other challenges faced by companies bringing therapeutic products to market
- 505(b)(2) NDAs
- Anti-kickback laws
- APA challenges
- BLA licensing
- Citizen petitions
- Class action suits
- Clinical studies
- Corporate integrity agreements
- False Claims Act
- FDA inspections
- Good manufacturing practices
- Hatch-Waxman Act
- Lanham Act lawsuits
- Medicare and Medicaid
- NAD challenges
- NDA and ANDA approvals
- 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
- Prescription drug advertising
- Pricing, reporting and compliance
- Seizures, injunctions and criminal prosecutions