Life Sciences

Life sciences companies are in the business of helping people. The drugs and devices they develop are designed to alleviate pain, cure disease, treat illness, and much more. However, the life science industry continues to face the challenges of increased competition, demographic changes, technological innovation, and regulatory upheaval.

Blank Rome’s life sciences team works with clients to mitigate those challenges by looking at the issues from all angles. How will the changing regulatory and risk environment impact your business? What security and privacy adjustments are necessary to cope with increasing digitization? How do you preserve or build shareholder value with continued pricing pressures and rising R&D expenses? We take a pragmatic, business-focused approach to create comprehensive strategies to help you succeed at every stage of your business. 

We have deep experience in corporate transactions and M&A, intellectual property matters, commercial and product liability litigation, regulatory compliance, and anti-corruption. We address numerous government relations matters through our government affairs team of top lobbying and strategic communications professionals. 

Our team has also established themselves as not only thought-leaders but as the go-to attorneys within the compounding pharmacy sector. Blank Rome’s growing practice has a solid emphasis on counseling compounding pharmacies in both human and animal health in regard to compliance with state and federal laws. We have also acted as lead litigation counsel for clients (and coalitions) for disputes with the Food and Drug Administration (“FDA”) and the Drug Enforcement Administration (“DEA”), as well as various state boards of pharmacy in administrative proceedings and federal courts.

On behalf of our clients, our team has won significant case victories against the FDA on behalf of coalitions of compounding pharmacies. These successes include suits challenging the FDA’s memoranda of understanding (“MOU”) relating to a proposed volume limitation on interstate dispensing of compounds. Being that the MOU is one of the most critical issues facing compounding pharmacies, it is often immensely difficult to prevail against the FDA in such matters. Nonetheless our team managed to obtain the full relief that was sought by our clients. 

Many of our attorneys and advisers have significant government experience related to compliance, enforcement, and reimbursement issues before other federal agencies such as the National Institutes of Health (“NIH”), the Centers for Medicare and Medicaid Services (“CMS”), the Department of Justice (“DOJ”), and the Office of the Inspector General (“OIG”). 

When legal challenges arise, we deliver smart, effective defense strategies backed by solid industry experience. Beyond litigation, we also provide proactive support—offering routine counsel, customized training, and early liability assessments to help clients stay ahead of risk. When an FDA warning letter is issued, we act swiftly to minimize disruption and prepare for any potential legal action. Our team can assist clients with all related FDA letter issues, including:

• Merger & acquisition and related due diligence
• Patent applications
• Risks related to procurement and compliance
• Various FDA rules violations 

Our team also helps clients with numerous potential pre-market and post-market issues such as:

• Jurisdictional product identification
• Pre-market review
• FDA inspections
• Form 483 review
• Warning letter review and response
• Enforcement actions

Our industry team can also bring in attorneys focused on specific legal issues such as labor and employment, tax, business restructuring, due diligence, change of ownership, regulatory approvals, real estate, and others to address any issue that arises.

How We Can Help 

We represent a wide range of life sciences companies and industry professionals, including: 

• Drug and device developers, manufacturers, and distributors
• Active pharmaceutical ingredient producers and importers
• Biotechnology innovators
• Academic medical centers
• Telehealth platforms
• Online pharmacy and prescription management services
• Compounding and institutional pharmacies
• Hospital systems
• Outsourcing facilities
• Research institutions, laboratories, and investigators
• Contract research organizations
• Physician inventors
• Pharmaceutical consortia
• Financing companies

What Sets Us Apart

• Blank Rome’s regulatory team includes a former Associate Chief Counsel of the FDA.
• We add value for our clients by leveraging relationships within the life sciences and financial industries, as well as the government, to facilitate key introductions that create business opportunities and solve problems.
• Our life sciences industry team is bolstered by a deep bench of recognized intellectual property leaders with significant experience in acquiring, defending, enforcing, and invalidating medical device and pharmaceutical patents.
• We have achieved numerous wins in high-profile life science disputes and have extensive trial and appellate experience in federal and state courts across the country.
• We advise on compliance strategies with respect to global data protection laws and the processing of human biological samples, including transparency initiatives in clinical research.