Dinsmore's pharmaceutical and biotechnology clients rely on the firm's collective ability to provide integrated, practical advice for a variety of legal needs. Our practice benefits from the experience and assistance of our corporate, litigation, product liability, intellectual property, immigration and healthcare colleagues, and we strive to leverage our diverse legal assets and experience to provide comprehensive solutions in our clients' domestic and international business transactions.
Our clients include large pharmaceutical and biotechnology companies, smaller innovative organizations, entrepreneurs, as well as entities that work with these companies, such as clinical research organizations (CRO), drug development companies and pharmacy benefit managers. We advise on products that range from traditional prescription drugs, including controlled substances, over-the-counter medications and investigational new drugs. Our experience with and knowledge of government standards and practices as well as the breadth of our industry knowledge affords our clients substantial resources for their product development, approval and marketing needs.
Corporate Due Diligence
When a client considers purchasing a product or business from another company, we perform due diligence investigations of regulatory issues and risk factors, as well as other legal and strategy issues. In the past, our attorneys have conducted due diligence projects on behalf of manufacturers, investment banks, private equity and venture capital firms, as well as individual investors. In particular, we utilize our broad industry experience, knowledge of the FDA and FTC regulatory process for drugs to perform risk assessments on regulatory processes affecting product approval, evaluate commercialization and post-approval activities, assess litigation risk in product liability actions, and provide input on the regulatory issues presented in financial disclosures and other transaction documents. To provide our clients as detailed assessments as possible, we typically provide this advice by drawing on the experience of our colleagues across multiple departments, such as the corporate and securities, litigation, healthcare, intellectual property and antitrust practices.
We also assist clients with their general corporate transactional needs, and function as de facto general counsel for several clients. In this role, we utilize our broad knowledge of the industry to draft, negotiate and review various commercial contracts upon which our clients rely to conduct their businesses, including the following types of agreements:
- Licensing and sub-licensing (in/out)
- Co-promotion agreements
- Development agreements
- Marketing/Co-marketing agreements
- Manufacturing/ supply agreements
- Authorized generic agreements
- Clinical trial/study agreements
- Wholesale/distribution agreements
- Managed care agreements
- Medicare Part D agreements
- Direct to pharmacy supply agreements
- PBM rebate agreements
- GPO agreements
- CDAs, NDAs and Term Sheets
Dinsmore's pharmaceutical and biotechnology clients benefit from our substantial experience navigating the regulatory frameworks governing the industries in which they operate. For example:
- We continuously monitor developments and enforcement initiatives in the labeling, advertising and promotional area, including decisions brought under federal and state false claims acts and the application of FDA requirements to the internet advertising and promotion. We also have counseled clients on various aspects of product promotion and labeling, including direct-to-consumer advertising, to ensure compliance with the FDA, FTC and DOJ requirements and regulations
- We also counsel clients on FDA's current Good Manufacturing Practice (cGMPs) requirements in connection with their development of standard operating procedures for their manufacturing processes, as well as on FDA's product distribution and sampling requirements governed by the Prescription Drug Marketing Act of 1987 (PDMA) and FDA’s multiple post-marketing reporting requirements including safety and manufacturing problem reports
- We provide guidance to pharmaceutical and biotechnology clients with respect to regulation by the Drug Enforcement Administration. Whether it is a manufacturer, pharmacy, distributor, physician or other health care facility, our clients have come to rely on our experience with various FDA and DEA requirements governing the safe marketing and distribution of pharmaceutical products and controlled substances
- Our practice includes a number of the firm's health and litigation lawyers who advise clients on coverage and reimbursement for drugs, biologics and human tissue products, as well as compliance with federal and state fraud and abuse laws such as the Medicare and Medicaid anti-kickback laws, false claims statutes.
- We counsel clients regarding state pharmacy laws as well as federal privacy laws (HIPAA) and relevant state statutes.
FDA Enforcement and Related Litigation
We assist clients with various types of FDA enforcement actions, including FDA inspections, responses to FDA 483 Inspectional Observations as well as Untitled and Warning Letters. We also represent drug and biotechnology product manufacturers in injunction and seizure actions, recalls and market withdrawals, criminal prosecutions, assessments of civil penalties and other regulatory actions brought by the FDA, FTC and state authorities. We also provide assistance with the review, development and implementation of manufacturing policies, inspection policies and corporate compliance programs that take into account FDA requirements, including clinical Good Manufacturing Practices.
The Products Liability Practice Group within Dinsmore's litigation department has represented scores of pharmaceutical and medical device manufacturers in cases filed in various state and federal courts throughout the United States. Included in the group are individuals who are trained in medicine, nursing, pharmacy, x-ray technology, toxicology and engineering. With respect to pharmaceutical and device products, our litigators have worked on behalf of the manufacturers of such products as Bendectin, DES, Thalidomide, Accutane, Phentermine, Parlodel, Phenylpropanolamine, Oxycontin, Pyridostigmine Bromide, blood and blood products, bone screws, breast implants, food supplements such as L-tryptophan and ephedra, neutraceuticals, orthopedic implants, over-the-counter cough, cold and sleep aid medications, pacemakers, pacemaker leads, silicone implant products, surgical gloves, tampons and urethral stone retrieval devices.
Dinsmore also represents a wide range of medical device clients. But whatever the size of our clients, we leverage our years of experience to assist them to devise practical solutions to meet their legal, business or strategic objectives. Our medical device lawyers are drawn from across the firm and include colleagues from the corporate, litigation, product liability, intellectual property, immigration, antitrust and healthcare practice groups. Our clients rely on us for help obtaining FDA approval to market device products, complying with FDA's postmarket requirements and defending them in FDA enforcement actions. Like our pharmaceutical clients, we also frequently assist our medical device clients with FDA-related aspects of commercial contracting and acquisitions and divestitures.
Our attorneys' representative experience includes:
- Corporate due diligence in connection with several acquisitions, including such responsibilities as determining a company’s state of FDA compliance or a particular product's compliance with FDA requirements, the transfer of 510(k) notices and PMA applications and reviewing FDA-related provisions of transaction documentation
- The review, drafting and negotiation of various commercial contracts
- Counseling on FDA's post-marketing regulations to assist clients in understanding FDA's requirements for manufacturing medical devices in accordance with applicable quality system standards, advising on defending our clients in product recalls, market withdrawals, product seizures and injunctive actions, reporting adverse events and responding on behalf of our clients in connection with FDA enforcement actions such as FDA Form 483s, Warning Letters and Untitled Letters