King & Spalding’s FDA & Life Sciences Practice focuses on representing pharmaceutical, medical device, biotechnology and other healthcare technology companies, as well as food manufacturers, in a wide range of regulatory, compliance, policy, and litigation matters. More than 33 lawyers and non-lawyer professionals in our Washington, D.C., office provide sophisticated counseling and advice to more than 100 drug and device manufacturers and others in the healthcare technology sector, including nine of the 25 largest pharmaceutical manufacturers, and 18 of the 25 largest device manufacturers.
We represent manufacturers, health technology and food companies, distributors, and providers at every stage of product development and use, from early-stage regulatory and approval issues, to ongoing counseling on FDA, DEA, and healthcare compliance issues, to manufacturing and supply-chain management, to defense in civil and criminal government investigations, and to the development and implementation of comprehensive compliance programs in accordance with HHS Office of Inspector General guidelines, the U.S. Sentencing Commission Guidelines and Sarbanes-Oxley requirements.
Members of our group have extensive governmental experience, having served with the FDA (five in the Chief Counsel's Office and one in the Center for Drug Evaluation and Research), Centers for Medicare and Medicaid Services and the U.S. Department of Justice.
The FDA & Life Sciences Practice in Washington, D.C., is supplemented by our Healthcare Industry Practice. Collectively, our team includes the former Assistant Attorney General, Criminal Division, U.S. Department of Justice, a former U.S. Attorney and several Assistant U.S. Attorneys from around the country, two former Special Counsel for Health Care Fraud at the U.S. Department of Justice, and a former compliance officer for an academic medical center.
The group provides counseling on a full array of FDA and related matters involving medical devices, pharmaceuticals, OTC drugs, biologics, biotechnology, food, animal drugs and consumer products, including:
- Assisting with planning, implementing and monitoring clinical trials, preparation of investigational and marketing applications and advisory panel presentations.
- Advising on promotion and advertising, scientific symposia, labeling issues, exports and imports, MDR reporting, QSR and GMP requirements, software issues and other FDA regulatory issues.
- Representing clients before the Agency on enforcement, policy and rulemaking issues, as well as in federal court litigation and legislative matters.
- Advising and assisting all FDA-regulated companies on both "voluntary" and mandatory product recalls.
- Developing and implementing successful strategies for start-up and larger companies to obtain expedited marketing clearance and to resolve disagreements with FDA regarding deficiencies in premarket approval applications and premarket notifications.
- Conducting independent internal investigations of alleged FDA violations in connection with qui tam actions and other compliance reviews.
- Assisting companies subject to FDA's Application Integrity Policy, including conduct of independent internal audits of clinical studies, development of Corrective Action Programs, clinical SOP's, and certification of data validity.
- Representing companies in meetings with FDA, including meetings with the Commissioner of Food and Drugs, CDRH Center Director, FDA's Center for Food Safety and Applied Nutrition, FDA's Center for New Drug Evaluation and Research, FDA's Office of the Chief Counsel, FDA District Offices, FDA's Office of Device Evaluations, and Office of Compliance.
- Assisting groups of manufacturers in obtaining reclassification of medical devices such as automated differential cell counters, automated blood cell separators, and cardiopulmonary bypass pumps. Companies involved saved millions of dollars by avoiding PMA filings.
- Helping companies respond to FDA inspections, warning letters and criminal investigations, including investigations conducted by FDA's Office of Criminal Investigations.
- Assisting companies in developing strategies for combination products, including preparation and filing of Requests for Designation.
- Assisting companies with regard to the regulatory status of tissue products that are subject to minimal processing.
- Helping companies prepare successful GRAS notifications for various food ingredients.
- Advising companies with regard to status of home brew and research use only diagnostic products, including preparation and filing of 513(g) petitions and responding to inquiries from the Office of In Vitro Diagnostics.
We are frequently involved in issues that threaten all or a large part of our client's business. We take pride in our consistent success in finding creative solutions to allow our clients to avoid substantial economic losses while, at the same time, maintaining a positive relationship with the Agency.
Life Sciences Practice
Lawyers in our FDA & Life Sciences Practice regularly advise pharmaceutical and medical device companies on issues arising under federal, state, and private insurance programs, with a particular focus on Medicare and Medicaid compliance issues. Our work in this area includes:
- Obtaining favorable agency determinations on product coverage, coding, payment and classification, as well as favorable coding determinations by the American Medical Association.
- Counseling companies on fraud and abuse issues under the Medicare/Medicaid Anti-Kickback Statute and related federal and state fraud/abuse laws; pricing and reimbursement issues under Medicare, Medicaid, and other federal and state healthcare programs; and federal, state and international data privacy and security laws and regulations, including HIPAA and the EU Data Protection Directive and US/EU Safe Harbor Agreement.
- Assisted pharmaceutical and medical device companies in negotiating Corporate Integrity Agreements with the HHS OIG and in complying with existing CIA obligations.
- Provide advice on compliance with state-level regulatory requirements; for example, we currently represent a coalition of 30+ pharmaceutical companies in connection with the growing number of state laws targeting pharmaceutical sales, marketing, and other practices.
- Advocating client positions to CMS and Congressional officials.
- Successfully navigating the National Coverage Decision process to ensure optimum coverage of drugs and devices.
- Directing CMS and contractor related field staff efforts designed to influence coverage and payment policies of specific new and existing technologies.
- Devising and implement coding and payment strategies to overcome impediments inherent in the APC, DRG, HCPCS, and CPT coding systems.
- Developing physician/specialty society advocacy and grassroots initiatives before contractors, Congressional representatives, and CMS.
- Effectively utilizing trade associations and relevant specialty societies to achieve reimbursement goals.
- Working with CMS to fashion Medicare and Medicaid "demonstration" programs to provide for items and/or services not within the scope of the Social Security Act.
- Assisting clients in developing health economic arguments and materials for private and public payors.
- Responding to AHRQ and private technology assessments to ensure appropriate coverage of assessed technologies.
- Providing advisory expertise on reimbursement strategies for diagnostic and screening tests utilizing genetics technologies, including appropriate coding mechanisms to secure appropriate reimbursement, and payor strategies for non-FDA regulated "home brew" tests.
- Conducting in-depth pricing assessments and working with manufacturers to develop and implement government price calculation and reporting policies, procedures and methodologies.
The reimbursement and fraud and abuse landscape, particularly for new and innovative technologies, is increasingly complex with implications that can threaten the launch or continued use of client products. We work closely with our Government Relations group to successfully craft creative solutions for the life cycle of client product portfolios while maintaining positive and productive relationships with CMS, its contractors, physician or patient advocacy groups and OIG.
Goals of Our Practice
Providing the very best advice and the highest quality legal services is our most important goal. We believe the best value in legal services is always delivering to you the best possible advice.
The knowledge and talent of the lawyers in our FDA & Life Sciences Practice Group are our most valued assets. Whether the goal is getting a new product to market or helping to avoid an agency enforcement action, we measure performance by the results we achieve.
Most of our client requests are for immediate advice or for written opinions within a few days. Our goal is to meet every client's deadline.
Emergency calls, where clients must speak with someone immediately, are very common in our practice. With a large number of experienced lawyers, we are always available to assist.
The best solution to your problem is not always the most expensive. We pride ourselves in efficiency and finding creative, practical solutions to complex regulatory problems.
The firm's current clients include large and small companies and trade associations involved in all segments of industry regulated by the FDA, DEA, and CMS. We represent a wide range of companies with products in the following categories: biotechnology, infectious diseases, cancer diagnosis and treatment, pharmaceutical, genomics, proteomics, cardiovascular, orthopedic, neurological, obstetrical and gynecological, blood banking and other software, gastroenterology-urology, ophthalmic, dental, radiology, general and plastic surgery, in vitro diagnostic, food, beverages, infant formula, dietary supplements, produce (including genetically modified produce), food service products ("fast food"), cosmetics and veterinary medicine.
Broad Based Practice
The lawyers in our FDA & Life Sciences Practice Group utilize the services of several additional practice areas within the firm. These include:
Product Liability Practice
King & Spalding is one of the only law firms in the country with nationally recognized practices in both FDA law and product liability law. These practices work together in defending clients involved in individual cases and mass tort litigation. We serve as both national FDA counsel and one of several national product liability counsels for clients involved in several mass tort actions. We are one of the few firms in the country to have obtained a jury verdict for the defense in a breast implant case. These complementary practice areas and strengths position us to be particularly well suited to defend FDA manufacturers in product liability cases.
Civil and Criminal Litigation
We have successfully represented numerous companies in a wide variety of civil and criminal matters, including Lanham Act unfair trade practice litigation, trademark infringement cases, securities litigation, FDA grand jury investigations, responding to subpoenas and FDA criminal investigations.
IPOs, Mergers and Acquisitions
We have represented many companies in numerous initial public offerings, as well as in mergers and acquisitions. Our FDA practice has performed due diligence, assisted in the preparation of registration statements and provided opinions to underwriters. Our corporate department has extensive experience with public offerings, including initial and secondary offerings, Rule 144A offerings, high yield debt offerings, tax advantaged preferred stock offerings, and mergers and acquisitions.
We have successfully represented clients who have been investigated by Congressional committees, and we are regularly up on the Hill advocating health policy changes to Members of Congress.
Intellectual Property Practice
Our Intellectual Property Practice provides traditional and innovative legal services to our clients with patent and trade secret issues.