FDA

Morgan Lewis counsels early-stage and mature global pharmaceutical and biotech companies from product development through the product life cycle. This includes clinical trial design, FDA regulatory approval, manufacturing and current good manufacturing practices (cGMPs), supply chain issues, promotions and marketing, pricing, and distribution. We also advise companies on the FDA and related regulatory aspects of corporate transactions, as well as government enforcement and investigations.

Many of our lawyers have held positions at key regulatory and enforcement agencies, including the FDA, the USDA, the US Department of Health and Human Services (HHS), and the US Department of Justice (DOJ). Consequently, we have a nuanced understanding of these agencies' goals and procedures, enabling us to help clients achieve their business and legal strategies.

Due to our deep bench and range of experience, our clients call on us for help in many areas, including:

• Advice on pharmaceutical product development pathway strategies and clinical trial design, including agreements and informed consent
• Orphan drug designations and submissions
• Investigational New Drug (IND) applications, New Drug Applications (NDAs), 505(b)(2) applications, Biologics License Applications (BLAs), 351(k) biosimilar applications, and special protocol assessments
• Patent and market exclusivity strategies, including for biosimilars
• Preparation for FDA and other advisory committee meetings
• Approval, negotiation, and dispute resolution, including for FDA complete response letters
• Risk Evaluation and Mitigation Strategies (REMS), US Drug Enforcement Administration (DEA) scheduling, and related issues
• Preparation of drug supply, quality, pharmacovigilance, and related agreements, and cGMP policies and procedures
• Advice on and resolution of cGMP inspection issues, FDA Form 483s, untitled letters, and warning letters
• Government contract pricing and enforcement matters
• Recalls, market withdrawals, and quarantines under the Drug Quality and Security Act (DQSA) and related crisis management issues
• Import and export issues

In the United States, medical device law is being dramatically reconfigured in response to rapidly evolving technology, as well as increasing budget and resource constraints within the Center for Devices and Radiological Health (CDRH). These changes affect small startup companies and large multinationals alike. Companies now need sophisticated and experienced guidance to navigate through the CDRH and resolve CDRH-related issues.

Within this new and complicated regulatory environment, our strategic assistance at the premarket stage focuses on avoiding costs and saving time. We assist with Section 510(k) premarket notifications, IDE submissions, PMA applications, humanitarian device exemption (HDE) submissions, panel reviews, scientific disputes and appeals, resolution of jurisdictional uncertainties, and device modification analyses.

At the postmarket stage, we help clients ensure that product marketing strategies are optimized, while compliance and other liability exposures are controlled. To maximize market potential, we provide creative promotional, reimbursement, marketing, and distribution strategies. We support day-to-day compliance activities by offering technical advice on such issues as medical device reporting, cGMPs, and recalls and field corrections. We also anticipate, and seek to contain, product liability exposure.

When enforcement concerns arise, we leverage our experience with some of the largest and most complex government investigations and settlements of the last decade. As the FDA, DOJ, Health Care Financing Administration (HCFA), and the HHS’s Office of Inspector General (OIG) continue to take an aggressive enforcement stance, we help clients respond to civil and criminal enforcement and compliance actions. These include:

• FDA Form 483 and warning letter responses
• Import/export issues
• Consent decree issues
• FDA integrity policy

Morgan Lewis represents companies that develop, market, and distribute food and color additives, dietary supplements, food components, generally recognized as safe (GRAS) substances, medical foods and infant formulas, packaging materials, and animal feed products. We have experience dealing with traditional and biotechnology-derived human and animal food additives, and bioengineered plant derived foods, and we routinely advise on labeling and marketing health and structure/function claims for foods.

Our team of lawyers helps clients with the appropriate safety assessment and submissions for food ingredients, including food additive petitions, food contact notices, and GRAS notifications and self-determinations. Supported by chemists and toxicologists, we provide the legal services needed to bring new food additives to market. At the postmarket stage, we handle product labeling and advertising issues, as well as FDA and state enforcement matters, including reportable food events, recalls, and import detention issues.

We counsel clients on food safety, Hazard Analysis and Critical Control Points (HACCP), Hazard Analysis and Risk-Based Preventive Controls (HARPC), and cGMP compliance issues and enforcement actions (Form 483s). We also have experience with issues involving the regulation of meat, poultry, and egg products by the USDA Food Safety and Inspection Service (FSIS). Our professionals assist packers, processors, and other elements of this industry in confronting the wide range of issues posed by the FSIS’s continuous inspection, prior label approval, and preventive food safety requirements.

Morgan Lewis lawyers help manufacturers file new dietary ingredient and 30-day market claim notices with the FDA. We also help determine the appropriateness of new or novel dietary supplement ingredients, and whether a product’s delivery mechanism affects its regulatory status. So that companies may avoid more rigorous regulation, we advise clients on the types of health claims and structure and function claims that are appropriate for dietary supplements.

We provide strategic assistance and creative solutions in connection with broadcast, print, and Internet advertising. We also help prepare defensible labeling to support claims that the supplement or food provides an enhanced function, while reducing the risk of additional FDA regulation.

We provide the regulatory and scientific support to advance a manufacturer’s products through the premarket approval (PMA) regimen of the FDA and its European counterparts. Our practice includes a number of doctoral and postdoctoral professionals with pharmaceutical and medical device backgrounds. Chemists, toxicologists, pharmacologists, electrical engineers, mechanical engineers, physicists, and professionals in other pharmaceutical- and device-related disciplines from around the firm also support our team. These individuals enhance our ability to provide manufacturers with sophisticated advice concerning the scientific aspects of their products and to resolve scientifically oriented legal issues.

For example, we counsel manufacturers on preparing and filing product submissions, including IND applications, investigational device exemptions (IDEs), NDAs and supplements, PMA)applications and supplements, panel reviews, 510(k) premarket notification submissions and modifications, orphan drug applications, food additive petitions and GRAS notices, dietary ingredient and 30-day market claim notices, and citizens’ petitions.

Our scientific knowledge informs our advice to clients on whether and what type of product submission is necessary, including whether product modifications, material, and related changes trigger new product filings.

During the last several years, and with the passage of the Consumer Product Safety Improvement Act (CPSIA), the CPSC transformed into an enforcement-oriented regulatory force in Washington, DC. The CSPC’s chair has expressed the intent to continue this aggressive regulatory and enforcement approach. We help manufacturers of consumer products succeed in this new regulatory environment.

Morgan Lewis lawyers, for example, routinely and successfully negotiate recalls and other corrective action programs, as well as settlement of significant penalty actions with the CPSC, on behalf of our clients. We advise clients regarding submission of Section 15(b) and Section 37 reports on product hazards, and product certifications, and we prepare corporate guidelines and compliance programs relating to CPSC testing and labeling requirements. We develop strategies to help our clients avoid or moderate CPSC regulation of specific products. Morgan Lewis has represented clients in administrative litigation with the CPSC.

CPSC recalls and enforcement actions can have significant financial, public relations, and litigation consequences. Morgan Lewis provides crisis management, helps navigate issues related to national media coverage, and develops strategies for dealing with the potential for product liability and class action claims that can follow recalls. Our lawyers also help clients with CPSC corporate due diligence reviews before the sale or acquisition of consumer product manufacturing and distribution companies.

Our team helps all types of life sciences, medical device, pharmaceutical, and biotech companies—including large, midsize, and emerging companies—with a variety of transactions. Our experience includes:

• Mergers and acquisitions
• Collaborations, joint ventures, and alliances
• Financing
• Securities
• Outsourcing
• Emerging business and technology

Our fraud and government investigations team combines lawyers with litigation and regulatory backgrounds to help clients with criminal and civil healthcare fraud investigations and related litigation. Our recent experience includes significant matters in the US pharmaceutical and medical device industry.

We advise clients at every stage of government enforcement activity, including:

• Responding to US federal and state grand jury subpoenas
• Responding to civil investigative demands from the DOJ and administrative subpoenas issued by federal executive branch agencies such as the HHS-OIG
• Representing clients through settlement discussions, Corporate Integrity Agreement (CIA) negotiations, pretrial proceedings, trial, and appeal
• We routinely handle parallel criminal, civil, and administrative proceedings that occur simultaneously in multiple jurisdictions involving claims under the following:
  • Anti-Kickback Statute
  • Criminal Health Care Fraud Statute
  • HHS OIG exclusion authorities
  • Civil Monetary Penalties Law
  • Responsible corporate officer (RCO) doctrine
  • US federal and state false claims acts
  • Suspension and debarment authorities

Our lawyers also regularly deal with state Medicaid Fraud Control Units and multijurisdictional Medicaid Fraud Task Forces organized by the National Association of Medicaid Fraud Control Units.

Additionally, Morgan Lewis counsels clients on the design, negotiation, and implementation of government-mandated compliance agreements, such as CIAs, deferred prosecution agreements, and state consent decrees. Our lawyers negotiate and assist large and small healthcare organizations with their CIA matters.