Ropes & Gray provides counsel, representation, and strategic advice to companies subject to Food and Drug and related law. Command of FDA regulatory matters and associated issues in patent and antitrust law is critical when seeking product approvals, developing an effective lifecycle management strategy, and in assuring that products are marketed in compliance with federal and state requirements. Our lawyers have served in Congress and in the administrative agencies of the federal government; this experience is extraordinarily valuable when designing and carrying out a plan to address our clients’ concerns.

We advise established and development-stage pharmaceutical, biotech, and medical device manufacturers and distributors on the requirements and strategies to pursue marketing authorizations including NDAs, BLAs, PMAs, and 510(k)s. With more than 25 years of experience on Hatch-Waxman Act and Orphan Drug issues, we have an in-depth understanding of the competitive issues that affect the industry. We are also recognized leaders in the field of pharmaceutical promotion and compliance and have represented major pharmaceutical and biotech companies in areas ranging from biologics regulation to life cycle management to Rx/OTC switches.

Our FDA experience, combined with our extensive knowledge in related areas such as research funding, health care regulatory matters, clinical trials, and legislation is rare in law firms. It allows us to thoroughly understand complex issues and to offer our clients an opportunity for coordinated action in conjunction with the firm’s patent, government enforcement, and transactional lawyers in several areas, including:

• Product Approvals
• Pharmaceutical Life Cycle Management
• Labeling, Advertising, and Other Promotional Activity
• Fraud & Abuse
• Reimbursement
• Price Reporting
• FDA Enforcement Actions
• Due Diligence Reviews
• Congressional Investigations
• Litigation

Product Approvals
Obtaining FDA approval or clearance to market drugs, biologics, medical devices and food additives, especially those that have encountered difficulties in the approval process, requires experienced counsel. We advise clients on product development, including clinical trial requirements and good laboratory practices, and assist them with advisory committee proceedings. Through our representation and guidance, clients have successfully overcome many challenges, including:

• One of the world’s largest biotech companies gained early FDA approval for a drug that represented a major improvement over existing products, despite the strenuous opposition of a competitor.
• Working with the FDA, a major pharmaceutical company was allowed to develop new policies for accelerated approval of drugs to treat life-threatening and serious conditions.
• A major pharmaceutical company fashioned complex drug applications in a way to satisfy the FDA’s combination drug policy.
• Companies receiving initial unfavorable rulings from the FDA were able to satisfy the agency and obtain product approvals on numerous occasions.
• Following very challenging regulatory proceedings, two of the most significant food additives to come to market in recent years were approved by the FDA.
• In a competitive dispute involving reimbursement, obtained a new 510(k) for a medical device with a different classification, permitting reimbursement to continue over the competitor’s objections.

Pharmaceutical Life-Cycle Management
Strategic and legal advice is essential on statutory provisions that confer exclusive marketing rights on qualifying products—the Hatch-Waxman Act, the Orphan Drug Act, and the pediatric studies provisions of the Federal Food, Drug, and Cosmetic Act. In-depth understanding of the relationship between patent and non-patent exclusivity rights, combined with our patent lawyers comprehensive experience, assures maximum exclusivity rights permitted by law. Some of our representative work includes:

• Providing strategic and legal advice to a global pharmaceutical company, we prepared submissions to the FDA and other federal agencies as it executed a variety of business and legal initiatives to maximize its patent and non-patent exclusivity rights for an important oncology drug.
• We have analyzed how the Hatch-Waxman rules (on pre-approval litigation of patent disputes with potential generic drug manufacturers) can be utilized to protect intellectual property.
• We successfully argued that proposed generic drug products should not be permitted to circumvent the innovator’s exclusivity rights by "carving-up" the approved labeling in a matter that made the drug less safe to use.
• Frequently petitioning the FDA, we presented scientific data and legal arguments demonstrating the differences between innovator and potential follow-on products.
• We represent several innovator companies in working on pending legislation that may result in an approval pathway for follow-on biologics, to help assure that sufficient incentives for innovation are retained.

Labeling, Advertising, and Other Promotional Activity
Proposed promotional activity for compliance with FDA and other requirements, including the Prescription Drug Marketing Act, is regularly reviewed by our attorneys. Competitors should be subject to the applicable standards, and we help clients ensure this is the case. We recently advised clients on labeling issues raised by claims on over-the-counter drug labels. Other representative matters include:

• A competitor’s advertising claims presented misleading information about our client’s prescription drug product. Our client was unsuccessful in federal Lanham Act litigation, but we successfully challenged the same claims at the FDA.
• In preparation for the launch of a new drug product in the face of threatened regulatory and Lanham Act challenges by a leading competitor, we reviewed more than 70 promotional pieces. The challenges did not materialize after the promotional campaign commenced.
• When the FDA decided to order the discontinuation of our client’s promotional campaign for a major cardiology drug, we worked with a team of experts, including world-renowned scientists, to meet this challenge.
• We represent a coalition of pharmaceutical, biotech and device companies regarding FDA’s policies concerning off-label dissemination and their relationship to fraud and abuse cases.
• Many of our clients have benefited from in-depth training we provided on the rules and regulations concerning promotional activity.
• We frequently assist clients in responding to DDMAC Warning and Untitled letters.

Fraud & Abuse
The government scrutinizes the relationships of pharmaceutical and medical device manufacturers with physicians, providers, managed care organizations, pharmacy benefit managers, and group purchasing organizations. We advise clients on compliance with federal and state anti-kickback laws, industry codes, and other requirements to achieve business objectives while avoiding the risk of severe penalties the government has imposed on many companies. Examples of our activities include:

• Assisting companies in developing or updating compliance policies and procedures on topics such as marketing interactions with physicians and other providers, grants, publications, privacy, charitable donations, and physician consultants.
• Analyzing specific marketing plans to assess their compliance with federal and state law and industry codes.
• Assisting clients in conducting internal compliance investigations.
• Advising manufacturers on patient-oriented programs, including the provision of coupons or rebates on prescription drugs to patients.

Reimbursement
Reimbursement for drugs and medical devices is a subject that we understand thoroughly. Government health care programs, such as Medicare and Medicaid, and private insurance programs have distinct and often complex reimbursement rules that vary depending on the setting in which the product is used. Representative work includes:

• Obtaining favorable coverage and reimbursement for a new product, through reimbursement environment analysis, strategies to improve reimbursement, and obtaining billing and other types of codes.
• Successfully lobbying for changes in coverage of off-label uses of drugs under Medicare.
• Advising clients on billing and reimbursement rules applicable to outpatient prescription drugs covered under Medicare Part B and Part D.

Price Reporting
Federal law establishes pharmaceutical price reporting rules as part of the Medicaid rebate program, Medicare Part B, the so-called 340B program, and the federal supply schedules. In addition, states have supplemental rebate programs. We counsel clients on these topics, including:

• Analyzing specific proposed transactions to determine their effect under the price reporting requirements of the Medicaid drug rebate program.
• Drafting company policies and procedures for price reporting.
• Preparing template rebate agreements for manufacturers offering discounts under Medicare Part D or to participants in the 340B program.
• Advising pharmaceutical manufacturers on Medicaid supplemental rebate programs that involve payments directly to the states, or “value added” services such as disease management programs in lieu of supplemental rebates.

FDA Enforcement Actions
FDA enforcement matters can range from advisory actions such as FDA Warning Letters, to formal actions such as proposed withdrawals of product approvals, product seizures, injunctions and consent decrees, recalls, import alerts, denial of export certificates, civil money penalty hearings, clinical investigator and IRB disqualification hearings, and criminal prosecutions. Our attorneys have:

• Investigated alleged Good Manufacturing Practice (GMP) violations at a pharmaceutical manufacturer's overseas plants and drafted responses to FDA that avoided the threatened imposition of an import alert on a blockbuster product.
• Assisted a pharmaceutical manufacturer in the negotiation, drafting, and implementation of a consent decree of permanent injunction relating to alleged violations of GMPs.
• Advised a leading medical device manufacturer on the regulatory aspects of a widely publicized, worldwide product recall.
• Prepared responses for FDA and Congress on high-profile allegations of GMP violations, and worked with public relations professionals to handle related crisis management matters.
• Represented a clinical investigator in disqualification hearings before FDA involving alleged violations of Good Clinical Practice requirements.
• Helped a cosmetics client obtain release of several imported products detained by FDA and Customs
• Developed and implemented a successful regulatory strategy for a medical device manufacturer to avoid adverse regulatory action due to an alleged product defect.
• Assisted numerous pharmaceutical and medical device clients in responding to FDA inspection reports (483s) and Warning Letters alleging violations of GMPs, adverse event reporting requirements for drugs and medical devices, and other FDA rules.

Due Diligence Reviews
Companies engaged in mergers, acquisitions and other corporate transactions seek our advice on conducting due diligence reviews, and on FDA-related issues that arise during these transactions. We conduct full FDA regulatory due diligence reviews for clients, including:

• A large joint venture transaction involving two global companies in the highly-regulated biologics area.
• The initial public offering of a new drug/device company that was developing an emerging technology.

Congressional Investigations
Congress represents a crucial component of the regulatory, litigation, and public relations environment for FDA-regulated companies. House and Senate oversight committees, as well as individual members of Congress on both sides of the aisle, have launched numerous investigations of pharmaceutical and medical device manufacturers' research, marketing, outsourcing, and other practices. Companies subject to such investigations must respond to burdensome subpoenas for documents, "invitations" to interview with committee staff, and the potential publication of inflammatory committee reports written by partisan professional staff members. Oversight committees routinely announce hearings in the wake of high-profile product safety problems or perceived regulatory lapses, often while FDA is in the midst of conducting a regulatory investigation, other state or federal government attorneys are considering various types of litigation, or plaintiffs' attorneys are pursuing products liability cases against the company.

We respond to subpoenas or informal document requests, interview with congressional staff, prepare for congressional hearings, and coordinate these activities to minimize the company's risk of adverse enforcement action or product liability exposure. Our wide-ranging capabilities allow us to:

• Assist clients in preparing responses to congressional inquiries, document requests, and subpoenas.
• Negotiate with congressional staff over the scope of document productions and the protection of company trade secrets and confidential business information.
• Draft congressional testimony for a pharmaceutical company's CEO and help prepare him for his appearance before a House oversight committee.
• Coordinate with company and outside public relations professionals in responding to press inquiries and news stories relating to a product crisis.

Litigation
Ropes & Gray has frequently sought to uphold the interests of its clients by bringing legal actions directly against FDA and other federal and state government agencies. In many cases, these legal actions involve complex scientific and legal challenges to decisions by the government that impact our clients or their products. They also entail strategic decisions about timing and access to the administrative records that govern federal agency determinations. Examples of such actions include:

• On a number of occasions we have represented clients in challenges under the Hatch-Waxman Amendments involving denial by FDA of citizen petitions that formally request the agency to take particular actions based on the science surrounding the particular pharmaceutical product.
• In an action brought by a generic drug company against an innovator company alleging antitrust and state law claims, we developed arguments based on FDA requirements that resulted in a favorable outcome on key points in the case.
• We litigated to protect the commercial confidentiality of our clients’ documents that the FDA was prepared to release to the public pursuant to the Freedom of Information Act.
• Working closely with a pharmaceutical client’s copyright litigation counsel, we protected intellectual property rights created as part of the patient assistance materials developed when switching the client’s products from prescription to OTC status.
• We were part of a team that successfully persuaded the California Supreme Court that the requirements of the state labeling initiative known as Proposition 65 are preempted when applied to our client's products.

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