This article provides a summary of the expansion of FDA's discretionary authority in the post-9/11 period, particularly with respect to FDA's authority to monitor and publicize potential health risks linked to food, dietary supplements, nonprescription drugs, and other consumer health products. In addition, this article evaluates the need for FDA to establish procedural safeguards to reduce the significant risks of unintended and undue harm to people and regulated companies that can result from adverse publicity in the more "transparent" post 9/11 FDA regulatory environment. Specifically, Part I summarizes the amendments to the FDCA enacted during the post-9/11 period that have expanded FDA's postmarket authority to monitor, evaluate, and publicize potential health risks linked to food, dietary supplements, nonprescription drugs and other consumer health products marketed in the United States, in conjunction with FDA's Sentinel Initiative, Reportable Food Registry, and other adverse event reporting requirements. Part II discusses the convergence of FDA's expanded postmarket authority to publicize product-related risks with President Obama's transparency initiative aimed at fostering "open government" through increased public access to government information. In addition, Part II considers the nature of the procedural safeguards needed in the post-9/11 FDA regulatory environment, in view of FDA's historical record and illustrative cases that help expose how adverse "transparency" surrounding FDA warning letters, recalls and safety alerts concerning products in the marketplace can have undue and unintended prejudicial and harmful effects for the people and companies that are legally responsible for such products. Finally, based on these analysis, this article concludes with some observations concerning the nature of the procedural safeguards needed to reduce the significant risks of "transparency" policy harms in the pos-9/11 regulatory environment.
This article updates the author's previously published article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work.
Congress created 180-day exclusivity for generic drug applicants in the 1984 Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) and amended the provision substantially in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The fundamental goal behind 180-day exclusivity was to provide an incentive for generic drug applicants to challenge innovator patents, and the core of the concept--as it has been applied by the Food and Drug Administration (FDA) and the courts--is that the first generic drug applicant to challenge an innovator's patent is entitled to six months of exclusivity against subsequent patent challengers for the same innovator drug. 180-day exclusivity is governed by sections 505(j)(5)(B)(iv) and 505(j)(5)(D) of the FDCA. In this article, the authors provide a comprehensive resource on 180-day exclusivity for old abbreviated new drug applications (ANDAs) (but less detail in some places where the 2007 article may be referenced) but focus more discussion on the new provisions as well as some policy and legal issues related to 180-day exclusivity that have not previously addressed.
This article summarizes the history of the 180-day exclusivity provision on the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA). Part II presents the statutory language, as amended in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), and summarizes the law that applies to new abbreviated new drug applications (ANDAs) (those filed after December 8, 2003, provided there was no paragraph IV certification to the listed drug prior to December 8), as well as the law that applies to all other ("old") ANDAs. Part III describes the legislative history of the original 1984 provision and traces its judicial and administrative history through the present. Part IV describes the history of the 2003 amendments and describes the key changes made in 2003. While Congress addressed in 2003 a number of the interpretive issues that had arisen since 1984, the new law is intricate and undoubtedly will give rise to new interpretive questions in the months and years ahead.
Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act), to address an imbalance between the patent protection interests of pioneer drug developers and the need of American consumers for lower-cost generic alternatives to pioneer drugs. Although the Act appears to be accomplishing its basic objectives of increased competition in the drug marketplace and increased innovation in new drug development, recent case law indicates the balance is being disturbed by some actions in the drug industry. Proposed legislation, as well as rules proposed by the Food and Drug Administration, address problems encountered under the Hatch-Waxman Act; however, legislative changes may be needed to restore the balance. This article seeks to provide both a comprehensive review of the Hatch-Waxman Act and related statutory and case law and an analysis of how legislative and regulatory changes may be needed to thwart the undermining of the Act's objectives by the drug industry.
This article examines the recent legal and regulatory issues that have arisen since the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Topics include the decision of the District Court of Utah in Pharmanex v. Shalala, the regulatory framework governing the use of 'health claims' (including the potential impact of the D.C. Circuit Court's opinion in Pearson v. Shalala on those regulations), the FDA-proposed rule regarding the use of structure/function claims, and a discussion of regulation by other governmental and nongovernmental entities, including the Federal Trade Commission and the National Advertising Division of the Better Business Bureau. The authors explain how flawed agency policies have undermined the goal of DSHEA to remove 'unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers,' as well as the reason that some of those policies have been found to be unconstitutional. In addition, the authors demonstrate how the absence of FDA enforcement activity has made it difficult for manufacturers of quality, standardized dietary supplements to compete in a market deluged with inexpensive, substandard products.
Utilizing a formal dispute resolution process provided for in section 404 of the Food and Drug Administration Modernization Act of 1997, the Center for Devices and Radiological Health (CDRH) convened in September 2001 the first, and to date only, Medical Devices Dispute Resolution Panel (MDDRP) to adjudicate a scientific controversy between CDRH and a sponsor pertaining to the approvability of a premarket application (PMA). This proceeding was convened at the sponsor's request, prompted by a not-approvable determination issued by CDRH. The MDDRP concluded that the not-approvable determination by CDRH was incorrect, and the Center Director concurred with this finding. Subsequently, the PMA was approved. This article reviews the legal and scientific basis for the request for formal dispute resolution by the sponsor, describes the procedures utilized and precedents established in the course of this administrative process, and explores the potential use of this process to resolve future scientific disputes.
In 1997, Congress passed the Food and Drug Administration Modernization Act, which included a provision relaxing the Food and Drug Administration's long-standing prohibition on promotion of off-label use of previously approved products. Although the provision on dissemination of information on unapproved uses had been anticipated eagerly by many commentators, physicians, and patients, this paper concludes that the hope for real reform has been sorely disappointed by the intricate statutory and regulatory scheme. As enacted, the dissemination provision provides inadequate incentives for drug manufacturers to seek agency approval before distributing information regarding off-label uses of their products. This paper advocates a system of priority review for supplemental new drug applications submitted with requests to disseminate information on off-label uses. This system would create adequate incentives for manufacturers to comply with the new policy.
In 1984, Congress passed the Hatch-Waxman Act, a landmark statute designed both to encourage innovation by pioneer drug companies and to increase competition by generic drug companies. After its enactment, drug companies attempted to "ga the regulatory regime to their respective economic advantage. In 2003, in an effort to address these issues, FDA promulgated a final rule and Congress passed the Medicare Modernization Act, amending the Hatch-Waxman Act. This article provides a comprehensive look at the 2003 statutory and regulatory changes. First, the article analyzes the history and provisions of the original Hatch-Waxman Act and the issues that arose after its enactment. Second, the article discusses the passage of the 2003 FDA rule and the 2003 Medicare Modernization Act. Next, the article demonstrates that, although the 2003 amendments may have definitively resolved some issues, the amendments did not resolve all interpretive issues and have even led to unintended consequences. In particular, the article discusses several areas of current controversy, including the effect of patent delisting and patent expiration on 180-day exclusivity, the patent delisting counterclaim provision, the declaratory judgment action provision, patent settlement agreements, and authorized generics. Finally, the article assesses the potential for future reform of the Hatch-Waxman Act. The article concludes that maintaining the balance between innovation and competition will likely remain a daunting task for legislators and regulators in the future.
This article analyses the history, impact, and limitations of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)-the first federal law enacted in the United States aimed directly at helping protect the health and safety of the over thirteen million Americans with certain food sensitivities. The FALCPA establishes a comprehensive scheme for labeling specified food allergens effective January 1, 2006, and implements the most sweeping changes to the food label in America since the Nutrition Labeling and Education Act of 1990. The FALCPA's important benefits are explored, as well as its significant shortfalls.
In 2004, Congress mandated labeling of food allergens on packaged foods for the first time by passing the Food Allergen Labeling and Consumer Protection Act (FALCPA). FALCPA requires that manufacturers of foods containing one of the eight major allergens responsible for 90 percent of food allergies either state on the food's packaging that the food contains the allergen, or refers to the allergen by a name easily understandable by consumers in the ingredients listing. Despite this important first step in protecting consumers with food allergies, FALCPA left unregulated the use of conditional precautionary statements (e.g., "may contain [allergen]"), which many manufacturers have used as a low-cost shield to liability. Further, FALCPA applies only to packaged foods, and does not mandate listing of food allergen ingredients in restaurants. This article discusses the history of food allergen litigation in the United States, highlighting the problems plaintiffs have faced in seeking recovery for allergic reactions to a defendants' food product, and some of the practical difficulties still extant due to the lack of regulation of precautionary statements. Also presented is a review of the Massachusetts Food Allergy Awareness Act, the first state legislation requiring restaurants to take an active role in educating employees and consumers about the presence and dangers of food allergens.
The pharmaceutical industry lobbied Congress for years to pass a tort reform measure. Its prayers were answered with the Class Action Fairness Act of 2005 (CAFA). Since the passage of CAFA, class action practitioners have had more than 18 months to understand and comprehend its ramification. CAFA undoubtedly has made fundamental changes to the class action landscape. Gradually its impact is becoming clear through various court decisions. However, since CAFA is only in its second year, it will take a few more years before plaintiffs and defendants fine-tune their strategies. This article reviews some of the prominent court decisions interpreting CAFA.
This article examines various legal issues facing the medical device, biotechnology, and pharmaceutical industries through a discussion of regulatory actions taken by agencies, and court decisions or settlements occurring, in the year 2005 that impacted these industries. The article suggests future activities industry should consider undertaking as a result of these actions, decisions, and settlements. The article looks at fraud and abuse issues and the False Claims Act; enforcement activities undertaken by the Securities and Exchange and Federal Trade Commissions; the impact cases brought by states, local governments, and consumers have had on pharmaceutical product pricing; the Class Action Fairness Act and efforts by the Food and Drug Administration (FDA) to preempt state tort claims-highlights of a number of events favorable to industry. Cases addressing the learned intermediary doctrine in the context of post-sale duty to warn cases and those where FDA has sought restitution from those prescription drug manufacturers violating the Federal Food, Drug, and Cosmetic Act are reviewed. The article concludes that many of these issues can be best addressed by having integrated compliance plans in place that result in comprehensive oversight of a company's activities in FDA's, the SEC's, and the FTC's regulatory spheres; in payor coverage, payment, and pricing strategies; and in marketing programs and postmarketing surveillance.
Before 1990, food products bearing organic labels transacted in largely unregulated markets; since 1990, many countries have established labeling standards and domestic and international trade in these products has flourished. Because the emergence of this market has been recent, it has had global aspects from the beginning. The complete harmonization of standards has proved elusive, however, because the market is based on the accommodation of ecological principles and farming practices that are geographically and culturally distinct. This article reviews the major legal provisions that facilitate international trade in organic food products.
In September 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Title III of the FDAAA, the Pediatric Medical Safety and Improvement Act (Title III), created new incentives, mandates, Food and Drug Administration (FDA) authority and funding with the aim of increasing the availability of devices for pediatric populations while assuring the safety and effectiveness of those devices. This article describes the complex problem Title III addresses and situates Title III within the context of the regulatory scheme previously in place, particularly in relation to the one in place to address the parallel problem for pediatric drugs, and the concerns and policy recommendations of diverse stakeholders voiced leading up to Title III.
Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective.
In March 2010, Congress passed the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This law established a statutory pathway for approval of "biosimilars," follow-on versions of innovative biological products. This article traces the history of the BPCIA, beginning with a discussion of the origins of federal regulation of drugs and biologics, including passage of the Hatch-Waxman amendments, in Section I. Section I also describes the development of the European approval framework for biosimilars in the mid-2000s and how this increased interest in creation of a pathway in the United States. The article then provides, in Section II, an overview of early stakeholder discussions in the United States regarding legal and scientific issues relating to biosimilars, spanning the years 1998-2006. The legislative debate began in earnest in late 2006, when the first biosimilars bill was introduced. Section III of the article examines introduced bills, other legislative proposals, and related stakeholder discussion in detail, leading up to enactment of the BPCIA. Section IV describes the BPCIA as enacted, and the paper ends with the authors' concluding observations about the legislative negotiations and their implications for interpretation of the Act.
The Biologics Price Competition and Innovation Act of 2009 ("Biosimilars Act") is for the field of pharmaceutical products the single most important legislative development since passage of the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act"), on which portions of the Biosimilars Act are clearly patterned. Congress revised section 351 of the Public Health Service Act (PHSA) to create a pathway for FDA approval of "biosimilar" biological products. Each biosimilar applicant is required to cite in its application a "reference product" that was approved on the basis of a full application containing testing data and manufacturing information, which is owned and was submitted by another company and much of which constitutes trade secret information subject to constitutional protection. Because the Biosimilars Act authorizes biosimilar applicants to cite these previously approved applications, the implementation of the new legislative scheme raises critical issues under the Fifth Amendment of the Constitution, pursuant to which private property--trade secrets included--may not be taken for public use, without "just compensation." FDA must confront those issues as it implements the scheme set out in the Biosimilars Act. This article will discuss these issues, after providing a brief overview of the Biosimilars Act and a more detailed examination of the law of trade secrets.
An abbreviated pathway for the approval of biosimilar biological products, often called "follow-on biologics," has been enacted into law as part of the health care legislation recently passed by Congress and signed by the President. The subtitle of the health care bill establishing this approval pathway, the Biologics Price Competition and Innovation Act of 2009, includes many provisions governing the identification of patents relevant to a given biosimilar biological product and the assertion of those patents in infringement suits. This article provides a section-by-section analysis of the patent-related provisions of the new approval pathway for biosimilar biological products, and points out several ways in which the new law differs fundamentally from the Hatch-Waxman Act, which provides the approval pathway for generic versions of small molecule drugs.
During this period, FDA focused considerable effort on its transparency initiative, which is likely to continue into the coming year, as well as continuing to ramp up its enforcement activities, as we predicted last year. The scope of the agency's ability to pre-empt state laws in product liability litigation involving pharmaceutical products still is developing post-Levine, and we are likely to see new decisions in the coming year. Fraud and abuse enforcement still is a major factor facing the industry, with the added threat of personal exposure to criminal sentences, fines and debarment from participation in federal and state programs under the Responsible Corporate Officer doctrine, or under the authorities exercised by the Department of Health and Human Services Office of the Inspector General. Consequently, it is increasingly important that senior corporate officers ensure active oversight of an effective compliance program which should mitigate these risks. The Federal Trade Commission continues to battle consumer fraud, particularly respecting weight loss programs, and it appears to be fighting a losing battle in its effort to prevent "reverse" payments to generic manufacturers by Innovator Manufacturers to delay the introduction of generics to the market. The Securities and Exchange Commission continues to be actively enforcing the Foreign Corrupt Practices Act. The Supreme Court gave shareholders more leeway in bringing stockholder suits in situations where a company conceals information that, if revealed, could have a negative effect on stock prices.
The current combination of widespread consumer alarm about foodborne illness outbreaks and industry concern about profitability has encouraged Congress, for the first time in many years, to consider major food safety reform. The House of Representatives has already passed its version of reform, the Food Safety Enhancement Act of 2009. The Senate appears ready to pass its bill, the FDA Food Safety Modernization Act. Both bills will subject firms in the food industry to a number of new requirements and will considerably increase Food and Drug Administration's (FDA's) enforcement authority. This article addresses how the passage of major food safety reform in 2010 will potentially affect food importation into the United States, by using the Food Safety Enhancement Act of 2009, the bill passed in the House, as a model for what food safety reform will entail. Under the bill, food facilities and importers will have to register yearly with FDA and pay a fee. Customs brokers will also have to register with FDA. FDA will have the authority to subject certain foods to a certification requirement for obtaining entry into the United States. Food facilities will be required to evaluate hazards and implement preventive controls and food safety plans. FDA will establish mandatory performance standards and produce standards. Specific foods identified by FDA will be subject to traceability requirements. FDA will follow a mandatory risk-based inspection schedule, will have far greater access to records, and will have the authority to enforce mandatory recalls. U.S. trading partners may take issue with the substantial burdens placed on those importing food into the United States and may consider bringing a challenge against the United States claiming that the new food safety legislation violates World Trade Organization obligations.
This year the government aggressively pursued Manufacturers under the enhanced provisions of the False Claims Act (FCA), as well as under the provisions of the Food, Drug and Cosmetics Act (FDCA). In addition, the government pursued actions against individual executives under the Responsible Corporate Officer Doctrine ("RCO Doctrine") because it does not believe sanctions against the companies provide sufficient deterrence to inappropriate behavior. Companies need to focus on implementing effective compliance programs in order to prevent the occurrence of allegedly improper activity. It should be noted that the existence of an effective program will not protect executives from liability under the RCO Doctrine if improper behavior takes place. The Food and Drug Administration's (FDA's) has undertaken a number of initiatives during the past year in an attempt to counter claims that its review processes for domestic products is driving the development of drugs and devices to overseas markets. The Agency also has improved its capacity to review products imported from overseas by undertaking initiatives with foreign agencies and stationing more FDA employees in foreign countries. The FDA increased the number of warning letters and other enforcement actions. The FDA added two new topics of enhanced authority during the year. One was an expansion of its regulatory authority over foods, and the second was new authority to regulate certain tobacco products. The former is being subjected to some review by the courts, and the scope of its authority over tobacco is the subject of ongoing major litigation. The Federal Trade Commission (FTC) and Securities and Exchange Commission (SEC) are unlikely to experience significant change regarding their regulation of Manufacturers. The FTC, as it has for many years, continues to try to prevent "reverse" payments to generic drug manufacturers by Innovator Manufacturers to diminish generic drug competition, and proposed legislation is before Congress. The SEC still appears focused on the Foreign Corporate Practices Act with respect to enforcement against pharmaceutical and device manufacturers. Federal preemption of State law continues to be a topic of concern, with Court's taking different positions on the effect of the various Supreme Court decisions made in the last two years.
