Food and Drug Law, Seton Hall Law School, Prof. Paradise, Fall 2015
1. Understand the Institutional Framework of the Agency
2. Understand the Scope & Authority of the FDA and its association to other Agencies
3. Gain knowledge of the Regulations, Caselaw, and gov’t bodies regulating these areas
4. Understand the Agency as a Responder – responding to public health crises
5. How is FDA doing their job? Are they making law, issuing a Warning Letter, inspecting, seizing, etc.?
6. Is that activity tailored to what the public expects them to be doing?
7. Identify the regulatory powers of FDA – rulemaking authority, adjudicatory authority, inspection authority
The Focus of Food and Drug Law
· Food and Drug Law is about certain types of physical things.
· Most of these things are put into or onto, or are used with, the bodies of humans or animals –
o foods, drugs, medical devices, cosmetics, and since 2009 – tobacco products.
· Food and drug law also concerns aspects of radiation-emitting products (microwave ovens, laser lights) that relate to safety.
· The principal requirements and prohibitions of the law are about things:
o They shall not be adulterated or misbranded;
o They shall be manufactured and tested in accordance with certain standards;
o Certain disclosures shallb e made on their labels and in their labeling;
o Certain kinds of claims shall not be made;
o Certain kinds of things shall not be introduced into interstate commerce until their distribution has been authorized by the regulatory agency.
· Enforcement Action:
· During the first few decades of modern Food and Drug Law, the law’s characteristic form of enforcement action was an in rem seizure action against physical objects that were in violation of the law.
· In recent decades, seizure actions have largely (though not completely) been replaced by recalls, which serve the same purpose without intervention by a court.
· To the extent Food and Drug Law regulates people and what they do, it regulates them only in relation to the physical things that are within the jurisdiction of the law –
o through injunctive, criminal, debarment, civil-penalty, or certain other types of proceedings.
· Food and Drug Law addreses the various stages of the regulated products’ life cycles.
· Whereas other administrative agencies have gone through periods of deregulation, in recent years Congress has expanded FDA’s jurisdiction and its regulatory authorities.
FDA’s most labor-intensive Activities:
1. review of applications to test potential new medical products in human subjects
2. review of applications for permission for commercial marketing of new products or ingredients for use in products, and for changes in already marketed products
3. review of reports and other data bearing on the safety of marketed products
4. inspections of factories and of goods offered for importation, and testing of samples obtained in such inspections
5. reivew of advertising and marketing of products
6. regulatory and enforcement actions that result from such inspections and reviews
7. development and publication of regulations and guidance documents relating to products and activities within its jurisdiction
History of the Law
· Pure Food and Drugs Act of 1906 was championed by USDA specified conditions under which foods and drugs would be considered adulterated or misbranded (and therefore barred from interstate commerce), and authorized USDA’s Bureau of Chemistry to recommend enforcement actions to the Department of Justice. The law did not provide for governmental review of products prior to their marketing, and was limited in other ways.
· The FDCA of 1938 remedied many of the recognized defects in the 1906 act. The FDCA is the FDA’s organic statute and the principal authority for its regulatory activities. This statute greatly expanded FDA’s authority by providing for premarket review of drugs under a requirement of safety, for standards of identity and quality for food, for regulation of medical devices and cosmetics, and for inspections by FDA empoyees of factories, warehouses, and other places where regulated products are made, tested, or held. This statute remains the basic food and drug law. It has been amended many times in ways that expand and strengthen the regulatory scheme.
FDA’s Interaction with other Agencies:
· Certain regulatory functions relating to some of the regulated products are also performed by:
o Drug Enforcement Administration (DEA) in DOJ
o Federal Trade Commission
o individual States
o Centers for Medicare and Medicaid Services in the Dept. of Health and Human Services
Sources of Food and Drug Law – both 21 U.S.C. and FDCA
How do they relate? For example:
· 21 U.S.C. Section 371. Regulations and hearings = FDCA 701
Basic Admin Law Concepts:
1) Agency à FDA
What is an agency?
· Part of the Executive branch / President
· Falls under the HHS (Dept. of Health & Human Services)
· Who is the Head of the FDA? The Commissioner.
· Who is the Head of the Dept. of HHS? The Secretary.
· Congress sets up agencies which are situated within the federal government.
· Most of them are executive agencies overseen by the President.
· Under the HHS, the FDA is one of 12 agencies.
· The Secretary delegates a lot of these specific responsibilities to the Commissioner.
· FDA has no authority to represent itself in court, but is represented by DOJ.
· All litigation – civil and criminal – involving the agency and including litigation brought against the agency, is supervised on behalf of the agency by the Consumer Protection Branch (CPB) in the Civil Division of DOJ.
· Responsibility for the actual conduct of litigation on behalf of FDA is divided between the CPB and the Offices of the United States Attorneys throughout the country.
· FDA originated as the Bureau of Chemistry in USDA before the enactment of the Pure Food & Drugs Act of 1906.
· Today, FDA is a part of the Department of Health and Human Services (DHHS).
2) FDA Powers
1. Rulemaking à tied to legislative branch
2. Adjudication à tied to judicial branch
Where does the Agency get these powers?
Enabling Act (Statute) = The Food Drug & Cosmetic Act.
There are 20+ other statutes where FDA has responsibilities, but we will focus on the FDCA.
3. Investigation & Enforcement
o FDA can inspect facilities.
o Enforcement means: Seizure, injunction.
o Who does the agency need to partner with for enforcement? DOJ (Dept. of Justice).
3) FDA Mission
· Protect the public health
· But also speed innovation
· Breaks mission down into areas:
(B) Human and Vet drugs
(E) Electronic Radiation
4) History of FDA
· 1906: Upton Sinclair’s The Jungle sparks the Pure Food & Dru
o Despite broad delegations by the Secretary to the Commissioner, the Secretary reserved the authority to approve regulations promulgated by FDA that:
§ 1) establish procedural rules applicable to a general class of foods, drugs, cosmetics, medical devices, or other subjects of regulation; or
§ 2) present highly significant public issues involving the quality, availability, marketability, or cost of one or more foods, drugs, cosmetics, medical devices, or other subjects of regulation.
Food and Drug Law and Regulation & Practice of the Healing Arts
· Although the food and drug laws and FDA’s regulations apply to articles that affect health and to articles used to protect, promote, and restore health, they do not apply directly to the practice of medicine or other healing arts.
· In general, physicians, dentists, pharmacists, and other healthcare providers are regulated by their respective professional societies and by state governmental agencies.
· In general, FDA does not regulate medical professionals except when they engage in clinical research, and when they manufacture, prepare, dispense, or market products within FDA’s jurisdiction.
· As a matter of food and drug law and regulation, practitioners are free to use such products outside the conditions stated in their labeling, but they are responsible for such use under state law.
FDA Administrative Procedures
· The agency’s decisions interpreting statutory provisions are generally embodied in “orders” and “rules” as defined by the Administrative Procedure Act (APA).
· In some cases, the agency’s decisions are embodied in final rules issued in response to petitions described by statute.
· FDA also establishes by regulation various pre- and postmarketing requirements for products within its jurisdiction.
· The more formal rulemaking processes through which FDA administers the law are primarily adjudications and rulemakings.
· The agency’s interpretations of the law are also often reflected in guidance documents or in responses to petitions that are not part of a marketing-authorization process.
· Like other federal agencies, FDA also uses many informal communication tools – such as press or other media communications, speeches, and responses to letters – to inform and educate the rgulated industry and the public.
· As a regulatory agency, FDA’s interpretations of the law are reflected in its enforcement actions and policies.
· For example, FDA exercises its authority and conveys it sviews through communications during inspections, Warning Letters, initiation and prosecution of administrative actions and civil and criminal judicial actions, and import-detention actions.
· The FDCA specifies many of the procedures FDA is to follow in implementing the statute’s substantive requirements.