FDA Law

FTC

Federal Trade Commission. Possess concurrent jurisdiction over the labeling and advertising of foods, otc drugs, veterinary drugs and related products, and cosmetics. Under the FTC Act, the FTC investigates and prosecutes unfair methods of competition including unfair or deceptive practices and methods of competition.

Pre-Clinical Stage

First stage in drug's regulatory life cycle. Used to identify potential effects in body of chemical substance being investigated. Used to gather enough evidence on new drug to determine if reasonably safe to begin trials in humans.

FAA

Food Additives Amendment. Gave FDA authority to require premarket approval for safety of components added to food.

PTO

Patent and Trademark Office. Any patents that seek extension must be submitted an application. FDA assists in reviewing patent applications if the thing applied for falls under its regulation.

PREA

Pediatric Research Equity Act of 2003. Encourages drug research for pediatric use.

Paper NDA

Permitted competing versions of approved new drug based on submission of publicly available reports of well-controlled studies demonstrating drugs safety and efficacy. 505b2 codified

New Drug

A drug that is not generally recognized as safe and effective for use under the prescribed conditions or as suggested by its labeling but which has not been used except during the investigation to determine its safety and effectiveness. Essentially this is any drug that came into market after enactment of 1938 Act unless drug is GRAS/E. Must have an NDA or a recognized variant to be marketed lawfully in the US.

Adulterated

A drug which failed to meet the standards of strength, purity, or quality as prescribed by the USP or the NF. Or the drug failed to meet its own labeled strength or purity. Unless the drug's container plainly stated a different standard of purity.

Informed Consent

A phrase often used in law to indicate that the consent a person gives to participate in clinical trials. Have to consent when being asked to participate in research. Process now for informing and documenting this consent.

Clinical Trials

A set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about) a certain drug before it obtains pre-market approval. This is one of FDA's main areas of concern.

ANDA

Abbreviated New Drug Application. An application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.

Drug Amendments of 1962

Added requirement of proving effectiveness and safety of a drug before it is marketed. New record and reporting requirements were also added. Came about after the Thalidomide Tragedy.

Phase IV

After drug approval, obtain additional safety data, obtain additional efficacy data, detect new uses, determine effectiveness for labeled uses.

Post-Marketing

After drug has been approved. Look for changes in drug effects. If FDA becomes aware of changes it will take action. FDA must notify the sponsor who has 30 days to submit a labeling supplement or explain why not warranted.

AMS

Agricultural Marketing Services. Carries out a number of functions designed to aid in the efficient marketing of agricultural products.

Drug

All medicines and preparations recognized in the United States Pharmacopoeia (USP) or National Formulary (NF) for internal or external use. Any substance and mixture of substances intended to be used for the cure, mitigation, or prevention of disease in either humans or animals. Any substance intended to affect the structure or any function of the body of man or other animals and intended for use as a component of any article specified in the above definition.

Waxman-Hatch Act

Also known as the Drug Price Competition and Patent Restoration Act of 1984. Designed to promote generics while leaving intact a financial incentive for research and development. Allows generics to win FDA marketing approval by submitting bioequivalence studies. Also grants the patented drug an additional five years of marketing exclusivity.

ASCA

Anabolic Steroid Control Act of 2004. Addresses the abuse of steroids by professional athletes and the widespread use of steroids and steroid precursors among students.

Biological Product

Any virus, therapeutic serum, etc. that demonstrates potential to address and treat a disease or condition in human beings.

Misbranded

As defined in the 1906 Pure Food and Drug Act. The package or label of which shall bear any statement, design, or device regarding such article (or its components) which shall be false or misleading in any particular way would be misbranded.

Fast Track Approval

Available for drugs, biologics that demonstrate potential for addressing unmet serious medical needs.

BDAC

Bureau of Drug Abuse Control. FDA established this. Recruited those FDA inspectors who enjoyed such activity as well as law enforcement personnel from other federal and state agencies. Was transferred to DOJ as part of Bureau of Narcotics and Dangerous Drugs and more recently to DEA.

CBER

Center for Biologics Evaluation and Research. Regulates products such as vaccines, blood, and gene therapy.

CDRH

Center for Devices and Radiological Health. Regulates medical devices from thermometers to kidney dialysis machines to electric products that give off radiation.

CDC

Center for Disease Control. Lead federal agency for conducting disease surveillance. CDC monitors the occurrence of illness, outbreaks in the US attributable to food and other FDA regulated products.

CDER

Center for Drug Evaluation and Research. Regulates OTC and prescription medications.

CFSAN

Center for Food Safety and Applied Nutrition. Operating unit of FDA. Regulates most foods, food additives, infant formulas, dietary supplements, and cosmetics.

CVM

Center for Veterinary Medicine. Regulates feed and drugs and devices used in pets, farm animals, and other animals.

CPA

Child Protection Act of 1996. Bans hazardous toys and other articles, broadening FDA's jurisdiction over products not covered by FDCA. In 1972, jurisdiction was transferred to the newly created CPSC (Consumer Product Safety Commission).

CAA

Color Additives Amendment of 1960. Required manufacturers to establish the safety of color additives in foods, drugs, and cosmetics.

Enabling Legislation

Congress creates agencies and gives them power through laws called enabling legislation. This specifies what the agency is to do, how the agency is structured, and its budget.

CPSC

Consumer Product Safety Commission. Major component of FDA's bureau of Product Safety. To administer provisions of the Federal Hazardous Substances Act relating to the labeling of products.

CPEHS

Consumer Protection and Environmental Health Service. Consumer protection unit in public health service. FDA placed in Dept of HEW under PHS in the CPEHS but not anymore.

GMP or cGMP

Current Good Manufacturing Practices. Refers to the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system, etc. Guidance that outlines the aspects of production and testing that can impact the quality of a product.

DHHS

Department of Health and Human Services. US Government's principal agency for protecting the health of all Americans and providing essential human services.

DOJ

Department of Justice. Only Federal agency that can prosecute criminal charges. If FDA wants to bring a charge against the individual or business, it must bring its case to the DOJ.

DOS

Department of State. Area of joint enterprise in enacting schedules for drugs of abuse. Establish level of control in the manufacture, import, prescription, and handling of drugs.

DSHEA

Dietary Supplement Health Education Act of 1994. Addresses the regulation of dietary supplements by exempting them from some regulatory requirements.

DESI

Drug Efficacy Study Implementation Review. Examines all available data or drugs approved between 1938 and 1962. Makes recommendations as to their efficacy.

DEA

Drug Enforcement Administration. Shared enterprise with FDA for regulating drugs.

DLA

Drug Listing Act of 1972. Congress enacted the Drug Listing Act requiring that all marketed drugs be listed with FDA when a company first registers. Lists must be updated each June and December.

DPCPTRA

Drug Price Competition and Patent Term Restoration Act of 1984. Expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand name drugs without repeating the research done to prove them safe and effective. At the same time, the brand name companies can apply to extend the patent term for up to five years to make up for time lost while their products were going through FDA's approval process.

DHA

Durham Humphrey Amendment of 1951. Defines the kinds of drugs that cannot be safely used without medical supervision and restricts their sale to prescription by a licensed practitioner.

EPA

Environmental Protection Agency. Administers two laws that have a great impact on food supply. FIFRA - Federal Insecticide, Fungicide and Rodenticide Act and SDWA - Safe Drinking Water Act.

Phase II

Expanded patient group of afflicted with disease or condition being shared. Looking for effectiveness and further exploring risks and side effects.

EREA

Export Reform and Enhancement Act of 1996. EREA amended the FDCA to alter FDA's role in regulating the trade of drugs, biologics, and medical devices. Eased import and export restrictions on drugs and medical devices.

Withdrawal

FDA has statutory authority to withdraw NDAs. Halt further use or distribution of a drug or IND. Serious patient risk is found or deficiencies are found in application.

Clinical Hold

FDA may forestall a proposed or clinical investigation or suspend an existing one for any number of reasons, unreasonable and significant risk to patients, use of improperly qualified Investigators, deficient IND. Must provide specific sponsor with notice in 30 days.

Rulemaking

FDA must follow a defined process before it can release a new rule. In addition, it must first publish the proposed regulation in the Federal Register.

Suitability Petitions

FDCA permits generic products to incorporate differences from requirements where such differences ultimately will not affect the safety and efficacy of the generic product.

FPLA

Fair Packaging and Labeling Act of 1966. Requires all consumer products in interstate commerce to be honestly and informatively labeled, with FDA enforcing provisions on foods, drugs, cosmetics, and medical devices.

FDCA

Food Drug and Cosmetic Act of 1938. Gives authority to the US FDA to oversee the safety of foods, drugs, and cosmetics. This Act also required new things than its predecessor, such as requiring new drugs to be shown safe before marketing, authorizing standards of quality, factory inspections, and adding the remedy of court injunctions to the previous penalties of seizures and civil prosecutions.

FSIS

Food Safety and Inspection Service. Agreements exist between FDA and this and concerning public education initiative. Coordinate efforts in meat and seafood industries to curtail the contamination of meat, poultry, and fish products from harmful microorganisms.

FDAAA

Food and Drug Administration Amendment Act of 2007. Requires a sponsor to post on a public registry certain summary information about any clinical trial for a serious or life-threatening disease. Must be other than a Phase I investigation.

FDAMA

Food and Drug Administration Modernization Act of 1997. Broadened FDA's authority and reformed several areas of regulation. Looking for safety and effectiveness. Included a unique provision, which amended the FDCA to encourage drug manufacturers to study their drugs in pediatric populations.

FDA

Food and Drug Administration. Oversees safety of food and drugs and cosmetics in the United States. Part of the executive branch of government. Can regulate products that are in interstate commerce

OTC Review

GRAS, generally recognized among experts qualified by scientific training and experience to evaluate safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, that such regulation be based on adequate published data demonstrating the drug's safety and efficacy and that the drug have been used to a material extent and for a material time under the labeled conditions

GRAS/GRAE

Generally Recognized as Safe And Effective. Any product that has been around for a long time that we know is safe and effective.

GRAS

Generally Recognized as Safe. Part of the definition of food additive in that it was defined as any substance reasonably expected to become a food component. Not generally recognized by qualified experts as safe for its intended use based on scientific procedures or for substances based on experience form common use in food. The Food Additives Amendment dealt with this and established formal rule-making procedures for this process.

GDEA

Generic Drug Enforcement Act of 1992. Imposes debarment and other penalties for illegal acts involving approval of abbreviated new drug applications (ANDA). Criminal penalties associated with this.

GLP

Good Laboratory Practices. Specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, quality, etc. of chemical pre-clinical safety tests. Codified in CFR. Governs lab work and facilities. Associated with any nonclinical study. Intended to support a marketing application for an FDA regulated product. Establishes minimum requirements for testing lab's practices. Subjects lab to FDA inspection and oversight. Provides penalties for non-compliance.

HACCP

Hazard Analysis and Critical Control Points. Procedures designed to ensure the safest food supply.

Personal imports

Imports into the country of drugs from elsewhere. Main area of concern for FDA.

Bioterrorism Act of 2002

Increased the capacity of government at all levels to detect and respond effectively to public health emergencies related to bioterrorist attacks. Maintenance of certain manufacturing and shipping records, administrative detention of adulterated foods, pre-importation notifications, prohibitions against port shopping, debarment for repeated violations.

Phase I

Initial administration of drug to small number of healthy test subjects or patients to determine metabolism and pharmacologic effects of drugs.

IRB

Institutional Review Board. Independent ethics committee formally designated to approve, monitor, and review biomedical and behavioral research involving humans. Committee designed by an institution to review and approve study before it can begin and to monitor study as it progresses. Membership will be from sufficiently diverse backgrounds and disciplines. Checks compliance with regulatory requirements for informed consent. Reviews and monitors clinical studies. IRB is on site. IRB records are subject to FDA inspection.

Virus Act of 1902

Intended to ensure purity and safety of therapeutic serums, vaccines, toxins, etc. The 1902 Federal law arose from two tragedies; Smallpox vaccine contaminated in Camden Diphtheria antitoxin contaminated in Saint Louis This Act triggered the pre-market approval process, which was a huge step forward to prevent tragedies.

IND

Investigational New Drug Application. Request for authorization from the FDA to administer an investigational drug or biological product to humans. Requirements set out in CFR. IND includes chemical structure and quantitative composition, sources and methods of production, all pre-clinical investigations. Once submitted, if you don't hear from FDA within 30 days after filing IND, clinical trials may be started, if they object they will put you on hold.

Substantial Equivalence

Maintains that a novel food/drug/device should be considered the same as and as safe as a conventional food/drug/device if it demonstrates the same characteristics and composition as the conventional food/drug/device.

MDA

Medical Device Amendments of 1976 to the FDCA. Passed to ensure the safety and effectiveness of medical devices, including diagnostic products. The amendments require manufacturers to register with FDA and follow quality control procedures. Some products must have premarket approval by FDA; others must meet performance standards before marketing.

MDUFMA

Medical Device User Fee and Modernization Act of 2002. Enacted to amend the FDCA to subject medical device manufacturers to medical device user fees for certain applications, reports, applications, supplements, and submissions sent to FDA for evaluation. Law also established performance goals for FDA to meet.

MPDIMA

Medicare Prescription Drug Improvement Modernization Act of 2003. Access to affordable pharmaceuticals. Provisions on importation of prescription drugs from Canada.

NCTR

National Center for Toxicological Research. FDA's internationally recognized research center, plays a critical role in the FDA's mission. The unique scientific expertise of NCTR is critical in supporting FDA product centers and their regulatory roles.

NIDA

National Institute on Drug Abuse. Shared enterprise with FDA for regulating drugs.

NDA

New Drug Application. Vehicle through which drug sponsors formally propose the FDA approve a new pharmaceutical for sale and marketing in the US. Includes information on the study drug itself and information on the proposed clinical investigation. FDA will refuse to file if incomplete, improper form, omits critical data, or fails to make required certifications.

Phase III

Notification to FDA, collect data necessary to meet safety and efficacy, standards required for FDA approval.

NLEA

Nutrition Labeling and Education Act of 1990. Provides FDA with specific authority to require nutrition labeling of most foods regulated by the Agency. Requires that all nutrient content claims (i.e., 'high fiber', 'low fat', etc.) and health claims be consistent with agency regulations.

OIG

Office of Inspector General. Investigates health care fraud and abuse. Also sets internal compliance standards for false claims of off labeling prescriptions

ODA

Orphan Drug Act of 1982. Provided economic incentives for the development of drugs to treat rare diseases. i.e. affects fewer than 200,000 people in the United States.

Advisory Committee

Outside experts respond to specific questions posed by agency regarding safety and effectiveness.

OTC

Over the counter drugs. Drugs that can be obtained without a prescription. May be sold directly to consumers.

PMA

Pre-Market Approval. FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Off label prescribing

Prescribing a drug for uses other than those it is intended for. FDA is very concerned with this practice.

PDMA

Prescription Drug Marketing Act of 1987. Addressed the unacceptable risks associated with counterfeit, adulterated, misbranded, sub-potent or expired drugs.

PDUFA

Prescription Drug User Fee Act of 1992. Adds more resources to FDA's review process for drugs and biologics. FDA collects user fee for each NDA, performance goals taken very seriously. Established requirements for drug and biologics manufacturers to pay fees for applications and supplements that require FDA to review clinical studies. User fees enable FDA to hire more reviewers.

Biologics

Products derived from living organisms. Regulated by Public Health Service Act.

PHSA

Public Health Service Act of 1944. Regulates biologics.

PHS

Public Health Service. Formed service led by the Surgeon General, providing highly trained and mobile health professionals who promote public health.

PFDA

Pure Food & Drugs Act of 1906. The original pure food and drugs act commanded the federal government to ferret out adulterated and misbranded foods and drugs in interstate commerce. Did not authorize the government to establish industry wide standards or broad rules to protect the public health.

RCHSA

Radiation Control for Health and Safety Act. Intended to protect the public from unnecessary exposure to radiation from electronic products. The law authorizes FDA to set emissions standards for things that give off radiation (microwaves, X-rays, color TV's).

RTF

Refusal to File. Not accepted for review by FDA. FDA uses this for obvious deficiencies in application such as; Omission of required section of NDA, Failure to include evidence of effectiveness, or Omission of critical data.

REMS

Risk Evaluation and Mitigation Strategy. FDA may require a sponsor to include in NDA when agency deems it necessary to ensure that the benefits of drug outweigh risks of the drug. Certain timetable for submission should be included. Distribution of medication guide maybe required or patient package insert when dispensed.

SMDA

Safe Medical Devices Act of 1990. First major revision of the medical device requirements of 1976. The SDMA increases FDA's regulatory authority over the medical device industry, particularly in the areas of post-marketing requirements and pre-market notification and approval process.

Clinical Investigation

Stage of regulatory process that gathers information about the safety and efficacy of drug to support an NDA. More active FDA oversight to protect human test subjects. Notice of claimed investigational exemption for ND (IND) application (NCIE). Manufacturers must file with FDA for a New Drug IND Application.

Safety and Effectiveness

Standard of Review for approving products. Substantial evidence that the drug will have the effect it purports to have under the indicated conditions of use. Weighs products demonstrated effectiveness against its risks, seriousness of disease, alternative remedies, adverse reaction and other safety data.

Bioequivalent

Term of art meaning absence of significant difference and generic drug is as safe and effective as the original innovator drug. Primary requirement of ANDA is that the proposed generic drug be shown to be the same "" to the innovator drug it purports to copy. Absence of significant difference—provides same total active ingredients

TSCA

Toxic Substances Control Act of 1976. Gives EPA authority to regulate mixtures of chemical substances and articles containing such substances or mixtures.

USCS

United States Customs Service. Overlaps with FDA's authority in regulating customs.

USDA

United States Department of Agriculture. Carries out functions to aid in the regulation of agricultural products.

Wheeler-Lea Amendments of 1938 to the FTCA

United States federal law that amended Section 5 of the Federal Trade Commission Act to proscribe "unfair or deceptive acts or practices" as well as "unfair methods of competition". It provided civil penalties for violations of Section 5 orders. Also added a clause to Section 5 that stated "unfair or deceptive acts or practices in commerce are hereby declared unlawful" to the Section 5 prohibition of unfair methods of competition in order to protect consumers as well as competition. Until this amendment was passed, the Federal Trade Commission could only restrict practices that were unfair to competitors. This broadened the FTC's powers to include protection for consumers from false advertising practices.