Acts and Amendments

Pure, Food, and Drug Act

Pure, Food, and Drug Act

This law prohibited the adulteration and misbranding of foods and drugs in interstate commerce. The law fell short of short of providing that protection that Congress intended, because of a US Supreme Court decision held that the misbranding provision in the law did not prevent false of misleading efficacy claims.

Food, Drug, and Cosmetic Act

This law along with amendments forms the nucleus of todays’ law. It provided that no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA. This law also expanded the definitions of misbranding and adulteration, requiring that labels must contain adequate direction for use and warning about the habit-forming properties of certain drugs.

Durham-Humphrey Amendment

This amendment established two classes of drugs-prescription and OTC- and provided that the labels of prescription drugs need not contain “adequate directions for use” so long as they contain the legend “Caution: Federal law prohibits dispensing without a prescription”. This amendment also authorizes oral prescriptions and refill of prescription drugs.

Food Additives Amendment

This amendment requires that components added to food products receive premarket approval for safety. Also contain in this law is the anticancer provision (Delaney Clause) which prohibits the approval of any food additive that might cause cancer.

Color Additive Amendment

The amendment requires manufacturers to establish the safety of color additives in foods, drugs, and cosmetics. Under this amendment the FDA can approve a color for one use but not for others (e.g. external use only).

Kefauver-Harris Amendment

This amendment is also called the Drug Efficiency Amendment, it strengthen the new drug approval process by requiring that drugs be proved not only safe but also effective. The efficacy requirement was made retroactive to all drugs marketed between 1938 and 1962. In addition, the amendment also transferred jurisdiction of prescription drug advertising form the FTC to the FDA, established GMP requirements and added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug reactions.

Medical Device Amendment

This amendment requires classification of devices according to their function, premarket approval, establishes performance standards, conformance of GMP requirement and adherence to record and reporting requirements of medical devices.

Orphan Drug Act

Congress passes this Act to provide tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of “rare diseases or conditions (defined as those affecting fewer than 200,000 Americans).

Drug Price Competition and Patent Term Restoration Act

Also called the Waxman-Hatch Amendment, that act was enacted to streamline the generic drug approval process while giving patent extensions, in certain cases, to innovator drugs.

Prescription Drug Marketing Act

Congress enacted this act in response to the growing alarm that a secondary or diversionary distribution system for prescription drugs was threatening the public health and safety. Further this law establishes sales restrictions and record keeping requirements for prescription drug samples and prohibits hospitals and other healthcare entities from reselling their purchases to other businesses and requires the state licensing of drug wholesalers.

Safety Medical Device Act

This act further strengthened the Medical Device Amendment giving the FDA additional authority especially related to post marketing requirements and premarket notification and approval, while expediting the premarket device approval process.

The Generic Drug Enforcement Act

This act resulted from a scandal that occurred when some FDA staff accepted bribed from generic drug industry personnel in order to facilitate the approval process of certain generic drug products. This law authorizes the FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies.

Prescription Drug User Fee Act

The act requires manufacturers seeking NDAs to pay fees for applications and supplements when the FDA must review clinical studies. The fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and speed up the NDA reviews. In addition, this Act must be reauthorized every 5 years.

Nutrition Labeling and Education Act

The Act mandates nutrition labeling on food products and authorizes health claims on product labeling, as long as that are made in compliance with FDA regulations.

Dietary Supplement Health and Education Act

This act defines dietary supplements and permits manufacturers to make certain claims that otherwise would be illegal under the FDCA. Under this Act FDA regulates dietary supplements more as foods than as drugs.

FDA Modernization Act

This act was passed primarily to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices. The intent of this act is to eliminate backlogs in the approval process and ensure the timely review of applications. This act creates a fast-track approval process for drugs intended for serious or life threatening diseases, establishes a databank of information on clinical trials, authorizes scientific panels to review clinical investigations and expands the rights of manufacturers to disseminate unlabeled use information. This act also expands the FDA’s authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients. The law also affects the regulation of medical devices in part by mandating priority review for breakthrough technologies in medical devices and allowing the FDA to contract with outside scientific experts for review of medical device applications.

Medical Device User Fee and Modernization Act

This act established user fee requirement for premarket reviews of medical devices and also established performance goals for many types of premarket reviews, inspections that can be conducted at establishments by accredited third parties and new regulatory requirements for reprocessed single use devices. This also must be renewed by Congress every 5 years.

FDA Amendment Act

This act reauthorized and amended many drug and medical device provisions that were set to expire, also provided the FDA with new funding and significantly more authority over drug safety. This act allows the FDA broader use of the fees generated by PDUFA, while increasing the fees. The law also provides the FDA with significantly enhanced responsibilities and authorization to regulate drug safety, authority to mandate labeling changes related to safety, require clinical trial data reporting and registries, require postmarket clinical studies to assess risk, and require companies to implement risk evaluation and mitigation strategies (REMS) when necessary.

FDA Safety and Innovation Act

The law allows the FDA to continue to collect fees from manufacturers seeking NDAs or medical device approvals. It also adds the Generic Drug User Fee Act and Biosimilar User Fee Act. The purpose of imposing fees on these manufacturers is to increase resources for the FDA in order to speed the generic drug and biosimilar approval process. The law also contains several provisions directed at reducing drug counterfeiting, blocking the import of adulterated products, detecting and reducing drug shortages, and enhancing the exchange of prescription drug diversion information across state lines. Additionally this law enables the FDA to inspect foreign drug manufacturers more regularly and requires the agency to target problematic manufacturing sites.

Drug Quality and Security Act

Two titles under this act. Title 1 also called the Compounding Quality Act, clarifies and strengthens FDA oversight over pharmacies engaged in the large scale compounding and shipping of sterile products to other licensed entities. The law also removed uncertainty regarding when a product compounded by a pharmacy is exempt from CGMOP, labeling and the new drug approval process. Title II known as the Drug Supply Chain Security Act, adds “track and trace” requirements for all entities in the chain of distribution of pharmaceutical products. Requires manufacturers to provide transaction information to purchasers, who in turn must provide transaction information to subsequent purchasers. The law also mandates an electronic, interoperable product tracing system by 2023, strengthens wholesaler and third party logistics licensure requirements and requires manufacturers to serialize drugs by 2017.

The 21st Century Act

This Act was passed in large part to streamline and add flexibility and innovation to the drug development and approval process, primarily by creating new clinical trial design options and by accelerating the pathways to market for drugs intended to treat certain serious or life threatening diseases. This law also provides for billions of dollars of additional funding to the National Institute of Health (NIH).

FDA Reauthorization Act

This act reauthorized the user fee programs and enhanced the goals of the Cures Act and created a new category of OTC hearing aids.