Pharmacy Law - FDCA Amendments

Pure Food and Drug Act of 1906

- prohibited the adulteration and misbranding of foods and drugs in interstate commerce
- fell short of providing protection that Congress intended because of a Supreme Court decision --> failed to achieve its purpose
- difficult to enforce because required the government to prove fraudulent intent on the part of one who made false statements on the label
- did not grant FDA authority to ban unsafe drugs

Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)

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

Durham-Humphrey Amendment of 1951

- established two classes of drugs --> rx and OTC
- provided that labels of rx drugs do not need to contain "adequate directions for use" as long as they contained the legend "Caution: Federal law prohibits dispensing without a prescription"
- authorizes oral prescriptions and refill of prescription drugs

Food Additives Amendment of 1958

- requires that components added to food products receive premarket approval for safety
- anticancer provision (Delaney Clause) --> prohibits approval of any food additive that may cause cancer

Color Additive Amendments of 1960

- requires manufactures to establish safety of color additives in foods, drugs, and cosmetics.
- FDA can approve a color for one use but not for others (ex. external use only)

Kefauver-Harris Amendment of 1962

- also called the Drug Efficiency Amendment
- strengthened the new drug approval process by requiring that drugs be proved safe and effective
- efficacy requirement made retroactive to all drugs marketed between 1938 and 1962
- transferred jurisdiction of prescription drug advertising from FTC to FDA
- established GMP requirements and added more extensive controls for clinical investigations by requiring informed consent of research subjects and reporting of adverse drug reactions

Medical Device Amendment of 1976

- 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 of 1983

- provides tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for treatment of rare diseases and conditions (affecting 200,000 Americans or fewer)

Drug Price Competition and Patent Term Restoration Act of 1984

- Waxman-Hatch Amendment
- streamlined the generic drug approval process while giving patent extensions, in some cases, to innovator drugs

Prescription Drug Marketing Act of 1987

- enacted in response to growing alarm that a secondary or diversionary distribution system for prescription drugs was threatening public health and safety
- established sales restrictions and record keeping requirements for prescription drug samples
- prohibits hospitals and healthcare entities from reselling purchases to other businesses and requires state licensing of drug wholesalers

Safe Medical Devices Act of 1990

- further strengthened the Medical device amendment giving FDA additional authority related to post marketing requirements and premarket notification and approval, while expediting the premarket device approval process

Generic Drug Enforcement Act of 1992

- resulted from a scandal where some FDA staff accepted bribes from generic drug industry personnel in order to facilitate approval process of certain generic drug products
- authorizes FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies

Prescription Drug User Fee Act of 1992

- requires manufacturers seeking NDAs to pay fees for applications and supplements when the FDA must review clinical studies
- fees provide FDA with resources to hire more reviewers to assess clinical studies and speed up NDA reviews
- act must be reauthorized every 5 years

Nutrition Labeling and Education Act of 1990 (NLEA)

- mandates nutrition labeling on food products and authorizes health claims on product labeling as long as in compliance with FDA regulations

Dietary Supplement Health and Education Act of 1994 (DSHEA)

- defines dietary supplements and permits manufacturers to make certain claims that otherwise would be illegal under the FDCA
- FDA regulates dietary supplements more as food than drugs

Food and Drug Administration Modernization Act of 1997 (FDAMA)

- passed primarily to streamline regulatory procedures to ensure expedited availability of safe & effected drugs and devices
- intent was to eliminate backlogs in the approval process and ensure timely review of applications
- creates fast track approval process for drugs intended for life threatening /serious diseases, establishes data bank of information on clinical trials, authorizes scientific panels to review clinical investigations, and expands the rights of manufacturers to disseminate unlabeled use information
- expands FDA authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients
- mandated priority review for breakthrough technologies of medical devices

Medical Device User Fee and Modernization Act of 2002

- establishes user fee requirement for premarket reviews of medical devices and established performance goals for different types of premarket reviews, inspections that can be conducted at establishments by accredited third parties and new regulatory requirements for reprocessed single use devices
- must be reviewed by Congress every 5 years

Food and Drug Administration Amendments Act of 2007 (FDAAA)

- provided FDA with new funding and significantly more authority over drug safety
- allows the FDA broader use of fees generated by PDUFA, while increasing fees
- provides 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 post market clinical studies to assess risk, and require companies to implement risk evaluation and REMS when necessary

FDA Safety and Innovation Act of 2012

- allows FDA to continue to collect fees from manufacturers seeking NDAs or medical device approvals
- purpose of imposing fees is to increase resources for FDA in order to speed the generic drug and biosimilar approval process
- contains several provisions directed at reducing drug counterfeiting, blocking import of adulterated products, detecting and reducing drug shortages, and enhancing the exchange of prescription drug diversion information across state lines
- enables FDA to inspect foreign drug manufacturers more regularly and requires agency to target problematic manufacturing sites

Drug Quality and Security Act of 2013

- Title I - Compounding Quality Act - clarifies and strengthens FDA oversight over pharmacies engaged in large scale compounding and shipping of sterile products to other licensed entities
- removed uncertainty regarding when a compound is exempt from CGMOP, labeling and the new drug approval process
- Title II - 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, 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

21st Century Cures Act of 2016

- passed 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 pathways to market for drugs intended to treat serious diseases
- also provides billions in additional funding to NIH

FDA Reauthorization Act of 2017

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