pharmacy law- FDCA Amendments Flashcards
(35 cards)
FDCA
What is its purpose/goal
Under the Act, no new drug may be marketed and sold unless it has been proved both safe and effective for its intended use and approved by the federal Food and Drug Administration.
Pure Food and Drug Act
concern for the risks to public health and safety associated with unsanitary and poorly labeled foods and drugs prompted Congress in 1906 to pass the Pure Food and Drug Act
The law prohibited the adulteration and misbranding of foods and drugs in interstate commerce (trading btwn states)
Sulfanilamide elixir tragedy
Sulfanilamide was one of the first of the “miracle” anti-infective sulfa drugs marketed.
Manufacturer produced the drug in an elixir form with diethylene glycol (like antifreeze for cars; a poison) as a solvent so it could smell better
No toxicity tests had been conducted.
Solvent was a found to be a deadly poison and 107 deaths were attributed to this elixir.
The 1906 law had not granted the FDA the authority to ban unsafe drugs.
FDA removed the elixir on a technicality.
Elixirs must contain alcohol, the elixir of sulfanilamide did not contain alcohol.
Food, Drug, and Cosmetic Act
The FDCA with Amendments forms the nucleus of today’s law.
Provided that no new drug could be marketed until proved safe for use under the conditions described on the label and approved by the FDA.
The law expanded the definition of misbranding and adulteration under the earlier act.
FCDA Label policy
Labels must contain adequate directions for use and warnings about the habit-forming properties of certain drugs.
Applies to cosmetics and devices as well.
Durham-Humphrey Amendment
The 1938 FDCA required all drugs to be labeled with “adequate directions for use.”
Drugs on the market at this time were not safe for use except under medical supervision.
Durham-Humphrey Amendment was enacted to solve this problem
Durham-Humphrey Amendment established what
Amendment established two classes of drugs
prescription and over the counter
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”
Durham-Humphrey Amendment is satisfied by what and authorizes what
When dispensed by a pharmacist, inclusion on the label of directions from the prescriber satisfies the “adequate directions for use” requirement.
Amendment also authorizes oral prescriptions and refills of prescription drugs
Food Additives Amendment to add what and prohibits what
Congress amended the FDCA to require that components added to food products must receive premarket approval for safety.
Anticancer provision, (Delaney Clause)
prohibits the approval of any food additive that might cause cancer.
Color Additive Amendments
Requires manufacturers to establish the safety of color additives in foods, drugs, and cosmetics.
The FDA can approve a color for one use but not the others (e.g. external use only)
Thalidomide
1950’s a popular sedative was being marketed in Europe.
The FDA withheld final approval of the new drug application (NDA) pending safety information.
In 1961, confirmed that thalidomide caused a birth defect, in thousand of infants.
Due to the FDA refusal to allow marketing of the drug in the US, the number of birth defects in the US was low.
Congress enacted the Kefauver-Harris Amendment
Kefauver-Harris Amendment
Strengthened the new drug approval process by requiring drugs to be proved not only safe but also effective.
The efficacy requirement was made retroactive to all drugs marketed between 1938 and 1962.
Amendment also:
transferred jurisdiction of prescription drug advertising from the Federal Trade Commission to the FDA
established the Good Manufacturing Practices (GMP) requirements
added more extensive controls for clinical investigations
informed consent
reporting of adverse drug reactions
Medical Device Amendment
Under the 1938 Act, the FDA had no authority to review medical devices for safety and efficacy before marketing
Prompted by public safety concerns with certain devices, Congress amended the FDCA in 1976 to provide for more extensive regulation administrative authority regarding the safety and efficacy of medical devices.
what does the Medical Device Amendment require
classification of devices according to their function
premarket approval
establishment of performance standards
conformance with GMP regulations
adherence to record and reporting requirements
Orphan Drug Act
Pharmaceutical manufacturers had urged Congress to recognize that the NDA process was too expensive to warrant development and marketing of drugs for diseases that affected few people.
In 1983, Congress passed legislation to provide tax and exclusive licensing incentives for manufacturers to develop and market these drugs or biologicals
what is an Orphan Drug
“rare diseases or conditions” (defined as those affecting fewer than 200,000 Americans.)
Drug Price Competition and Patent Term Restoration Act
Waxman-Hatch Amendment
Enacted to streamline the generic approval process while giving patent extensions, in certain circumstances, to innovator drugs.
The intent is to make generic drugs more readily available to the public while providing incentives to manufactures to develop new drugs.
Prescription Drug Marketing Act
Due to growing alarm that a secondary distribution system for prescription drugs was threatening the public health and safety and creating an unfair form of competition.
Law establishes sales restrictions and record keeping requirements for prescription drug samples.
Prohibits hospitals and other health care entities from reselling their pharmaceuticals to other businesses and requires state licensing of drug wholesalers.
Safe Medical Devices 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
Occurred when some FDA staff accepted bribes from generic drug industry personnel in order to facilitate the approval process of certain generic drug products.
FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies.
Imposes severe civil penalties for any false statements, bribes, failures to disclose material facts and other related offenses.
Prescription Drug User Fee Act
The FDA and Congress took the approach that private industry should shoulder part of the costs for new drug approval rather than the taxpayers.
Requires manufacturers to pay fees for applications and supplements when the FDA must review clinical studies.
Fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and hopefully speed up the NDA review.
Nutrition Labeling and Education Act
Mandates nutrition labeling on food products and authorizes health claims on product labeling, as long as they are made in compliance with FDA regulations.
Dietary Supplement Health and Education Act (DSHEA)
Dietary supplement manufacturers felt that the NLEA left too much authority with the FDA and unduly restricted the promotion of dietary supplements.
DSHEA defines dietary supplements and permit manufacturers to make certain claims that otherwise would have been illegal under the FDCA
FDA to regulate dietary supplements more as foods than as drugs.
Dietary Supplement
A product that is intended:
For ingestion;
To supplement the diet;
Contains any one or more of the following:
a vitamin
a mineral
an herb or other botanical
an amino acid
a dietary substance for use by humans to supplement the diet by increasing the total dietary intake
a concentrate, metabolite, constituent, extract, or combination of the previous
