pharmacy law- FDCA Amendments

Question 1

FDCA
What is its purpose/goal

Answer 1

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.

Question 2

Pure Food and Drug Act

Answer 2

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)

Question 3

Sulfanilamide elixir tragedy

Answer 3

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.

Question 4

Food, Drug, and Cosmetic Act

Answer 4

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.

Question 5

FCDA Label policy

Answer 5

Labels must contain adequate directions for use and warnings about the habit-forming properties of certain drugs.
Applies to cosmetics and devices as well.

Question 6

Durham-Humphrey Amendment

Answer 6

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

Question 7

Durham-Humphrey Amendment established what

Answer 7

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”

Question 8

Durham-Humphrey Amendment is satisfied by what and authorizes what

Answer 8

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

Question 9

Food Additives Amendment to add what and prohibits what

Answer 9

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.

Question 10

Color Additive Amendments

Answer 10

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)

Question 11

Thalidomide

Answer 11

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

Question 12

Kefauver-Harris Amendment

Answer 12

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

Question 13

Medical Device Amendment

Answer 13

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.

Question 14

what does the Medical Device Amendment require

Answer 14

classification of devices according to their function

premarket approval

establishment of performance standards

conformance with GMP regulations

adherence to record and reporting requirements

Question 15

Orphan Drug Act

Answer 15

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

Question 16

what is an Orphan Drug

Answer 16

“rare diseases or conditions” (defined as those affecting fewer than 200,000 Americans.)

Question 17

Drug Price Competition and Patent Term Restoration Act

Answer 17

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.

Question 18

Prescription Drug Marketing Act

Answer 18

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.

Question 19

Safe Medical Devices Act

Answer 19

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.

Question 20

The Generic Drug Enforcement Act

Answer 20

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.

Question 21

Prescription Drug User Fee Act

Answer 21

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.

Question 22

Nutrition Labeling and Education Act

Answer 22

Mandates nutrition labeling on food products and authorizes health claims on product labeling, as long as they are made in compliance with FDA regulations.

Question 23

Dietary Supplement Health and Education Act (DSHEA)

Answer 23

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.

Question 24

Dietary Supplement

Answer 24

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

Question 25

Dietary Supplement claim btwn food and disease

Answer 25

Manufacturers may make limited health claims for dietary substances that describe the relationship between a food substance and a disease.
“folic acid may reduce the risk of neural tube birth defects”

To make the claims, the manufacturer must receive FDA approval for the health claim as judged by the “significant scientific agreement” standard.

Today, the FDA has appeared to relax its standard for evaluation, stating it would approve such claims if the scientific evidence in support of the claim outweighs the evidence against the claim.

Question 26

Food and Drug Administration Modernization Act (FDAMA)

Answer 26

Due to FDA criticism, the FDA was not efficiently administrating its statutory responsibilities and that the FDCA was too burdensome a regulatory system for drug approval.

FDAMA passed to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices.

Question 27

Food and Drug Administration Modernization Act intent

Answer 27

The intent is eliminate backlogs in the approval process and ensure timely review of applications.

Creates fast track approval process for drugs intended for serious or life threatening diseases, establishes a database of information on clinical trials, authorizes scientific panels to review clinical investigations and expands the rights of manufacturers to disseminate unlabeled use information.

Expands the FDA’s authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients.

Question 28

Medical Device User Fee and Modernization Act

Answer 28

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.

Question 29

Food and Drug Administration Amendments (FDAAA)

Answer 29

FDA broader use of the fees generated from PDUFA, substantially increasing fees

In response to postmarket problems with certain drug products (ie Vioxx), the law provides FDA with increased responsibilities and authority to regulate drug safety, label changes related to safety, clinical trial data reporting and registries, requiring postmarket clinical studies to assess risk and requires companies to implement risk evaluation and mitiation strategies (REMS).

Question 30

What does the FDA Safety and Innovation Act allow

Answer 30

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

Question 31

what does the FDA Safety and Innovation Act do concerning drug counterfeiting

Answer 31

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.

Question 32

what is the first title of the Drug Quality and Security Act

Answer 32

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 CGMP, labeling and the new drug approval process.

Question 33

what is the 2nd title of the Drug Quality and Security Act

Answer 33

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.

Question 34

The 21st Century Cures Act

Answer 34

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).

Question 35

FDA Reauthorization Act

Answer 35

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