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46 Cards in this Set
- Front
- Back
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required the federal government to grant premarket approval for every biological drug and for the process and the facility producing such biological drugs
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Biologics Act of 1902
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Goal: Accurate labeling of food & drugs
Did not apply equally to advertising Two definitional bases for enforcement Adulteration Misbranding Results: Product Seizure and/or Fines Recognizes USP-NF as official standard |
Pure Food and Drug Act of 1906
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A drug listed in the USP, but which did not meet USP specifications (unless variations from the USP were clearly labeled)
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Adulterated:
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A drug containing any of several potentially dangerous or addictive drugs, and its label failed to indicate the accurate quantity or proportion of such drugs
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Mis-branded
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addressed “false and fraudulent” claims
FDA had to prove knowledge and intent High standard of proof Amendment didn’t help all that much |
1912 (Sherley) Amendment
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Taxed the production, sale, and use of opium
Required prescriptions for products exceeding the allowable limit of narcotics Mandated increased record keeping for doctors and pharmacists dispensing narcotics Predecessor of the Controlled Substances Act We’ll cover more in a couple of lectures |
Harrison Narcotics Act of 1914
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New drugs must be proven safe for use under labeled conditions prior to marketing
Labeling to contain adequate directions for use Approval by FDA required prior to marketing Cosmetics and devices included under legislation |
Food Drug and Cosmetic Act (FDCA)
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Significant pre-1938 Drugs
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Thyroxine
Digoxin Nitroglycerin Phenobarbital |
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Drugs NOT requiring medical supervision for their safe use were referred to as:
“Over-The-Counter” drugs (OTC) OTC’s must give “adequate directions for use” ----------------------------------------------------------------------------------- The Amendment also provides for: Oral Prescriptions; and Prescription Refills |
Durham-Humphrey Act
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Drugs REQUIRING medical supervision for their safe use must have a “legend” stating:
Caution: Federal law prohibits dispensing without a prescription Must appear on the manufacturer’s label, but then DO NOT need to give “adequate directions for use” Drug MUST then be dispensed with prescriber’s directions for use |
Durham-Humphrey Act
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Properly Labeled Prescriptions
have 7 requirements: |
1. Patient’s Name
2. Sequential Rx number 3. Date the Rx is filled 4. Prescriber’s directions for usage 5. Prescribing Physician’s name 6. Name and Address of the pharmacy 7. Name and dosage of the drug dispensed |
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Adds efficacy to safety as a prerequisite for FDA new drug approval process
Shifted from pre-market notification to FDA pre-market approval by FDA |
Kefvauer-Harris Amendment
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Kefvauer-Harris Amendment
drugs may not be marketed unless: (4 things) |
Proven safe & effective for intended use;
Adequate labeling (approved by FDA); Meets Good Manufacturing Practices; Produced by a registered manufacturer |
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Key: This Amendment forever changed the FDA Drug Review and Approval process
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Kefvauer-Harris Amendment
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Expands FDA authority over medical devices
Establish device classes & device GMPs Some “Generally Recognized As Safe” (GRAS) devices have yet to be approved Grandfathered |
Medical Device Amendment
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Class of device?
Tongue depressors, gauze, manual stethoscopes, etc Subject to Good Manufacturing Practices (GMPs), etc |
Class I devices (low risk)
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Class of device?
Infusion pumps, x-ray machines, powered wheelchairs Subject to same controls as Class I devices; AND Product-specific controls or performance standards |
Class II devices (medium risk)
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Class of device?
Artificial hearts, pacemakers, stents and catheters, etc Subject to FDA approval process like new drugs Have to be proven safe and effective in clinical trials and pass an FDA premarket approval process (510k |
Class III devices (high risk)
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Designed to promote development of drugs for rare diseases, but which are prohibitively expensive/un-profitable to develop
Defined as diseases affecting fewer than 200,000 people in the U.S. Companies rewarded with tax reductions and marketing exclusivity for an extended time 7 years post FDA-approval 249 orphan drugs approved in the US since 1983 |
Orphan Drug Act
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Streamlining of generic drug approval process
“Abbreviated New Drug Application” Demonstration of Bio-equivalency = sufficient now “Patent term extensions” to brand name drugs Compensate for length of FDA Review process Extension capped at 5 extra years |
Waxman-Hatch Amendment
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Requires FDA to publish the “Orange Book”
Bio-equivalency of “brand” to “generics” |
Waxman-Hatch Amendment
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Addresses secondary drug distribution systems
Record-keeping & re-sale limits on “samples” Prohibits re-sale of drugs bought by non-profits Except for its patients, employees, and related entities (i.e., “own use” doctrine) Known as the Non-Profit Institutions Act (Antitrust) Requires state licensure of wholesalers and other secondary distributors, repackagers, etc |
Prescription Drug Marketing Act
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Created the current uniform label format
Key change = standardized “Serving Size” Labeling required for most food products Lobbying exempted “restaurant prepared” food Cost concerns exempted small companies Small package size can exempt labeling, too Standardizes “descriptor” use Regulates nutrient/disease relationships |
Nutrition and Labeling Education Act
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Supplements treated more like foods than drugs
“Overstating” can result in regulation as a drug Structure/function & general well-being claims = OK Calcium builds strong bones; Ginko promotes mental awareness; BUT sufficient nutrient levels must be in the supplement “Intended to treat, prevent, cure…” = Prohibited Use this Calcium supplement to prevent osteoporosis = Drug Disclaimer req’d: “Statement not evaluated by FDA” |
Dietary Supplement and Health Education Act
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Main intent was to get FDA additional non-government source of revenue, so it could hire more personnel to assist in the drug review process
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Prescription Drug User Fee Act
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Enacted to overhaul the FDA & its regulatory processes
Main purpose was to expedite the drug review process Fast track approval for drugs for “life threatening” diseases Response, primarily, to the AIDS epidemic Renewed the PDUFA |
Food and Drug Administration Modernization Act of 1997 (FDAMA)
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Permits mfgs to provide info about off-label uses
From scientific publications; other requirements as well Limits prescription compounding w/o mfg license Aimed at bulk-compounding pharmacies “Anticipatory” Compounding States are enlisted to enforce these restrictions/limitations |
Food and Drug Administration Modernization Act of 1997 (FDAMA)
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type of drug approval application:
For generic drugs Require less data; requires pharmacokinetic and bioavailability data |
Abbreviated New Drug Application (ANDA)
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Type of drug approval application:
After marketing, manufacturer may desire to make changes in the drug’s synthesis, production procedures, packaging, labeling, etc. |
Supplemental New Drug Application (SNDA)
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Requires child-resistant containers (CRCs) on certain “household substances”
Requires CRCs on all prescription drugs, except for certain listed products Requires CRCs on specifically listed OTCs Authorizes Consumer Products Safety Commission (CPSC) to set standards for child-resistant packaging, or “special packaging” as its called in the Act |
Poison Prevention Packaging Act
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Provides Indicator or barrier to entry
If breached or missing, there is visible evidence of tampering Label statement describing barrier or indicator Required for certain OTCs, devices, and cosmetics Dermatologicals, lozenges, and insulin are excluded |
Federal Anti-Tampering Act of 1982
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Class of recall:
Likelihood of injury or death from use of product; may include public warning |
Class I
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Class of recall:
Temporary or reversible health problems from use of product |
Class II
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Class of recall:Use of product NOT likely to cause health problems
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Class III
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Class of recall:Minor health risk or minor FDA violation
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Market withdrawal
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“Condition of Participation” in the Federal Medicaid Funds Matching Program
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Omnibus Budget Reconciliation Act (OBRA) of 1990
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3 duties arising from OBRA....
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Duty To Maintain Patient Profiles
Duty To Screen Therapy Duty To Counsel Patients About Their Drug Therapy (duty to warn |
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Restraint of Trade = Unlawful (Sec 1)
Monopolies = Unlawful (Sec 2) Market Power vs. a Monopoly Per Se Violations Price Fixing Boycotting Tying Arrangements Some Exclusive Contracts |
The Sherman Act (1890)
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Price Discrimination among similarly
situated purchasers = generally unlawful, if it tends to injure/limit competition |
The Robinson-Patman Act (1936)
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Application for New Registration
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DEA Form-224
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Schedule II order forms
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DEA Form-222
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Renewal Application for Registration
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DEA Form-224a
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Authorization for destruction form
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DEA Form-41
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Form for CS theft or loss
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DEA Form-106
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Provides for Federal Investigation of pharmaceutical
thefts and robberies if any of these conditions exist: Replacement cost of the controlled substances taken is $500 or more. A registrant or other person is killed or suffers “significant” bodily injury during the commission of the robbery or theft of a controlled substance. 3. Interstate or foreign commerce is involved in planning or executing the crime. |
Controlled Substance Registrant Protection Act of 1984
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form for requesting additional order forms
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DEA Form-222a
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