Chapter 4: Legal and Professional Issues in Prescribing Flashcards
Food, Drug and Cosmetic Act of 1906 (FDCA):
Established to oversee drug safety and labeling.
Created the Bureau of Chemistry, later the FDA.
Food, Drug and Cosmetic Act of 1938:
Implemented stricter drug safety regulations post-sulfanilamide tragedy.
Introduced pre-market safety testing and quality standards.
Kefauver-Harris Amendments of 1962:
Raised drug approval standards post-thalidomide tragedy.
Demanded proof of safety and efficacy, introduced informed consent.
Established GMP regulations and DESI program for drug evaluation.
Orphan Drug Act of 1983:
Addressed rare disease treatment scarcity via incentives for orphan drug development: tax credits, grants, market exclusivity.
Drug Price Competition and Patent Term Restoration Act of 1984:
Simplified generic drug approval for affordability, balancing innovation. Introduced patent extensions to compensate for regulatory review delays.
Pediatric Research Equity Act of 2003 (Pediatric Rule):
Tackled the absence of pediatric data on drug labels by mandating drug manufacturers to conduct pediatric studies for certain drugs, ensuring their safety and efficacy in children.
Drug Quality Safety and Security Act of 2013:
Enhanced oversight post-fungal meningitis outbreak. Bolstered supervision of compounding facilities, supply chain. Implemented drug tracking system to deter counterfeiting, diversion.
Scope of Authority:
FDA regulates drugs from premarket to post-market. It controls manufacturing, labeling, advertising, and distribution. Covers prescription and over-the-counter drugs, and medical devices.
Classification of Drugs:
Prescription drugs need a healthcare provider’s prescription. Over-the-counter drugs don’t need one but must meet FDA standards. FDA also regulates biologics like vaccines, blood products, and cellular therapies.
Preclinical Research:
Developing a new drug costs roughly $985.3 million, covering lab studies for pharmacological properties, toxicity, and therapeutic effects. Preclinical research pinpoints candidates for human testing.
Medical Devices Regulation:
FDA ensures safety and effectiveness of medical devices. Classified into three categories (Class I, II, and III) based on risk. Higher-risk devices face stricter regulations.
Investigational New Drug (IND) application
contains all known info about the drug compound.
Phase I trials:
Evaluate safety and pharmacokinetics in a small group of healthy volunteers.
Phase II trials:
Assess efficacy and side effects in a larger group of patients with the target disease.
Phase III trials:
Confirm efficacy, safety, and optimal dosage in a diverse patient population.
Phase IV trials:
Post-marketing studies monitor safety and effectiveness in real-world settings.
Bioavailability Studies:
Conducted on healthy volunteers to document the rate of absorption and excretion of a compound’s active ingredients from the body.
New Drug Application (NDA):
FDA approval: Submission includes preclinical/clinical data, manufacturing, labeling, risk plans. Expedited review for critical needs.
Expedited Processes for Drug Approval:
Priority Review
Breakthrough therapy
Accelerated approval
Fast track
Breakthrough therapy:
“Accelerates drug development for severe conditions, showing significant improvement over existing treatments, with evidence of reduced irreversible harm or death.”
Priority Review:
Directs the FDA to review the application within 6 months based on potential “significant improvement” in safety or effectiveness over current treatment.
Accelerated approval:
Allows drugs to be approved for a serious illness based on surrogate or intermediate endpoints which measure laboratory results or clinical effects.
Fast track
Development and review of drugs to treat serious conditions and that fill an unmet medical need.
Phase IV studies:
“Assessment conducted post-approval to evaluate long-term safety, effectiveness, and rare adverse events. Utilizes large-scale observational studies, registries, or post-marketing surveillance programs.”
MedWatch:
FDA’s system for voluntary reporting of adverse events, medication errors, and product quality issues. Open to reports from healthcare professionals, patients, and manufacturers.
Official Labeling:
FDA-approved prescribing information offers crucial details on a drug’s safety, dosage, and more. Healthcare providers depend on drug labeling to guide prescribing decisions and educate patients on medication usage.”
FDA-approved drug labeling
Offers guidance on approved uses, dosages, and administration. The FDA doesn’t regulate medical practice or dictate prescribing. Healthcare providers can prescribe off-label based on clinical judgment and evidence.”
Legend Drug/OTC
Requires a written prescription
Doesn’t require written prescription
Off-label use
When a drug is used for purposes not FDA-approved. This practice relies on clinical judgment, scientific evidence, or medical necessity. Healthcare providers assess risks and benefits, informing patients about alternative treatments when considering off-label use.”
