PVC Post-Marketing Surveillance 2 — Questions and Answers
Question 1: Which regulatory mechanism allows the FDA to require a manufacturer to conduct post-marketing studies after drug approval?
- Post-Market Commitment (PMC)
- Risk Evaluation and Mitigation Strategy (REMS)
- Post-Market Requirement (PMR) (Correct answer)
- New Drug Application (NDA) amendment
Correct answer: Post-Market Requirement (PMR)
Post-Market Requirements (PMRs) are legally mandated studies the FDA can require of sponsors after approval, distinct from voluntary Post-Market Commitments.
Question 2: In a passive post-marketing surveillance system, data are primarily collected through:
- Prospective patient registries
- Spontaneous adverse event reports submitted voluntarily (Correct answer)
- Randomized controlled trials conducted after approval
- Insurance claims databases analyzed in real time
Correct answer: Spontaneous adverse event reports submitted voluntarily
Passive surveillance relies on voluntary, spontaneous reporting of adverse events by healthcare professionals, patients, and manufacturers.
Question 3: The Weber effect in pharmacovigilance refers to:
- Increased reporting of ADRs for older drugs due to greater familiarity
- A peak in adverse event reporting that occurs within the first 1–2 years after a drug's launch (Correct answer)
- Underreporting of ADRs by physicians due to fear of liability
- The tendency for serious ADRs to be reported more than mild ones
Correct answer: A peak in adverse event reporting that occurs within the first 1–2 years after a drug's launch
The Weber effect describes the pattern where spontaneous adverse event reporting peaks 1–2 years after a drug is marketed, then declines as novelty fades.
Question 4: Which database is the FDA's primary tool for receiving and managing post-marketing safety reports in the United States?
- VigiBase
- FAERS (FDA Adverse Event Reporting System) (Correct answer)
- EudraVigilance
- Yellow Card database
Correct answer: FAERS (FDA Adverse Event Reporting System)
FAERS is the FDA's spontaneous reporting database that collects adverse event and medication error reports submitted by healthcare professionals, consumers, and manufacturers.
Question 5: A drug sponsor identifies a new safety signal in post-marketing data. What is the FIRST regulatory action typically required?
- Immediately withdraw the product from the market
- Conduct a full clinical trial to confirm the signal
- Evaluate the signal and report it to the FDA within required timeframes (Correct answer)
- File a Supplemental NDA before taking any other action
Correct answer: Evaluate the signal and report it to the FDA within required timeframes
Upon identifying a potential safety signal, the sponsor must evaluate it and report to the FDA according to prescribed expedited or periodic reporting timelines.
Question 6: Prescription Event Monitoring (PEM), as used in the UK, is best described as:
- A database of spontaneous reports submitted by patients only
- An active surveillance method tracking all prescriptions for selected new drugs and collecting outcomes from GPs (Correct answer)
- A hospital-based study comparing drug users to matched controls
- A regulatory audit of marketing authorization holders' pharmacovigilance systems
Correct answer: An active surveillance method tracking all prescriptions for selected new drugs and collecting outcomes from GPs
PEM is an active, observational, cohort-based system that monitors prescriptions issued by GPs and follows up to collect patient outcome data.
Question 7: Under 21 CFR Part 314.81, a US drug manufacturer is required to submit a Periodic Adverse Drug Experience Report (PADER) to the FDA at what minimum frequency for a product within its first three years post-approval?
- Monthly
- Quarterly (Correct answer)
- Annually
- Every two years
Correct answer: Quarterly
For the first three years post-approval, PADERs must be submitted quarterly, after which annual submissions are required.
PVC Post-Marketing Surveillance 2
Which regulatory mechanism allows the FDA to require a manufacturer to conduct post-marketing studies after drug approval?