MPJE Federal Food, Drug, and Cosmetic Act 4 — Questions and Answers
Question 1: Under the FD&C Act, what is the minimum period for which a brand-name drug manufacturer must provide patent and exclusivity information listed in the 'Orange Book'?
- The duration of the patent or exclusivity period as applicable (Correct answer)
- 5 years from date of NDA approval regardless of patent
- 3 years for all new drug products
- 10 years for biologics, 5 years for small molecules
Correct answer: The duration of the patent or exclusivity period as applicable
Orange Book listing reflects the actual remaining patent life and any applicable exclusivity period granted at NDA approval.
Question 2: A pharmacy receives a drug product with labeling that lacks the required National Drug Code (NDC) number. Under the FD&C Act, this drug is considered:
- Misbranded (Correct answer)
- Adulterated
- Counterfeit
- Investigational
Correct answer: Misbranded
Absence of required labeling information such as the NDC number renders the drug misbranded under the FD&C Act.
Question 3: Which of the following triggers the 30-month stay on FDA approval of a generic drug's ANDA?
- The brand manufacturer files a patent infringement lawsuit within 45 days of receiving the Paragraph IV certification (Correct answer)
- The brand manufacturer files a citizen petition with FDA challenging bioequivalence
- The generic applicant fails to submit required bioequivalence data
- FDA places the reference listed drug on the discontinued drug product list
Correct answer: The brand manufacturer files a patent infringement lawsuit within 45 days of receiving the Paragraph IV certification
A 30-month stay automatically results when the NDA holder sues for patent infringement within 45 days of receiving a Paragraph IV certification notice.
Question 4: Under the FD&C Act, 'homeopathic' drug products are regulated as:
- Drugs subject to the same adulteration and misbranding provisions as other drugs (Correct answer)
- Dietary supplements exempt from all drug approval requirements
- Medical devices requiring 510(k) clearance
- Biologics requiring a BLA
Correct answer: Drugs subject to the same adulteration and misbranding provisions as other drugs
Homeopathic products are regulated as drugs under the FD&C Act and must comply with adulteration and misbranding requirements.
Question 5: Which FD&C Act pathway provides 5 years of new chemical entity (NCE) exclusivity for a newly approved drug?
- Hatch-Waxman new chemical entity exclusivity under Section 505(j) (Correct answer)
- Orphan drug exclusivity under Section 527
- Pediatric exclusivity under Section 505A
- Fast track designation under Section 506(b)
Correct answer: Hatch-Waxman new chemical entity exclusivity under Section 505(j)
The Hatch-Waxman Act (which amended the FD&C Act) grants 5 years of NCE exclusivity to drugs containing an active moiety never previously approved by FDA.
Question 6: A pharmacist dispenses a drug product that was imported from a foreign country without FDA approval. Under the FD&C Act, this product is classified as:
- Unapproved drug subject to seizure and enforcement action (Correct answer)
- Legal if the product bears equivalent foreign regulatory approval
- Exempt from FDA oversight if brought in for personal use under the personal importation policy
- Permitted if the FDA import alert has been lifted for that product
Correct answer: Unapproved drug subject to seizure and enforcement action
Dispensing a non-FDA-approved imported drug violates the FD&C Act, and the product is subject to FDA seizure and enforcement regardless of foreign approval.
Question 7: Under the FD&C Act, which entity is primarily responsible for reporting serious and unexpected adverse drug reactions from clinical trials to FDA?
- The IND sponsor (Correct answer)
- The principal investigator only
- The IRB chairperson
- The contract research organization (CRO)
Correct answer: The IND sponsor
The IND sponsor bears primary responsibility for submitting IND safety reports (including 15-day alert reports) to FDA for serious unexpected adverse reactions.
MPJE Federal Food, Drug, and Cosmetic Act 4
Under the FD&C Act, what is the minimum period for which a brand-name drug manufacturer must provide patent and exclusivity information listed in the 'Orange Book'?