CRAP Enforcement Actions & Penalties 3 — Questions and Answers
Question 1: Which federal statute authorizes FDA to pursue criminal prosecution of individuals who commit prohibited acts under the FD&C Act, even without proof of fraudulent intent?
- The Park Doctrine under United States v. Park
- The Responsible Corporate Officer doctrine under Dotterweich
- Both the Park Doctrine and Dotterweich doctrine apply separately (Correct answer)
- The Sherman Antitrust Act
Correct answer: Both the Park Doctrine and Dotterweich doctrine apply separately
Both United States v. Dotterweich (1943) and United States v. Park (1975) established the Responsible Corporate Officer doctrine allowing criminal liability without proof of personal wrongdoing.
Question 2: A medical device manufacturer repeatedly violates GMP regulations. FDA seeks to bar the company from future FDA submissions. This action is called:
- Suspension of operations
- Application integrity policy hold
- Debarment (Correct answer)
- Application refusal
Correct answer: Debarment
Debarment prohibits individuals or firms convicted of certain felonies from submitting or assisting in applications to FDA.
Question 3: Under 21 CFR Part 16, what type of proceeding does FDA use for most administrative enforcement actions involving civil penalties?
- Formal evidentiary hearing before an Administrative Law Judge
- Informal conference with district compliance officer
- Regulatory hearing process (Correct answer)
- Federal district court bench trial
Correct answer: Regulatory hearing process
21 CFR Part 16 establishes the regulatory hearing process, an informal but structured process FDA uses for various administrative enforcement proceedings.
Question 4: FDA's Application Integrity Policy (AIP) is triggered when FDA finds:
- Manufacturing deficiencies in a facility inspection
- Potentially fraudulent data or misrepresentations in regulatory submissions (Correct answer)
- Failure to pay user fees on time
- Inadequate post-market surveillance reporting
Correct answer: Potentially fraudulent data or misrepresentations in regulatory submissions
AIP is invoked when FDA has information that raises significant questions about the integrity of data or information in pending or approved applications.
Question 5: What is the key difference between a 'voluntary' and a 'mandatory' recall under current US law?
- Voluntary recalls are initiated by the company; mandatory recalls are ordered by FDA and currently only authorized for certain product categories (Correct answer)
- Voluntary recalls are always Class III; mandatory recalls are always Class I
- Voluntary recalls do not require FDA notification; mandatory recalls do
- There is no legal distinction; all recalls are treated equally under FD&C Act
Correct answer: Voluntary recalls are initiated by the company; mandatory recalls are ordered by FDA and currently only authorized for certain product categories
Most recalls are voluntary, initiated by the firm; FDA has mandatory recall authority for infant formula, medical devices, and tobacco products but relies primarily on voluntary cooperation for other products.
Question 6: A consent decree of permanent injunction typically includes which of the following provisions?
- Criminal fines payable to FDA directly
- Third-party expert oversight at company expense and remediation requirements (Correct answer)
- Automatic license revocation upon signing
- Prohibition on all future FDA submissions for five years
Correct answer: Third-party expert oversight at company expense and remediation requirements
Consent decrees routinely require companies to hire FDA-approved independent experts to oversee remediation and verify compliance, at the company's expense.
Question 7: Under 18 USC § 1001, making a materially false statement to FDA is a federal crime punishable by:
- Up to 1 year imprisonment and fines
- Up to 5 years imprisonment and fines (Correct answer)
- Civil penalties only, not criminal imprisonment
- Up to 10 years imprisonment for repeat offenders only
Correct answer: Up to 5 years imprisonment and fines
18 USC § 1001 makes materially false statements to any federal agency, including FDA, punishable by up to 5 years imprisonment plus fines.
CRAP Enforcement Actions & Penalties 3
Which federal statute authorizes FDA to pursue criminal prosecution of individuals who commit prohibited acts under the FD&C Act, even without proof of fraudulent intent?