FDA Administrative Enforcement vs FDA Judicial Enforcement
[edit] FDA Administrative Enforcement
1. Inspections for evidence of noncompliance: This is the main enforcement method that FDA applies. It has been steadily growing in the number of inspections in the US (between 2003 to 2007, there have been around 18,000 inspections per year), and outside the US for facilities that sell products in the US (700 inspections in 2003, and over 1,000 in 2007).
2. Warning letters: written warning to a company, for the purposes of achieving compliance.
3. Public warning: FDA can warn the public about adverse events from the products of a company.
4. Recalls: FDA has the authority to order a recall, but most product recalls are done by the company voluntarily.
5. Changing approval state: FDA can withdraw a product that has been approve, temporarily suspend the approval, refuse reviewing all of the company's products, and conducting lengthy validity assessments to verify falsified or unreliable data.
6. Prevent imported products: adulterated, misbranded products are denied entry.
7. Civil money penalties: a fine can be brought to a company and/or the individual, for up to $15,000 per violation or up to $1,000,000 for all violations (medical devices), from $50,000 to $1,000,000 (drugs), up to $100,000 per day (biological products), up to $250,000 for an individual and up to $1,000,000 for a company (generics). There are other penalties such as noncompliance to REMS (risk evaluation and mitigation strategies) of up to $250,000 per violation to $1,000,000 of all violations.
8. Referral to state authorities: FDA and the states can work together ego bring state enforcement actions. State officials can (1) suspend the license of a manufacturer, distributor, or retailer, and (2) embargo violative products immediately without court approval.
9. Debarment: an individual debarred can never provide any services to a company that has approved or pending drug product applications. A debarred company will not receive approval for any ANDAs.
10. Specific enforcement for medical devices: detention, notification order, ordering cease of distribution, and restricting sale/distribution.
[edit] FDA Judicial Enforcement
1. Seizure: products that are misbranded and/or adulterated can be seized, usually from manufacturing facilities or warehouses, but can be taken from hospitals or even consumers.
2. Injunction: a court order can be issued to cease manufacture and distribution of a company's products. FDA can (1) seek a temporary restraining order, (2) request for preliminary relief, and (3) seek a permanent injunction, leading to a consent decree.
3. Prosecution: criminal charges can be brought on individuals and companies.
