Getting in Trouble With FDA Becomes Even More Expensive
Getting in trouble with the US Food and Drug Administration (FDA) is about to become a bit more expensive thanks to a new regulation proposed by the agency and required by law.
Background
In 1990, the US Congress passed and the president signed into law the Federal Civil Penalties Inflation Adjustment Act (FCPIAA). The law requires federal agencies to, at least once every four years, adjust for inflation the maximum civil money penalties it assesses for regulatory and statutory violations.
"FCPIAA defines a CMP as any penalty, fine, or other sanction that is for a specific monetary amount as provided by Federal law; or has a maximum amount provided for by Federal law; and is assessed or enforced by an agency pursuant to Federal law; and is assessed or enforced pursuant to an administrative proceeding or a civil action in the Federal Courts," FDA explained in a Federal Register notice.
The intent of the law is that rates of inflation do not discount the intended impact of a fine, and thereby maintain its effectiveness as a deterrent or punishment.
While FDA hasn't adjusted its CMP rates since 2008-it's not clear why not-it's just released a new regulation to do just that.
In a 31 January 2014 Federal Register announcement, the agency said it is issuing a direct final rule-a rule without the opportunity for comment-bringing the CMP in line with inflation rates as determined by the Consumer Price Index (CPI). Adjustments may not exceed 10% of the total penalty.
Civil Monetary Penalties for 2013
| 21 U.S.C. Section | Former Maximum Penalty ($) | Adjusted Maximum Penalty ($) | Assessment Method | Year of Last Adjustment |
|---|---|---|---|---|
| 333(b)(2)(A) | 60,000 | 65,000 | For each of the first two violations in any 10-year period | 2013 |
| 333(b)(2)(B) | 1,200,000 | 1,275,000 | For each violation after the second conviction in any 10-year period | 2013 |
| 333(b)(3) | 120,000 | 130,000 | Per violation | 2013 |
| 333(f)(1)(A) | 16,500 | 16,500 | Per violation | 2008 |
| 333(f)(1)(A) | 1,200,000 | 1,275,000 | For the aggregate of violations | 2013 |
| 333(f)(2)(A) | 55,000 | 60,000 | Per individual | 2013 |
| 333(f)(2)(A) | 300,000 | 325,000 | Per "any other person" | 2013 |
| 333(f)(2)(A) | 600,000 | 650,000 | For all violations adjudicated in a single proceeding | 2013 |
| 333(f)(3)(A) | 10,000 | 11,000 | For all violations adjudicated in a single proceeding | 2013 |
| 333(f)(3)(B) | 10,000 | 11,000 | For each day the violation is not corrected after a 30-day period following notification until the violation is corrected | 2013 |
| 333(f)(4)(A)(i) | 250,000 | 275,000 | Per violation | 2013 |
| 333(f)(4)(A)(i) | 1,000,000 | 1,075,000 | For all violations adjudicated in a single proceeding | 2013 |
| 333(f)(4)(A)(ii) | 250,000 | 275,000 | For the first 30-day period (or any portion thereof) of continued violation following notification | 2013 |
| 333(f)(4)(A)(ii) | 1,000,000 | 1,075,000 | For any 30-day period, where the amount doubles for every 30-day period of continued violation after the first 30-day violation | 2013 |
| 333(f)(4)(A)(ii) | 10,000,000 | 10,850,000 | For all violations adjudicated in a single proceeding | 2013 |
| 333(f)(9)(A) | 15,000 | 15,000 | Per violation | 2009 |
| 333(f)(9)(A) | 1,000,000 | 1,050,000 | For all violations adjudicated in a single proceeding | 2013 |
| 333(f)(9)(B)(i)(I) | 250,000 | 275,000 | Per violation | 2013 |
| 333(f)(9)(B)(i)(I) | 1,000,000 | 1,050,000 | For all violations adjudicated in a single proceeding | 2013 |
| 333(f)(9)(B)(i)(II) | 250,000 | 275,000 | For the first 30-day period (or any portion thereof) of continued violation following notification | 2013 |
| 333(f)(9)(B)(i)(II) | 1,000 | 1,050,000 | For any 30-day period, where the amount doubles for every 30-day period of continued violation after the first 30-day violation | 2013 |
| 333(f)(9)(B)(i)(II) | 10,000,000 | 10,525,000 | For all violations adjudicated in a single proceeding | 2013 |
| 333(f)(9)(B)(ii)(I) | 250,000 | 275,000 | Per violation | 2013 |
| 333(f)(9)(B)(ii)(I) | 1,000,000 | 1,050,000 | For all violations adjudicated in a single proceeding | 2013 |
| 333(f)(9)(B)(ii)(II) | 250,000 | 275,000 | For the first 30-day period (or any portion thereof) of continued violation following notification | 2013 |
| 333(f)(9)(B)(ii)(II) | 1,000,000 | 1,050,000 | For any 30-day period, where the amount doubles for every 30-day period of continued violation after the first 30-day violation | 2013 |
| 333(f)(9)(B)(ii)(II) | 10,000,000 | 10,525,000 | For all violations adjudicated in a single proceeding | 2013 |
| 333(g)(1) | 250,000 | 275,000 | For the first violation in any 3-year period | 2013 |
| 333(g)(1) | 500,000 | 550 000 | For each subsequent violation in any 3-year period | 2013 |
| 333 note | 250 | 250 | For the second violation (following a first violation with a warning) within a 12-month period by a retailer with an approved training program | 2009 |
| 333 note | 500 | 500 | For the third violation within a 24-month period by a retailer with an approved training program | 2009 |
| 333 note | 2,000 | 2,000 | For the fourth violation within a 24-month period by a retailer with an approved training program | 2009 |
| 333 note | 5,000 | 5,000 | For the fifth violation within a 36-month period by a retailer with an approved training program | 2009 |
| 333 note | 10,000 | 11,000 | For the sixth or subsequent violation within a 48-month period by a retailer with an approved training program | 2013 |
| 333 note | 250 | 250 | For the first violation by a retailer without an approved training program | 2009 |
| 333 note | 500 | 500 | For the second violation within a 12-month period by a retailer without an approved training program | 2009 |
| 333 note | 1,000 | 1,100 | For the third violation within a 24-month period by a retailer without an approved training program | 2013 |
| 333 note | 2,000 | 2,000 | For the fourth violation within a 24-month period by a retailer without an approved training program | 2009 |
| 333 note | 5,000 | 5,000 | For the fifth violation within a 36-month period by a retailer without an approved training program | 2009 |
| 333 note | 10,000 | 11,000 | For the sixth or subsequent violation within a 48-month period by a retailer without an approved training program | 2013 |
| 335b(a) | 300,000 | 325,000 | Per violation for an individual | 2013 |
| 335b(a) | 1,200,000 | 1,275,000 | Per violation for "any other person" | 2013 |
| 360pp(b)(1) | 1,100 | 1,100 | Per violation per person | 2008 |
| 360pp(b)(1) | 355,000 | 375,000 | For any related series of violations | 2013 |
| 42 U.S.C. Section | Former Maximum Penalty | Adjusted Maximum Penalty | Assessment Method | Date of Last Adjustment |
| 263b(h)(3) | 11,000 | 11,000 | Per violation | 2008 |
| 300aa-28(b)(1) | 120,000 | 130,000 | Per occurrence | 2013 |