Regulatory Focus™ > News Articles > Getting in Trouble With FDA Becomes Even More Expensive

Getting in Trouble With FDA Becomes Even More Expensive

Posted 31 January 2014 | By Alexander Gaffney, RAC 

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

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