Regulatory Focus™ > News Articles > Senators Call for New Limits on 'Medically Important' Antibiotics

Senators Call for New Limits on 'Medically Important' Antibiotics

Posted 06 March 2015 | By Alexander Gaffney, RAC 

Senators Call for New Limits on 'Medically Important' Antibiotics

A new bill introduced this week in the US Senate would restrict the use of "medically important" antibiotics in agriculture in the hopes of reducing the risk of bacteria developing resistance to those drugs.

Background

The bill, the Preventing Antibiotic Resistance Act (PARN) (PDF), was introduced on 2 March 2015 by Sens. Dianne Feinstein (D-CA) and Susan Collins (R-ME), with support from Sens. Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA).

The legislation is the latest in long line of legislative efforts meant to confront resistance. Since 2012, legislators have introduced at least a dozen bills related to developing new antibiotics or safeguarding the effective use of existing antibiotics. (See the end of this article for a complete list)

The bill is in fact similar to one introduced in 2013 by Feinstein, which was also intended to restrict the use of antibiotics.

As with the old bill, Feinstein and Collins' latest effort focuses on the use of antibiotics in agricultural settings.

"The Centers for Disease Control and Prevention, CDC, estimate that antibiotic-resistant bacteria cause at least 23,000 deaths and 2 million infections each year in the United States. The CDC also estimates that antibiotic resistance costs the United States $20 billion in excess health costs each year," Feinstein said in remarks earlier this week. "These statistics will only worsen if we do not take meaningful steps to reduce inappropriate and unnecessary antibiotic use."

Combatting Resistance

The PARN Act would take those "meaningful steps" by preventing some "medically important" antibiotics from being used in food-producing animal populations. Any New Animal Drug Application (NADA)—the application used by FDA to approve new veterinary drugs—for a medically important antibiotic that fails to demonstrate that it would not contribute to antibiotic resistance could be rejected by FDA.

"Medically important" antimicrobials include penicillin, tetracycline, macrolide, lincosamide, streptogramin, aminoglycoside, sulfonamide, cephalosporin, fluoroquinolone, and any drug listed as ‘highly important’, ‘critically important’, or ‘important’ by the World Health Organization (WHO).

Drug sponsors will be required to, as of 1 January 2018, submit data indicating:

  • there is evidence of effectiveness in controlling or preventing bacterial disease
  • an approved use is consistent with accepted veterinary practice
  • an approved use is linked to a specific etiologic agent
  • an approved use is appropriately targeted to animals at risk of developing a specific bacterial disease
  • an approved use has an explicitly defined duration of therapy
  • there is reasonable certainty of no harm to human health due to the development of antimicrobial resistance

FDA would then be tasked with either updating the labels of animal antibiotics to reflect their appropriate uses, or removing from the market any drugs which fail to provide sufficient evidence under the above criteria.

The bill has won praise from the Pew Charitable Trusts, which said it would "ensure that antibiotics are used appropriately based on the best available evidence."

Other Antibiotic Legislation

Legislation and SummaryLink to TextExecutive SummaryDate Introduced
2015
21st Century Cures ActLink to legislationDraft legislation which would overhaul the way in which FDA regulates drugs, devices, biotechnology products and more. Also includes several provisions related to antibiotics.Not Yet Introduced
DISARM Act of 2015Link to legislationWould create a new regulatory designation status--DISARM status--which would increase federal reimbursement for certain antibiotics.22 January 2015
Promise for Antibiotics and Therapeutics for Health (PATH) ActLink to legislationWould create a new pathway for antibiotic approvals in "limited populations."16 January 2015
2014
Promise for Antibiotics and Therapeutics for Health (PATH) ActLink to legislationWould create a new pathway for antibiotic approvals in "limited populations."10 December 2014
Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014Link to legislationWould require the DEA to schedule FDA-approved drug products more quickly.18 September 2014
Strategies to Address Antimicrobial Resistance ActLink to legislationFDA asked to consult with Antimicrobial Resistance Office on any new antibiotics.10 April 2014
2013
Antibiotic Development to Advance Patient Treatment Act of 2013Link to legislationBill would permit FDA to approve antibiotics for limited populations.12 December 2013
Preventing Antibiotic Resistance Act of 2013Link to legislationWould restrict the use of antibiotics in agricultural settings.27 June 2013
Antimicrobial Data Collection ActLink to legislationRequires further FDA study of the relationship between antibiotics prescribing and antimicrobial resistance trends.8 May 2013
Preservation of Antibiotics for Medical Treatment Act of 2013Link to legislationFDA can reject an application for an animal antibiotic if they believe its approval would put human health at risk.14 March 2013
Delivering Antimicrobial Transparency in Animals Act of 2013Link to legislationWould enhance data reporting requirements for marketers of antibiotics.26 February 2013
2012
Food and Drug Administration Safety and Innovation Act (FDASIA)Link to legislationMassive reform legislation reauthorized numerous user fee programs, created new user fee programs for biosimilars and generic drugs, and created several new regulatory pathways and programs, including a new incentive program for antibiotics. 15 May 2012. (Became law on 9 July 2012.)

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