US - The Food & Drug Administration (FDA) claims there is full industry engagement on its Antimicrobial Resistance strategy.
The FDA says that all 26 drug manufacturers affected by Guidance for Industry (GFI) #213 have now agreed to fully engage in the strategy by phasing out the use of medically important antimicrobials in food-producing animals for food production purposes and phasing in the oversight of a veterinarian for the remaining therapeutic uses of such drugs.
While GFI #213 specified a three-year timeframe (until December 2016) for drug sponsors to complete the recommended changes to their antimicrobial products, some sponsors have already begun to implement them.
FDA said it is committed to updating the public on the progress that drug sponsors have made in aligning their products with GFI #213 and intends to do so on a six-month basis. FDA’s progress reports will summarise current and pending actions taken by sponsors to align with the guidance, including the type of action (e.g. withdrawal, change in marketing status) and, when possible without revealing confidential business information, the type of animal for which the drug is approved for use and the type of application (pioneer, generic, combination).
As of 30 June 2014, FDA reports the following progress in the animal health industry’s engagement in GFI #213:
- The last sponsor, Pharmaq AS, has agreed in writing to engage in the judicious use strategy, and has consented to allow FDA to publicly acknowledge its participation. With this addition, all 26 sponsors of 283 affected applications have now confirmed in writing their intent to engage with FDA as defined in GFI #213 and have given FDA consent to identify them as participants. (See FDA’s update on 26 March 2014 for a list of companies that had previously committed to the strategy.)
- There have been two published label changes, one to withdraw a production claim and one to change a product’s marketing status from over-the-counter to available by prescription only. These changes are documented in the online chart of Applications Affected by GFI #213, and FDA will continue to update this chart in real time when label changes are approved.
- One additional drug label change is currently pending. The change is from over-the-counter marketing status to prescription status. More details about the product and the change in labeling will be available after the paperwork is complete.*
- To date, 31 approvals for affected products have been withdrawn and there are no drug approval withdrawals currently pending. After an approval is voluntarily withdrawn, those product(s) can no longer be marketed or sold in the United States.
FDA said it will continue to work with the animal pharmaceutical industry, animal producers and the veterinary community to address antimicrobial resistance and preserve the effectiveness of antimicrobials of human health importance.
However, Rep. Louise M. Slaughter who is leading the campaign against antibiotic use in livestock and overuse in humans said that because there are no reporting requirements in the guidance, there is no way to measure whether the number of antibiotics given to animals in the farm would actually decrease.
At the time it was released, Slaughter called the guidance “an inadequate response to the overuse of antibiotics on the farm with no mechanism for enforcement and no metric for success.”
She said: “If something sounds too good to be true – it usually is. It would take an extraordinary leap of faith to believe that asking pharmaceutical companies to change the labelling on packages of antibiotics will result in a tangible reduction of antibiotic overuse on the farm.
"In fact, Juan Ramon Alaix, CEO of Zoetis, the world’s largest animal pharmaceutical company, revealed in November 2013 that the FDA’s voluntary approach would not curb the problem of overuse, saying the guidance, ‘will not have a significant impact on our revenues.’ Until the FDA comes up with an enforceable, measurable guidance that will actually limit the amount of antibiotics used in agriculture production, we will continue to erode the effectiveness of antibiotics until we reach a point where routine infections like strep throat become fatal and life-saving surgeries that require antibiotics to stave off infection become obsolete.”
TheMeatSite News Desk