viernes, 24 de marzo de 2017

FDA Law Blog: GAO Identifies Gaps in Oversight of Use of Medically Important Drugs in Food Animals

FDA Law Blog: GAO Identifies Gaps in Oversight of Use of Medically Important Drugs in Food Animals

Posted: 23 Mar 2017 04:12 PM PDT
By Riëtte van Laack –

Antibiotic-resistant bacteria are claimed to be one of the biggest threats to global health, sickening an estimated 2 million people in the United States each year. There is evidence that some resistance in bacteria is caused by antibiotic use in food animals (cattle, poultry, swine). In the last decade, federal agencies including FDA and APHIS, have taken a number of actions addressing the use of medically important antibiotics in food animals.

Medically important antibiotics are antibiotics that are used in both animals and humans and that are important to treat human infections. Two federal departments are involved in ensuring the safe use of antibiotics in food animals, HHS (primarily FDA) and USDA (primarily APHIS and FSIS). FDA approves and regulates the manufacture and distribution of antibiotics use in food animals and FSIS and APHIS collect information about antibiotic use and resistance in food animals.

In 2011, GAO reported on antibiotic use and identified major gaps in data collection. On March 16, 2017, GAO issued an update. For the update, GAO examined actions by HHS (FDA) and USDA since 2011 to manage the use of antibiotics in food animals and to assess the impact of these actions, actions in other countries, and the extent to which HHS and USDA have conducted on-farm investigations regarding outbreaks from antibiotic-resistant pathogens in animal products.

GAO notes that HHS has made significant progress in veterinary oversight of medically important antibiotics. Actions by FDA include issuance of voluntary guidance to industry and revisions to the veterinary feed directive regulation (herehere, and here). According to FDA, as of January 2017, medically important antibiotics in feed and water of food animals may be used only under the supervision of a veterinarian. (FDA actions did not address oversight of antibiotics administered in injections or through other routes). However, data collection continues to be an issue. FDA has no measures to assess the impact of these actions. Thus, FDA cannot assess whether it is achieving its objective of ensuring judicious use of medically important antibiotics in food animals. Another “gap” identified by GAO is the use of long-term and open-ended use of medically important antibiotics for disease prevention.

In 2016, FDA issued a request for comments regarding the establishment of duration of medically important antimicrobial drugs that currently do not have a duration limitation. The comment period closed March 13, 2017, i.e., just before the GAO report was issued. FDA received a significant number of comments opposing a limit to duration of these drugs.

GAO noted improvements in collecting and reporting data on antibiotics. However, GAO believes that the agencies should have a joint effort to further assess the relationship between the use of antibiotics and antibiotic resistance. Although the agencies have developed a joint data collection plan, lack of funding may hinder the execution of this plan.

GAO reviewed programs to manage the use of antibiotics in food animals in the Netherlands, Canada, Denmark, and the European Union (EU). The programs in those countries and in the EU have resulted in a reduction in the use or sales of antibiotics. However, it is unclear whether the actions taken by those countries would be successful in the US. According to GAO, some U.S. federal officials and stakeholders believe that similar U.S. actions are not feasible because of production differences and other factors.

GAO makes a number of recommendations, including that HHS address oversight gaps, HHS and USDA develop measures to assess success or effectiveness and progress of the actions, and that USDA and HHS develop a framework to decide when to conduct on-farm investigations.

USDA agreed with GAO’s recommendations. HHS neither agreed nor disagreed because the incoming HHS transition personnel had insufficient time for review.

In response to the report, U.S. Senators Kirsten Gillibrand (D-N.Y.), Dianne Feinstein (D-Cal.), and Elizabeth Warren (D-Mass.) and U.S. Representatives Rosa DeLauro (D-Conn.) and Louise Slaughter (D-N.Y.) sent a letter to HHS and the USDA urging increased collaboration and oversight to reduce the inappropriate use of medically important antibiotics in food animal production. They ask for prompt answers to issues raised by GAO.

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