Breaking Down the President's Plan on Combating Antibiotic Resistance

Today, the President announced some initiatives to deal with antibiotic resistance.

The White House released an Executive Order to create a taskforce to develop a national plan. They also released a national strategy for combating antibiotic resistance. And finally, released a report by the President’s Council of Advisors on Science and Technology (PCAST) on antibiotic resistance.

Here is our main takeaways from these documents:

  • Antibiotic resistance is a crisis.
  • Livestock use is part of the problem.
  • Unfortunately, the White House is recommending FDA’s flawed policy as the solution to the livestock part of the problem.
  • There is some good news in that the White House seems to anticipate increased surveillance and use reporting to better help track progress on the issue.

These documents essentially confirm that we are facing a crisis of ever more bacteria becoming resistant to the antibiotics that we rely on to make us well when we are sick. They say that we need to address both healthcare and agriculture uses to tackle this problem. They point out a lot of things we can do on the human side.  But when it comes to livestock use of antibiotics, they take a wait and see approach to see if the one voluntary thing we’re doing on the agriculture side is working before we do anything more there.

The report says:

“Although knowledge in this area is still incomplete, it is clear that at least some drug-resistant pathogens have evolved under selective pressure from antibiotic use in agriculture and may have contributed significantly to resistance in clinical settings. A national strategy to reduce the emergence and incidence of antibiotic resistance must therefore include substantial changes in the use of antibiotics in agricultural settings, in order to preserve antibiotic utility in human medicine.”

Unfortunately, the recommended solution will not bring about any substantial change.

The Executive Order says that “The Food and Drug Administration (FDA) in HHS, in coordination with the Department of Agriculture (USDA), shall continue taking steps to eliminate the use of medically important classes of antibiotics for growth promotion purposes in food-producing animals.”

Same with the National Strategy. “Implement FDA Guidance for Industry #213 to eliminate the use of medically important antibiotics for growth promotion in animals and bring other therapeutic uses of medically important antibiotics under veterinary oversight. FDA should evaluate the adoption of the proposed changes under Guidance #213 during the three-year implementation period and take further action as appropriate.”

As I mentioned before, the FDA’s voluntary policy (Guidance 213) ignores “disease prevention” uses of antibiotics and only goes after growth promotion uses. This means that the dangerous, low dose, routine use of medically-important antibiotics can continue without restriction.  Worse, many drugs are currently labeled for both disease prevention and growth promotion uses so even if drug companies change the labels, livestock operators can just keep using them.  

There is a positive note.

We have been concerned about making sure that we are collecting data on antibiotic use (not just antibiotic sales) to track the use trends. The documents released suggest that collecting that use data will be important.

The Executive Order says that “USDA, the Environmental Protection Agency (EPA), and FDA shall strengthen coordination in common program areas, such as surveillance of antibiotic use and resistance patterns in food-producing animals, inter-species disease transmissibility, and research findings.” It also says “USDA, EPA, and FDA shall work together with stakeholders to monitor and report on changes in antibiotic use in agriculture and their impact on the environment.”

And the National Strategy continues that the government will “Assess progress toward eliminating the use of medically important antibiotics for growth promotion in food-producing animals through enhanced data collection on antibiotic sales and use.”

We hope that these efforts result in the development of a real data use reporting system. Without such use data, it will be difficult to track whether any of these steps being taken are actually reducing antibiotic use.

As if aware that its own recommendations might fall short, the PCAST report says:

“If the FDA guidances are ultimately not effective in mitigating the risk of antibiotic resistance

associated with antibiotic use in farm animals, FDA should take additional measures to protect

human health.”

But how much longer do we have to wait for FDA and the administration to take additional measures to eliminate disease prevention uses? We’ve been told that we are on a precipice, and looking at entering a post-antibiotic era. It is irresponsible to sit by and watch us fall off the cliff before deciding to take more decisive action.