We Cannot Move Backwards On Superbugs, But Congress Might

Steven Roach, ​Food Safety Program Director, Food Animal Concerns Trust contributed to this blog post. 

The House Energy and Commerce Committee is poised to pass a bill that could send us backwards on efforts to fight against antibiotic resistance.

There is a law called the Animal Drug User Fee Act (ADUFA), and Congress is working on current amendments to it. The Committee will be voting on those amendments, including one on conditional approvals that could have disastrous impacts on antibiotic resistance.

The Food and Drug Administration (FDA) loves ADUFA because it requires pharmaceutical companies to pay tens of millions of dollars in fees that pay salaries and maintain FDA budgets. Pharmaceutical companies love ADUFA because it has greatly reduced the time needed for FDA to approve new animal drugs, meaning increased product sales and profits. Because antibiotics used in animals fall under ADUFA, the things they do in this bill can have serious impacts on antibiotic resistance.

Antibiotic resistance is one of the world’s greatest health crises. And the misuse and overuse of antibiotics in animal agriculture is an important driver for creating antibiotic resistant bacteria. Already at least 2 million Americans suffer infections each year due to bacteria that are increasingly resistant to treatment with antibiotics. These infections result in more than 23,000 deaths. Without urgent action to reduce antibiotic use, deaths will climb, and dialysis, transplant surgeries, chemotherapy, and other ‘miracle’ of modern medicine that rely on antibiotics may soon disappear.

And yet, next week members of the House Energy and Commerce committee are poised to vote to greatly expand the use of these same critical drugs in cattle, in pigs, and in poultry. That step would be rash, unforgivable, and will hasten the spread of antibiotic resistance.

What are they trying to do?  

Pharmaceutical companies are pushing hard for the FDA to expand “conditional” drug approvals.

For background, since 1962, FDA’s primary job has been to make sure that human and animal drugs are both safe and effective. In 2004, Congress allowed “conditional approvals” which allowed companies to sell certain new animal drugs without submitting all the data showing that those products are effective. Congress intentionally limited these conditional approvals to minor animal species (like goats and rabbits) or to minor uses in major species (intended for small numbers of dogs, cats, pigs, cattle, turkeys, or chickens). They rationalized that because the markets for these products were so small, pharmaceutical companies needed lower costs to bother making them.

The problem is that now these same companies want Congress to expand conditional approvals to major uses in major animal species like cattle, pigs and poultry. These markets are enormous. If this provision passes, companies won’t have to submit all the data needed to approve drugs (including antibiotics) used in tens of millions of animals.

This ploy is dangerous to public health. It is laser focused on increasing the use and sales of drugs, including animal antibiotics. And that increase will speed up the development and spread of superbugs.

It could also lead to millions of animals receiving ineffective drugs. That means more sick animals, more need to use antibiotics, and more risk of developing resistant bacteria.

The health and security of our country can ill afford this outcome. It flies in the face of the public health mission that is supposed to be at the core of the FDA.

Stopping any proposals in ADUFA to expand conditional approvals of antibiotics and other drugs for cattle, pigs and other major species is critical. We can't let pharmaceutical companies let profits get in the way of beating the antibiotic resistance crisis.