October 19, 2018

FDA Will Not Expand Requirements for ADUFA Reporting

In a document just released in the Federal Register, the FDA has signaled it will not recommend expanding current requirements under the Animal Drug User Fee Act (ADUFA) that drug companies report details about their sales of antibiotics.  It’s through these summaries that we know how antibiotics are being used in food animals.

The nontherapeutic use of antibiotics in food animals has been widely criticized by many public health organizations. Antibiotics are used by farmers and ranchers in small quantities in animal feed to promote growth and to prevent diseases that can be caused by overcrowding and poor conditions. The prevalence of antibiotics and those low doses can fuel the development of antibiotic-resistant bacteria.

In fact, Dr. Margaret Chan, Director-General of the World Health Organization, has stated that antibiotic resistance could “end modern medicine as we know it. Things as common as strep throat or a child’s scratched knee could once again kill.” More antibiotics are used in healthy animals than in healthy human beings. As a result, we are losing first-line antimicrobials. Newly developed antibiotics are more expensive, have more toxic side effects, and may require treatment in-hospital.

Food Poisoning Bulletin spoke with Tyler Smith, Senior Research and Policy Associate at the Johns Hopkins Center for a Livable Future about this issue.  He said that when ADUFA was re-authorized, more supportive members of Congress added an amendment that requires drug companies to report their antibiotic sales. Public health groups have urged FDA to recommend that Congress expand these requirements when the Act is re-authorized in 2013, but it appears the agency has no plans to do so.

Smith said, “we want the FDA to release more data now than it does. The agency already collects a great deal of data, but conceals most of what it collects. We want to see data on quantities of drugs sold that are approved for growth promotion, and quantities sold that require veterinary prescriptions, for example.”

The FDA is beginning a process that would ask drug companies to voluntarily withdraw drugs for growth promotion. What may be likely, according to Smith, is that drug companies will get rid of approvals to use the antibiotics for growth promotion, but add approvals to use the drugs for disease prevention. If there is a decrease in sales for growth promotion but a corresponding increase in sales for disease prevention, that could mean the drug companies are just changing terminology. With no expanded requirements for reporting, no one outside of the FDA will be able to see this data.

Public health groups have been asking the FDA to be more transparent about antibiotic reporting. In October, Representative Henry Waxman announced the DATA Act that would provide information to the FDA about the types of antibiotics that are routinely given to farm animals.  The bill has not been voted on.

In addition, the FDA has been reluctant to abide by its decision, made in 1977, to remove growth-promoting antibiotics that are put into animal feed. Judge Theodore Katz ruled this spring that the FDA must begin proceedings to withdraw approval for antibiotic use. But the FDA has just issued guidance documents to industry that are completely voluntary and not enforceable.

The FDA makes millions of dollars from ADUFA, which lets the agency speed up approvals of new animal drugs. Industry supports ADUFA because of the faster drug approvals, but the industry is also opposed to antibiotic sales reporting. FDA is reluctant to expand reporting requirements because the industry is so against it. This conflict of interest is troubling. You can comment on the FDA’s proposal at Regulations.gov.

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