December 5, 2012

Government Accountability Project Sues FDA for Antibiotic Sales Data

Tyler Smith

Tyler Smith

Program Officer, Food Production and Public Health

Johns Hopkins Center for a Livable Future

Shouldn't we have access to data about which drugs are being sold for use in food animals?

If you do not sue the Food and Drug Administration (FDA), it will not do its job.  At least when it comes to animal drugs, this has been the lesson of the past year.

Until this spring, FDA had done almost nothing to stop antibiotic misuse in food animal production.  Then, in April, a judge ordered the agency to take action to prevent the food animal industry from feeding penicillins and tetracyclines to livestock and poultry to make them grow faster. In June, the same judge told FDA to reconsider its denial of two citizen petitions that asked the agency to go even further.  The agency has appealed both decisions, with a decision expected early next year.

Now the Government Accountability Project (GAP) is suing FDA for data on antibiotic sales.  Almost two years ago, CLF approached GAP for help obtaining these data, which are collected from drug companies under the Animal Drug User Fee Act (ADUFA).  FDA releases a limited summary of these data each year, but withholds almost all of what companies report.  If we want more, we have to sleuth it out of the agency ourselves.

GAP submitted a Freedom of Information Act request to FDA in February 2011.  The agency denied the request.  When GAP appealed to the Public Health Service, which includes FDA, the appeal was ignored for more than a year and then denied in September.  After 20 months of patient pressure, it became clear that a lawsuit was the only option.  GAP filed a complaint in federal court this morning.

It should not be this hard.  Antibiotic resistance is a public health crisis; just one resistant pathogen, MRSA, results in more than 94,000 invasive infections and 18,000 deaths in the U.S. each year.  The annual health care costs attributable to resistance are estimated at between $17 and 26 billion.  The public has a right to know information that impacts its health—especially when the impact is so great.

Why is FDA so lethargic?  Its inaction appears to result from a major conflict of interest centered on ADUFA.  The main purpose of this law is to collect millions of dollars in “user fees” from drug companies to speed review and approval of applications for new animal drugs submitted by drug companies.  The agency collected $18 million under ADUFA last year.

ADUFA will expire next year unless Congress reauthorizes it.  FDA is desperate for industry support for reauthorization—without ADUFA, the agency clearly would lose a great deal of money.  Although drug companies generally favor the law because it leads to faster drug approvals, they need it less than FDA does.  They are also opposed to reporting on antibiotic sales.

FDA will not bite the hand that feeds it by enhancing ADUFA’s reporting requirements.  Indeed, in recommendations to Congress on how ADUFA should be amended when it’s reauthorized, the agency did not even mention the requirements.  FDA just swept them under the rug.

Rep. Henry Waxman has announced legislation that would require drug companies and others to report better data and require the agency to release more of these data to the public.  This excellent legislation may be included in ADUFA when the latter is reauthorized next year.  In the mean time, it appears that litigation is public health advocates’ only option.

Photo: The General Negative Collection, North Carolina State Archives.