Its Master's Voice: The FDA's Dependence on Drug Industry Fees

April 11, 2013 | 11:14 am
Margaret Mellon
Former contributor

I’ve spent many years wondering why the Food and Drug Administration (FDA) has been so slow to curb the rampant overuse of antibiotics in agriculture.

Original Nipper, by Francis Barraud (1856–1924) (Transferred from en.wikipedia) [Public domain], via Wikimedia Commons

For a public health agency, this issue would seem a no-brainer. Overuse of drugs in agriculture leads to resistant populations of bacteria impervious to antibiotics. Increasingly ineffective antibiotics lead to more severe, more difficult-to-treat diseases, which increases health costs and leaves physicians helpless at the bedside of suffering patients.

The scientific data connecting antibiotic use in agriculture to the evolution of resistant human disease have been compelling for decades. Recent studies only strengthen the case. The FDA knows that ongoing antibiotic use leads to more resistant bacteria and that the crisis deepens every year we fail to address the issue.

The solution to the crisis is straightforward: avoid the unnecessary use of antibiotics in both human and veterinary medicine and animal agriculture. In agriculture, most antibiotic use compensates for crowded, stressful raising conditions that can be avoided with good animal husbandry, so meaningful reductions are possible and economically feasible. (Of course, when animals fall ill or are directly exposed to contagious disease, antibiotics are called for and should be used.)

The FDA has the legal tools to cancel approvals for unnecessary uses of the antibiotic classes that are important in human medicine. Using those legal tools would go a long way to preserve the efficacy of our precious, but ever dwindling, store of drugs.

Regardless, over a 30-year time frame, the FDA has only occasionally addressed this crisis. The agency’s foot-dragging has astounded even a federal court judge.

What gives?

User Fees and Data Reporting Requirements

The way the Senate and FDA have handled the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 (ADUFA) gives a strong hint. ADUFA is a law that allows the drug industry to pay fees to the FDA to expedite the review of animal drug applications. The fees, which are negotiated for a five-year term between FDA and the industry, supplement the agency’s budget. The ADUFA reauthorization bill introduced in Senate in March (S.622) would provide FDA more than $21 million annually from 2014 through 2018 to support new animal drug reviews, and about $7 million a year over the same period to handle generic drug applications.

That is not chump change. FDA financial reports for fiscal year 2011 attributed 92 full-time positions to the ADUFA fees.

The convergent interests of the FDA and the industry it is supposed to regulate make ADUFA a “must-pass” piece of legislation that offers an opportunity to enact public health measures along with expedited drug reviews. The 2008 ADUFA included the first-ever requirements for collecting and publishing sales data for animal antibiotics.

This year the public interest community is urging very modest improvements to those 2008 requirements: more information on species, purpose, and how the animal drugs are administered. These data would be valuable for scientists to understand and respond to the antibiotic crisis. But the bill reported out of the Senate Health, Education, Labor and Pensions (HELP) Committee was “clean”—not a speck of public health reporting was added.

Modest as they were, the additional reporting requirements were too much for industry and the HELP Committee.

As former FDA Commissioner David Kessler said in a recent New York Times op-ed, both industry and the HELP Committee are being “aided and abetted” by the FDA, which has not uttered a peep in favor of stronger reporting requirements. Why? With $30 million a year and 90 or so positions on the line, the FDA doesn’t want to rock the boat, not even to achieve important public health goals.

Fortunately, two senators not on the HELP committee, Dianne Feinstein (D-Calif.) and Kirsten Gillibrand (D-N.Y.) are continuing to fight to strengthen the Senate version of ADUFA, while the House is  considering more robust, but still very reasonable, reporting requirements that could be added to its its version of the bill. But so far there is no indication that the FDA will throw its weight behind stronger reporting requirements.

User Fees and Agency Priorities

It turns out that the agriculture industry gets even more for its millions than help in quashing important data collection improvements. In exchange for the fees, the FDA has agreed to detailed performance deadlines to ensure the drug review process moves along quickly and the agency rarely misses its deadlines. But when it comes to addressing the threat posed by the overuse of antibiotics, the agency moves at a snail’s pace, if at all. The industry’s milestones are sacrosanct, but the agency’s public health mission—whenever. The user fees set the agency’s priorities.

I also wonder what role industry played in the evolution of the FDA’s timid, voluntary program to remove injudicious antibiotic uses from the market. As I argued in an earlier post, that program envisions lopsided, drug company-friendly negotiations to determine which products go off the market. Could the agency’s dependence on the same companies for its budget have factored into the program’s design?

The public bears a big responsibility here. If taxpayers were willing to step up and fund the FDA, the public, not the regulated community, would be calling the shots.

That said, under the current situation, user fees are giving the animal drug industry too much say in the choices and priorities of the FDA. Like Nipper, the iconic dog sitting at attention next to the RCA Victrola, the FDA appears to be listening to its master’s voice.