What Are They Trying To Hide?

There is a battle brewing in the Senate right now, on one of the most important public health issues facing us today. And the fight isn’t even about how to address the problem, but about whether we can get basic information out of the Food and Drug Administration.

As I wrote last week, the Senate Health, Education, Labor and Pension Committee (commonly referred to as the HELP Committee) held a hearing on renewing user fees that the animal drug industry pays to have its applications processed quickly by FDA.  But as I noted before, the HELP Committee leadership has fought all attempts to even raise the issue of antibiotic resistance as a result of the misuse of the very animal drugs that the industry is paying FDA to quickly approve.

Fortunately for the public, two strong Senators have stood up to lead on this issue. Senators Kirsten Gillibrand (NY) and Dianne Feinstein (CA) have jointly offered a provision amending the next version of the fee bill that will strengthen the requirements in the bill for how antibiotic sales are reported to the public(by requiring FDA to disclose how the antibiotics sold are administered and marketed — i.e. over-the-counter, prescription, etc.— and how important they are for human medicine).  Unfortunately, the Committee Chairman Senator Tom Harkin (IA), many committee members, and the FDA are opposed to the Gillibrand/Feinstein provision, and so far none of the Committee members have spoken up and challenged Senator Harkin and others who are opposed.

The Gillibrand/Feinstein provision is very modest and only requires FDA to make available to the public data that it already collects but is not disclosing to the public. This includes information that it has previously disclosed in response to specific enquiries from a member of congress. The extent to which the industry, FDA, and even the Committee leadership have fought against even this simple provision -- and the speed with which they are trying to rush through the process to cut off discussion -- begs the question, “What are they trying to hide?”

If the public is going to get the information it needs to better address widespread misuse of antibiotics which threatens the viability of some of our most important medicines, then members of the HELP committee must tell Senator Harkin that they support including the Gillibrand/Feinstein provision in the bill. And to make that happen, we need to call these Senators today and ask them to act.

The membership of the HELP Committee includes many Senators who have been good champions for public health issues.   They are: 

• Barbara Mikulski (Maryland) (202) 224-4654
• Patty Murray (Washington) (202) 224-2621
• Bernie Sanders (Vermont) (202) 224-5141
• Bob Casey (Pennsylvania) (202) 224-6324
• Kay Hagan (North Carolina) (202) 224-6342
• Al Franken (Minnesota) (202) 224-5641
• Michael Bennet (Colorado) (202) 224-5852
• Sheldon Whitehouse (Rhode Island) (202) 224-2921
• Tammy Baldwin (Wisconsin)  (202) 224-5653
• Chris Murphy (Connecticut) (202) 224-4041
• Elizabeth Warren (Massachusetts) (202) 224-4543
• Mark Kirk (Illinois) (202) 224-2854

Direct phone calls from constituents saying that this is an important issue could make a critical difference in whether Senators Gillibrand and Feinstein can succeed. We need all of these offices to receive calls between now and this Friday afternoon. A senator should hear from a constituent, “I am calling to ask you to tell Chairman Harkin that you support including the Gillibrand/Feinstein provision in the ADUFA bill that will be marked-up next week, and that you will withhold your support for ADUFA reauthorization until it includes the Gillibrand/Feinstein provision. “

Here’s a quick summary of why this is so important:

• Antibiotic use in factory farms constitutes the vast majority of antibiotics sales in the US--about 80%. Most of this use is on animals that are not sick.
• This use is contributing to a growing public health crisis of antibiotic resistance, which is putting the effectiveness of essential medicines -- antibiotics -- at risk.
• The Director General of the World Health Organization has warned, bacteria are becoming so resistant to common antibiotics that it could mean “the end of modern medicine as we know it,” and “[t]hings as common as strep throat or a child’s scratched knee could once again kill.” Just this January, the UK’s top medical official described an “apocalyptic scenario” in 20 years’ time, in which simple operations could lead to death from routine infections “because we have run out of antibiotics.”   
• The CDC has said that there is “strong scientific evidence of a link between antibiotic use in food animals and antibiotic resistance in humans.”
• We need better information about where and how antibiotics are being used at factory farms to better target solutions and evaluate the success of efforts to curtail such use.
• ADUFA provides funding for evaluation and approval of new animal drug applications, including antibiotics. It should also include public health improvements as it has done in the past in 2008, when ADUFA reauthorization required reporting on total antibiotic sales. Today, that reporting requirement provides the only data we have on antibiotic sales in the US. We need better data.
• FDA has failed to address this issue and take meaningful action for more than 30 years – under Republican and Democratic administrations, and won’t unless compelled to do so by Congress.  A Senator’s primary mission is to protect public health, and that means directing the FDA to do its job.