PAMTA and STAAR Will Protect Public from Antibiotic Resistance
Letter to Congress from UCS and other members of Keep Antibiotics Working coalition
March 31, 2008
The Honorable Edward M. Kennedy
United States Senate
527 Hart Senate Office Building
Washington, DC 20510
The Honorable Michael B. Enzi
United States Senate
428 Dirksen Senate Office Building
Washington, DC 20510
Dear Chairman Kennedy, Ranking Member Enzi, and members of the Health, Education, Labor, and Pensions Committee:
Re: STAAR and PAMTA: A double-barreled response to a public health crisis
We, the undersigned members of Keep Antibiotics Working (KAW), a coalition of health, consumer, agricultural, environmental, humane, and other advocacy groups, are writing to urge the Health, Education, Labor, and Pensions Committee to pass S. 549, the Preservation of Antibiotics for Medical Treatment Act (PAMTA), and S. 2313, the Strategies to Address Antimicrobial Resistance Act (STAAR Act). These bipartisan pieces of legislation are vital to addressing the public health crisis of antibiotic-resistant diseases.
Antibiotic-resistant diseases are becoming more common and fatal, as evidenced by the explosion of methicillin-resistant Staphylococcus aureus (MRSA). MRSA, like other resistant diseases, is emerging in response to the overuse of antibiotics partly in medical settings, but also in animal production operations. The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture (USDA), after reviewing the scientific evidence, concluded in December 2007 that "The evolution of MRSA and other drug-resistant pathogens has been linked to extensive antibiotic use in medicine and food animal production....MRSA-colonized pigs in the Netherlands were implicated as a source of infection which spread to farmers, their families, and hospital staff." Antibiotic-resistant diseases, regardless of the source of the resistance, increase human suffering and deaths and drive up already high medical costs by exacerbating the severity of disease and lengthening hospital stays. Overuse in both medical and agricultural settings needs to be addressed.
PAMTA would reduce the unnecessary—but massive—use of human antibiotics in the production of food animals. The STAAR Act would strengthen the public health infrastructure essential to the long-term management of antibiotic-resistant diseases in settings such as hospitals, clinics, veterinarians' offices, and animal production operations. If enacted together, the two statutes would constitute an effective comprehensive response to this critical public health crisis.
KAW fully supports the aim and general approach of both STAAR and PAMTA and endorses PAMTA as is. If STAAR were to be improved in the three ways outlined below, we would endorse STAAR without reservation.
PAMTA
The fundamental driver behind antibiotic-resistant diseases is the selection of resistant traits as a result of drug use. In addition to their use in human medicine, antibiotics are used in food animal production. Although the government does not systematically collect data on antibiotic use, the Union of Concerned Scientists has estimated that 70% of all antibiotics and related drugs in the United States are used for non-therapeutic purposes (growth promotion and routine disease prevention) in cattle, swine, and poultry. These massive uses could be eliminated by changing animal production practices in ways that prevent disease and keep animals healthy in the first place.
PAMTA directly addresses the development of resistance by reducing this unnecessary use of antibiotics. The bill would phase out the uses of seven classes of drugs used in human medicine (e.g., penicillins and tetracyclines) for growth promotion and routine disease prevention in food animals unless the drug company can demonstrate such use is safe. PAMTA would allow those drugs to be used to treat sick livestock, and, of course, in veterinary medicine. Drug classes not used in human medicine would not be affected by the bill and could continue to be used for any purpose in animal production.
The bill would also require the Food and Drug Administration (FDA) to collect, compile, and publish antibiotic sales data. It would also provide payments to livestock producers to help them transition away from use of these antibiotics and provide for research and demonstration of livestock management techniques to help livestock producers phase out non-therapeutic uses of these drugs.
STAAR Act
The STAAR Act addresses the emergence of resistant diseases by strengthening the government's infrastructure for tracking and responding to the diseases. Specifically, STAAR would strengthen the Federal Interagency Task Force on Antimicrobial Resistance established in 1999, and set up systems to collect data on antibiotic sales and use. KAW strongly supports the aim and approach of STAAR but believes that it needs to be improved in the following three ways.
1. Include public interest representation on the Public Health Advisory Board
A central feature of the STAAR bill is the establishment of a new Office of Antimicrobial Resistance in the Department of Health and Human Services (HHS) overseeing an antimicrobial task force and a permanent Public Health Advisory Board to the Director of that office. The task force is to be made up of representatives of federal agencies, including the Centers for Disease Control and Prevention, the FDA, the National Institutes of Health, the USDA, and six other agencies.
The Public Health Advisory Board would be made up of 13 members appointed by the Secretary of HHS that "shall include experts from the medical professions (including hospital and community-based physicians), public health, veterinary, research, and international health communities." [Section (3)(a)(2)(B)(i)] KAW recommends that S. 2313 be amended to read "shall include experts from the medical professions (including hospital and community-based physicians), public health, veterinary, research, and international health communities, and the public interest community," to ensure that the public interest community is represented on the advisory board.
2. Ensure strong conflict-of-interest provisions for the Public Health Advisory Board
The field of antibiotic resistance offers a host of opportunities for consulting, investment, and other activities that could pose financial conflicts of interest for advisory board members. To ensure objective public policy, KAW recommends that the STAAR Act be amended to explicitly address such conflicts. KAW believes that the 18 USC 208, the general conflict-of-interest statute for federal employees and advisory committee members, which ensures that board members disclose their conflicts, is inadequate, as it does not minimize the use of waivers.
3. Harmonize and strengthen the data collection provisions of the House bill
While section 4 of the House STAAR bill (H.R. 3697) requires animal drug companies to submit to the FDA data on sales by March 31 of each year and the FDA to make those data public, section 4 of the Senate bill (S. 2313) only requires the animal drug companies to annually submit to the FDA the data they are already required to submit under 21 CFR 514.80(b)(4)(I). The rest of section 4 of the Senate bill simply authorizes FDA to consider supplementing this data.
KAW recommends that the Senate bill be amended to include provisions similar to the House bill. Specifically, the Senate bill should indicate that sales data be submitted, and establish a date for annual submission, preferably the date found in the House bill (March 31).
It should be noted that both PAMTA and the STAAR Act contain data collection provisions; if they are both passed, these data collection requirements can be merged and harmonized.
Summary
In summary, Keep Antibiotics Working believes that antibiotic-resistant disease is a looming public health crisis that deserves concerted and serious response from the federal government. Enacting both PAMTA to reduce unnecessary antibiotic use in the short term and STAAR to strengthen governmental infrastructure would establish a strong foundation for that response. We fully endorse PAMTA, and support the aim and approach of the STAAR Act. If the STAAR Act were improved in the ways described above we would enthusiastically endorse it as well.
Thank you for considering our views.
Sincerely,
Keep Antibiotics Working
Center for Science in the Public Interest
Environmental Defense
Food Animal Concerns Trust
Global Resource Action Center for the Environment
Humane Society of the United States
Institute for Agriculture and Trade Policy
National Catholic Rural Life Conference
Natural Resources Defense Council
Physicians for Social Responsibility
Safe Tables Our Priority (S.T.O.P.)
Sierra Club
Union of Concerned Scientists
Waterkeeper Alliance
