Animal Drug User Fee Act
H.R. 6432
An estimated 70 percent of all antibiotics used in the United States are regularly added to the feed of livestock and poultry that are not sick. Bacteria that are constantly exposed to antibiotics develop antibiotic resistance. This means that when humans get sick from resistant bacteria, the antibiotics prescribed by doctors don't work.
Antibiotic resistance is becoming increasingly common, and scientists agree that the overuse of antibiotics in CAFOs (confined animal feeding operations) plays a big role. Today, new antibiotic-resistant diseases are being linked to CAFO practices, including Methicillin-resistant Staphylococcus aureus (MRSA), a disease responsible for over 18,000 deaths each year in the United States.
Why isn't the Food and Drug Administration (FDA) putting an end to the use of these drugs in CAFOs for animals that are not even sick? Even if the FDA had the will to act, agency resources are tied up elsewhere. Applications by drug companies for new animal drugs are reviewed by the FDA in exchange for fees from industry. But this faulty "user fee" arrangement forces the FDA to be financially dependent on the very industry it is tasked with regulating, dictates the agency's priorities, and forces the agency to adhere to strict deadlines for new drug approvals. As a consequence, other priorities, such as reviewing the effect of already approved antibiotics on human and animal health, are virtually ignored.
Congress is now considering the Animal Drug User Fee Act (ADUFA), a bill to continue this FDA fee program. The House has passed ADUFA with an important provision to collect data on antibiotics sold for use in animal agriculture. This is an important first step. Now it is up to the Senate to strengthen ADUFA to include provisions to direct the FDA to review currently approved animal antibiotics and to revoke approvals for unnecessary uses of these drugs that are found to cause human antibiotic resistance. These provisions are similar to those found in a bill UCS has long worked to pass—The Preservation of Antibiotics for Medical Treatment Act.
Below is a letter sent by UCS and other members of the Keep Antibiotics Working coalition to the Senate on ADUFA.
July 24, 2008
Dear Senator:
Re: Animal Drug User Fee Act (ADUFA) and Preservation of Antibiotics for Medical Treatment Act (PAMTA)
Antibiotic resistance is a growing threat. Antibiotics, the miracle drugs of the last century, are in danger of being lost as a result of overuse in both human and animal medicine. While both settings deserve urgent attention, food animal production is a relatively neglected area where enormous, often inappropriate, use of antibiotics is commonplace.
We, the undersigned members of Keep Antibiotics Working, write to urge that the reauthorization of the Animal Drug User Fee Act (ADUFA), along with its substantial incentives for approving new animal drugs, include provisions that will ensure public health and drug safety after the animal drug is on the market. Keep Antibiotics Working is a coalition of health, environmental, agricultural, animal welfare, and science organizations with more than 10 million supporters. The coalition is dedicated to the preservation of antibiotics for use in human and animal medicine.
According to the Centers for Disease Control (CDC) and the World Health Organization, antimicrobial resistance is the greatest public health risk we face. Antimicrobials (including antibiotics) are different from most other drugs in that resistance results from exposure and worsens over time. This means that in order to avoid the consequences of resistance-increasingly virulent diseases, higher medical costs, and increased suffering-the Food and Drug Administration (FDA) must continue to address resistance after drugs are approved. Many antibiotics routinely used in animal agriculture were approved decades ago, before resistance concerns were even considered.
We urge that ADUFA, when it is passed, include provisions from Title 1 and Title 2 of the Preservation of Antibiotics for Medical Treatment Act (PAMTA, S. 549) to address the ongoing resistance issues associated with approved antibiotics. The PAMTA provisions would:
1) Initiate the immediate review of existing antibiotics, in classes that are used both in human and animal medicine, of their safety for nontherapeutic purposes with regard to antibiotic resistance, and direct the FDA to take timely action on the basis of that review.
2) Require the collection of drug use data essential to the assessment and management of resistance risks associated with approved antibiotic drugs.
For both of these areas of post-market drug safety, the FDA must move quickly.
When the Prescription Drug User Fee Act (PDUFA) was reauthorized as part of the FDA Amendments Act of 2007, it addressed post-market safety issues in human drugs. Similarly, any reauthorization of ADUFA should address post-market animal drug safety.
Over the past five years, FDA has consistently neglected the tasks necessary for the long-term management of resistance, as it has given priority to other goals funded by fees. Congress should not allow this failure to continue. Current funding now built into the agency's base, thanks to an earlier appropriation amendment, can be applied to the reviews required by Title 1 of PAMTA.
According to its mission statement, FDA is a consumer protection agency with a mandate to provide safe drugs. The most important aspect of safety when dealing with antibiotics is the evolution of resistant organisms. Congress should assist FDA in fulfilling its mission by assuring through the steps outlined above that antibiotics approved by the agency for nontherapeutic purposes, both in the past and in the future, are safe with regard to the evolution of resistance.
We urge you not to let ADUFA go forward without the vital public health provisions of PAMTA.
Sincerely,
Richard Wood
Executive Director
Keep Antibiotics Working
The Keep Antibiotics Working Coalition
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
