Pharmaceutical Issues

Issue Summaries for the 113th Congress


This legislation amends the Controlled Substances Act to allow a veterinarian to transport and dispense controlled substances in the usual course of veterinary practice outside of their registered locations. See AVMA's new infographic and interactive graphic to learn why veterinarians need to use controlled substances beyond their places of business.

Get more information about why Congress should pass the Veterinary Medicine Mobility Act on AVMA's Web page>>
Learn more in AVMA's issue brief on H.R. 1528/S. 1171>>
See also the DEA's letter to Congress from May 8, 2013 and AVMA's letter to the DEA on Dec. 17, 2013 >>

Status: U.S. Reps. Kurt Schrader (D-Ore.-5) and Ted Yoho (R-Fla.-3) introduced H.R. 1528 on April 12, 2013, and it was referred to the House Committee on Energy & Commerce, Subcommittee on Health, and to the House Judiciary Committee. U.S. Sens. Jerry Moran (R-Kan.) and Angus King (I-Maine) introduced S. 1171 on June 17, 2013, and it was referred to the Senate Committee on the Judiciary. S. 1171 passed the Senate by unanimous consent on Jan. 8, 2014.
 
AVMA Position: Active Pursuit of Passage
Primary Contact: Dr. Ashley Morgan
 

 
H.R. 4023, Fairness to Pet Owners Act
This legislation is purported to promote competition and help consumers save money by giving them the freedom to choose where they buy prescription pet medications. Veterinarians would be required to provide to a pet owner with a copy of their pet’s prescription, whether or not requested and prior to offering to fill or dispensing the medication. The veterinarian may not require payment for the prescription or require the pet owner to sign a waiver or disclaim liability.

AVMA was opposed to similar legislation, H.R. 1406, in the 112th Congress.
 
See also:
AVMA Principles of Veterinary Medical Ethics>>
AVMA’s Policy on Internet Pharmacies>>
FTC workshop page>>

Status: U.S. Reps. Jim Matheson (D-UT-4) and Jason Chaffetz (R-UT-3) introduced H.R. 4023 on February 10, 2014, and it was referred to the House Committee on Energy & Commerce.

AVMA Position: Active Pursuit of Defeat
Primary Contact: Dr. Ashley Morgan 
  

 
H.R. 820, Delivering Antimicrobial Transparency in Animals (DATA) Act of 2013
This bill amends the Federal Food, Drug, and Cosmetic Act to enhance the reporting requirements pertaining to the use of antimicrobial drugs in food animals.

Status: Rep. Henry Waxman (D-Calif.-33) introduced H.R. 820 on March 1, 2013, and it was referred to the House Committee on Energy & Commerce, Subcommittee on Health.

AVMA Position: Nonsupport
Primary Contact: Dr. Ashley Morgan
 

 
H.R. 1150, Preservation of Antibiotics for Medical Treatment Act (PAMTA) of 2013
The purpose of this bill is to amend the Federal Food, Drug and Cosmetic Act to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases. The bill would require an applicant that is seeking approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. The bill would also prohibit the administration of a medically important antimicrobial (including by means of animal feed) to a food-producing animal for nonroutine disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the food-producing animal. It requires the administration of the microbial to be: (1) necessary to prevent or reduce the risk of transmission; (2) for the shortest duration possible to prevent or reduce the risk of transmission; and (3) at a scale no greater than the barn, house, or pen level and to the fewest animals possible to prevent or reduce the risk of transmission.

Learn more in AVMA's issue brief on H.R. 1150>>
 
Status: U.S. Rep. Louise Slaughter (D-N.Y.-25) introduced H.R. 1150 on March 15, 2013, and it was referred to the House Committee on Energy & Commerce, Subcommittee on Health.
 
AVMA Position: Active Pursuit of Defeat
Primary Contact: Dr. Ashley Morgan
 

 
S. 1256, Preventing Antibiotic Resistance Act (PARA) of 2013
The purpose of this bill is to amend the Federal Food, Drug and Cosmetic Act to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases. The bill would require an applicant that is seeking approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. The bill would also prohibit the administration of a medically important antimicrobial (including by means of animal feed) to a food-producing animal for nonroutine disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the food-producing animal. It requires the administration of the microbial to be: (1) necessary to prevent or reduce the risk of transmission; (2) for the shortest duration possible to prevent or reduce the risk of transmission; and (3) at a scale no greater than the barn, house, or pen level and to the fewest animals possible to prevent or reduce the risk of transmission. It is also the sense of the Senate that a valid veterinarian-client-patient relationship should exist to ensure that medically important antimicrobials are used in a manner that is consistent with professionally accepted best practices.
 
Status: U.S. Sen. Dianne Feinstein (D-Calif.) introduced S. 1256 on June 27, 2013, and it was referred to the Senate Committee on Health, Education, Labor and Pensions.
 
AVMA Position: Active Pursuit of Defeat
Primary Contact: Dr. Ashley Morgan
 

 
S. 895, Antimicrobial Data Collection Act
This bill amends the Public Health Service Act to enhance efforts to address antimicrobial resistance. The bill would require the secretary of Health and Human Services to develop a research program that studies the relationship between the sales, distribution and end-use practices of animal drugs containing an antimicrobial ingredient in food-producing animals and antimicrobial resistance trends. It would also require the secretary to analyze the data to determine how it contributes to the study of antimicrobial resistance and establish an antimicrobial data collection strategy.

Status: U.S. Sen. Kirsten Gillibrand (D-N.Y.) introduced S. 895 on May 8, 2013, and it was referred to the Senate Committee on Health, Education, Labor and Pensions.

AVMA Position: Nonsupport
Primary Contact: Dr. Ashley Morgan
 

 
H.R. 2285, Strategies to Address Antimicrobial Resistance (STAAR) Act of 2013
This bill amends the Public Health Service Act to reauthorize through fiscal 2018 and revise a program to combat antimicrobial resistance. Among other things, it would also require the Health and Human Services secretary to establish: an Antimicrobial Resistance Office, which would consult with the Food and Drug Administration on any pending applications of new human or animal antimicrobial drugs; and a Public Health Antimicrobial Advisory Board, which would make recommendations to the HHS secretary regarding issues such as research priorities and implementation of a Public Health Action Plan to Combat Antimicrobial Resistance.
 
Status: U.S. Rep. Jim Matheson (D-Utah-4) introduced H.R. 2285 on June 6, 2013, and it was referred to the House Committee on Energy & Commerce.
 
AVMA Position: Support
Primary Contact: Dr. Ashley Morgan
 

 
H.R. 1407, Animal Drug User Fee Reauthorization Act / H.R. 1408, Animal Generic Drug User Fee Reauthorization Act / S. 622, Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013
These pieces of legislation amend the Federal Food, Drug, and Cosmetic Act to reauthorize programs that will collect user fees from companies to facilitate the Food and Drug Administration’s review of new animal drugs and generic new animal drugs.
 
Status: U.S. Rep. John Shimkus (R-Ill.-15) introduced H.R. 1407 on April 9, 2013, and it was referred to the House Committee on Energy & Commerce, Subcommittee on Health. U.S. Rep. Cory Gardner (R-Colo.-4) introduced H.R. 1408 on April 9, 2013, and it was referred to the House Committee on Energy & Commerce, Subcommittee on Health. U.S. Sen. Tom Harkin (D-Iowa) introduced S. 622 on March 20, 2013, and it was referred to the Senate Committee on Health, Education, Labor, and Pensions.
 
All three of these bills were signed into law on June 13, 2013, as Public Law 113-014.
 
AVMA Position: Support
Primary Contact: Dr. Ashley Morgan