Legislation would increase number of drugs approved for minor species, minor uses
Posted April 1, 2004
The Minor Use and Minor Species Animal Health Act came a step closer to enactment when the Senate approved the legislation by unanimous consent March 8. The next step is for the House of Representatives to pass the bill.
Similar to the program created in 1983 by the Human Orphan Drug Act that increased the availability of drugs for rare human diseases, the MUMS bill would offer pharmaceutical companies incentives to develop drugs to treat uncommon diseases in major animal species and diseases in minor species.
Minor species encompass thousands of animal species, including fish and sheep. Minor uses are drug treatments for animal diseases that occur infrequently or in limited geographic areas in all animals.
"The Human Orphan Drug Act has done wonders for the health and welfare of humans suffering uncommon or rare diseases. We anticipate MUMS will do the same for animals that, all too often, have previously gone untreated, suffer, and die," said Dr. A. David Scarfe, assistant director of the AVMA Scientific Activities Division.
A critical shortage of approved animal drugs for minor uses and minor species exists because of limited sales opportunity, low profit margins, and the high capital investment necessary for bringing a drug to market.
A coalition of 43 organizations, including the AVMA, American Farm Bureau Federation, Animal Health Institute, American Pet Product Manufacturers Association, and National Aquaculture Association, has worked closely with Senate and House sponsors and with the Food and Drug Administration on MUMS legislation introduced in the 107th and 108th sessions of Congress. For three years, the MUMS Coalition has lobbied Congress to pass the bill.
"This act will reduce the economic risks and hardships which fall upon ranchers and farmers as a result of livestock diseases. It will benefit pets and their owners and benefit various endangered species and aquatic animals," said Alabama Sen. Jeff Sessions on the night of the Senate vote.
"The act also will promote the health of all animal species while protecting human health and will alleviate unnecessary animal suffering. This is commonsense legislation which will benefit millions of American pet owners, farmers, and ranchers."
Sessions introduced the MUMS bill in March 2003 and garnered the support of 21 fellow senators who co-sponsored the bill, including the Senate's two veterinarians, Wayne Allard of Colorado and John Ensign of Nevada.
The bill was referred to the Senate Health, Education, Labor, and Pensions Committee, which approved it in November.
FDA Commissioner Mark B. McClellan, MD, PhD, applauded the Senate action, saying the agency "looks forward to providing further technical assistance to the House regarding this legislation."
In the House of Representatives, Charles "Chip" Pickering of Mississippi introduced a version of the MUMS bill last May. So far, 34 congresspersons are co-sponsoring the bill, which is under consideration by a subcommittee of the House Energy and Commerce Committee.
Numerous activist groups were initially opposed to the legislation, fearing it would fast-track transgenic animals and prevent the FDA from ensuring antimicrobial safety. But the MUMS Coalition backed an amendment to the Senate bill that assuaged the groups' concerns. It is that amended version that the coalition wants the House to pass.
"The MUMS bill passed by the Senate is a culmination of cooperative working relationships, compromises, and persuasion by members of the MUMS Coalition to reach this successful point," said Dr. Michael Chaddock, director of the AVMA Governmental Relations Division.
"We need to diligently continue those efforts in the U.S. House of Representatives to ultimately succeed in having the president sign a MUMS law this year."
A MUMS law would allow drug applications for minor species and minor uses to receive conditional approval when the drug is demonstrated to be safe and have a reasonable expectation of efficacy. This conditional approval, evaluated annually, would be limited to five years until full approval is achieved.
Included in the bill is a provision creating a category of index drugs targeted at providing for legal use of drugs in nonfood minor species for which even conditional approval is not economically feasible.
Most importantly, a MUMS law would provide legal basis for veterinarians to use such drugs.
Speaking in support of the legislation, Sessions explained that Alabama's catfish industry ranks second in the nation and is vital to the state's economy. The catfish industry estimates its losses at $60 million per year because of diseases for which drugs are not available, he said.
The U.S. aquaculture industry produces more than 800 species of fish, and yet, only six drugs are approved by the FDA for treating aquacultural animal diseases.
The senator added that the sheep industry estimates feedlot deaths would be reduced by up to 2 percent, approximately $8 million of revenue, if approved drugs were available to treat ill sheep.
"This results in tremendous economic hardship and animal suffering," Sessions said.
For information on how you can help work with your member of Congress to support this legislation, contact Dr. David Scarfe or Dr. Elizabeth Curry-Galvin of the AVMA Scientific Activities Division, (800) 248-2862; Dr. John Melcher, (202) 546-4084; or Dr. Gerald Rushin of the AVMA Governmental Relations Division, (800) 321-1473, or via e-mail at email@example.com.