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Animal Drugs for Minor Uses and Minor Species

New legislation, officially named “The Minor Use and Minor Species Animal Health Act of 2004,” dubbed the “MUMS act” for Minor Use/Minor Species, was signed into law on August 2, 2004. The law helps make more medications legally available to veterinarians and animal owners to treat minor animal species and uncommon diseases in the major animal species.
 
The legislation is expected to benefit people who own small or unusual pets such as guinea pigs or ornamental fish, and it will likely be a great help to zoo veterinarians. The new law provides innovative ways to bring such products to market and is designed to help pharmaceutical companies overcome the financial roadblocks they face in providing limited-demand animal drugs. Before this legislation, pharmaceutical companies could rarely afford to bring to market drugs for novel pets and zoo animals, because the markets were too small to generate an adequate financial return.

Minor use drugs are drugs for use in major species (cattle, horses, swine, chickens, turkeys, dogs, and cats) that are needed for diseases that occur infrequently or in limited geographic areas and, therefore, affect a relatively small number of animals. Minor species are all animals other than the major species, which includes zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance are also minor species. These include sheep, goats, catfish, and honeybees.

The law modifies provisions of the Federal Food, Drug and Cosmetic Act in three key ways.

Conditional Approval: A sponsor of a veterinary drug can ask CVM for “conditional approval,” which allows the sponsor to make the drug available before collecting all necessary effectiveness data, but after proving the drug is safe. The drug sponsor can keep the product on the market for up to five years, through annual renewals, while collecting the required effectiveness data.

Indexing: In some cases, the potential market for a minor species drug is just too small to ever support the costs of the drug approval process, even under a conditional approval. In such cases, FDA now may add the drug to an index of legally marketed unapproved new animal drugs. This provision will be especially helpful to veterinarians treating zoo or endangered animals or classes of animals that include numerous different species, such as ornamental fish.

Designation: Similar to the “Orphan Drug Act” for humans, which helps pharmaceutical firms develop drugs for limited human uses, this provides incentives for approval. Grants to support safety and effectiveness testing will be available. Companies who gain approval for designated new animal drugs will be granted seven years of marketing exclusivity, which means the sponsor will face no competition in the marketplace for the approved use of the drug for that time.

Questions concerning MUMS should be addressed to (240) 276-9090 or to the following OMUMS staff:

Dr. Margaret (Meg) Oeller
Acting Director
Office of Minor Use and Minor Species Animal Drug Development
Center for Veterinary Medicine
7500 Standish Place
Rockville, MD 20855
(240) 276-9005
mailto:Margaret.Oeller@fda.hhs.gov

or

Dr. Andrew Beaulieu
Office of Minor Use and Minor Species Animal Drug Development
Center for Veterinary Medicine
7500 Standish Place
Rockville, MD 20855
(240) 276-9338
mailto:Andrew.Beaulieu@fda.hhs.gov

or

Dr. Joan Gotthardt
Office of Minor Use and Minor Species Animal Drug Development
Center for Veterinary Medicine
7500 Standish Place
Rockville, MD 20855
(240) 276-9331
mailto:Joan.Gotthardt@fda.hhs.gov

CVM Updates/FDA News

Laws/Regulations 

Federal Register Notices

  • Proposed Rule - Docket No. 2008N-0011, CVM 200775. Defining Small Number of Animals for Minor Use Designation. Pages 14411-14417 [FR Doc. E8-05385] March 18, 2008 [TXT] [PDF] [PRE-PUB] Comments due July 16, 2008

  • Final Rule - Docket No. 2006N-0067, CVM 200710. Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. Pages 69108-69131 [FR Doc. E7-23580] December 6, 2007 [TXT] [PDF] [PRE-PUB] Effective date February 19, 2008

  • Final Rule - Docket No. 2005N-0329, CVM 200641. Designation of New Animal Drugs for Minor Uses or Minor Species. Pages 41010-41022 [FR Doc. E7-14444 ] July 26, 2007 [TXT] [PDF] [PRE-PUB] Effective date October 9, 2007

  • Docket No. 2006N-0067, CVM 200678. Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Extension of Comment Period. Pages 57892-57893 [FR Doc. E6-16208] October 2, 2006 | htm | | pdf | | Pre-Pub | Comments due December 20, 2006

  • Docket No. 2006N-0067, CVM 200537. Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. Pages 48840-48864 [FR Doc. 06-07070] August 22, 2006 | htm | | pdf | | Pre-Pub | Agency Information Collection Comments Due September 21, 2006 Comments due November 20, 2006

  • Proposed Rule - Docket No. 2005N-0329, CVM 200589. Designation of New Animal Drugs for Minor Uses or Minor Species; Reopening of the Comment Period. Page 76732 [FR Doc. 05-24512] | htm | | pdf | | Pre-Pub | Comments due January 27, 2006

  • Proposed Rule - Docket No. 2005N-0329, CVM 20053. Designation of New Animal Drugs for Minor Uses or Minor Species. Pages 56394-56409 [FR Doc. 05-19196] September 27, 2005 | htm | | pdf | Comments on document by December 12, 2005 Comments on information collection due October 27, 2005

  • CVM 200448.  International Workshop on Minor Use and Minor Species: A Global Perspective; Public Workshop.  Page  34683 [FR Doc. 04-14015] June 22, 2004 | htm | | pdf | Meeting on October 7, 2004 and October 8, 2004 

  • CVM 200198. Oxytetracycline Hydrochloride for Marking Fish; Availability of Data. Pages 46527-46528 [FR Doc. 02-17749 ] July 15, 2002 | htm | | pdf |

Freedom of Information Summary (doc)

  • Docket No. 99D-2638, CVM 2000116. Extra-Label Use of Medicated Feeds for Minor Species; Compliance Policy Guide; Availability. Pages 20469-20470 [FR Doc. 01-10164 ] April 23, 2001 | htm | | pdf |

The Guidance (pdf)

Guidance Documents - Draft and/or Final

Meetings

MUMS Drug Designations

Links to Other Minor Use Minor Species Sites


Web Page Updated by jmo - May 29, 2008, 1:50 PM ET




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