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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
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CVM Update - FDA Issues a Notice of Proposed Rule Making Defining Small Number of Animals for Minor Use Designation, March 18, 2008
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CVM Update - FDA Issues Final Regulations on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, December 6, 2007
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CVM Update - FDA Approves New Antimicrobial for Salmonids for Treatment of Furunculosis, November 6, 2007
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CVM Update - FDA Publishes Final Rule on Designation of New Animal Drugs for Minor Uses or Minor Species, July 26, 2007
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CVM Update - FDA Clarifies Extra-label use of medicated feed in minor species per CPG #615.115, May 4, 2007
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CVM Update - First FDA Conditionally Approved New Animal Drug for Columnaris Disease in Catfish, April 18, 2007
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CVM Update - Environmental Considerations and Limitations for Use of Hydrogen Peroxide in Aquaculture, February 21, 2007
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CVM Update - FDA Approves New Drug for Freshwater-Reared Finfish, February 5, 2007
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CVM Update - Dr. Dunham Now Director of OMUMS and Acting CVM Deputy Director, August 23, 2006
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CVM Update - FDA Issues Proposed Regulations for MUMS Indexing, August 22, 2006
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CVM Update - FDA Approves New Antimicrobial for Catfish, October 25, 2005
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CVM Update - FDA Approves TYLAN Soluble for the Control of American Foulbrood in Honey Bees, October 20, 2005
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CVM Update - FDA Grants First Minor Use and Minor Species Drug Designations, October 6, 2005
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CVM Update - FDA Issues Proposed Regulations for MUMS Designation, September 27, 2005
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CVM Update - FDA Announces Establishment of MUMS Office and Requests Comment on MUMS Implementation, November 9, 2004
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CVM Update - New Legislation To Help Make Animal Drugs Available For Limited Uses, Minor Species, August 3, 2004
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FDA News - FDA Commends Passage by the House of Representatives of S. 741, a Bill Providing Improved Consumer Protection and Incentives for Animal Drug Development, July 21, 2004
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CVM Update - FDA Holding Workshop on Minor Use and Minor Species Drugs , June 22, 2004
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FDA News - FDA Commends Senate Passage of Bill Providing Improved Consumer Protection and Incentives for Animal Drug Development, March 8, 2004
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CVM Update - CPG on Extra-Label Use of Medicated Feeds for Minor Species Available, April 24, 2001
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CVM Update - Sheep Reclassified as Minor Species For All Data Collection Purposes, August 4, 2000
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CVM Update - FDA Holding Meeting on Establishing Resistance and Monitoring Thresholds, August 1, 2000
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CVM Update - Draft CPG On Use Of Medicated Feeds For Minor Species Available, August 26, 1999
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CVM Update - Finalized Minor Uses/Minor Species Guidance Available, February 11, 1999
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CVM Update - FDA Seeking Comments on a Discussion Draft of MUMS Proposals, December 23, 1997
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CVM Update - Minor Uses/Minor Species Draft Guidance Published, Oct. 6, 1997
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CVM Update - Request for Comments on Minor Species and Minor Uses Approval Options, June 26, 1997
Laws/Regulations
Federal Register Notices
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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
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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
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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
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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
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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
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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
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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
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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
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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)
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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