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Aquaculture NADA Coordinator

Special News

July 26. 2004

MUMS Legislation Passes

The MUMS legislation was passed by the House of Representatives on June 20. After a fairly short process in which the legislation is put in a form suitable for a presidential signature, it is enrolled and sent to Executive Records where it will go to President Bush for his signature.

While the MUMS legislation created several new incentives, most prominent are the conditional drug approval and the index of legally marketed unapproved drugs (drug index). Each has certain advantages and limitations. Additional incentives include safeguards that have been created to protect existing New Animal Drug Approvals (NADA) from unwarranted scrutiny should a pharmaceutical company attempt to supplement the existing approval to address minor animal species or minor uses. The legislation also creates a new approach to facilitating drug development through a designated new animal drug classification system. Designated new animal drugs are eligible for grants for safety and efficacy testing, and for manufacturing process development. Designated drugs are also eligible for an exclusive seven year marketing time period. A new Office of Minor Use and Minor Animal Species Drug Development is created whose mission is to issue the grants, determine eligibility for listing on the drug index and for serving as a liaison amongst government agencies to improve opportunity for drug approvals.

The MUMS Coalition, chaired by NAA President Dr. Randy MacMillan, working together, particularly with the FDA-CVM as technical advisors and key congressional sponsors (Senator Sessions and Congressman Pickering), were able to amend the Federal Food, Drug, and Cosmetic Act in a way never before accomplished. The Coalition's effort was to provide incentives for pharmaceutical companies to devote resources for drug development for minor animal species and minor uses in major species. With the passage of the MUMS legislation, there is strong reason to believe the effort was successful.