In 1968 amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act established the Animal Drugs and Feeds Program in the Food and Drug Administration (FDA). The new law extended authorities to FDA to regulate animal drugs, devices, and feed.
Animal Drugs and Feed Regulated Under 21 Different Laws
Today, the animal drug and feed industries are regulated under authorities in 21 different acts including;
- Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321-399);
- Public Health Service Act (42 U.S.C. 201, et seq.);
- Animal Drug Amendments (1968) (21 U.S.C. 360b);
- Generic Animal Drug and Patent Term Restoration Act (1988);
- Animal Medicinal Drug Use Clarification Act of 1994;
- Animal Drug Availability Act of 1996;
- FDA Export Reform and Enhancement Act of 1996;
- Food and Drug Administration Modernization Act of 1997;
- Antimicrobial Regulation Technical Corrections Act of 1998;
- Public Health Security and Bioterrorism Preparedness and Response Act of 2002;
- Animal Drug User Fee Act of 2003 (21 U.S.C. 379j-11 – 379j-12);
- Minor Use and Minor Species Animal Health Act of 2004;
- Sanitary Food Transportation Act of 2005;
- Food and Drug Administration Amendment Act of 2007;
- Animal Drug User Fee Amendments of 2008 (P.L. 110-316);
- Animal Generic Drug User Fee Act of 2008 (P.L. 110-316);
- Patient Protection and Affordable Care Act; FDA Food Safety Modernization Act (P.L. 111-353);
- FDA Safety and Innovation Act (P.L. 112-144);
- Animal Drug User Fee Reauthorization Act of 2013 (P.L. 113-14);
- Animal Generic Drug User Fee Reauthorization Act of 2013 (P.L. 113-14); and
- Drug Quality and Security Act (2013)
Combination of Congressional Appropriations & User Fees Fund FDA
- Animal Drug User Fee Act (ADUFA),
- Animal Generic Drug User Fee Act (AGDUFA), and
- FDA Export Reform and Enhancement Act (Export Certificate program).
Both the ADUFA and AGDUFA must be reauthorized in 2018!
Along with fulfilling FDA’s responsibilities to ensure that new animal drug products are safe and effective for animals and the public, user fees help FDA “..enhance the timeliness and predictability of application reviews for sustained performance.”
Below are charts showing the total annual congressional appropriations for the FDA and the breakdown in discretionary funding provided by Congress for FY’s 2013 through 2017 and the level of user fees that are anticipated to be collected in the fiscal year.
Total FDA Annual Appropriations and User Fees FY 2013-2017
Total Animal Drugs and Feed Programs FY 2013-2017
Administrative Changes in FY 2018
In their first budget request for FDA’s Animal Drugs and Feeds program, the Trump administration proposed a $43 million reduction in annual appropriations. In addition, the administration proposed to increase Animal Drugs and Feeds program user fees from $32.2 million to $75.7 million, a 135% increase. Appropriators in Congress disagreed with the Administration and will likely adopt similar level of appropriations and user fees as FY 2017 in their Agriculture, Rural Development, Food and Drug Administration and Related Agencies appropriations bill for FY 2018.
Earlier this year as part of a broader agency realignment, FDA‘s Office of Regulatory Affairs (ORA) began implementing a program-based management structure aligning FDA staff by regulated product. Previously, FDA management was organized by geographic regions. The FDA rationalized the realignment would “allow for better vertical integration within field offices and labs by commodity category, such as food and feed, drugs, and devices. Program alignment also offers better horizontal integration between the field and headquarters programs. Program alignment improves agency efficiency, streamlines operations, and allows better cost accounting and personnel management.”
Establishment Inspections FY 2018
In FY 2016 FDA conducted a total 5,652 inspections of establishments: 373 animal drug establishments and 5,301 animal feed establishments. In FY 2017 the Obama Administration reduced the total number of inspections to 5,572; 369 animal drug establishments and 5,235 feed establishments. The Trump Administration maintained the total number of FDA establishment inspections for FY 2018.
The breakdown of establishment inspections for FY 2018 include:
Domestic Establishment Inspections: Animal Drugs 298 Animal Feeds 1,398
Foreign Establishment Inspections: Animal Drugs 71 Animal Feeds 5
State Contract Inspections:
Bovine Spongiform Encephalopathy (BSE), 3500
Feed Manufacturers, 620
Illegal Tissue Residue, 130
Each year FDA electronically screens all import entries and performs over 100,000 analyses on thousands of import product samples. FDA also conducts physical exams on imports. For FY 2018 FDA’s goal is to conduct physical exams on 497 animal drugs and 4,165 animal feeds, about the same level as last year.
Each year FDA’s Animal Drugs and Feeds Program’s performance measures focus on pre-market animal drug application review, high risk inspections, warning letter review, and lab coordination for detections and responses. In FY 2016 FDA established a goal of completing 90% of their review and actions on new animal drug applications and reactivations received during the fiscal year within 180 days. That same fiscal year FDA completed reviews and actions on new animal drug applications with 180 days 99.8% of the time.
For FY’s 2017 and 2018 FDA is maintaining their established goal of completing 90% of their review and actions on new animal drug applications and reactivations within 180 days.
Time To Engage is Now
Already we know Congress must reauthorize both the ADUFA and AGDUFA next year! And, given federal budget constraints, the new Administration is highly likely to continue proposing shifts in funding of FDA programs that increase user fees on stakeholders. The Administration is also realigning FDA operations.
With the enormity of legislative and regulatory changes taking place in the Animal Drugs and Feeds Programs in the FDA, the time to impact policy decisions that will most certainly impact your bottom line is now. You need a solid government relations firm to help you positively impact legislative and regulatory outcomes.
At Cansler Consulting we understand successful government relations is when preparedness meets opportunity. With Cansler Consulting as your government relations firm, we can position your company to take advantage of coming opportunities as Congress prepares to reauthorize ADUFA and AGDUFA. With as much as one-third of your potential earnings at stake, it is imperative companies timely engage in government relations to minimize the impacts of government actions or inactions.