Advocacy in action

Getting results from regulatory agencies: Is it possible?

Perhaps a more pertinent question is, can the AASV impact regulatory decisions? Or, more bluntly stated, can a group of 1500 members with a small staff and limited budget and resources affect United States policy and regulations?

Not only can the AASV positively affect the outcome of regulatory decisions, it has. Historically, the AASV has positively influenced the outcome of regulatory decisions on many issues. Swine veterinarians benefit every day from these successes. For example, what would practice be like without the ability to prescribe extra-label drug use for medicated early weaning and segregated early weaning of pigs to avoid morbidity or death loss that may occur before clinical signs appear? The AASV successfully advocated for such appropriate preventive extra-label use during the FDA's proposed rulemaking process for the Animal Medicinal Drug Use Clarification Act (AMDUCA).

The Veterinary Feed Directive (VFD) is a category of veterinary drugs that was advocated for and led by the AASV as an alternative to a prescription-only status that was originally discussed by the FDA. Inclusion of the VFD category ushered in another avenue of drug approvals that led to a new veterinary feed additive for swine.

There are other examples of the AASV's impact on the regulatory process. Granted, some are less visible in terms of impact, but no less important to swine veterinarians.

Adopt a David-versus-Goliath mentality

How does a small association make an impact on regulatory decisions? The AASV's success is related to its characteristics as a whole. Those attributes are passion for the profession, healthy ability to question authority, rebel-with-a-cause attitude, innovative problem-solving skills, tenacity, and persuasiveness. With issues that have been around so long they are called "career" issues, the high dose of energy and enthusiasm of swine veterinarians is an added bonus.

Missed opportunities are worse than no opportunities

However, those attributes are worthless if the AASV chooses to sit on the sidelines. There's a joke about a person who tells everyone he wants to win the lottery, but he never buys a lottery ticket. The AASV must be involved in the decision-making process to have any expectation of having an impact.

There are plenty of opportunities to be a player regarding regulatory issues. In the fiscal year ending September 30, 2003, the FDA Center for Veterinary Medicine requested public comments on 14 documents. Those documents included an advance notice of proposed rulemaking, proposed rules, draft guidance documents, and food additive petitions. The AASV drafts and submits comments to the appropriate federal agency when the proposals will affect swine veterinarians. AASV members can substantially help the collective effort by submitting comments individually.

The AASV and its members are stakeholders from whom governmental agencies must solicit opinions and feedback. Requests for comments, proposed agency rules, and new regulations are published in the Federal Register. These notices are required to provide contact names and telephone numbers and information about how to submit comments, including deadlines for comments. Written comments from stakeholders who explain why they care about the issue and how they will be affected are encouraged and considered by the agencies.

AASV members can increase the impact of their comments by forwarding them, when appropriate, to their elected officials who, in turn, may decide to write a letter to the agency as well. Although government agencies are independent agencies, Congress still creates them, oversees how they address public policy, and determines their budgets. The FDA's Center for Veterinary Medicine received 10 inquiries from Congress during the fiscal period ending September 30, 2003. Some agencies receive thousands of Congressional inquiries a year; in some cases, Congress is the most frequent pen pal of some federal agencies. It's not unusual for elected officials to take up a cause at the request of a constituent.

Answer the call

The AASV anticipates asking members to submit comments in the future. The AASV office would provide members with background on the issue and details on how to submit comments. Members can substantially add to the AASV's formal comments by providing their individual comments. Take the opportunity!