Congress Passes Dr. Rand Paul’s Reform to Improve the FDA’s Approval Process | Senator Rand Paul


FOR IMMEDIATE RELEASE:
August 1, 2018
 Contact: Press@paul.senate.gov, 202-224-4343

WASHINGTON, D.C. – Today, U.S. Senator Rand Paul (R-KY) applauded the U.S. Congress for bringing greater efficiency to the Food and Drug Administration’s approval process for animal food additives and helping provide more certainty to the animal food manufacturing industry regarding the rules they have to follow, as the U.S. Senate passed H.R. 5554, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, on Tuesday, which included Dr. Paul’s proposal securing the policy change.  

“I am pleased to see Congress address Kentuckians’ concerns by passing a reform that will help reduce unnecessary bureaucratic delays, increase the amount of information the FDA takes into consideration on animal food additives, and ensure Kentucky’s farmers and manufacturers are not kept in the dark on the submission and approval process for their food-additive petitions,” said Dr. Paul.
 
Dr. Paul’s reform, which he introduced after hearing about this issue from a Kentucky company, requires the FDA to consider data from studies conducted in other countries when a company submits those studies as part of their food additive petition. 
 
It also requires the FDA to provide a scientific rationale for why additional studies would be needed to supplement the data companies have already submitted, and it would repeal 2007 language that brings uncertainty to the long-standing relationship between state-based feed regulators and the FDA.

The proposal passed the Senate Health, Education, Labor, and Pensions (HELP) Committee in February as an amendment to the Senate version of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 and was subsequently included in the House legislation.
  
You can find more information on the issue and Dr. Paul’s reform below: 
 
Background:
 
•    Currently, the law requires that any substance that is added to or is expected to become a component of animal food, either directly or indirectly, must be used in accordance with a food additive petition, unless it is generally recognized as safe (GRAS).
 
•    While there is a statutory deadline of 90 days for the FDA to approve or deny the petition, the industry reports that many food additive petitions take between three and five years to reach completion, due in part to a lengthy pre-submission process. This process can consist of meetings and calls between the petitioner and the FDA, the submission of preliminary data packages (“white papers”), and the submission of proposed frameworks or “protocols” for animal studies.
 
•    In response to a serious pet food contamination and recall, Congress passed language in the Food and Drug Administration Amendments Act (FDAAA) of 2007 requiring the FDA to establish “ingredient standards and definitions with respect to pet food.” To date, the FDA has not issued these regulations because of their conflicting nature with the FDA’s responsibilities for food additive petitions under section 409 of the United States Federal Food, Drug, and Cosmetic Act (FFDCA). Furthermore, this language has called into question FDA’s longstanding relationship with the Association of American Feed Control Officials (AAFCO), a voluntary membership association that maintains a published list of animal food ingredient definitions. 
 
Summary of Dr. Paul’s Reform:
 
•    Requires the Secretary to review, if submitted by the petitioner, data from studies conducted in foreign countries.
 
•    Requires the FDA to post the following information on its website: the number of petitions for animal food additives that are pending, and how long those petitions have been pending, as well as the number of animal study protocol proposals that have been pending for over 50 days, and those that have received an extension.
 
•    Requires FDA to provide petitioners with information on the required contents of the petition. If they require additional studies beyond what the petitioner has proposed, the FDA must provide a scientific rational for that requirement.
 
•    Strikes FDAAA section 1002(a)(1), which requires the FDA to issue regulations establishing “standards and definitions with respect to pet food,” due to its conflicting nature with the FFDCA and to address the uncertainty it causes for the FDA/AAFCO relationship.
 
•    Requires the issuance of guidance, within 18 months, to include the recommended format for submission of existing data related to animal food additives, including foreign data, the number of days in which the FDA will respond to such data, circumstances under which the submission of study protocols are recommended, how the FDA will inform the person submitting those protocols if the review will take longer than 50 days, and best practices for communication between the FDA and industry on the development of pre-submission data packages. 
 

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