{"database": "press", "table": "releases", "rows": [["https://www.paul.senate.gov/news-congress-passes-dr-rand-pauls-reform-improve-fdas-approval-process/", "Congress Passes Dr. Rand Paul\u2019s Reform to Improve the FDA\u2019s Approval Process", "2018-08-01", "2018", "2018-08", "Republican", "Senate", "KY", "Rand Paul", "P000603", "www.paul.senate.gov", "paul", "https://www.paul.senate.gov/news/", "scraper", "FOR IMMEDIATE RELEASE:\n\nAugust 1, 2018\n\nContact: Press@paul.senate.gov, 202-224-4343\n\nWASHINGTON, D.C. \u2013 Today, U.S. Senator Rand Paul (R-KY) applauded the U.S. Congress for bringing greater efficiency to the Food and Drug Administration\u2019s 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\u2019s proposal securing the policy change.\n\n\u201cI am pleased to see Congress address Kentuckians\u2019 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\u2019s farmers and manufacturers are not kept in the dark on the submission and approval process for their food-additive petitions,\u201d said Dr. Paul.\n\nDr. Paul\u2019s 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.\n\nIt 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.\n\nThe 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.\n\nYou can find more information on the issue and Dr. Paul\u2019s reform below:\n\nBackground:\n\n\u2022 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).\n\n\u2022 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 (\u201cwhite papers\u201d), and the submission of proposed frameworks or \u201cprotocols\u201d for animal studies.\n\n\u2022 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 \u201cingredient standards and definitions with respect to pet food.\u201d To date, the FDA has not issued these regulations because of their conflicting nature with the FDA\u2019s 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\u2019s 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.\n\nSummary of Dr. Paul\u2019s Reform:\n\n\u2022 Requires the Secretary to review, if submitted by the petitioner, data from studies conducted in foreign countries.\n\n\u2022 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.\n\n\u2022 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.\n\n\u2022 Strikes FDAAA section 1002(a)(1), which requires the FDA to issue regulations establishing \u201cstandards and definitions with respect to pet food,\u201d due to its conflicting nature with the FFDCA and to address the uncertainty it causes for the FDA/AAFCO relationship.\n\n\u2022 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.\n\n###", 1, "2026-03-30T01:40:41Z", "2026-06-27T23:04:48Z"]], "columns": ["url", "title", "date", "year", "month", "party", "chamber", "state", "member_name", "bioguide_id", "domain", "scraper", "source", "date_source", "text", "has_text", "collected_at", "updated_at"], "primary_keys": ["url"], "primary_key_values": ["https://www.paul.senate.gov/news-congress-passes-dr-rand-pauls-reform-improve-fdas-approval-process/"], "units": {}, "query_ms": 1.5380908735096455, "source": "dwillis/congress-press", "source_url": "https://github.com/dwillis/congress-press", "license": "MIT", "license_url": "https://github.com/dwillis/congress-press/blob/main/LICENSE"}