Better FDA Act of 2025

— 456 — Mandate for Leadership: The Conservative Promise abortion providers and whether better prenatal physical, mental, and social care improves infant outcomes and decreases abortion rates, especially among those who are most vulnerable. The Ensuring Accurate and Complete Abortion Data Reporting Act of 20239 would amend title XIX of the Social Security Act and Public Health Service Act to improve the CDC’s abortion reporting mechanisms by requiring states, as a condition of federal Medicaid payments for family planning services, to report streamlined variables in a timely manner. The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities. FOOD AND DRUG ADMINISTRATION (FDA) The FDA’s mission includes ensuring the safety and efficacy of drugs, biological products, and medical devices. Federal Laws That Shield Big Pharma from Competition. Because generics generally cost far less than brand-name drugs, consumers begin to save money as soon as a generic product comes on the market. The vast majority are very afford- able with 93 percent of generic products costing $20 or less. Savings would be even higher under proposals that prevent brand-name man- ufacturers from slowing down or impeding the entrance of generic products into the marketplace. Specifically, the FDA should prohibit pharmaceutical companies from purposely sitting on their legally available right to be the first to sell generic versions of their drugs. Additionally, Congress should create legal remedies for generic companies to obtain samples of brand-name products for their generic development efforts and should prohibit meritless “citizen petitions” submitted by manufacturers to delay approval of a generic competitor.10 Approval Process for Laboratory-Developed or Modified Medical Tests. Learning from the failed early COVID-19 testing experience, Congress and the FDA should focus on reforming laws and regulations governing medical tests, especially with respect to laboratory-developed tests. Commercial tests are developed with the intention of being widely marketed, distributed, and used, while laboratory-developed tests are created with the intention of being used solely within one laboratory. A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a “new” laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlab- oratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories with- out the current regulatory burdens.11 — 457 — Department of Health and Human Services The “laboratory-developed tests” category currently encompasses a range of possible tests, many of which would be characterized more appropriately as “lab- oratory-modified tests” because they are not truly novel tests but rather modified versions of existing tests. To avoid stifling innovation and access to medical care, the applicable statutes and regulations should be revised to facilitate greater access to such modified tests.12 Finally, the FDA has long held that it has regulatory authority over such tests, while others have argued that they should be considered clinical services regulated by the Centers for Medicare and Medicaid Services (CMS). The FDA currently has regulatory authority over in vitro diagnostics, and under the Clinical Lab- oratory Improvement Amendments (CLIA),13 the CMS ensures that labs meet analytical validity standards for test methods. Congress, the FDA, and the CMS need to clarify and disentangle overlapping authorities over tests to eliminate regulatory confusion.14 Drug Shortages. The very thin profit margins and the regulatory burdens associated with generic drug manufacturing discourage inventory and capacity investments by manufacturers and contribute to drug shortages. HHS and the FDA should encourage more dependable generic drug manufacturing. The FDA should expand its current pass/fail approach to drug facility inspec- tions into a graded system that recognizes manufacturers that exceed minimum standards by investing in improving production reliability. The FDA should also add facility codes to drug packaging and construct a searchable database that cross-references product codes and facility codes. That would enable wholesalers and pharmacy benefit managers to identify and preference drugs manufactured at more reliable facilities, thus encouraging generic drug manufacturers to compete on reliability as well as on price. For its part, HHS should exempt multi-source generic drugs from requirements to pay rebates to Medicaid and other federally funded health programs, as those provisions penalize new investments in expanding manufacturing capacity when supply is unable to meet demand.15 Additionally, FDA and NIH should promote efficacy trials of new applications for generic drugs, which might include NIH fund- ing such trials or conducting its own. Abortion Pills. Abortion pills pose the single greatest threat to unborn chil- dren in a post-Roe world. The rate of chemical abortion in the U.S. has increased by more than 150 percent in the past decade; more than half of annual abortions in the U.S. are chemical rather than surgical. The abortion pill regimen is typically a two-part process. The first pill, mifepris- tone, causes the death of the unborn child by cutting off the hormone progesterone, which is required to sustain a pregnancy. The second pill, misoprostol, causes con- tractions to induce a delivery of the dead child and uterine contents, usually into a toilet at home. The abortion-pill regimen is currently approved for up to 70 days

— 315 — Department of Agriculture 79. U.S. Department of Agriculture, Food and Nutrition Service, “WIC Data Tables,” December 9, 2022, https:// www.fns.usda.gov/pd/wic-program (accessed December 16, 2022). 80. U.S. Food and Drug Administration, “Regulations and Information on the Manufacture and Distribution of Infant Formula,” May 16, 2022, https://www.fda.gov/food/infant-formula-guidance-documents-regulatory- information/regulations-and-information-manufacture-and-distribution-infant-formula (accessed December 14, 2022). 81. U.S. Department of Agriculture, Food and Nutrition Service, “History of the National School Lunch Program,” January 17, 2008, https://www.fns.usda.gov/nslp/program-history (accessed December 14, 2022). 82. U.S. Department of Agriculture, Food and Nutrition Service, “School Breakfast Program History,” July 24, 2013, https://www.fns.usda.gov/sbp/program-history (accessed December 14, 2022), and U.S. Department of Agriculture, Food and Nutrition Service, “History of the National School Lunch Program.” 83. Crystal FitzSimons, “Free School Meals for All Is the Key to Supporting Education and Health Outcomes,” Journal of Policy Analysis and Management, Vol 41, No. 1 (2022), pp. 358–364, https://econpapers.repec.org/ article/wlyjpamgt/v_3a41_3ay_3a2022_3ai_3a1_3ap_3a358-364.htm (accessed December 14, 2022). 84. Jonathan Butcher and Vijay Menon, “Returning to the Intent of Government School Meals: Helping Students in Need,” Heritage Foundation Backgrounder No. 3399, March 22, 2019, https://www.heritage.org/sites/ default/files/2019-03/BG3399.pdf. 85. Daren Bakst and Jonathan Butcher, “A Critical Fix to the Federal Overreach on School Meals,” Heritage Foundation Issue Brief No. 4976, July 11, 2019, https://www.heritage.org/hunger-and-food-programs/report/ critical-fix-the-federal-overreach-school-meals. 86. Ibid., and U.S. Department of Agriculture, Food and Nutrition Service, “Community Eligibility Provision,” April 19, 2019, https://www.fns.usda.gov/cn/community-eligibility-provision (accessed December 16, 2022). 87. See Payment Accuracy, https://www.paymentaccuracy.gov/ (accessed December 16, 2022). 88. Payment Accuracy, “Payment Integrity Scorecard,” https://www.cfo.gov/wp-content/uploads/2022/Q3/ FNS%20National%20School%20Lunch%20Program%20(NSLP)%20Payments%20Integrity%20Scorecard%20 FY%202022%20Q3.pdf (accessed December 14, 2022). 89. U.S. Government Accountability Office, “School Meals Programs: USDA Has Reported Taking Some Steps to Reduce Improper Payments But Should Comprehensively Assess Fraud Risks,” GAO–19–389, May 21, 2022, https://www.gao.gov/products/gao-19-389 (accessed December 14, 2022). 90. Payment Accuracy, “Payment Integrity Scorecard.” 91. White House, “Fact Sheet: The American Families Plan,” April 28, 2021, https://www.whitehouse.gov/ briefing-room/statements-releases/2021/04/28/fact-sheet-the-american-families-plan/ (accessed December 14, 2022). 92. Universal School Meals Program Act of 2021, S. 1530, 117th Cong., 1st Sess., https://www.congress.gov/ bill/117th-congress/senate-bill/1530 (accessed December 14, 2022). 93. See, for example, U.S. Department of Agriculture, “Find Meals for Kids When Schools Are Closed,” Food and Nutrition Service, September 22, 2022, https://www.fns.usda.gov/meals4kids (accessed December 16, 2022), and U.S. Department of Agriculture, Food and Nutrition Service, “Seamless Summer and Other Options for School,” July 16, 2013, https://www.fns.usda.gov/sfsp/seamless-summer-and-other-options-schools (accessed December 16, 2022). 94. Tom Driscoll, “From the Field: Farmers Are the Original Conservationists,” National Farmers Union, August 30, 2017, https://nfu.org/2017/08/30/from-the-field-farmers-are-the-original-conservationists/ (accessed December 16, 2022). 95. U.S. Department of Agriculture, Farm Service Agency, “Conservation Programs,” https://www.fsa.usda.gov/ programs-and-services/conservation-programs/index (accessed December 16, 2022), and U.S. Department of Agriculture, Natural Resources Conservation Service, “Programs and Initiatives,” https://www.nrcs.usda.gov/ programs-initiatives (accessed December 16, 2022). 96. U.S. Department of Agriculture, Farm Service Agency, “Conservation Reserve Program: About the Conservation Reserve Program (CRP),” https://www.fsa.usda.gov/programs-and-services/conservation- programs/conservation-reserve-program/ (accessed December 16, 2022). — 316 — Mandate for Leadership: The Conservative Promise 97. American Bakers Association et al., letter to U.S. Department of Agriculture Secretary Tom Vilsack, March 23, 2022, https://www.dropbox.com/s/yfyv04ilkom11zd/USDA%20Letter%20to%20Secretary%20Vilsack%20on%20 Tools%20to%20Address%20Global%20Commodity%20Supply%20Challenges%203.23.22_.pdf?dl=0 (accessed December 15, 2022). It is also necessary to increase food production to mitigate high food inflation. Approximately 25 percent of idled land is considered prime farmland. Therefore, one-quarter of idled land is merely idling, not producing food—and this does not include other land that may viably be used for food production. The Conservation Reserve Program should be eliminated. There are also two issues connected to property rights and fairness that should be addressed: challenging NRCS determinations and problems with USDA easements. To be eligible for many USDA programs, farmers must comply with certain conservation provisions enforced by NRCS. Conservation compliance of wetlands and highly erodible lands consist of federal restrictions that prevent farmers from using parts of their property. If farmers plant crops or modify the areas federal officials deem protected, farmers can lose all access to USDA programs and support. For farmers, there are real, practical concerns to challenging NRCS determinations, including the time and costs of challenging the federal bureaucracy. NRCS is empowered to declare areas wetlands and highly erodible areas, which are therefore off limits for farming. If these wetland-or-erodible-declared areas are used in a manner deemed unacceptable by federal officials, NRCS may revoke access to federal resources and subsidies by making technical determinations that carry potential penalties. There must be a fair and reasonable process for farmers to challenge such actions. See Daren Bakst, “Food Price Inflation Continues to Worsen. Here’s What Should Be Done About It,” The Daily Signal, April 25, 2022, https:// www.dailysignal.com/2022/04/25/food-price-inflation-continuing-to-worsen-heres-what-should-be-done- about-it/ (accessed December 15, 2022); American Bakers Association et.al., letter to Vilsack; U.S. Department of Agriculture, Natural Resources Conservation Service, “Conservation Compliance Appeals Process,” https://www. nrcs.usda.gov/getting-assistance/compliance/conservation-compliance-appeals-process (accessed December 15, 2022); and Chris Bennett, “Regulatory Hell: Farmer and Veteran Wins 10-Year Wetlands Fight With Government,” AG Web, August 30, 2021, https://www.agweb.com/news/crops/crop-production/regulatory-hell-farmer-and- veteran-wins-10-year-wetlands-fight (accessed December 15, 2022). 98. Fortunately, there are already resources available to help states establish their own wetlands conservation programs. One particular example, the American Legislative Exchange Council’s Wetlands Mapping and Protection Act model policy, is available for states to define the procedures, guidelines, and administration of wetlands programs. American Legislative Exchange Council, “Wetlands Mapping and Protection Act,” November 16, 2017, https://alec.org/model-policy/wetlands-mapping-and-protection-act/ (accessed December 16, 2022). The new Administration should focus on best practices instead of imposing prescriptive federal practices. It should support the policies contained within the “NRCS Wetland Compliance and Appeals Reform Act” and modify NRCS compliance rules to protect farmers and ranchers by adding protections against regulatory overreach—such as banning the practice of re-engaging farmers in new technical determinations appeals processes for the same areas of their farms. See NRCS Wetland Compliance and Appeals Reform Act, S. 4931, 117th Cong., 2nd Sess., https://www.congress.gov/bill/117th-congress/senate-bill/4931?s=1&r=8 (accessed December 15, 2022). 99. Ibid 100. See, for example, Daren Bakst and Jeremy Dalrymple, “Reducing Federal Barriers for the Sale of Meat,” Heritage Foundation Issue Brief No. 5078, June 1, 2020, https://www.heritage.org/agriculture/report/ reducing-federal-barriers-the-sale-meat, and U.S. Department of Agriculture, Food Safety and Inspection Service, “State Inspection Programs,” updated January 12, 2023, https://www.fsis.usda.gov/inspection/state- inspection-programs (accessed December 15, 2022). 101. U.S. Department of Agriculture, Food Safety and Inspection Service, “Cooperative Interstate Shipping Program,” September 7, 2022, https://www.fsis.usda.gov/inspection/state-inspection-programs/cooperative- interstate-shipping-program (accessed December 15, 2022). 102. U.S. Department of Agriculture, “State Inspection Programs.” 103. The Senate bill removes obstacles for both meat and poultry. The House version does not appear to cover poultry. New Markets for State-Inspected Meat and Poultry Act of 2021, S. 107, 117th Cong., 1st Sess., https:// www.congress.gov/bill/117th-congress/senate-bill/107#:~:text=This%20bill%20allows%20meat%20and,be%20 sold%20in%20interstate%20commerce (accessed December 15, 2022), and Expanding Markets for State- Inspected Meat Processors Act of 2021, H.R. 1998, 117th Cong., 1st Sess., https://www.congress.gov/bill/117th- congress/house-bill/1998 (accessed December 15, 2022).

— 309 — Department of Agriculture Eliminate or Reform the Dietary Guidelines. The USDA, in collaboration with HHS, publishes the Dietary Guidelines every five years.125 For more than 40 years, the federal government has been releasing Dietary Guidelines,126 and during this time, there has been constant controversy due to questionable recommenda- tions and claims regarding the politicization of the process. In the 2015 Dietary Guidelines process, the influential Dietary Guidelines Advi- sory Committee veered off mission and attempted to persuade the USDA and HHS to adopt nutritional advice that focused not just on human health, but the health of the planet.127 Issues such as climate change and sustainability infiltrated the process. Fortunately, the 2020 process did not get diverted in this manner. How- ever, the Dietary Guidelines remain a potential tool to influence dietary choices to achieve objectives unrelated to the nutritional and dietary well-being of Americans. There is no shortage of private sector dietary advice for the public, and nutrition and dietary choices are best left to individuals to address their personal needs. This includes working with their own health professionals. As it is, there is constantly changing advice provided by the government, with insufficient qualifications on the advice, oversimplification to the point of miscommunicating important points, questionable use of science, and potential political influence. The Dietary Guidelines have a major impact because they not only can influence how private health providers offer nutritional advice, but they also inform federal programs. School meals are required to be consistent with the guidelines.128 The next Administration should: l Work with lawmakers to repeal the Dietary Guidelines. The USDA should help lead an effort to repeal the Dietary Guidelines. l Minimally, the next Administration should reform the Dietary Guidelines. The USDA, with HHS, should develop a more transparent process that properly considers the underlying science and does not overstate its findings. It should also ensure that the Dietary Guidelines focus on nutritional issues and do not veer off-mission by focusing on unrelated issues, such as the environment, that have nothing to do with nutritional advice. In fact, if environmental concerns supersede or water down recommendations for human nutritional advice, the public would be receiving misleading health information. The USDA, working with lawmakers, should codify these reforms into law. ORGANIZATIONAL ISSUES Based on the recommended reforms identified as ideal solutions, the USDA would look different in many respects. One of the biggest changes would be a USDA that is not focused on welfare, given that means-tested welfare programs would — 310 — Mandate for Leadership: The Conservative Promise be moved to HHS. The Food and Nutrition Service that administers the food and nutrition programs would be eliminated. The Farm Service Agency, which administers many of the farm subsidy pro- grams, would be significantly smaller in size if the ideal farm subsidy reforms were adopted. Most important, a conservative USDA, as envisioned, would not be used as a governmental tool to transform the nation’s food system, but instead would respect the importance of efficient agricultural production and ensure that the government does not hinder farmers and ranchers from producing an abundant supply of safe and affordable food. For a conservative USDA to become a reality, and for it to stay on course with the mission as outlined, the White House must strongly support these reforms and install strong USDA leaders. These individuals almost certainly will be faced with opposition from some in the agricultural community who would fight changing subsidies in any fashion, although many of the reforms would likely be embraced by those in agriculture. There would be strong opposition from environmental groups and others who want the federal government to transform American agriculture to meet their ideo- logical objectives. Finally, there would be opposition from left-of-center groups who do not want to reform SNAP and would expand welfare and dependency—such as through universal free school meals—as opposed to reducing dependency. Reducing the scope of government and promoting individual freedom may not always be easy, but it is something that conservatives regularly should strive for. The listed reforms to the U.S. Department of Agriculture would help to accom- plish these objectives and are well worth fighting for to achieve a freer and more prosperous nation. CONCLUSION This chapter started with a discussion of the incredible success of American farmers and American agriculture in general. This is how the chapter should close as well. Americans are blessed with an agricultural sector, and a food system in general, which are worthy of incredible respect. A conservative USDA should appreciate this while recognizing that its role is to serve the interests of all Amer- icans, not special interests. By being a champion of unleashing the potential of American agriculture, a conservative USDA would help to ensure a future with an abundant supply of safe and affordable food for individuals and families in the United States and across the globe. AUTHOR’S NOTE: The author would like to thank all the contributors for their assistance, expertise, and insight into the development of this chapter. In addition, special thanks are due to Rachael Wilfong, who was instrumental in getting the chapter ready for submission.