To require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.

— 452 — Mandate for Leadership: The Conservative Promise Unaccountable bureaucrats like Anthony Fauci should never again have such broad, unchecked power to issue health “guidelines” that will certainly be the basis for federal and state mandates. Never again should public health bureaucrats be allowed to hide information, ignore information, or mislead the public concerning the efficacy or dangers associated with any recommended health interventions because they believe it may lead to hesitancy on the part of the public. The only way to restore public trust in HHS as an institution capable of acting responsibly during a health emergency is through the best of disinfectants—light. Goal #5: Instituting Greater Transparency, Accountability, and Over- sight. The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomer- ates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest. All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from pri- vate biopharmaceutical funding. In this realm, “public–private partnerships” is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight. We must shut and lock the revolving door between government and Big Pharma. Regulators should have a long “cooling off period” on their contracts (15 years would not be too long) that prevents them from working for companies they have regulated. Similarly, pharmaceutical company executives should be restricted from moving from industry into positions within regulatory agencies. Finally, HHS should adopt metrics across the agency that can objectively deter- mine the extent to which the agency’s policies and programs achieve desired health and welfare outcomes (not agency outputs). What is not measured is not achieved. CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) COVID and Structural Reform. COVID-19 exposed the Centers for Disease Control and Prevention (CDC) as perhaps the most incompetent and arrogant agency in the federal government. CDC continually misjudged COVID-19, from its lethality, transmissibility, and origins to treatments. We were told masks were not needed; then they were made mandatory. CDC botched the development of COVID tests when they were needed most. When it was too late, we were told to put our lives on hold for “two weeks to flatten the curve;” that turned into two years of interference and restrictions on the smallest details of our lives. Congress should ensure that CDC’s legal authorities are clearly defined and limited to prevent a recurrence of any such arbitrary and vacillating exercise of power. The CDC should be split into two separate entities housing its two distinct func- tions. On the one hand, the CDC is now responsible for collecting, synthesizing, — 453 — Department of Health and Human Services and publishing epidemiological data from the individual states—a scientific data-gathering function. This information is crucial for medical and public health researchers around the country. On the other hand, the CDC is also responsible for making public health recommendations and policies—an inescapably political function. At times, these two functions are in tension or clear conflict. In February 2022, for example, it was reported that “[t]wo full years into the pandemic, the agency leading the country’s response to the public health emergency has pub- lished only a tiny fraction of the data it has collected,” much of which “could [have helped] state and local health officials better target their efforts to bring the virus under control.” A CDC spokesman said that one of the reasons was “fear that the information might be misinterpreted.”4 These distinct functions should be separated into two entirely separate agen- cies with a firewall between them. We need a national epidemiological agency responsible only for publishing data and required by law to publish all of the data gathered from states and other sources. A separate agency should be responsible for public health with a severely confined ability to make policy recommendations. The CDC can and should make assessments as to the health costs and benefits of health interventions, but it has limited to no capacity to measure the social costs or benefits they may entail. For example, how much risk mitigation is worth the price of shutting down churches on the holiest day of the Christian calendar and far beyond as happened in 2020? What is the proper balance of lives saved versus souls saved? The CDC has no business making such inherently political (and often unconstitutional) assessments and should be required by law to stay in its lane. The CDC’s initial COVID-19 testing failures were largely the result of that agen- cy’s prioritizing its own development and production of tests using its internal staff and facilities. The private sector is much better positioned to tackle the chal- lenges inherent in developing and manufacturing novel products, as illustrated by the relative success of the alternative approach to facilitating the development of COVID-19 vaccines and therapeutics by private companies that was adopted by the Food and Drug Administration (FDA). When it comes to testing, the CDC’s role should similarly be to facilitate rather than supplant the efforts of private test developers, academic laboratories, state public health laboratories, and clinical testing providers. When responding to a novel pathogen, the CDC should focus on gathering and disseminating information, including specimens needed for development of positive controls and reference panels, and ensuring that test developers can develop and validate diagnostic tests. These changes will require a shift in priorities and culture at the CDC—and throughout HHS more broadly.5 Most problematically, the CDC presented itself as a kind of “super-doctor” for the entire nation. The CDC is a public health institution, not a medical institution. According to its mission statement, the agency focuses on “disease prevention and

— 452 — Mandate for Leadership: The Conservative Promise Unaccountable bureaucrats like Anthony Fauci should never again have such broad, unchecked power to issue health “guidelines” that will certainly be the basis for federal and state mandates. Never again should public health bureaucrats be allowed to hide information, ignore information, or mislead the public concerning the efficacy or dangers associated with any recommended health interventions because they believe it may lead to hesitancy on the part of the public. The only way to restore public trust in HHS as an institution capable of acting responsibly during a health emergency is through the best of disinfectants—light. Goal #5: Instituting Greater Transparency, Accountability, and Over- sight. The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomer- ates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest. All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from pri- vate biopharmaceutical funding. In this realm, “public–private partnerships” is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight. We must shut and lock the revolving door between government and Big Pharma. Regulators should have a long “cooling off period” on their contracts (15 years would not be too long) that prevents them from working for companies they have regulated. Similarly, pharmaceutical company executives should be restricted from moving from industry into positions within regulatory agencies. Finally, HHS should adopt metrics across the agency that can objectively deter- mine the extent to which the agency’s policies and programs achieve desired health and welfare outcomes (not agency outputs). What is not measured is not achieved. CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) COVID and Structural Reform. COVID-19 exposed the Centers for Disease Control and Prevention (CDC) as perhaps the most incompetent and arrogant agency in the federal government. CDC continually misjudged COVID-19, from its lethality, transmissibility, and origins to treatments. We were told masks were not needed; then they were made mandatory. CDC botched the development of COVID tests when they were needed most. When it was too late, we were told to put our lives on hold for “two weeks to flatten the curve;” that turned into two years of interference and restrictions on the smallest details of our lives. Congress should ensure that CDC’s legal authorities are clearly defined and limited to prevent a recurrence of any such arbitrary and vacillating exercise of power. The CDC should be split into two separate entities housing its two distinct func- tions. On the one hand, the CDC is now responsible for collecting, synthesizing,

— 438 — Mandate for Leadership: The Conservative Promise and their membership has too often been handpicked to achieve certain politi- cal positions. In the Biden Administration, key EPA advisory committees were purged of balanced perspectives, geographic diversity, important regulatory and private-sector experience, and state, local, and tribal expertise. Contrary to con- gressional directives and recommendations from the GAO and intergovernmental associations, these moves eviscerated historic levels of participation on key com- mittees by state, local, and tribal members from 2017 to 2020. As a result, a variety of EPA regulations lack relevant scientific perspectives, increasing the risks of economic fallout and a failure of cooperative federalism. EPA also has repeatedly disregarded legal requirements regarding the role of these advisory committees and the scope of scientific advice on key regulations.46 Needed Science Policy Reforms Instead of allowing these efforts to be misused for scaremongering risk com- munications and enforcement activities, EPA should embrace so-called citizen science and deputize the public to subject the agency’s science to greater scrutiny, especially in areas of data analysis, identification of scientific flaws, and research misconduct. In addition, EPA should: l Shift responsibility for evaluating misconduct away from its Office of Scientific Integrity, which has been overseen by environmental activists, and toward an independent body. l Work (including with Congress) to provide incentives similar to those under the False Claims Act47 for the public to identify scientific flaws and research misconduct, thereby saving taxpayers from having to bear the costs involved in expending unnecessary resources. l Avoid proprietary, black box models for key regulations. Nearly all major EPA regulations are based on nontransparent models for which the public lacks access or for which significant costs prevent the public from understanding agency analysis. l Reject precautionary default models and uncertainty factors. In the face of uncertainty around associations between certain pollutants and health or welfare endpoints, EPA’s heavy reliance on default assumptions like its low-dose, linear non-threshold model bake orders of magnitude of risk into key regulatory inputs and drive flawed and opaque decisions. Given the disproportionate economic impacts of top-down solutions, EPA should implement an approach that defaults to less restrictive regulatory outcomes. — 439 — Environmental Protection Agency l Refocus its research activities on accountable real-world examinations of the efficacy of its regulations with a heavy emphasis on characterizing and better understanding natural, background, international, and anthropogenic contributions for key pollutants. It should embrace concepts laid out in the 2018 “Back-to-Basics Process for Reviewing National Ambient Air Quality Standards” memo48 to ensure that any science and risk assessment for the NAAQS matches congressional direction. Legislative Reforms While some reforms can be achieved administratively (especially in areas where EPA clearly lacks congressional authorization for its activities), Congress should prioritize several EPA science activity reforms: l Use of the Congressional Review Act for Congress to disapprove of EPA regulations and other quasi-regulatory actions and prohibit “substantially similar” actions in the future. l Reform EPA’s Science Advisory Board and other advisory bodies to ensure independence, balance, transparency, and geographic diversity. l Build on recent bipartisan proposals to increase transparency for advisory bodies, subject to the Federal Advisory Committee Act49 as well as recommendations from the Administrative Conference of the U.S., to strengthen provisions for independence, accountability, geographic diversity, turnover, and public participation. This should include a prohibition on peer review activities for unaccountable third parties that lack independence or application of these same principles to non- governmental peer review bodies (including NASEM). l Add teeth to long-standing executive orders, memoranda, recommendations, and other policies to require that EPA regulations are based on transparent, reproducible science as well as that the data and publications resulting from taxpayer-funded activities are made immediately available to the public. l Reject funds for programs that have not been authorized by Congress (like IRIS) as well as peer review activities that have not been authorized by Congress. l Revisit and repeal or reform outdated environmental statutes. A high priority should be the repeal or reform of the Global Change Research Act of 1990,50 which has been misused for political purposes.