Bottles and Breastfeeding Equipment Screening Enhancement Act

— 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

— 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,

— 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