Supporting the goals and ideals of "Creutzfeldt-Jakob Disease (CJD) Awareness Day".

— 455 — Department of Health and Human Services family formation. It should ensure that it is not promoting abortion as health care. It should fund studies into the risks and complications of abortion and ensure that it corrects and does not promote misinformation regarding the comparative health and psychological benefits of childbirth versus the health and psychological risks of intentionally taking a human life through abortion. The CDC oversaw and funded the development and testing of the COVID-19 vaccines with aborted fetal cell lines, insensitive to the consciences of tens of thousands to hundreds of thousands of people who objected to taking a vac- cine with such a link to abortion. As evidenced by litigation across the country, it is likely that thousands were fired unjustly because of the exercise of their consciences or faith on this question, which could have been avoided with a modicum of concern for this issue from CDC. There is never any justification for ending a child’s life as part of research, and the research benefits from splicing or growing aborted fetal cells and aborted baby body parts can easily be provided by alternative sources. All such research should be prohibited as a matter of law and policy. CDC should update its public messaging about the unsurpassed effectiveness of modern fertility awareness–based methods (FABMs) of family planning and stop publishing communications that conflate such methods with the long-eclipsed “rhythm” or “calendar” methods. CDC should fund studies exploring the evi- dence-based methods used in cutting-edge fertility awareness. Data Collection. The CDC’s abortion surveillance and maternity mortality reporting systems are woefully inadequate. CDC abortion data are reported by states on a voluntary basis, and California, Maryland, and New Hampshire do not submit abortion data at all. Accurate and reliable statistical data about abortion, abortion survivors, and abortion-related maternal deaths are essential to timely, reliable public health and policy analysis. Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion. Moreover, abortion should be clearly defined as only those procedures that intentionally end an unborn child’s life. Miscarriage management or standard ectopic pregnancy treatments should never be conflated with abortion. Comparisons between live births and abortion should be tracked across vari- ous demographic indicators to assess whether certain populations are targeted by — 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

— 455 — Department of Health and Human Services family formation. It should ensure that it is not promoting abortion as health care. It should fund studies into the risks and complications of abortion and ensure that it corrects and does not promote misinformation regarding the comparative health and psychological benefits of childbirth versus the health and psychological risks of intentionally taking a human life through abortion. The CDC oversaw and funded the development and testing of the COVID-19 vaccines with aborted fetal cell lines, insensitive to the consciences of tens of thousands to hundreds of thousands of people who objected to taking a vac- cine with such a link to abortion. As evidenced by litigation across the country, it is likely that thousands were fired unjustly because of the exercise of their consciences or faith on this question, which could have been avoided with a modicum of concern for this issue from CDC. There is never any justification for ending a child’s life as part of research, and the research benefits from splicing or growing aborted fetal cells and aborted baby body parts can easily be provided by alternative sources. All such research should be prohibited as a matter of law and policy. CDC should update its public messaging about the unsurpassed effectiveness of modern fertility awareness–based methods (FABMs) of family planning and stop publishing communications that conflate such methods with the long-eclipsed “rhythm” or “calendar” methods. CDC should fund studies exploring the evi- dence-based methods used in cutting-edge fertility awareness. Data Collection. The CDC’s abortion surveillance and maternity mortality reporting systems are woefully inadequate. CDC abortion data are reported by states on a voluntary basis, and California, Maryland, and New Hampshire do not submit abortion data at all. Accurate and reliable statistical data about abortion, abortion survivors, and abortion-related maternal deaths are essential to timely, reliable public health and policy analysis. Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion. Moreover, abortion should be clearly defined as only those procedures that intentionally end an unborn child’s life. Miscarriage management or standard ectopic pregnancy treatments should never be conflated with abortion. Comparisons between live births and abortion should be tracked across vari- ous demographic indicators to assess whether certain populations are targeted by

— 462 — Mandate for Leadership: The Conservative Promise In May 2022, documents obtained pursuant to a FOIA request revealed that NIH Director Francis Collins, NAIAD Director Anthony Fauci, and Fauci’s Deputy Director, Clifford Lane, all received royalties from pharmaceutical companies between 2009 and 2014.22 Nonprofit watchdog Open the Books estimates that from 2010 to 2020, third parties paid more than $350 million in royalties to NIH and its scientists, who are credited as coinventors. Most problematically, in the years when they received payments, Collins, Fauci, and Lane were NIH administrators, not researchers, with no plausible claim to be scientific co-discoverers. Most of the world’s other advanced science countries have stricter prohibitions on such conflicts, which helps to explain why the most significant studies on COVID treatments, on natural immunity, and on vaccine efficacy have come mostly from outside the U.S. Funding for scientific research should not be controlled by a small group of highly paid and unaccountable insiders at the NIH, many of whom stay in power for decades. The NIH monopoly on directing research should be broken. Term limits should be imposed on top career leaders at the NIH, and Congress should consider block granting NIH’s grants budget to states to fund their own scientific research. Nothing in this system would prevent several states from partnering to co-fund large research projects that require greater resources or impact larger regions. Likewise, the establishment of funding for scientific research at the state level does not preclude more modest federal funding through the National Insti- tutes of Health: The two models are not mutually exclusive. The CDC and NIH Foundations, whose boards are populated with pharma- ceutical company executives, need to be decommissioned. Private donations to these foundations—a majority of them from pharmaceutical companies—should not be permitted to influence government decisions about research funding or public health policy. Woke Policies. Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a cer- tain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished. NIH has been at the forefront in pushing junk gender science. Instead, it should fund studies into the short-term and long-term negative effects of cross- sex interventions, including “affirmation,” puberty blockers, cross-sex hormones and surgeries, and the likelihood of desistence if young people are given counseling that does not include medical or social interventions. CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS) With the goal of being a societal safety net, Medicare and Medicaid touch more American lives than does any other federal program. While they help many, they — 463 — Department of Health and Human Services operate as runaway entitlements that stifle medical innovation, encourage fraud, and impede cost containment, in addition to which their fiscal future is in peril. Both programs should be managed so that the individuals enrolled are empow- ered to make decisions for themselves and have quality options with affordable prices driven by competition and innovation. Providers who participate should retain (or have restored) the freedom to practice medicine and take care of their patients according to their patients’ unique needs. Medicare. Medicare should be reformed according to four goals and principles: l Increase Medicare beneficiaries’ control of their health care. Patients are best positioned to determine the value of health care services, working with their health care providers. They also benefit from increased choice of doctors, hospitals, and insurance plans. Access to reliable information with respect to physicians, hospitals, and insurers is therefore essential. l Reduce regulatory burdens on doctors. Doctors must be free to focus on treating patients first, not entering codes on computers, and should not be tempted to change their medical judgment based on arbitrary or illogical reimbursement incentives. l Ensure sustainability and value for beneficiaries and taxpayers. Prices are best for patients when determined by economic value rather than political power and when they are known in advance of the receipt of services. Government’s use of non-market-based methods to determine reimbursement leads to overspending on low-value services and products and underpayment for high-value services and products, stifles beneficial innovation, and because of Medicare’s size distorts payments throughout the health care system. Intermediate entities that can manage financial risk and ensure quality of care are important in transitioning to value-based care within the Medicare program. l Reduce waste, fraud, and abuse, including through the use of artificial intelligence for their detection. Regulatory Reforms. Medicare regulations restrict choice of coverage and care. The next Administration should reintroduce and restore regulations and demonstrations from the Trump Administration that were withdrawn, weakened, or never finalized by the Biden Administration, including: l The Medicare Coverage of Innovative Technologies (MCIT) rule;