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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Roger Severino

sexuality, gender identification, ethnicity, and a host of other categories.2

As a result of HHS’s having lost its way, U.S. life expectancy, instead of return- ing to normal after the COVID-19 pandemic, continued to drop precipitously to levels not seen since 1996 with white populations alone losing 7 percent of their expected life span in just one year.3 Nothing less than America’s long-term survival is at stake. Accordingly, HHS must return to serving the health and well-being of all Americans at all stages of life instead of using social engineering that leaves us sicker, poorer, and more divided.

OVERVIEW

HHS consists of 11 operating divisions that have varying degrees of practical independence from the Secretary of Health and Human Services and 15 staff divisions that are directly under the Office of the Secretary. This chapter’s rec- ommendations are limited to those divisions that most need reform and address, wherever possible, five cross-cutting goals.

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Goal #1: Protecting Life, Conscience, and Bodily Integrity. The Secretary should pursue a robust agenda to protect the fundamental right to life, protect con- science rights, and uphold bodily integrity rooted in biological realities, not ideology. From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural

death: Abortion and euthanasia are not health care.

A robust respect for the sacred rights of conscience, both at HHS and among gov- ernments and institutions funded by it, increases choices for patients and program beneficiaries and furthers pluralism and tolerance. The Secretary must protect Americans’ civil rights by ensuring that HHS programs and activities follow the letter and spirit of religious freedom and conscience-protection laws.

Radical actors inside and outside government are promoting harmful identity politics that replaces biological sex with subjective notions of “gender identity” and bases a person’s worth on his or her race, sex, or other identities. This destructive dogma, under the guise of “equity,” threatens American’s fundamental liberties as well as the health and well-being of children and adults alike. The next Secretary must ensure that HHS programs protect children’s minds and bodies and that HHS programs respect parents’ basic right to direct the upbringing, education, and care of their children.

Goal #2: Empowering Patient Choices and Provider Autonomy. Basic eco- nomics holds that costs tend to decrease and quality and options tend to increase when there is robust and free competition in the provision of goods and services. Health care is no exception. Health care reform should be patient-centered and market-based and should empower individuals to control their health care–related dollars and decisions.

Of course, providers who deliver health care also need the freedom to address the unique needs of their patients. States should be the primary regulators of the medical profession, and the federal government should not restrict providers’ abil- ity to discharge their responsibilities or limit their ability to innovate through government pricing controls or irrational Medicare and Medicaid reimburse- ment schemes.

Finally, America’s broken insurance system, run largely through confusing pro- vider networks and third-party payers (employers), induces overconsumption of health care, limits consumer shopping, and hides true costs from patients.

The federal government should focus reform on reducing burdens of regulatory compliance, unleashing innovation in health care delivery, ceasing interference in the daily lives of patients and providers, allowing alternative insurance coverage options, and returning control of health care dollars to patients making decisions with their providers about their health care treatments and services.

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Goal #3: Promoting Stable and Flourishing Married Families. Families comprised of a married mother, father, and their children are the foundation of a well-ordered nation and healthy society. Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on “LGBTQ+ equity,” subsidizing single-motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.

Working fathers are essential to the well-being and development of their children, but the United States is experiencing a crisis of fatherlessness that is ruining our children’s futures. In the overwhelming number of cases, fathers insulate children from physical and sexual abuse, financial difficulty or poverty, incarceration, teen pregnancy, poor educational outcomes, high school failure, and a host of behavioral and psychological problems. By contrast, homes with non-related “boyfriends” present are among the most dangerous place for a child to be. HHS should prioritize married father engagement in its messaging, health, and welfare policies.

In the context of current and emerging reproductive technologies, HHS policies should never place the desires of adults over the right of children to be raised by the biological fathers and mothers who conceive them. In cases involving biolog- ical parents who are found by a court to be unfit because of abuse or neglect, the process of adoption should be speedy, certain, and supported generously by HHS. Goal #4: Preparing for the Next Health Emergency. The COVID-19 pan- demic demonstrated how catastrophic a micromanaging, misinformed, centralized, and politicized federal government can be. Basic human rights, medical choice, and the doctor–patient relationship were trampled without scientific justification and for extended periods of time. Excess deaths, not due to COVID-19, skyrocketed because of forced lockdowns, isolation, vaccine-related mass firings, and colossal

disruptions of the economy and daily rhythms of life.

The federal government’s public health apparatus has lost the public’s trust. Before the next national public health emergency, this apparatus must be funda- mentally restructured to ensure a transparent, scientifically grounded, and more nimble, efficient, transparent, and targeted response that respects the unique needs and input of patient populations and providers.

Every one of the overreaching policies during the pandemic—from lockdowns and school closures to mask and vaccine mandates or passports—received its supposed legal justification from the state of emergency declared (and renewed) by the HHS Secretary. Tellingly, however, the threshold for what constitutes a public health emergency—how many cases, hospitalizations, deaths, etc.—was never defined. For the sake of democratic accountability, we must know with clarity what will trigger the next emergency declaration and, just as important, what will trigger its end.

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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,

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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

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control, environmental health, and health promotion and health education activi- ties.”6 It is not qualified to offer (and usually does not purport to offer) professional medical opinions applicable to specific patients.

From time to time, the CDC offers findings and recommendations that compe- tent medical practitioners often will consider in arriving at a professional medical judgment for a particular patient. In this respect, CDC guidelines are analogous to guidelines from other public health associations or medical societies: They are informative, not prescriptive.

By statute or regulation, CDC guidance must be prohibited from taking on a prescriptive character. For example, never again should CDC officials be allowed to say in their official capacity that school children “should be” masked or vaccinated (through a schedule or otherwise) or prohibited from learning in a school building. Such decisions should be left to parents and medical providers. We have learned that when CDC says what people “should” do, it readily becomes a “must” backed by severe punishments, including criminal penalties. CDC should report on the risks and effectiveness of all infectious disease-mitigation measures dispassionately and leave the “should” and “must” policy calls to politically accountable parties.

Conflicts of Interest. There was a time when the CDC could not take money from the pharmaceutical industry, but in 1992, the agency discovered a loophole in federal law that allowed it to accept pharma contributions through the nonprofit CDC Foundation. The money started flowing immediately: From 2014 through 2018, the CDC Foundation received $79.6 million from pharmaceutical corpo- rations like Pfizer, Biogen, and Merck.7 This practice presents a stark conflict of interest that should be banned.

Data Systems. The COVID-19 pandemic has revealed the disastrous public health consequences of the CDC’s failure to follow multiple congressional mandates to modernize its data infrastructure. Current reporting methods are burdensome for frontline medical workers, yet they result only in fragmented data that are not available in real time or usable across systems.

Congress should require HHS to prioritize the electronic collection and dis- semination of robust, privacy-protected data that better leverages existing systems while reducing burdens on clinicians. HHS should also enter into a public–private partnership with a data-management expert to develop a system that makes crit- ical information available to health care workers and policymakers in real time.8

The CDC operates several programs related to vaccine safety including the Vac- cine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA, which is responsible for post-market surveillance and evaluation of all other drugs and biological products. Respect for Life and Conscience. The CDC should eliminate programs and projects that do not respect human life and conscience rights and that undermine

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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

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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

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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

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(10 weeks) into pregnancy and before Biden was subject to a heightened safety restriction called a Risk Evaluation and Mitigation Strategy (REMS) that requires an in-person visit with a physician who can check for dangerous contraindications such as ectopic pregnancies and can advise the mother seeking an abortion of the risks of chemical abortion, including hemorrhaging, and what to do in such cir- cumstances. Chemical abortion has been found to have a complication rate four times higher than that of surgical abortion.

Since its approval more than 20 years ago, mifepristone has been associated with 26 deaths of pregnant mothers, over a thousand hospitalizations, and thousands more adverse events, but that number does not account for all complications. Of course, this does not count the hundreds of thousands to millions of babies whose lives have been unjustly taken through chemical abortion. FDA should therefore:

•   Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women. It never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary

safeguards for pregnant girls and women who undergo this dangerous drug regimen. Furthermore, at no point in the past two decades has the FDA ever acknowledged or addressed federal laws that prohibit the distribution of abortion drugs by postal mail; to the contrary, the FDA has permitted and actively encouraged such activity.

Now that the Supreme Court has acknowledged that the Constitution contains no right to an abortion, the FDA is ethically and legally obliged to revisit and withdraw its initial approval, which was premised on pregnancy being an “illness” and abortion being “therapeutically” effective at treating this “illness.” The FDA is statutorily charged with guaranteeing the

safety and efficacy of drugs and therefore should withdraw this drug that is proven to be dangerous to women and by definition fatally unsafe for unborn children.

As an interim step, the FDA should immediately restore the REMS by removing the in-person dispensing requirement to eliminate dangerous tele-abortion and abortion-by-mail distribution.

Mail-Order Abortions. Allowing mail-order abortions is a gift to the abortion industry that allows it to expand far beyond brick-and-mortar clinics and into

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pro-life states that are trying to protect women, girls, and unborn children from abortion. The FDA should therefore:

•   Reinstate earlier safety protocols for Mifeprex that were mostly eliminated in 2016 and apply these protocols to any generic version of mifepristone. A bare-minimum policy of limiting abortion pills to the pre-2016 policy of 49 days gestation, returning to the pre-2021 in-person dispensing requirement, and returning to requiring prescribers to report all serious adverse events, not just deaths, to the drug sponsor would increase women’s health and safety.

•   Address weaknesses in the current FAERS (FDA Adverse Events Reporting System). The Administration and policymakers should ensure that health care workers, particularly those in hospitals and emergency rooms, report abortion pill complications. Women who experience complications from abortion pills typically go to an emergency room, not to the abortion pill prescriber, so putting the onus of reporting on the prescriber who typically has no idea that a complication has occurred means that the FAERS is seriously undercounting adverse events. Submitting an adverse event to the database should be a quick and efficient process for busy health care practitioners. Currently, providers report that the process is difficult and convoluted.

•   Implement a policy of transparency about inspections of the abortion pill’s sponsors, Danco and GenBioPro, as well as facilities that manufacture the pills. The FDA should respond to congressional requests and Freedom of Information Act (FOIA) requests about inspections, compliance, and post-marketing safety in a timely manner.

•   Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.16

Vaccine Importation. Thousands of Americans of faith and conscience wish to receive various childhood vaccinations for themselves and their families but are not allowed to receive vaccines that are derived through or tested on aborted fetal cells. For example, the chickenpox, Hepatitis, and MMR vaccines in the U.S. are all linked to abortion in this way. There are ethically derived alternatives abroad that have been used safely there for decades, but the FDA makes it exceedingly difficult for Americans to import them.

In January 2021, the HHS Office for Civil Rights (OCR) and the FDA jointly announced that HHS was required by the Religious Freedom Restoration Act

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(RFRA)17 to allow bulk importation by doctors of certain Japanese-made vaccines to accommodate religious needs of patients, but the Biden FDA unlawfully revoked this waiver. The FDA should restore the waiver to comply with RFRA and for the obvious public health benefits of increased childhood vaccination by families seek- ing ethically derived alternatives.

To avoid future moral coercion of the sort experienced with the COVID-19 vac- cines, the FDA and NIH should require the development of drugs and biologics that are free from moral taint and switch to cell lines that are not derived from aborted fetal cell lines or aborted baby body parts.

Conflicts of Interest. A 2018 report in Science found that more than two-thirds of FDA reviewers later ended up at the same companies whose products they had been reviewing while they were working for the government.18 This revolving door is one mechanism by which pharmaceutical companies capture the agencies that regulate them. The FDA should impose a lengthy cooling off period for reviewers, preventing them from working for companies they regulated.

In 1997, the FDA relaxed regulations to permit broadcast drug advertisements, after which Big Pharma began routine direct-to-consumer advertising, making the United States and New Zealand the only countries where such practices are legal. Following the 1997 changes, pharma became the largest advertiser for all major media organizations. This buys considerable influence in the newsroom—whether media companies acknowledge this or not—and distorts independent reporting on public health issues. The FDA or Congress should regulate where and how paid advertising is used by pharmaceutical companies more stringently, especially on media outlets.

NATIONAL INSTITUTES OF HEALTH (NIH)

The National Institutes of Health (NIH) is the world’s largest biomedical research agency and is made up of 27 different components called Institutes and Centers. Despite its popular image as a benign science agency, NIH was respon- sible for paying for research in aborted baby body parts, human animal chimera experiments, and gain-of-function viral research that may have been responsible for COVID-19.

Bioethics Reform. Research using fetal tissue obtained from elective abortions is immoral and obsolete. Research using human embryonic stem cells also involves the destruction of human life and should not be subsidized with taxpayer dollars. Good science and life-affirming, ethical research are not mutually exclusive. In fact, ethically derived sources such as discarded surgical tissue and adult stem cells (made pluripotent), not tissue obtained from elective abortions, have contributed the most successful treatments for a variety of ailments.

Congress authorized HHS to choose not to fund extramural abortion-de- rived fetal tissue research that fails ethics advisory board review, and in 2019, the

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Trump Administration’s HHS chose that course. Subsequently, however, the Biden Administration restored unrestricted funding of abortion-derived fetal tissue research. HHS should:

•   Promptly restore the ethics advisory committee to oversee abortion- derived fetal tissue research, and Congress should prohibit such research altogether.

•   End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem

cell registry.

•   Aggressively implement a plan to pursue and fund ethical alternative methods of research in order to ensure that abortion and embryo- destructive related research, cell lines, and other testing methods become both fully obsolete and ethically unthinkable.

In addition, the Administration should reconvene a new National Council on Bioethics (NCB) to discuss new and emerging areas of ethical concern, to assess whether the ends justify the means when it comes to the promise of therapies and cures, and to establish what limiting principles should guide research and health policy. Because the male–female dyad is essential to human nature and because every child has a right to a mother and father, three-parent embryo cre- ation and human cloning research should be banned. A new NCB should convene leading experts to examine these issues and provide policy recommendations for the new frontier of bioethical questions that our country will have to address in the coming years.