HALT Fentanyl 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

— 459 — Department of Health and Human Services pro-life states that are trying to protect women, girls, and unborn children from abortion. The FDA should therefore: l 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. l 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. l 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. l 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 — 460 — Mandate for Leadership: The Conservative Promise (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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S. 401, Conscience Protection Act of 2021, 117th Congress, introduced February 24, 2021, https://www.congress. gov/117/bills/s401/BILLS-117s401is.pdf (accessed March 17, 2023). 58. U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, and Office of the Secretary, “Nondiscrimination in Health Programs and Activities,” Notice of Proposed Rulemaking; Notice of Tribal Consultation, Federal Register, Vol. 87, No. 149 (August 4, 2022), pp. 47824–47920, https://www.govinfo. gov/content/pkg/FR-2022-08-04/pdf/2022-16217.pdf (accessed March 17, 2023). 59. Ibid., p. 47916. 60. The regulation was not finalized before the end of the Administration. 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Children Deserve Better,” Heritage Foundation Commentary, November 10, 2022, https://www.heritage.org/education/commentary/over-1000-safety- violations-mar-head-start-children-deserve-better. 69. American Hospital Association v. Becerra, 596 U.S. ___ (2022), https://www.supremecourt.gov/ opinions/21pdf/20-1114_09m1.pdf (accessed March 17, 2023). 70. U.S. Department of the Treasury, Internal Revenue Service; U.S. Department of Labor, Employee Benefits Security Administration; and U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, “Coverage of Certain Preventive Services Under the Affordable Care Act,” Notice of Proposed Rulemaking, Federal Register, Vol. 88, No. 22 (February 2, 2023), pp. 7236–7281, https://www. govinfo.gov/content/pkg/FR-2023-02-02/pdf/2023-01981.pdf (accessed March 17, 2023). — 502 — Mandate for Leadership: The Conservative Promise 71. 42 U.S. Code § 238n, https://www.law.cornell.edu/uscode/text/42/238n (accessed March 17, 2023). 72. U.S. Department of Health and Human Services, Health Resources and Services Administration, “Early Childhood Health,” last reviewed October 2022, https://mchb.hrsa.gov/programs-impact/focus-areas/early- childhood-health (accessed March 17, 2023). 73. American Pregnancy Association, “Having a Doula—What Are the Benefits?” https://americanpregnancy. org/healthy-pregnancy/labor-and-birth/having-a-doula/#:~:text=Other%20studies%20have%20shown%20 that%20having%20a%20doula,massage%20to%20reduce%20stress%20and%20anxiety%20during%20labor (accessed March 17, 2023). 74. S. 2372, VA MISSION [Maintaining Internal Systems and Strengthening Integrated Outside Networks] Act of 2018, Public Law No. 115-182, 115th Congress, June 6, 2018, https://www.congress.gov/115/plaws/publ182/ PLAW-115publ182.pdf (accessed March 17, 2023). 75. U.S. Department of Health and Human Services, “Securing Updated and Necessary Statutory Evaluations Timely,” Final Rule, Federal Register, Vol. 86, No. 11 (January 19, 2021), pp. 5694–5764, https://www.govinfo. gov/content/pkg/FR-2021-01-19/pdf/2021-00597.pdf (accessed March 22, 2023). 76. U.S. Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, “Compliance with Statutory Program Integrity Requirements,” Final Rule, Federal Register, Vol. 84, No. 42 (March 4, 2029), pp. 7714–7791, https://www.govinfo.gov/content/pkg/FR-2019-03-04/pdf/2019-03461.pdf (accessed March 18, 2023). 77. U.S. Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, “Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services,” Final Rule, Federal Register, Vol. 86, No. 192 (October 7, 2021), pp. 56144–56180, https://www.govinfo.gov/content/ pkg/FR-2021-10-07/pdf/2021-21542.pdf (accessed March 18, 2023). 78. S. 624, Title X Abortion Provider Prohibition Act, 118th Congress, introduced March 2, 2023, https://www. congress.gov/118/bills/s624/BILLS-118s624is.pdf (accessed March 18, 2023). 79. 50 U.S. Code Chapter 55, https://www.law.cornell.edu/uscode/text/50/chapter-55 (accessed March 22, 2023). 80. 18 U.S. Code § 13, https://www.law.cornell.edu/uscode/text/18/13 (accessed March 18, 2023). 81. Bowen v. American Hospital Association, 476 U.S. 610 (1986), https://tile.loc.gov/storage-services/service/ll/ usrep/usrep476/usrep476610/usrep476610.pdf (accessed 22, 2023). 82. U.S. Department of Health and Human Services, Office of the Secretary, “Notification of Interpretation and Enforcement of Section 1557 of the Affordable Care Act and Title IX of the Education Amendments of 1972,” Federal Register, Vol. 86, No. 99 (May 25, 2021), pp. 27984–27985, https://www.govinfo.gov/content/pkg/FR- 2021-05-25/pdf/2021-10477.pdf (accessed March 18, 2023). 83. U.S. Department of Health and Human Services, Office for Civil Rights, “HHS Notice and Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy,” March 2, 2022, https://www.hhs.gov/sites/default/files/hhs- ocr-notice-and-guidance-gender-affirming-care.pdf (accessed March 18, 2023). 84. Heckler v. Chaney, 420 U.S. 821 (1985), https://caselaw.findlaw.com/us-supreme-court/470/821.html (accessed March 18, 2022). 85. U.S. Department of Health and Human Services, Office for Civil Rights, “Guidance to Nation’s Retail Pharmacies: Obligations Under Federal Civil Rights Laws to Ensure Access to Comprehensive Reproductive Health Care Services,” content last reviewed July 14, 2022, https://www.hhs.gov/civil-rights/for-individuals/ special-topics/reproductive-healthcare/pharmacies-guidance/index.html (accessed March 18, 2023). 86. H.R. 3103, “Health Insurance and Portability and Accountability Act of 1996, Public Law No. 104-191, 104th Congress, August 21, 1996, https://www.congress.gov/104/plaws/publ191/PLAW-104publ191.pdf (accessed March 18, 2023). 87. U.S. Department of Human Services, “HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care,” content last reviewed June 29, 2022, (accessed March 18, 2023). See also “Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone or Tablet,” content last reviewed June 29, 2022, https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/ cell-phone-hipaa/index.html (accessed March 18, 2023).