Right Drug Dose Now Act of 2025
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Rep. Swalwell, Eric [D-CA-14]
ID: S001193
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Bill Summary
Another bill, another exercise in futility. The "Right Drug Dose Now Act of 2025" - because what could possibly go wrong with a title that sounds like it was written by a committee of pharmaceutical lobbyists?
**Main Purpose & Objectives:** The bill's main purpose is to update the National Action Plan for Adverse Drug Event Prevention, which is a fancy way of saying "we want to reduce the number of people who die from taking the wrong medication." The objectives are to:
* Update the plan to include advances in pharmacogenomic research and testing (because science!) * Improve electronic health records to better utilize pharmacogenomic information (because technology!) * Educate healthcare professionals on the importance of pharmacogenomic testing (because they clearly need it)
**Key Provisions & Changes to Existing Law:** The bill makes several key changes, including:
* Requiring the Secretary of Health and Human Services to submit a report on the implementation of the National Action Plan for Adverse Drug Event Prevention (because accountability!) * Updating the plan to consider advances in scientific understanding and technology pertaining to drug-gene interactions (because science again!) * Improving electronic health records to automatically indicate when pharmacogenomic testing is appropriate (because automation!)
**Affected Parties & Stakeholders:** The affected parties include:
* Healthcare professionals, who will be required to undergo education on pharmacogenomic testing (poor dears) * Patients, who might actually benefit from this bill if it's implemented correctly (but let's not get too optimistic here) * Pharmaceutical companies, which will likely see increased profits from the expanded use of pharmacogenomic testing (because money!)
**Potential Impact & Implications:** The potential impact of this bill is to reduce adverse drug events, which would be a nice change of pace for the healthcare industry. However, let's not forget that this is just another example of legislative theater - a feel-good measure designed to make politicians look good without actually addressing the underlying issues.
In reality, this bill will likely lead to:
* Increased costs for healthcare providers and patients (because testing isn't cheap) * More bureaucratic red tape for healthcare professionals to navigate (because paperwork!) * A slight increase in profits for pharmaceutical companies (because they're always the real winners)
Overall, this bill is a classic example of "do something" legislation - a half-hearted attempt to address a complex issue without actually solving it. But hey, at least it sounds good on paper!
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Rep. Swalwell, Eric [D-CA-14]
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Project 2025 Policy Matches
This bill shows semantic similarity to the following sections of the Project 2025 policy document. Higher similarity scores indicate stronger thematic connections.
Introduction
— 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
Introduction
— 500 — Mandate for Leadership: The Conservative Promise 32. Owcharenko Schaefer, “Medicaid at 55: Understanding the Design, Trends, and Reforms Needed to Improve the Health Care Safety Net.” 33. Brian Blase, “Managed Care in Medicaid: Need for Oversight, Accountability, and Reform,” Paragon Health Institute Policy Brief, October 13, 2022, https://paragoninstitute.org/wp-content/uploads/2022/10/20221012- Managed-Care-in-Medicaid-Need-for-Oversight-Accountability-and-Reform-FOR-DISTRIBUTION-V2.pdf (accessed February 13, 2023). 34. Owcharenko Schaefer, “Medicaid at 55: Understanding the Design, Trends, and Reforms Needed to Improve the Health Care Safety Net.” 35. 42 U.S. Code § 1315, https://www.law.cornell.edu/uscode/text/42/1315 (accessed March 17, 2023). 36. Chad D. Savage and Lee S. Gross, “Direct Primary Care: Update and Road Map for Patient-Centered Reforms,” Heritage Foundation Backgrounder No. 3635, June 28, 2021, https://www.heritage.org/sites/default/ files/2021-06/BG3635.pdf. 37. H.R. 133, Consolidated Appropriations Act, 2021, Public Law No. 116-260, 116th Congress, December 27, 2020, Division BB, Title I, https://www.congress.gov/116/plaws/publ260/PLAW-116publ260.pdf (accessed March 17, 2023). 38. Doug Badger, “On Surprise Medical Bills, Congress Should Side with Consumers, Not Special Interests,” Heritage Foundation Commentary, January 31, 2020, https://www.heritage.org/health-care-reform/ commentary/surprise-medical-bills-congress-should-side-consumers-not-special. 39. Edmund F. Haislmaier and Abigail Slagle, “Premiums, Choices, Deductibles, Care Access, and Government Dependence Under the Affordable Care Act: 2021 State-by-State Review,” Heritage Foundation Backgrounder No. 3668, November 2, 2021, https://www.heritage.org/sites/default/files/2021-11/BG3668.pdf. 40. 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, “Transparency in Coverage,” Final Rule, Federal Register, Vol. 85, No. 219 (November 12, 2020), pp. 72158–72310, https://www.govinfo.gov/ content/pkg/FR-2020-11-12/pdf/2020-24591.pdf (accessed March 17, 2023). 41. David N. Bernstein and Robert E. Moffit, “New Price Transparency Rule Will Help Transform America’s Health Care System,” Heritage Foundation Commentary, November 1, 2020, https://www.heritage.org/health-care- reform/commentary/new-price-transparency-rule-will-help-transform-americas-health-care. 42. Sluzala and Haislmaier, “Lessons from COVID-19: How Policymakers Should Reform the Regulation of Clinical Testing.” 43. Ibid. 44. Most recently enacted in H.R. 2471, Consolidated Appropriations Act, 2022, Public Law No. 117-103, 117th Congress, March 15, 2022, Division H, Title V, §§ 506–507, https://www.congress.gov/117/plaws/publ103/ PLAW-117publ103.pdf (accessed March 17, 2023). 45. President Joseph R. Biden Jr., Executive Order 14079, “Securing Access to Reproductive and Other Healthcare Services,” August 3, 2022, in Federal Register, Vol. 87, No. 154 (August 11, 2022), pp. 49505–49507, https:// www.govinfo.gov/content/pkg/FR-2022-08-11/pdf/2022-17420.pdf (accessed March 16, 2023). 46. Planned Parenthood, 2020–2021 Annual Report, p. 27, https://www.plannedparenthood.org/uploads/ filer_public/40/8f/408fc2ad-c8c2-48da-ad87-be5cc257d370/211214-ppfa-annualreport-20-21-c3-digital.pdf (accessed March 22, 2023). 47. Ibid., pp. 30 and 31. Total revenue of $1,714.4 million (p. 30) minus $1,580.7 million in total expenses (p. 31) yields $133,7 million. 48. Ibid., p. 28. 49. Ibid., p. 30. 50. H.R. 372, Protecting Life and Taxpayers Act of 2023, 118th Congress, introduced January 17, 2023, https://www. congress.gov/118/bills/hr372/BILLS-118hr372ih.pdf (accessed March 17, 2023). 51. 42 U.S. Code § 18023, https://www.law.cornell.edu/uscode/text/42/18023 (accessed March 17, 2023). 52. H.R. 3128, Consolidated Omnibus Budget Reconciliation Act of 1985, Public Law No. 99-272, 99th Congress, April 7, 1986, Title IX, Subtitle A, Part 1, Subpart B, § 9121, https://www.congress.gov/99/statute/STATUTE-100/ STATUTE-100-Pg82.pdf (accessed March 17, 2023). 53. H.R. 8070, Rehabilitation Act of 1973, Public Law No. 93-112, 93rd Congress, September 26, 1973, https://www. congress.gov/93/statute/STATUTE-87/STATUTE-87-Pg355.pdf (accessed March 17, 2023). — 501 — Department of Health and Human Services 54. U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, Office of Civil Rights, and Office of the Secretary, “Special Responsibilities of Medicare Hospitals in Emergency Cases and Discrimination on the Basis of Disability in Critical Health and Human Service Programs or Activities,” draft of Proposed Rule, January 14, 2021, https://www.hhs.gov/sites/default/files/infants-nprm.pdf (accessed March 17, 2023). 55. H.R. 26, Born-Alive Abortion Survivors Protection Act, 118th Congress, introduced January 9, 2023, https:// www.congress.gov/118/bills/hr26/BILLS-118hr26pcs.pdf (accessed March 17, 2023). 56. H.R. 7, No Taxpayer Funding for Abortion and Abortion Insurance Full Disclosure Act of 2023, 118th Congress, introduced January 9, 2023, https://www.congress.gov/118/bills/hr7/BILLS-118hr7ih.pdf (accessed March 17, 2023). 57. 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. U.S. Department of Agriculture, Food and Nutrition Services, “Revision of Categorical Eligibility in the Supplemental Nutrition Assistance Program (SNAP),” Proposed Rule, Federal Register, Vol. 84, No. 142 (July 24, 2019), pp. 35570–55581, https:// www.federalregister.gov/documents/2019/07/24/2019-15670/revision-of-categorical-eligibility-in-the- supplemental-nutrition-assistance-program-snap (accessed March 17, 2023). 61. 45 Code of Federal Regulations § 75.300(c) and (d), https://www.ecfr.gov/current/title-45/subtitle-A/ subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.300 (accessed March 17, 2023). 62. H.R. 1750, Child Welfare Provider Inclusion Act of 2021, 117th Congress, introduced March 10, 2021, https:// www.congress.gov/117/bills/hr1750/BILLS-117hr1750ih.pdf (accessed March 17, 2023), and S. 656, Child Welfare Provider Inclusion Act of 2021, 117th Congress, introduced March 10, 2021, https://www.congress.gov/117/bills/ s656/BILLS-117s656is.pdf (accessed March 17, 2023). 63. S. 3949, Trafficking Victims Protection Reauthorization Act of 2022, Public Law No. 117-348, 117th Congress, January 25, 2023, https://www.congress.gov/117/plaws/publ348/PLAW-117publ348.pdf (accessed March 17, 2023). 64. Kelsey Y. Santamaria, “Child Migrants at the Border: The Flores Settlement Agreement and Other Legal Developments,” Congressional Research Service In Focus No. IF11799, April 1, 2021, https://crsreports.congress. gov/product/pdf/IF/IF11799 (accessed March 17, 2023). 65. Report, Building a Happy Home: Marriage Education as a Tool to Strengthen Families, Social Capital Project Report No. 1-22, March 2022, p. 17, https://www.jec.senate.gov/public/_cache/files/3d102525-6f0d-48ed- 92f4-d71edd468ad6/building-a-happy-home.pdf (accessed March 17, 2023). The cover of the report reflects that the Social Capital Project is “[a] project of the Joint Economic Committee – Republicans.” 66. See, for example, Alan J. Hawkins, “Are Federally Supported Relationship Education Programs for Lower-Income Individuals and Couples Working? A Review of Evaluation Research,” American Enterprise Institute, September 2019, https://www. congress.gov/117/plaws/publ228/PLAW-117publ228.pdf (accessed March 17, 2023). 67. H.R. 8404, Respect for Marriage Act, Public Law No. 117-228, 117th Congress, December 13, 2022, https://www. congress.gov/117/plaws/publ228/PLAW-117publ228.pdf (accessed March 17, 2023). 68. Madison Marino, “Over 1,000 Safety Violations Mar Head Start. 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).
Introduction
— 500 — Mandate for Leadership: The Conservative Promise 32. Owcharenko Schaefer, “Medicaid at 55: Understanding the Design, Trends, and Reforms Needed to Improve the Health Care Safety Net.” 33. Brian Blase, “Managed Care in Medicaid: Need for Oversight, Accountability, and Reform,” Paragon Health Institute Policy Brief, October 13, 2022, https://paragoninstitute.org/wp-content/uploads/2022/10/20221012- Managed-Care-in-Medicaid-Need-for-Oversight-Accountability-and-Reform-FOR-DISTRIBUTION-V2.pdf (accessed February 13, 2023). 34. Owcharenko Schaefer, “Medicaid at 55: Understanding the Design, Trends, and Reforms Needed to Improve the Health Care Safety Net.” 35. 42 U.S. Code § 1315, https://www.law.cornell.edu/uscode/text/42/1315 (accessed March 17, 2023). 36. Chad D. Savage and Lee S. Gross, “Direct Primary Care: Update and Road Map for Patient-Centered Reforms,” Heritage Foundation Backgrounder No. 3635, June 28, 2021, https://www.heritage.org/sites/default/ files/2021-06/BG3635.pdf. 37. H.R. 133, Consolidated Appropriations Act, 2021, Public Law No. 116-260, 116th Congress, December 27, 2020, Division BB, Title I, https://www.congress.gov/116/plaws/publ260/PLAW-116publ260.pdf (accessed March 17, 2023). 38. Doug Badger, “On Surprise Medical Bills, Congress Should Side with Consumers, Not Special Interests,” Heritage Foundation Commentary, January 31, 2020, https://www.heritage.org/health-care-reform/ commentary/surprise-medical-bills-congress-should-side-consumers-not-special. 39. Edmund F. Haislmaier and Abigail Slagle, “Premiums, Choices, Deductibles, Care Access, and Government Dependence Under the Affordable Care Act: 2021 State-by-State Review,” Heritage Foundation Backgrounder No. 3668, November 2, 2021, https://www.heritage.org/sites/default/files/2021-11/BG3668.pdf. 40. 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, “Transparency in Coverage,” Final Rule, Federal Register, Vol. 85, No. 219 (November 12, 2020), pp. 72158–72310, https://www.govinfo.gov/ content/pkg/FR-2020-11-12/pdf/2020-24591.pdf (accessed March 17, 2023). 41. David N. Bernstein and Robert E. Moffit, “New Price Transparency Rule Will Help Transform America’s Health Care System,” Heritage Foundation Commentary, November 1, 2020, https://www.heritage.org/health-care- reform/commentary/new-price-transparency-rule-will-help-transform-americas-health-care. 42. Sluzala and Haislmaier, “Lessons from COVID-19: How Policymakers Should Reform the Regulation of Clinical Testing.” 43. Ibid. 44. Most recently enacted in H.R. 2471, Consolidated Appropriations Act, 2022, Public Law No. 117-103, 117th Congress, March 15, 2022, Division H, Title V, §§ 506–507, https://www.congress.gov/117/plaws/publ103/ PLAW-117publ103.pdf (accessed March 17, 2023). 45. President Joseph R. Biden Jr., Executive Order 14079, “Securing Access to Reproductive and Other Healthcare Services,” August 3, 2022, in Federal Register, Vol. 87, No. 154 (August 11, 2022), pp. 49505–49507, https:// www.govinfo.gov/content/pkg/FR-2022-08-11/pdf/2022-17420.pdf (accessed March 16, 2023). 46. Planned Parenthood, 2020–2021 Annual Report, p. 27, https://www.plannedparenthood.org/uploads/ filer_public/40/8f/408fc2ad-c8c2-48da-ad87-be5cc257d370/211214-ppfa-annualreport-20-21-c3-digital.pdf (accessed March 22, 2023). 47. Ibid., pp. 30 and 31. Total revenue of $1,714.4 million (p. 30) minus $1,580.7 million in total expenses (p. 31) yields $133,7 million. 48. Ibid., p. 28. 49. Ibid., p. 30. 50. H.R. 372, Protecting Life and Taxpayers Act of 2023, 118th Congress, introduced January 17, 2023, https://www. congress.gov/118/bills/hr372/BILLS-118hr372ih.pdf (accessed March 17, 2023). 51. 42 U.S. Code § 18023, https://www.law.cornell.edu/uscode/text/42/18023 (accessed March 17, 2023). 52. H.R. 3128, Consolidated Omnibus Budget Reconciliation Act of 1985, Public Law No. 99-272, 99th Congress, April 7, 1986, Title IX, Subtitle A, Part 1, Subpart B, § 9121, https://www.congress.gov/99/statute/STATUTE-100/ STATUTE-100-Pg82.pdf (accessed March 17, 2023). 53. H.R. 8070, Rehabilitation Act of 1973, Public Law No. 93-112, 93rd Congress, September 26, 1973, https://www. congress.gov/93/statute/STATUTE-87/STATUTE-87-Pg355.pdf (accessed March 17, 2023).
Showing 3 of 5 policy matches
About These Correlations
Policy matches are calculated using semantic similarity between bill summaries and Project 2025 policy text. A score of 60% or higher indicates meaningful thematic overlap. This does not imply direct causation or intent, but highlights areas where legislation aligns with Project 2025 policy objectives.