By: Rebecca Herzberg ‘26
Volume XI – Issue I – Fall 2025
I. BACKGROUND
i. Section 340B of the Public Health Service Act (42 U.S.C. § 356)
a. Overview
In 1992, the 340B Drug Discount Program was established under the Public Health Service Act under section 602 of the Veterans Health Care Act (P.L. 102-585). [1], [2] Overseen by the Health Resources and Services Administration (HRSA), this program was created and has continuously worked to support hospitals serving vulnerable populations with less financial resources. [3] As the cost of prescription drugs continues to rise, the 340B program is viewed by many hospitals as invaluable. [4] Under the program, drug manufacturers must enter a purchase price agreement (PPA) with the Secretary of the Department of Health and Human Services (HHS) to participate. They are then required to follow the predescribed maximum price calculated from the statutory formula. Notably, providers are not required to pass drug discounts on to patients. [5]
To qualify for the 340B program, hospitals must serve patients who are a majority low-income and/or uninsured. After meeting this criteria, hospitals can purchase outpatient drugs at reduced prices. [6] These discounted rates are calculated by taking the average manufacturer price (AMP) and subtracting the unit rebate amount (URA) to determine the maximum price drugs can be sold at to all hospitals participating in the 340B program. [7] Qualifying organizations, referred to as “covered entities” include health care providers that serve vulnerable populations and have limited resources, such as federally qualified health centers, rural hospitals, disproportionate share hospitals (DSH), and specialized clinics, among many other facilities. [8] Many of these hospitals are considered safety net hospitals, meaning that these hospitals’ patient populations are predominantly uninsured or Medicaid beneficiaries. [9], [10]
The 340B program is intended to reduce the financial burden covered entities face. For example, in 2023, 44 percent of rural hospitals—a primary target of the 340B program—had negative operating margins. [11] The savings generated from the 340B program are intended to enable hospitals to support their communities through free health care, free vaccines, mental health services, medication management, and community health programs. [12] While the intention of the 340B program is to support hospitals serving vulnerable populations, it is important to acknowledge the significant purchasing role the 340B program plays in the pharmaceutical market. Drug sales from the 340B program make up approximately 7.2 percent of the overall U.S. drug market. To ensure covered entities are meeting requirements for the 340B program, HRSA and drug manufacturers are allowed to audit covered entities to ensure they meet requirements for the program. Furthermore, they have the ability to fine noncompliant entities with civil monetary penalties (CMP) and govern alternative dispute resolutions (ADR) surrounding overcharges of drugs. [13]
b. Restrictions: Duplicate Discounts and Designated Dispensing
Duplicate discounts are one of the largest issues within the 340B program. Drugs that were purchased under 340B prices and also rewarded with a rebate for that same drug are considered duplicate discounts, because covered entities receiving outpatient drugs at 340B discount prices are prohibited from receiving rebates from the Medicaid Drug Rebate Program (see section II.i.e). [14], [15], [16] The Government Accountability Office (GAO) has found that HRSA is not sufficiently assessing duplicate discounts. [17] Audits conducted by HRSA’s Office of Pharmacy Affairs found duplicate discount errors in 25 percent of the covered entities they reviewed. [18] There have been many calls, from both the government and drug manufacturers, to address this costly issue. [19], [20]
Additionally, covered entities have a specific designation for who they can dispense drugs to. They are prohibited from distributing and selling drugs purchased under the 340B program to non-eligible patients, defined as those individuals who are not medicaid enrolled or uninsured. [21] However, contract pharmacies working with 340B hospitals can serve the general public, so it is possible that individuals not eligible for 340B drugs are receiving discounted drugs, despite these sales being prohibited. [22]
c. Contract Pharmacies
Many hospitals that do not have in-house pharmacies form contracts with outside pharmacies, which are generally referred to as contract pharmacies. [23] Contract pharmacies include major household names such as CVS and Walgreens. Between 1992 and 2007, the number of covered entities utilizing contract pharmacies remained relatively consistent. However, in 2010, this number spiked drastically when HRSA edited its language to allow an “unlimited number “of contract pharmacies to be used by covered entities. [24], [25] This led to an expansion from 3,000 to 19,868 contract pharmacies between 2010 and 2017. This increase has led to concerns that HRSA may not be capable of managing the program, as HRSA’s Office of Pharmacy Affairs (OPA) has a small workforce that has not grown in size proportionally to the increase in contract pharmacies. Additionally, the number of audits conducted by OPA has not increased between 2012-2017 despite the increase in the number of contract pharmacies (see section I.i.b for descriptions of issues with the 340B program). [26] To enter the 340B program, HRSA requires contract pharmacies to develop a method to prevent duplicate discounts. Research has found that some contract pharmacies determine drugs that qualify for 340B retroactively. Moreover, contract pharmacies have been found to categorize some prescriptions as qualifying for the 340B program, which government administrators did not agree with. Both covered entities and these government administrators are provided with the same guidelines, yet covered entities still categorized the prescription differently. This discrepancy suggests some covered entities might be marking certain prescriptions as 340B even though they are not going to patients not included in the 340B population. [27]
II. DEFINITIONS
i. Relevant Programs and Laws
a. Public Health Service Act of 1944
In 1944, the Public Health Service Act was updated to expand its scope and combined all existing public health efforts to bolster the jurisdiction of the Public Health Service. This 1944 law combined all existing public health efforts to bolster the jurisdiction of the Public Health Service. This Act gives various federal agencies, including HRSA, the ability to develop and enforce health care regulations on relevant health care groups such as pharmaceutical manufacturers. [28] Furthermore, it is from this Act, Section 340B, that explicitly gives HRSA jurisdiction to oversee the 340B program through audits ensuring the compliance of covered entities with the requirements and stipulations outlined in 340B. [29]
b. Veterans Health Care Act of 1992
This act was created to improve and expand health care services to veterans. [30] It encompasses a variety of provisions, including the establishment of women veterans health programs, health care sharing agreements between the Department of Veterans Affairs and the Department of Defense, adjustments to nurse pay, regulation of state services to veterans, and drug pricing agreements. This provision, known as Title VI, established agreements between the Secretary of HHS and drug manufacturers. These agreements restrict the cost at which drugs can be acquired by covered entities and prohibit duplicate discounts. If an entity is found to have engaged in duplicate discounts, HHS will hold the entity responsible for covering the full pre-discount/rebate cost of the drug. [31]
c. Administrative Procedure Act (APA)
This law outlines federal agencies' authority to create rules and make judgments. Rulemaking can be defined as an “agency[‘s] process for formulating, amending, or repealing a rule.” [32] The APA describes parameters for formal, informational, and other types of rulemaking. It also provides standards for judicial review. The informal rule section of the act includes a description of the Notice and Comment Rule. This section states that the public must be given adequate notice, which can be defined as a “reasonable and meaningful opportunity to participate in the rulemaking process.” The Federal Register must reflect the final rule 30 days before its effective date. The Arbitrary and Capricious section of the act—under the Notice and Comment Rule section—states that an agency is in violation of the APA if they fail to use the resources and factors Congress intended it to utilize in its rulemaking and oversight duties. To prove this criticism is false, agencies must demonstrate that they put thought and reasoning into their decision. [33] This APA standard still holds true in the present day. [34]
e. Medicaid Drug Rebate Program (MDRP)
The MDRP is important to understand because of its role in illegal duplicate discounts with the 340B program (see section I.i.b), which is discussed later in this article. The MDRP was established under the Omnibus Budget Reconciliation Act of 1990. To participate in this program, pharmaceutical manufacturers must enter a National Drug Rebate Agreement (NDRA) with the Secretary of HHS. The NDRA states that pharmaceutical manufacturers that want their drugs to be covered under a state’s Medicaid program must provide a rebate to that plan. [35] Unlike the 340B discount program, hospitals purchasing drugs under the MDRP receive rebates after they purchase the drug, rather than discounts upfront. [36] Rebates are paid on a quarterly basis and shared between states and the federal government. [37] Under the MDRP, the Centers for Medicare and Medicaid (CMS), state Medicaid programs, and participating drug manufacturers work together to reduce federal and state costs for outpatient prescription drugs. Currently, 780 manufacturers participate. Similarly to the 340B program, MDRP has grown significantly, which has made it challenging to regulate and prevent duplicate discounts. [38]
III. LITIGATION
i. Precedent
In the following three cases, the pharmaceutical companies Astrazeneca, Novartis Pharmaceuticals, and Eli Lilly filed lawsuits against the federal government for issuing them violation letters—which threatened civil monetary penalties—on the grounds that they could not limit the sales of discounted drugs to covered entities that only work with one contract pharmacy. [39] While 340B requires pharmaceutical companies to sell discounted drugs to covered entities, it does not explicitly describe the role of contract pharmacies. However, pharmaceutical companies complain of a significant increase in costs and abuse of the program due to the drastic rise in the number of contract pharmacies that covered entities utilize. This concern led pharmaceutical manufacturers to issue new policies restricting the use of contract pharmacies. HRSA believed these new policies violated 340B, and issued the predescribed letters in response. [40]
In AstraZeneca Pharmaceuticals LP v. Becerra, the U.S. District Court for the District of Delaware found that the 340B Program’s “silence on [contract pharmacies]” meant that HRSA could not require drug manufacturers to provide drugs to a certain number of pharmacies. The 340B statute never uses the term “contract pharmacy,” so the court ruled that HRSA could not require pharmaceutical manufacturers to distribute drugs to an unlimited number of “contract pharmacies” since they were never mentioned in the law. Furthermore, the court found that HRSA did not adequately describe how 340B’s language enabled the government to require such conditions. Additionally, the court noted that in 1992 Congress briefly added in language about “contract pharmacies" but then removed it, which indicates contract pharmacies were deliberately not included.
In Novartis Pharmaceuticals Corp. v. Espinosa (No. 1:2021cv01479 (D.D.C. 2021)), Novartis filed a lawsuit against the federal government stating that HRSA’s attempt to regulate their sales through the use of violation letters violates the APA. [41] The U.S. District Court for the District of Columbia found that HRSA’s interpretation of 340B had changed over time despite HRSA’s argument that the violation letters were in “long standing interpretation of the statute.” Since HHS’s guideline language regarding contract pharmacies changed multiple times, Novartis’ decision to deny hospitals contracting with more than one contract pharmacy was in line with the 1996 guidelines (see section III.ii.a). [42] This ruling led to the conclusion that the violation letters were not viable.
Alternatively, some courts found the government was justified in its issuance of violation letters to pharmaceutical companies. In Eli Lilly & Co. v. U.S. HHS (No. 1:21-cv-00081-SEB-MJD (S.D. Ind. 2021)), the U.S. District Court for the Southern District of Indiana found that 340B’s plain language did not give drug manufacturers the ability to impose conditions on covered entities. Drug manufacturers could not restrict the number of contract pharmacies that covered entities utilized since the 340B statute gave them no ability to do so. Therefore, HRSA’s violation letters were upheld by the courts since they notified drug manufacturers of their inability to restrict the sale of their drugs to covered entities. Separately, but with the same outcome of ruling in favor of HRSA, the U.S. District Court of New Jersey, in Sanofi-Aventis US LLC v. U.S. HHS (No. 21-3167 (3d Cir. 2023)), the court found that the “shall offer” provision of the 340B statute did include contract pharmacies. This provision states that drug manufacturers must offer their drugs to covered entities. Furthermore, covered entities are not restricted in how they dispense the drugs they purchase. In contrast to the AstraZeneca case, this Court found that Congress’s addition and removal of “contract pharmacy” language did not mean contract pharmacies were intentionally not included. Additionally, HRSA’s guidance in 2010 stated covered entities could utilize an unlimited number of contract pharmacies, so drug manufacturers' restriction lawfully warranted violation letters from HRSA. [43]
ii. Sanofi-Aventis U.S. LLC v. HHS
a. Context
The aforementioned exponential growth of the 340B program, specifically the increase in contract pharmacies, has created a tense relationship between drug manufacturers and covered entities utilizing these pharmacies. In 1992, it was understood that since most hospitals lacked in-house pharmacies, they would purchase the drugs and then need to contract and send the drugs to outside pharmacies. In 1996, HHS amended its language to limit each covered entity to one contract pharmacy. However, in 2010, the HHS changed this number to “unlimited,” which led to a significant increase in contract pharmacies. [44] These changes to the 340B program over the last 30 years created significant concern amongst drug manufacturers. Specifically, drug manufacturers were concerned that the lack of oversight in the 340B program was contributing to billions of dollars worth of abuse via duplicate discounts. [45]
b. Actions Leading to Lawsuit
In response to the growing number of contract pharmacies and perceived lack of action to regulate their use, three drug makers decided to make their own policies in 2020. Sanofi-Aventis required covered entities using an unlimited number of contract pharmacies to provide claims data. Novo Nordisk required covered entities to receive approval if they planned to use multiple contract pharmacies. AstraZeneca required covered entities to use only one contract pharmacy. Following these announcements, HHS issued violation letters to these drug manufacturers stating the “shall offer” clause in 340B required these manufacturers to provide drugs to any contract pharmacies that a hospital chose to work with. [46] The drug manufacturers argued that these letters were arbitrary and capricious, and proceeded to file a lawsuit claiming that HHS violated the APA.
c. Litigation
The plaintiff (Sanofi-Aventis) stated that the plain language of 340B has no explicit requirement to deliver an unlimited number of drugs to contract pharmacies. Under their argument, the “shall offer” provisions do not include a requirement to deliver to contract pharmacies. In fact, there is no mention of “contract” pharmacies in 340B. [47] The defendant (HRSA) argued that requirements for manufacturers to sell and offer drugs include contract pharmacies since this language in 340B does not give pharmaceutical manufacturers the ability to restrict their sales. Additionally, HRSA stated that drug manufacturers' creation of policies to limit the sale of their drugs was illegal since 340B did not explicitly give manufacturers the ability to create these types of policies. Moreover, manufacturers are not given the ability to restrict sales under 340B, which may make the plaintiff’s actions illegal. Congress’s intention in creating the 340B program was to relieve safety net hospitals of the financial burden associated with purchasing prescription drugs, so HRSA was following its assigned mission by issuing letters. [48] HRSA argued that drug manufacturers' claim of the situs of delivery argument was irrelevant because the 340B statute only describes the sale of the drug to the hospital, but it does not dictate the delivery location (e.g. contract pharmacy). It is just required that the drug be sold to the covered entity. There is no requirement or direction on through which locations the hospital can choose to deliver and distribute the drugs. [49], [50]
d. Opinion of the Third Circuit
Ultimately, the court found that the government could not impose its interpretation of the statute onto drug manufacturers. Judge Bibas found that Section 340B did not explicitly mandate drug manufacturers to deliver drugs to an unlimited number of contract pharmacies as HRSA argued. The lack of explicit mention of contract pharmacies in 340B meant that drug manufacturers were not required to provide drugs in the manner HRSA required in its violation letters. Furthermore, legal precedent shows that in the past, Congress has been explicitly clear about specifying which groups a law applies to. Therefore, Congress’ lack of mentioning “contract pharmacies” should not be viewed as an oversight since Congress has explicitly stated which groups a law is applicable to in the past. Additionally, see section III.i for a description of Congress' removal of the term “contract pharmacy” from this law. Finally, 340B’s lack of specification of drugmakers’ ability to make policies does not therefore prohibit them from doing so.
IV. FUTURE IMPLICATIONS AND CONCLUSION
While Sanofi-Aventis U.S., LLC v. U.S. Department of Health and Human Services et al. resulted in a decision that sided with drug manufacturers, this case is just one of many ongoing 340B lawsuits. Various courts across the country have issued varying opinions about the meaning of 340B’s ambiguous language surrounding contract pharmacies. Since HHS is no longer subject to Chevron Deference (in existence at the time of many legal proceedings), future decisions will fall to the courts. [51] The lack of clarity in 340B’s text, which has allowed for such vastly different interpretations, could be fixed by Congressional action. If Congress were to amend the 340B statute to define contract pharmacies, ambiguity in the statute would be greatly reduced. [52] Specifically, GAO recommends that HRSA and CMS should increase their oversight to ensure there are no duplicate discounts. [53] Notably, in Fiscal Year 2026, the 340B program will be moved from HRSA to CMS. [54] This change in oversight should hopefully provide more manpower to oversee the 340B program.
As drug prices continue to rise and hospitals serving vulnerable communities struggle to get by financially, the existence of a prescription drug discount program will become increasingly critical. While these disagreements largely lie between contract pharmacies and drug manufacturers, it is the hospitals and their uninsured and low-income patients that are at greatest risk of suffering. Reducing a hospital’s ability to provide medication to its patients who are not able to pay the high costs associated with these drugs could have dangerous results for Americans. Congress must clarify the role of contract pharmacies in the 340B program. There is currently too much ambiguity in 340B’s language, which requires amendments by Congress to guide future oversight of this program and courts’ decisions. While the current statute is unclear, there is undoubtedly a current deficiency in oversight of this program, which has led to much of the concern surrounding lawsuits. In addition to clarification from Congress, there must be increased oversight and reporting standards for the 340B program to ensure that there are no duplicate discounts, patients are benefiting from hospitals’ savings, and the program is carrying out its intended purpose of supporting safety net hospitals with their extremely limited resources.
Endnotes
[1] Congress.gov. "Overview of the 340B Drug Discount Program." November 23, 2025. https://www.congress.gov/crs-product/IF12232.
[2] 340B HEALTH. “Detailed Overview - 340B Health.” 340bhealth.org, 2019. https://www.340bhealth.org/members/340b-program/overview/.
[3] Kristi Martin, “The 340B Drug Pricing Program: How It Works and Why It’s Controversial.” Commonwealthfund.org, August 6, 2025. https://doi.org/10.26099/210h-wv98.
[4] Martin, “340B Drug Pricing Program.”
[5] Congress.gov. "Overview of the 340B Drug Discount Program." November 23, 2025. https://www.congress.gov/crs-product/IF12232.
[6] American Hospital Association. “Fact Sheet: The 340B Drug Pricing Program | AHA.” www.aha.org, January 2025. https://www.aha.org/fact-sheets/fact-sheet-340b-drug-pricing-program.
[7] MACPAC. “May 2018 Advising Congress on Medicaid and CHIP Policy,” May 2018. https://www.macpac.gov/wp-content/uploads/2018/05/340B-Drug-Pricing-Program-and-Medicaid-Drug-RebateProgram-How-They-Interact.pdf.
[8] HRSA. “340B Eligibility | HRSA.” www.hrsa.gov, June 2024. https://www.hrsa.gov/opa/eligibility-andregistration.
[9] American Hospital Association. “Fact Sheet: The 340B Drug Pricing Program | AHA.” www.aha.org, January 2025. https://www.aha.org/fact-sheets/fact-sheet-340b-drug-pricing-program.
[10] Communications, NYU Web. “What Defines a Safety-Net Hospital?” www.nyu.edu, September 7, 2023. https://www.nyu.edu/about/news-publications/news/2023/september/safety-net-hospital.html.
[11] Hulver, Scott. “10 Things to Know about Rural Hospitals | KFF.” KFF, April 16, 2025. https://www.kff.org/healthcosts/10-things-to-know-about-rural-hospitals/.
[12] American Hospital Association. “Fact Sheet: The 340B Drug Pricing Program | AHA.” www.aha.org, January 2025. https://www.aha.org/fact-sheets/fact-sheet-340b-drug-pricing-program.
[13] Congress.gov. "Overview of the 340B Drug Discount Program." November 23, 2025. https://www.congress.gov/crs-product/IF12232.
[14] Congress.gov, “Overview of the 340B Drug Discount Program.”
[15] MACPAC. “May 2018 Advising Congress on Medicaid and CHIP Policy,” May 2018. https://www.macpac.gov/wp-content/uploads/2018/05/340B-Drug-Pricing-Program-and-Medicaid-Drug-RebateProgram-How-They-Interact.pdf
[16] Martin, 340B Drug Pricing Program.
[17] GAO. “Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement.” Gao.gov, 2018. https://www.gao.gov/products/gao-18-480.
[18] Jason Hardaway, “340B Program Puts Manufacturers at Risk of Duplicate Drug Discounts.” Pharmacy and Therapeutics 41, no. 1 (2016): 38. https://pmc.ncbi.nlm.nih.gov/articles/PMC4699484/.
[19] Congress.gov, “Overview of the 340B Drug Discount Program.”
[20] Martin, “340B Drug Pricing Program.”
[21] Congress.gov, “Overview of the 340B Drug Discount Program.”
[22] GAO, “Drug Discount Program.”
[23] Congress.gov, “Overview of the 340B Drug Discount Program.”
[24] Martin, “340B Drug Pricing Program.”
[25] Martin, “340B Drug Pricing Program.”
[26] MACPAC, “Advising Congress on Medicaid and CHIP Policy.”
[27] MACPAC, “Advising Congress on Medicaid and CHIP Policy.”
[28] Gugu Ntsele, “Understanding the Public Health Service Act (PHSA) and HIPAA.” Paubox.com. Paubox, April 18, 2025. https://www.paubox.com/blog/understanding-the-public-health-service-act-phsa-and-hipaa.
[29] HRSA. “340B Patient Definition Compliance Resources | HRSA.” www.hrsa.gov, January 2024. https://www.hrsa.gov/opa/educational-resources/patient-definition-resources.
[30] George Bush, “Statement on Signing the Veterans Health Care Act of 1992 | the American Presidency Project.” Ucsb.edu, 2025. https://www.presidency.ucsb.edu/documents/statement-signing-the-veterans-health-care-act-1992.
[31] Congress.gov. “H.R.5193 - 102nd Congress (1991-1992): Veterans Health Care Act of 1992.” Congress.gov, 2025. https://www.congress.gov/bill/102nd-congress/house-bill/5193.
[32] Legal Information Institute. “Administrative Procedure Act.” LII / Legal Information Institute, n.d. https://www.law.cornell.edu/wex/administrative_procedure_act.
[33] Congress.gov. "A Brief Overview of Rulemaking and Judicial Review." November 23, 2025. https://www.congress.gov/crs-product/R41546.
[34] Jack Beermann, “Chevron Deference Is Dead, Long Live Deference.” SSRN Electronic Journal, 2024. https://doi.org/10.2139/ssrn.4907206.
[35] Medicaid.gov. “Medicaid Drug Rebate Program (MDRP) | Medicaid.” Medicaid.gov, 2022. https://www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program.
[36] MACPAC. “Advising Congress on Medicaid and CHIP Policy.”
[37] Medicaid.gov. “Medicaid Drug Rebate Program (MDRP) | Medicaid.” Medicaid.gov, 2022. https://www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program.
[38] MACPAC. “Advising Congress on Medicaid and CHIP Policy.”
[39] Tom Mirga, “Appeals Court Consolidates AstraZeneca, Sanofi, and Novo Nordisk’s 340B Contract Pharmacy Cases.” 340B Report, May 3, 2022. https://340breport.com/appeals-court-consolidates-astrazeneca-sanofi-and-novonordisks-340b-contract-pharmacy-cases/?utm_source=chatgpt.com.
[40] Dorthula Powell-Woodson and Brooke DeLoatch, “Manufacturers Are ‘Winning’ in the 340B Drug Discount Dispute.” wileyrein, 2024. https://www.wiley.law/alert-Manufacturers-Are-Winning-in-the-340B-Drug-DiscountDispute?utm_source=chatgpt.com.
[41] Novartis Pharmaceuticals Corporation V. Espinosa et al, No. 1:2021cv01479 (D.D.C. 2021).
[42] Congress.gov. "Courts Evaluate the Role of Contract Pharmacies in the 340B Drug Discount Program." November 23, 2025. https://www.congress.gov/crs-product/LSB10842.
[43] Congress.gov. “Courts Evaluate the Role of Contract Pharmacies.”
[44] Sanofi-Aventis U.S., LLC v. Department of Health & Human Services et al., No.21-3167 SB, (3d Cir., Jan. 30, 2023).
[45] O'Neill Institute. “Sanofi-Aventis U.S., LLC v. Department of Health & Human Services et Al. - Health Care Litigation Tracker.” Health Care Litigation Tracker, November 6, 2025. https://litigationtracker.law.georgetown.edu/litigation/sanofi-aventis-v-us-department-of-health-human-service/.
[46] Sanofi-Aventis U.S., LLC v. Department of Health & Human Services et al., No.21-3167
[47] Congress.gov. “Courts Evaluate the Role of Contract Pharmacies.”
[48] Congress.gov. “Courts Evaluate the Role of Contract Pharmacies.”
[49] Sanofi-Aventis U.S., LLC v. Department of Health & Human Services et al., No.21-3167 SB.
[50] Bernard Bell, “Resurrecting the Dead: Sanofi Aventis v. HHS - Yale Journal on Regulation.” Yale Journal on Regulation, February 10, 2023. https://www.yalejreg.com/nc/resurrecting-the-dead-sanofi-aventis-v-hhs/.
[51] Bernard Bell, “Resurrecting the Dead”
[52] Congress.gov. “Overview of the 340B Drug Discount Program.”
[53] Congress.gov. “Overview of the 340B Drug Discount Program.”
[54] Martin, “The 340B Drug Pricing Program.”