As part of a broader resurgence in pharmaceutical pricing reform and manufacturing policies in 2025, President Donald Trump and bipartisan congressional leaders have introduced contemporaneous proposals to lower prescription...more
Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a perennial focus of stakeholders...more
The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security...more
4/24/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicare ,
National Security ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Prescription Drugs ,
Supply Chain
Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose...more
Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more
In honor of Rare Disease Day on February 28, 2025, Morgan Lewis is publishing a series of posts on As Prescribed and Health Law Scan throughout the month of February on issues impacting the rare disease community....more
Through the issuance of Inauguration Day executive orders, the Trump Administration signaled its apparent intent to tackle drug pricing reforms over the next four years. However, Biden-era policies are likely to limit a...more
Heading into the new year, a Trump-Vance administration will control the White House and the Republicans will hold a narrow majority in both the House and Senate. This control trifecta is likely to impact both legislative and...more
12/5/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Beneficiaries ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Section 340B ,
Trump Administration
Bipartisan efforts to lower prescription drug costs remains a core focus for the US Congress. Effective October 1, 2024, the Centers for Medicare and Medicaid Services (CMS) has announced the follow-on cohort for its...more
340B litigation remains full speed ahead. Manufacturer and covered entity (CE) disputes, not all of which are being actively litigated, include, but are not limited to, federal and state regulation of contract pharmacies,...more
In response to rising prescription costs and overall state-level healthcare spending, numerous states, including Maryland and Oregon, have established prescription drug affordability review boards (PDABs) to review certain...more
While audits are part of doing business in the ordinary course, businesses are generally less than eager to open the books. And the same is true when it comes to the 340B Drug Pricing Program. Audits are now making the list...more
Through its passage, the Inflation Reduction Act (IRA) ushered in several reforms directed at rising prescription drug costs, aiming to lower costs for Medicare enrollees and reduce spending by the federal government....more
In what can only be characterized as a necessary but significant proposed departure from current political initiatives focused on lowering pharmaceutical drug prices, the Centers for Medicare & Medicaid Services (CMS)...more
Medicare Part B enrollees as of July 1, 2024 will experience savings on coinsurance for 64 drugs selected by the Biden administration. Pursuant to the Inflation Reduction Act and its Medicare Prescription Drug Inflation...more
Pharmaceutical drug pricing and reimbursement continues to make headlines nationwide. In a recent development, Maryland’s Prescription Drug Affordability Board (PDAB) finalized its list of selected drugs for affordability...more
In what is being touted as a significant win for pharmaceutical drug manufacturers, the DC Circuit affirmed on May 21, 2024 that Section 340B of the Public Health Service Act does not categorically prohibit manufacturers from...more
The Centers for Medicare & Medicaid Services on May 3, 2024, released its draft guidance on administration of the Medicare Drug Price Negotiation Program for initial price applicability year 2027. The program—established by...more
At a time when pharmaceutical drug prices are at the height of political scrutiny, manufacturers can breathe a small sigh of relief as the Centers for Medicare and Medicaid Services (CMS) announced on May 15, 2024 that it...more
2024 is shaping up to be a big year for prescription drug affordability boards (PDABs). Like state price transparency reporting laws, state legislation establishing PDABs continues expansion. In response to rising...more
Effective April 1, 2024, California will expand its existing prescription drug price transparency requirements by enacting legislation to amend and clarify requirements on wholesale acquisition cost increase reporting and...more
The US District Court of Delaware recently ruled against AstraZeneca in its case challenging the constitutionality of Medicare’s new Drug Price Negotiation Program (the Program). The court, in granting the federal...more