On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA....more
After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs.
If finalized as proposed, FDA would implement a new...more
On September 29, 2023, the U.S. District Court for the District of Columbia vacated a Trump-era rule from 2021 that allowed insurers to exclude drug manufacturer co-pay support coupons and assistance from a patient’s annual...more
On October 3, 2023, the U.S. Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). The proposed rule and policy are the latest in an over...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
10/2/2023
/ Biologics ,
Clinical Trials ,
Compliance ,
Diagnostic Tests ,
Draft Guidance ,
EU ,
European Medicines Agency (EMA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Marketing ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Public Consultations ,
Regulatory Oversight ,
Regulatory Requirements ,
UK
On September 29, 2023, the U.S. Food and Drug Administration (FDA) posted and scheduled for publication its long-awaited proposed rule concerning FDA regulation of laboratory developed tests (LDTs). If enacted, the proposed...more
Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President (“OIRA”) has held stakeholder meetings regarding a proposed rule which, if enacted,...more
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program has now officially kicked off. Earlier today (August 29, 2023), the White House announced the list of the first 10 selected drugs under the program, prior...more
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. The statute sets a deadline of September 1, 2023 for the Secretary of Health and Human Services (HHS) to publish a list of the 10...more
As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more
6/30/2023
/ Biologics ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Marketing ,
Marketing Authorization Application ,
Med Tech ,
Medicaid ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs
The Supreme Court recently issued a significant decision clarifying what it means to “knowingly” submit a false claim under the False Claims Act. At issue in United States ex rel. Schutte v. SuperValu Inc. were allegations...more
6/6/2023
/ Discount Pricing ,
Drug Pricing ,
False Claims Act (FCA) ,
Federal Contractors ,
Fraud ,
Medicaid ,
Medicare ,
Mens Rea ,
Objective Standard ,
Petition for Writ of Certiorari ,
Pharmacies ,
Prescription Drugs ,
Safeco Insurance Co of America v Burr ,
Scienter ,
SCOTUS ,
Subjective Standard ,
US ex rel Tracy Schutte et al v SuperValu Inc et al ,
Willful Violations
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data.
Companies that once only developed hardware-based solutions for...more
5/26/2023
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Compliance ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Information Blocking Rules ,
Intellectual Property Protection ,
Med Tech ,
Medical Devices ,
Patent-Eligible Subject Matter ,
Popular ,
Safe Harbors ,
Software
For a healthcare or life sciences company settling a government enforcement action, the prospect of being subject to an independent monitor, independent review organization (IRO), or other government-mandated compliance...more
On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an initial guidance memorandum on the Medicare Drug Price Negotiation Program (Negotiation Program) created by the Inflation Reduction Act of 2022...more
On February 14, 2023, the U.S. Department of Health and Human Services (HHS) published a report identifying three models that the Center for Medicare & Medicaid Services’ (CMS) Center for Medicare & Medicaid Innovation (CMMI)...more
As part of a recent series of announcements regarding updates to its corporate compliance policies, the Department of Justice (DOJ) announced significant revisions to its evaluation criteria for corporate compliance programs,...more
3/8/2023
/ Chief Compliance Officers ,
Clawbacks ,
Compliance ,
Corporate Crimes ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Electronic Communications ,
Enforcement Priorities ,
Executive Compensation ,
Monaco Memo ,
White Collar Crimes
On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released initial program guidance addressing the inflation rebate provisions of the Inflation Reduction Act of 2022 (IRA). These provisions apply to how...more
2/24/2023
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Inflation Adjustments ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Prescription Drugs ,
Proposed Guidance ,
Rebates ,
Section 340B
On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released initial program guidance on the inflation rebate provisions of the Inflation Reduction Act of 2022 (IRA). These provisions apply to how Medicare...more
On January 30, 2023, the Court of Appeals for the Third Circuit issued a precedential decision rejecting a policy of the Department of Health and Human Services (HHS) in implementing the 340B Program. Under that policy, HHS...more
The Inflation Reduction Act’s (“IRA”) drug price negotiation provisions have captured the pharmaceutical and biotech industry’s attention. In part, the IRA allows the Centers for Medicare & Medicaid Services (“CMS”) to...more
1/27/2023
/ Biologics ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Medicare Part B ,
Medicare Part D ,
Negotiations ,
OMB ,
Prescription Drugs ,
Public Comment
The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 ( “PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once signed into law, this legislation will...more
The U.S. Food and Drug Administration’s (“FDA” or “the Agency”) Center for Devices and Radiological Health (“CDRH”) recently announced the launch of its Total Product Life Cycle Advisory Program (“TAP”) Pilot. The first phase...more
Under the Affordable Care Act, group health plans and health insurance issuers are required to provide health insurance coverage based on recommendations made by healthcare coverage professionals. The covered categories...more
On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more
8/10/2022
/ Civil Monetary Penalty ,
Drug Pricing ,
Enforcement ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pending Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rebates ,
Secretary of HHS
Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP) has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more
8/5/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Funding ,
Medicaid ,
Medicaid Drug Rebate Program ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Section 340B