The Latest in Regulatory and Reimbursement

The FDA launched a new CDER Center of Excellence and OCE Equity Program. The agency also released a final guidance on device remanufacturing and jointly issued an updated biotechnology regulatory plan alongside the EPA and USDA. CMS published its draft guidance for the next round of Medicare Drug Price “Negotiations” and the agency announced that a proposed “stacking” provision under the Medicaid Drug Rebate Program will not be finalized.

CDER Launches New Center of Excellence

FDA’s CDER recently established the Quantitative Medicine (QM) Center of Excellence to lead QM-related policy development and best practices to facilitate the consistent use of QM approaches during drug development and regulatory assessment.

Final Device Remanufacturing Guidance Released

The FDA released its final guidance on the Remanufacturing of Medical Devices, distinguishing between remanufacturing and servicing. The agency is hosting a webinar on June 27 for those interested in learning more about the guidance.

New Oncology Center of Excellence Equity Program

FDA’s Oncology Center of Excellence recently launched its Equity Program aimed at increasing the representation of racial and ethnic minorities, rural populations, sexual and gender minorities and individuals with healthcare barriers in trials.

FDA, EPA, USDA Issue Biotech Regulatory Plan

Last month, the FDA, EPA and USDA issued a regulatory plan updating the Coordinated Framework and clarifying their oversight of biotechnology products, including modified plants, animals, microorganisms and drugs, biologics and devices.

Proposed “Stacking” Provision Will Not Be Finalized 

In a recent update on the Medicaid Drug Rebate Program proposed rule, CMS noted that it will not finalize the proposed “stacking” provisions which would require a manufacturer to “stack” discounts to determine a final drug price.

Draft Guidance for Next Round of Drug Price “Negotiations” 

CMS released its draft guidance for price applicability year 2027 that details new and updated policies for the second cycle of “negotiations” for the Medicare Drug Price Negotiation Program. The next 15 Part D drugs will be selected by February 1, 2025.

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