Regulatory & Reimbursement Newsletter

Biocom California unveiled user fee infographics for PDUFA VII, MDUFA V, and BsUFA III. The FDA hosted its annual rare disease day, a prominent FDA director announced his retirement, and the agency recently released a new funding opportunity for pediatric medical devices. CMS held a MEDCAC meeting to review coverage with evidence development requirements, and CMMI plans to test three drug payment models in response to the administration’s executive order on lowering prescription drug costs.

Biocom California has responded to the White House’s recent Request for Information on the biotechnology and biomanufacturing initiative. The FDA has released a report highlighting last year’s novel drug approvals, CDER and CBER are resuming some in-person face-to-face meetings, and a final rule has been published with updates to radiological health regulations. CMS has announced key dates for the first year of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act and the agency has engaged stakeholders to provide more feedback on its Discarded Drug Refund Policy.

With its Broad Agency Announcement Day near, the FDA has published initiatives for advancing regulatory science research and development. The agency’s Cybersecurity Modernization Action Plan has been released, and in a recent report the FDA highlighted its successful use of computational modeling and simulation for regulatory decision making.

The FDA has started implementing its PDUFA, MDUFA, and BsUFA commitments. HHS has announced efforts to create a new National Biodefense Strategy and the Biden administration wants to take additional action to lower prescription drug costs. CMS has finalized its CY 2023 Physician Fee Schedule and has shared the principles that will be used to develop an accelerated coverage pathway for medical devices.

With just days to spare before the end of the fiscal year, the FDA’s user fee agreements have been reauthorized for another five years. The agency has been busy updating a COVID-19 EUA guidance document and finalizing a highly anticipated digital health guidance and proposed rule on investigational drug reporting requirements. Biosimilars may see a temporary increase in Medicare payments while Medicare’s telehealth services have been under review by the U.S. Government Accountability Office.

Biocom California’s advocacy efforts are in full swing with the submission of two new comment letters to federal agencies and with the opposition of drug pricing provisions in the Inflation Reduction Act. Updated COVID vaccine booster doses will be available this fall while N95 respirators are no longer in short supply. The FDA has had a busy month issuing a historic final rule and releasing data on pharmaceutical drug and site quality.

The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have had a busy summer with the release of multiple draft guidance documents and proposed rules. We are seeing a transition away from COVID-19 policies by the FDA while CMS is proposing payment adjustments for domestic NIOSH-approved N95 respirators. Regulatory and reimbursement policies are shifting with our evolving public health landscape.