Alert

Recommended Alerts

Sign Up For Alerts

CMS Issues Final Rule Redefining Medicare Part D “Negotiated Price” As Pharmacy’s Lowest Possible Reimbursement

On April 29, 2022, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule revising the way Medicare determines the “negotiated price” (i.e., the price upon which beneficiary cost-sharing is based at the pharmacy counter) under Medicare Part D.

Read More

Proposed Legislation Would Authorize FDA To Approve Follow-on Biologics


Time to Read: 1 minutes Practices: Life Sciences Industries: Biotechnology & Pharmaceuticals

Printer-Friendly Version

The "Access to Life-Saving Medicine Act," introduced in late September, would authorize the Food and Drug Administration to approve follow-on biologics that closely resemble previously approved biological products. In its current version, the bill provides manufacturers of follow-on biologics with virtually everything they could ask for. The bill gives FDA substantial discretion to approve follow-on biologics and, in sharp contrast to the current legislative scheme governing drugs, the bill would not afford innovator companies any period of marketing exclusivity whatsoever for their biologic products. As a result, the manufacturers of previously approved biological products would be well-served to follow the forthcoming legislative debate on this issue very closely. For more on the bill and its various provisions, please click "Download PDF" to read Ropes & Gray's client alert.

Printer-Friendly Version

Cookie Settings