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DEA Announces Proposed Expansion of Controlled Substance Monitoring Requirements

On November 2, 2020, the Drug Enforcement Administration (“DEA”) issued a notice of proposed rulemaking expanding the obligations of DEA registrants to monitor and report suspicious orders for controlled substances (the “Proposal”). The Proposal sets forth a two-option framework for reviewing and reporting suspicious orders, adds new reporting and recordkeeping requirements, and expands the scope of suspicious order monitoring obligations to cover certain hospitals, practitioners and other dispensers. Notably, the Proposal asserts that those hospitals, practitioners and dispensers should already be in compliance with the purported requirements.

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Proposed Legislation Would Authorize FDA To Approve Follow-on Biologics


Time to Read: 1 minutes Practices: Life Sciences

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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.

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