Healthcare

Long-Awaited DSCSA Guidances Published

On June 3, the Food and Drug Administration (FDA) released four  guidances implementing the Drug Supply Chain Security Act (DSCSA). Final Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification  (Suspect Product Final Guidance) Final Guidance for Industry: Product Identifiers under the Drug Supply Chain Security Act – Questions …

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FDA Reverses Trump Administration’s Unapproved Drugs Policy

On May 26, the Food and Drug Administration (FDA) reversed a Trump Administration policy that revoked the agency’s longstanding Unapproved Drugs Initiative (UDI).  On November 15, 2020, then HHS Secretary Alex Azar issued a notice and a request for information entitled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for Information Regarding …

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FDA Reverses a Trump Administration Drug Review Transparency Policy

On April 30, the Food and Drug Administration (FDA) reversed a  Policy issued by the Department of Health and Human Services (HHS) near the end of the Trump Administration that was purportedly intended to increase drug review timeline transparency.  The Policy was announced in the Federal Register on January 15 and would have required FDA …

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Federal Trade Commission Announces New Multilateral Working Group to Examine Pharma Mergers

On March 16, Rebecca Kelly Slaughter, the Acting Chair of the Federal Trade Commission (FTC) announced that the agency will create a working group to revise its approach used to analyze the effects of pharmaceutical mergers. The group will include the Department of Justice’s Antitrust Division, state attorneys general, and foreign antitrust agencies including the …

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Health Groups Sue HHS in Response to Trump Administration’s “Sunset Rule”

On March 9, several health groups including the American Lung Association and the Center for Science in the Public Interest joined Santa Clara County, California and other advocacy groups in a lawsuit against the Department of Health and Human Services (HHS) over the Trump administration’s “sunset rule” in the U.S. District Court for the Northern …

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CDRH Cracks Down on Misleading “Registration Certificates”

On March 3, Rear Admiral Sean Boyd, Director of the Office of Regulatory Programs at the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced an uptick in firms selling and issuing fraudulent “FDA registration certificates” which indicate that a medical device has been authorized, approved, cleared, or reviewed by the …

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Janet Woodcock is Named Acting FDA Commissioner, As Stephen Hahn Steps Down

In typical fashion, as the new administration took over, i.e., as President Biden was sworn in on Wednesday, Dr. Stephen M. Hahn resigned as FDA Commissioner.  His resignation was part of the routine departure of political appointees seen when a new President takes office. Dr. Janet Woodcock has become Acting Commissioner on an interim basis, …

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HHS’s Last Ditch Policy Moves – What is the End Game?

Earlier this month, the Department of Health and Human Services (HHS) published a proposed rule that would require sunset dates for its regulations, including regulations under its agencies like the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). The proposed rule, “Securing Updated and Necessary Statutory Evaluations Timely,” flew …

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FDA announces enforcement discretion and 3-year delay in DSCSA Requirements for Wholesale Distributors and Dispensers

This week, the Food and Drug Administration (FDA) announced release of a new guidance for immediate implementation that extends for another 3 years, until November 27, 2023, its enforcement discretion regarding verification of a prescription drug returns prior to resale.  FDA also announced that it is delaying until November 27, 2023, its requirement that pharmacies …

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QHC for Cranberry Products and Reduced Risk of Recurrent Urinary Tract Infection in Healthy Women

FDA has published a letter of enforcement discretion, which it sent to legal counsel for Ocean Spray Cranberries, Inc., that authorizes a qualified health claim (QHC) for specific cranberry products when consumed in specific amounts by specific people. The substantiation for the diet-disease relationship warranted a “limited and inconsistent” or “limited” scientific evidence qualifier. Based on …

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