Category: Regulatory/FDA

Regulatory/FDA

Regulatory/FDA

FDA Accelerated Approval Program Is Under Spotlight Again with Makena

FDA Accelerated Approval Program Is Under Spotlight Again with Makena

Oct. 28, 2022 – The Food and Drug Administration’s (FDA’s) accelerated approval process is being scrutinized anew following a recent FDA advisory committee recommendation to remove from the market Covis Pharma’s Makena, a drug that received an accelerated approval in 2011 to help prevent pre-term births. According to a September report from the Office of […]

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Regulatory/FDA

OPDP: Risk, Efficacy Claims for Cholesterol Drug in Doctor Promotion Are False/Misleading

OPDP: Risk, Efficacy Claims for Cholesterol Drug in Doctor Promotion Are False/Misleading

June 27, 2022 – False or misleading claims and representations in a professional promotion about the efficacy and risks of a prescription drug for high cholesterol are cited in a June 2 Untitled Letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to Althera Pharmaceuticals LLC. OPDP reviewed a “Doctor […]

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Regulatory/FDA

HHS Formally Withdraws SUNSET Final Rule

HHS Formally Withdraws SUNSET Final Rule

June 20, 2022 – The Department of Health and Human Services (HHS) has formally withdrawn a Trump administration rule that threatened to cause many HHS regulations to expire. HHS announced its decision in a recent 133-page withdrawal notice in the Federal Register, stating that the “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) final rule […]

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Regulatory/FDA

OPDP Reorg, Outreach Efforts Designed to Improve Relationship with Industry

OPDP Reorg, Outreach Efforts Designed to Improve Relationship with Industry

June 13, 2022 – From a staff reorganization to a monthly newsletter to increased collaborations with stakeholders, in 2022 the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) – under the direction of Dr. Catherine “Katie” Gray – has made a series of organizational and communications moves to make OPDP both more transparent […]

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Regulatory/FDA

OPDP to Study Risk/Benefit Tradeoff Decisions Made by Consumers, Physicians

OPDP to Study Risk/Benefit Tradeoff Decisions Made by Consumers, Physicians

May 31, 2022 – Understanding the tradeoffs among desirable and undesirable drug product characteristics that consumers and their treating physicians make “will provide valuable insight into the relevance and impact of various product attributes and promotional claims on informed choices and treatment decisions,” according to the Food and Drug Administration’s Office of Prescription Drug Promotion […]

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DTC Advertising

Presentation of Risks in DTC Video, HCP Webpage Yields Enforcement Letter for Bausch Health

Presentation of Risks in DTC Video, HCP Webpage Yields Enforcement Letter for Bausch Health

April 18, 2022 – A recent enforcement letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to Bausch Health Companies Inc. takes issue not only with omission of risk information in a direct-to-consumer (DTC) video and a webpage of a healthcare professional website, but also with a lack of balance […]

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Regulatory/FDA

CMS Sticks to Plan: No Aduhelm Coverage Unless in Clinical Trial

CMS Sticks to Plan: No Aduhelm Coverage Unless in Clinical Trial

April 12, 2022 – Despite roughly 10,000 public comments and intense lobbying regarding a draft national coverage determination for the controversial Alzheimer’s drug Aduhelm, last week the Centers for Medicare and Medicaid Services (CMS) announced it will retain the proposal’s coverage plan: Medicare will only fund prescriptions of Aduhelm for patients enrolled in randomized, controlled […]

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Regulatory/FDA

OPDP To Study DTC Website Promotion of Accelerated Approval Drugs

OPDP To Study DTC Website Promotion of Accelerated Approval Drugs

March 28, 2022 – As FDA Commissioner Robert Califf, M.D., determines how to fulfill his promise to re-examine the agency’s accelerated approval pathway and Congress continues to push for action, the FDA’s Office of Prescription Drug Promotion (OPDP) is tackling one piece of the puzzle: How well consumers understand the limitations of accelerated approval drugs […]

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Regulatory/FDA

Myers: Data Will Drive Califf’s Decisions at FDA

Myers: Data Will Drive Califf’s Decisions at FDA

March 14, 2021 – Nearly a month after being sworn in for the second time as Food and Drug Administration (FDA) Commissioner, Robert Califf, M.D., has a lot on his plate, including the ongoing COVID-19 pandemic — and lessons learned about processes and the harms of misinformation – as well as a call for clinical […]

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Regulatory/FDA

Fallout from Aduhelm Decision Could Undermine FDA Accelerated Approval Process

Fallout from Aduhelm Decision Could Undermine FDA Accelerated Approval Process

March 7, 2022 – Newly appointed Food and Drug Administration Commissioner Robert Califf, M.D., who is returning to the position he briefly held during the Barack Obama administration, faces a daunting challenge as he begins anew: coming to terms with how the agency’s controversial accelerated approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease affects […]

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