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Reed Diskey

FDA Reverses Trump Administration’s Unapproved Drugs Policy

FDA, Healthcare, Life Sciences /

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

FDA, Healthcare, Life Sciences /

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

Healthcare /

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”

Healthcare, Government Relations, Public Policy /

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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The American Rescue Plan Act of 2021—What’s in It for CDC and FDA?

FDA /

On March 10, the House passed the Senate-amended version of the American Rescue Plan Act of 2021 (H.R. 1319), a $1.9 trillion COVID-19 relief package intended to address the impact of the pandemic on the economy, state and local governments, and individuals.  The package contains public health provisions intended to boost COVID testing and contact

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CDRH Cracks Down on Misleading “Registration Certificates”

FDA, Healthcare /

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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President Biden Revokes Trump Administration’s Executive Orders

Government Relations /

On February 26, President Biden issued Executive Order (EO) 14018, which revoked a number of EOs and Declarations issued during the Trump Administration.  The orders revoked include: Executive Order 13772—Core Principles for Regulating the United States Financial System.  This EO outlined the Trump Administration’s financial regulatory principles and required the Department of Treasury to review

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Biden Administration Releases Executive Order on America’s Supply Chains

Food Distribution & International Trade /

Throughout the COVID-19 pandemic, Americans have experienced shortages of essential products including food, medicine, personal protective equipment, and components used for manufacturing.  In response, on February 24, the Biden Administration issued an Executive Order (EO) on America’s Supply Chains to ensure resilient and secure supply chains for critical and essential goods.  The goal of the

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What’s Next for Neera Tanden?

Government Relations /

On November 30th, President Joe Biden nominated Neera Tanden to lead the Office of Management and Budget (OMB), the largest office within the Executive Office of the President tasked with producing the President’s Budget Request, reviewing rules and regulations, and coordinating policy initiatives across multiple agencies.  Ms. Tanden currently leads the Center for American Progress

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A big pile of bulk blue medical masks

FDA Issues Warning Letters Targeting COVID-19 (and other) Products

FDA /

Since the COVID-19 pandemic began to intensify in March 2020, the Food and Drug Administration (FDA) has sent warning letters to 146 manufacturers of products claiming to prevent, treat, mitigate, diagnose or cure coronavirus.  These products range from teas, tinctures, test kits, soaps, supplements, and CBD products.  In January, the FDA’s Office of Criminal Investigations

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Candidates Emerge to Lead FDA

FDA /

As the Biden Administration settles into Washington and works to address the COVID-19 pandemic, many medical products and food safety stakeholders wonder who will lead the Food and Drug Administration.  Janet Woodcock, M.D. who long led the Center for Drug Evaluation and Research (CDER) and advised “Operation Warp Speed” on COVID-19 therapeutics currently serves as

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Food and Drug Administration building

FDA Funding in the Energy & Commerce Reconciliation Bill

FDA, Government Relations /

House Energy & Commerce Committee Chairman Frank Pallone (D-NJ) announced that the committee will hold a markup on Thursday at 11:00 AM ET to consider legislative recommendations for its budget reconciliation instructions.  Section 3004 of the bill provides $500 million to the Food and Drug Administration to combat the COVID-19 pandemic by: Supporting the review

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Kenneth Ackerman

HHS Releases HIPAA Security Rule Risk Assessment Tool

FDA, Health Care /

The Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR), Office of the National Coordinator for Health Information Technology (ONC), and Office of the General Counsel (OGC), have released their Security Risk Assessment (SRA) tool.  The SRA tool is designed to assist Covered Entities and their Business Associates (BA) ensure compliance with

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