Legislation Introduced to Require Controlled Substance Providers Complete…
On July 15, 2021, Senator Ed Markey introduced S. 2354 – Safer Prescribing of Controlled Substances Act. The bill, cosponsored by…
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Yearly Archives
2021
FDA Releases Draft Guidance on Sponsor Safety Reporting Requirements
Earlier this summer, the United States Food and Drug Administration (FDA) released updated draft guidance for sponsors on safety…
Government Intervenes in False Claims Act Suit Against Kaiser
On July 30, 2021, the United States Department of Justice (DOJ) announced that it was intervening in six complaints against Kaiser…
Xavier Becerra Supports Continued Use of Telehealth
During an interview with The Washington Post, Xavier Becerra, Secretary of the Department of Health and Human Services (HHS),…
Interim Final Rule Released on Surprise Billing and Out-of-Network Charges
The Biden administration has released an interim final rule that bans surprise billing and certain out-of-network charges,…
Pfizer Agrees to Pay $345 Million to Resolve EpiPen Anti-Competitive…
In mid-July 2021, Pfizer, Inc. and two of its subsidiaries, Meridian Medical Technologies and King Pharmaceuticals, agreed to pay…
Most Hospitals Not Abiding by Transparency Rule
In mid-June, JAMA published a study that found that a majority of hospitals are not complying with the transparency rule finalized…
Congress to Investigate Aduhelm Approval
The controversial approval of Biogen’s Alzheimer’s drug, Aduhelm, has propelled investigations in at least two Congressional…
August 2021 Issue P&M Compliance Update features interview with…
Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth…
Discussion Draft for Cures 2.0 Starts Making the Rounds
Four years after the 21st Century Cures Act was signed into law, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) recently…