News & Analysis as of

Department of Health and Human Services (HHS) REMS

ArentFox Schiff

Modified REMS, Clarification on Mailing Drugs, and Movement in Texas Case Mark Significant Weeks in the Reproductive Health Legal...

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With the approval of the modified mifepristone Risk Evaluation and Mitigation Strategy (REMS), it has been a momentous few weeks in the reproductive health legal space. Modification to the REMS for Mifepristone - ...more

ArentFox Schiff

New Challenge to Abortion Access Takes on FDA Drug Approvals

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On November 18, 2022, a collection of organizations and providers that oppose abortion filed suit against the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS), seeking — among...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest - January 2019 #3

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Commissioner Gottlieb Welcomes Furloughed Staff Back to Work - The Food and Drug Administration (FDA) commissioner tweeted, “We’re making plans to welcome back all our employees who’ve been on furlough. I hope to...more

BakerHostetler

Capitol Hill Healthcare Update

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RYAN SAYS POTENTIAL COMPROMISE COMING ON RISK EVALUATION AND MITIGATION STRATEGY DRUGS - House Speaker Paul Ryan, R-Wis., last week said congressional leaders are trying to hammer out compromise legislation that would make it...more

WilmerHale

FDA Publishes List of Drug Companies Accused of Hindering Generic Entry: Antitrust Implications

WilmerHale on

Today, as part of the Trump Administration's stated goal to lower drug prices, the Food and Drug Administration (FDA) published a list of pharmaceutical companies that have allegedly refused to sell samples of their drugs to...more

Holland & Knight LLP

Administration Releases Blueprint to Lower Drug Prices, Reduce Out-of-Pocket Costs

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• "American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs" outlines actions that the Administration proposes to lower prescription drug prices. • The plan includes...more

Mintz - Health Care Viewpoints

President Trump Delivers Much Anticipated Drug Pricing Speech

On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs....more

Cooley LLP

Blog: Administration Releases Long-Awaited Drug Pricing Reform Plan

Cooley LLP on

The President and Health and Human Services (HHS) Secretary Alex Azar unveiled a 44-page Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, designed to bring “soaring drug prices back down to earth.” The President...more

BakerHostetler

Capitol Hill Healthcare Update

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Congress is expected this week to approve a fifth stopgap budget bill to keep the government open in advance of a Thursday shutdown deadline, and key healthcare provisions could be included in the budget package. If...more

Alston & Bird

Alston & Bird Healthcare Week In Review

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On January 22, 2018, the Drug Enforcement Administration (DEA) issued a final rule entitled, Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs...more

Alston & Bird

Alston & Bird Healthcare Week In Review

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On January 16, 2018, the Food and Drug Administration (FDA) issued a proposed rule entitled, Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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On December 11, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements. The guidance clarifies the requirements for...more

BakerHostetler

Capitol Hill Healthcare Update

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Lawmakers last week approved a stopgap budget bill to keep the government open until Dec. 22, creating a pre-Christmas showdown over a host of spending decisions and key healthcare priorities. Republican leaders on Capitol...more

Cooley LLP

Blog: OIG Releases October Work Plan Items; Includes Opioid REMS and Specialty Drug Coverage and Medicare Reimbursement

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As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The October updates include 5 new Work Plan items...more

BakerHostetler

Capitol Hill Healthcare Update

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Senate Republicans face a key procedural vote this week that would allow for debate of their healthcare legislation, but significant uncertainty remains about whether GOP senators can meet that procedural hurdle, what the...more

BakerHostetler

Capitol Hill Healthcare Update

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House Speaker Paul Ryan’s decision to cancel Friday’s vote on the American Health Care Act triggered post-mortem jockeying among vying GOP factions struggling to come to grips with how the party failed to repeal a law it has...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Congress and the administration focus on the opioid addiction epidemic... Override of the president’s veto of legislation that would have repealed the Affordable Care Act fails, to no one’s surprise... Senate...more

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