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Rx Drugs

December 11, 2018 | Daily News

FDA on Tuesday (Dec. 11) issued a proposed rule and a batch of guidance documents aimed at spurring biologics competition by bringing more biosimilars to market.

December 11, 2018 | Daily News

The Republican and Democratic senators who recently introduced a Medicaid-rebate bill support the House Medicare/Medicaid legislative package that their bill is being used to help pay for.

December 11, 2018 | Daily News

The PBM lobby said that the vendor role in the Trump administration’s Medicare Part B demo should be filled by entities such as pharmacy benefit managers or specialty pharmacies, but not by manufacturers in comments submitted to HHS and CMS on Thursday (Dec. 6).

December 11, 2018 | Daily News

Pennsylvania Auditor General Eugene DePasquale recommends state lawmakers let Pennsylvania directly manage its prescription drug benefit and no longer rely on pharmacy benefit managers, which DePasquale says are raking in huge profits at the expense of taxpayers.

December 10, 2018 | Daily News

FDA released new draft guidance on Monday (Dec. 10) that agency head Scott Gottlieb and Deputy Commissioner Anna Abram say will make it more feasible for compounding pharmacies to become outsourcing facilities and ensure those facilities maintain current good manufacturing practices (CGMP).

December 07, 2018 | Daily News

The House is using Medicaid-rebate legislation, introduced Dec. 4 in the Senate, to pay for a bill that combines a handful of Medicaid and Medicare bills from the past two years, according to legislation on the House floor schedule for the week of Dec. 10.

December 07, 2018 | Daily News

FDA’s Bob Temple, a drug center veteran of 46 years, will soon become senior advisor for the Office of New Drugs’ Immediate Office -- becoming the center’s point person on medical decisions that are controversial, complex or critical, center director Janet Woodcock said in an internal email on Friday (Dec. 7).

December 07, 2018 | Daily News

Congressional Medicare advisers said Thursday (Dec. 6) that Medicare spending on drugs doctors administer is growing fast, and on the same day, CMS actuaries said Medicare retail drug spending growth has slowed.

December 07, 2018 | Daily News

HHS hit back at conservative critics of its international price referencing Medicare Part B demo Thursday (Nov. 6) in a blog post authored by its new senior adviser for drug pricing reform, John O’Brien.

December 06, 2018 | Daily News

Through its new real-world evidence framework, FDA will evaluate how RWE can be used to support changes to labeling about a drug or biologic product’s effectiveness.

December 06, 2018 | Daily News

Spending on health care grew at a slower rate in 2017 than in 2016 in part because Medicaid spending slowed due to the lull in Medicaid expansions and drug spending growth slacked off following the spike in spending to treat hepatitis C, according to the CMS actuary’s office.

December 06, 2018 | Daily News

The Supreme Court heard oral arguments Tuesday (Dec. 4) in a case that pits brands versus generics over whether secret sales of drugs trigger the one-year countdown to file a patent.

December 06, 2018 | Daily News

The Federal Trade Commission says it stands ready to help FDA thwart citizen petition abuses aimed at delaying generic and biosimilar competition, but FTC’s comments to FDA offer no insights into how the antitrust enforcer would improve upon its past, limited performance in curtailing citizen petition abuses.

December 05, 2018 | Daily News

The American Hospital Association and a wide range of health care stakeholders urged congressional leaders to pass a key health security bill before the end of the lame-duck session, arguing that, without reauthorization from lawmakers, essential HHS emergency preparedness authorities will expire and gaps in federal response programs will remain unfilled.

December 05, 2018 | Daily News

The incoming Senate Finance Committee chair and ranking Democrat introduced Tuesday (Dec. 4) a bill to recoup Medicaid rebates from drug companies that misclassify drugs.

December 05, 2018 | Daily News

The incoming Senate Finance Committee chair and ranking Democrat introduced Tuesday (Dec. 4) a bill to recoup Medicaid rebates from drug companies that misclassify drugs.

December 05, 2018 | Daily News

The Institute for Clinical Economic Review (ICER) on Monday (Dec. 3) issued a final report featuring recommendations for how to develop policy on and increase access to extended-release medications for addiction treatment.

December 03, 2018 | Daily News

The administration criticized state laws that open up restricted pharmacy networks, because administration officials believe those laws make it difficult for plans and pharmacy benefit managers to negotiate discounts from providers, which increases costs to consumers.

December 03, 2018 | Daily News

In a further bid to streamline generic drug development, FDA on Monday (Dec. 3) clarified the procedures for generic drug makers to request meetings with the agency after receiving complete response letters (CRL) indicating deficiencies in their applications.

December 03, 2018 | Daily News

Sen. Bill Cassidy (R-LA) told Inside Health Policy that he is in the early stages of developing a bill that would address payment models for high-cost prescription drugs such as gene therapies.

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