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Rx Drugs

December 14, 2018 | Daily News

The Medicaid and CHIP Payment and Access Commission discussed recommending that Congress or CMS create “safe harbors” for the Medicaid best price rule to allow states to experiment with new payment models for high-cost prescription drugs.

December 14, 2018 | Daily News

CMS on Friday (Dec. 14) approved New Mexico’s request to add premiums and copayments and waive retroactive coverage for some beneficiaries in its Medicaid program, including drug copayments in some situations.

December 14, 2018 | Daily News

Janssen Pharmaceuticals, which is a subsidiary of Johnson & Johnson, announced Thursday (Dec. 13) that it entered into an outcome-based contract with Oklahoma’s Medicaid program for a long-acting injectable drug used to treat schizophrenia.

December 13, 2018 | Daily News

FDA on Thursday (Dec. 13) scrapped a controversial generic drug labeling proposal that would have allowed generic drug makers to update their drug labels with new information independent of labeling changes to the brand reference product.

December 13, 2018 |

The Congressional Budget Office’s Dec. 7 publication of its cost estimate for the Senate’s over-the-counter monograph reform bill bolstered stakeholders’ hopes that the bill might pass the upper chamber before the end of the lame-duck session.

December 13, 2018 | Daily News

The Congressional Budget Office’s Dec. 7 publication of its cost estimate for the Senate’s over-the-counter monograph reform bill bolstered stakeholders’ hopes that the bill might pass the upper chamber before the end of the lame-duck session.

December 12, 2018 | Daily News

The top regulatory officer at HHS said Wednesday (Dec. 12) that rebates are an “obvious problem” driving up list prices for prescription drugs, and noted that Pfizer recently raised list prices to make up for rebates it pays to pharmacy benefit managers.

December 12, 2018 | Daily News

Heading into 2019, FDA plans to step up pharmaceutical enforcement and improve its inspection assessments using digital tools, FDA Commissioner Scott Gottlieb said Wednesday (Dec. 12).

December 12, 2018 | Daily News

FDA issued final guidance intended to clarify the role data integrity plays in current good manufacturing practices (CGMP) for drugs and to promote partnerships between FDA and its international regulatory counterparts on best practices on data security to help manufacturers advance their own compliance policies, FDA Commissioner Scott Gottlieb said Wednesday (Dec. 12).

December 11, 2018 | Daily News

HHS Secretary Alex Azar invited safety net hospitals on Tuesday (Dec. 11) to give him feedback on how the 340B drug discount program could be improved, but said HHS is concerned about the rapid expansion of 340B and will focus future reforms on “targeting the program to the populations it was intended to serve.”

December 11, 2018 | Daily News

FDA announced Tuesday (Dec. 11) in new guidance documents that when insulin is reclassified from a drug to a biologic in 2020, it will not qualify for the 12-year exclusivity that new biologics receive.

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.

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