Rx Drugs

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.

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.

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.

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).

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.

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.

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.

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.

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.