Regulatory and Washington

Norman Sharpless, currently the head of the National Cancer Institute, will serve as acting FDA commissioner when Scott Gottlieb steps down next month.

Food and Drug Administration commissioner Scott Gottlieb will leave the agency next month after serving in this role for nearly two years.

PhRMA said that, among other efforts, it is working with the Association for Accessible Medicines to increase competition from generic drugs.

A record number of pharmacy advocates will keep the issue of DIR fee reform on the front burner at NACDS RxIMPACT day.

In comments to the House Ways and Means committee, the National Association of Chain Drug Stores pointed out that DIR fee reform can reduce patients’ out-of-pocket drug costs and overall healthcare spending,

The pilot will inform the development of the enhanced electronic, interoperable track-and-trace system for industry set to go into effect in 2023 as part of the Drug Supply Chain Security Act, the agency said.

The bill comes as teen misuse of DXM is on the decline, a trend the Consumer Healthcare Products Association partially attributes to state-level age restrictions that have been passed in 17 states.

The Trump Administration's plan is to lower drug costs by targeting backdoor rebates and encouraging direct discounts to patients.