Over the coming days, Inside Health Policy will roll out a series of articles based on conversations with key stakeholders regarding their impressions of Gottlieb’s progress thus far, and where they see him taking the agency on key issues, including: off-label promotion, regulatory reform and drug pricing.
If a fiscal 2020 agriculture funding bill passes the House Appropriations Committee on Tuesday (June 4), FDA will be one step closer to receiving millions of dollars to support new oversight efforts in its cosmetics, supplements and food import spaces.
The House is moving forward with a vote this week on the Senate’s pandemic preparedness bill, which does not include a measure to reform FDA’s over-the-counter (OTC) drug regulatory framework.
Days before the House Appropriations Committee is set to mark up an FDA funding bill, an expert on the agency’s budget process said there are plenty of challenges looming ahead that could sink the $184 million increase that House lawmakers propose in the bill.
The medical device lobby praised an interagency report that calls for increased research on potential pain management devices, such as neuromodulation devices and interspinous process spacer devices.
FDA Chief of Staff Lauren Silvis will leave the agency this month and be replaced by Keagan Lenihan, the agency’s associate commissioner for strategic initiatives and external affairs who has played key roles in the administration’s drug-pricing and drug-shortages initiatives, the agency confirmed to Inside Health Policy after former FDA Commissioner Scott Gottlieb tweeted about the departure on Monday (June 3).
FDA is considering how it could go about requiring certain opioids to be dispensed in unit-of-dose, or blister, packaging and is seeking input from stakeholders, the agency announced in the Federal Register Friday (May 30).
Stakeholders are urging FDA to quickly write regulations to strictly monitor the burgeoning cannabis industry, with one marijuana legalization advocacy group warning the lack of guidance and regulation on manufacturing, marketing, testing and selling products infused with cannabidiol (CBD) is creating an opportunity for “predatory companies” to market potentially unsafe products and is leading to confusion about the legal status and safety of CBD-containing products.
FDA’s approval Friday (May 24) of a new drug to treat breast cancer marks the first novel drug that has moved through the agency’s Real-Time Oncology Review (RTOR) Pilot program.
Senate Democratic Whip Dick Durbin (IL) again took FDA Acting Commissioner Ned Sharpless to task in a letter on Wednesday (May 29), saying their May 14 meeting in which they discussed youth e-cigarette use was “one of the most disappointing and alarming meetings” in his time in public service.
FDA’s drug center would receive an approximate $50 million increase in budget authority over fiscal 2019 levels under the 2020 funding bill passed by the House Appropriations agriculture subcommittee on Thursday (May 23), according to a preliminary analysis by the Alliance for a Stronger FDA.
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