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.
The Campaign for Tobacco-Free Kids on Thursday (May 23) urged Senate Majority Leader Mitch McConnell (R-KY) to remove from his bill, which raises the minimum purchase age of tobacco from 18 to 21, a provision that would require each state to individually pass laws raising the minimum age.
The House Appropriations agriculture subcommittee on Thursday (May 23) voted to send a fiscal 2020 funding bill that would give FDA a $184 million increase over its fiscal 2019 levels to the full committee.
FDA expects to propose a number of significant new rules over the next year that will address tobacco product applications, warnings for cigarette packages and advertisements, annual reporting requirements for investigational new drugs, and requirements for drug products that are deemed difficult to compound.
Republican senators call on FDA to expand access to investigational drugs to treat Alzheimer’s, cancer and amyotrophic lateral sclerosis (ALS) by widening the scope of a generations-old Parallel Track program that currently grants only patients with AIDS and other HIV-related diseases access to certain drugs shown to be safe but which haven’t completed FDA efficacy trials.
FDA issued a draft guidance Friday (May 17) stating the agency will exercise enforcement discretion to allow food manufacturers to use the phrase “potassium chloride salt” on the ingredient statement in food labels as an alternative to the commonly used name of “potassium chloride,” which is used as a partial substitute for sodium chloride to reduce the amount of sodium in prepared and processed foods.
In a letter to Sen. Dick Durbin (D-IL), JUUL Labs says none of its currently marketed products required premarket authorization from FDA because the flavored pod products were introduced before and right up to the deeming rule's Aug. 8, 2016, date after which newly marketed e-cigarettes and other electronic nicotine delivery systems required agency approval.
Much to the chagrin of Sen. Dick Durbin (D-IL), FDA Acting Commissioner Ned Sharpless plans to stick with FDA’s plan to not enforce premarket compliance dates for e-cigarettes until 2021, according to the senator, who met with Sharpless Tuesday (May 14).
Biosimilar maker Mylan and several experts in the field say FDA should allow insulin products shown to be biosimilar to reference products to simultaneously get interchangeability status, arguing insulins are less complex than most other biologic products and should be regulated more like small-molecule drugs.
FDA on Tuesday (May 7) sent a notice to the White House budget office about the agency’s plan to work with large research universities to evaluate whether a clinical need exists for certain bulk drug substances to be compounded at outsourcing facilities.
Acting FDA Commissioner Ned Sharpless predicts the agency’s biosimilar interchangeability guidance will bring down insulin prices by triggering interchangeable biosimilar competition.
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