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.
FDA wants to hear from stakeholders on whether new preapproval incentives are needed to encourage development of safer pain and addiction therapies at a public hearing slated for Sept. 17.
FDA will take into account a proposed opioid’s broader public health effects, including on non-users, and look at how the product compares in safety and effectiveness to already-approved analgesics when making future approval decisions, the agency revealed in a draft guidance published Thursday (June 20).
After two months as FDA acting commissioner, Ned Sharpless said he would like to be nominated for the position permanently, though he acknowledged the decision ultimately lies with the White House.
FDA drug center chief Janet Woodcock urged senators Wednesday (June 19) to reform the over-the-counter drug regulatory system to boost the self-care industry and save consumers money, marking the second time in the past few days that the issue has cropped up at Senate hearings on health care costs.
The House passed legislation Tuesday (June 18) to stop authorized generics from lowering the rebates that drug companies must pay in Medicaid. The rebate measure was also included in the president’s budget request.
A consumer advocacy group criticized FDA after the agency finalized a guidance meant to clarify how industry should label sugar on the nutrition facts panel for single-ingredient sugars, syrups and certain cranberry products.
FDA on Thursday (June 13) released draft guidance meant to help industry conduct tests on assisted reproduction technology (ART) devices, in order to ensure companies screen for toxicity.
Senate health committee Chair Lamar Alexander (R-TN) and ranking Democrat Patty Murray (WA) ultimately decided not to include drug-pricing provisions that would tie patient coinsurance to net prices instead of list prices and require drug makers to justify price hikes in the committee’s final package on lowering health care costs.
FDA has expanded its patent certification list to include additional data that can help subsequent generic drug applicants determine when their products can be approved and marketed, the agency announced Tuesday (June 18).
Senate health committee Chair Lamar Alexander (R-TN) told Sen. Robert Casey (D-PA) and the rest of the health committee he is committed to finding a path forward for over-the-counter drug monograph reform legislation that has stalled in the Senate.
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