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.
A key consumer advocacy group points to FDA's decision to let Eli Lilly quickly resubmit a recently denied application for a rheumatoid arthritis drug as new evidence the agency is weakening approval standards under commissioner Scott Gottlieb.
Despite glowing praise from industry, public health and consumer advocates are lukewarm over the action FDA has taken during Scott Gottlieb's first 100 days as FDA commissioner -- holding up several recent product decisions they view as troublesome.
In the wake of President Donald Trump's push toward deregulation, one regulatory policy watcher tells Inside Health Policy that the Scott Gottlieb-led FDA may be implementing a new regulatory paradigm centered more on individual regulatory decisions as opposed to formal rulemaking -- highlighting the agency's newly announced tobacco plan as one example.
FDA has issued fewer guidance documents and delayed some key rules during Scott Gottlieb's first 100 days as agency chief, but has yet to chop any major existing regulations despite the strong deregulatory press by a Trump White House intent on scaling back federal regulations.
Friday (Aug. 18) marked Scott Gottlieb’s 100th day as the 23rd FDA commissioner. In a time of political uncertainty, Gottlieb has, for most stakeholders, provided a sense of stability -- regardless of one’s vision for where the agency should move in the future.
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