Oct. 14, 2019 — “I’d be lying if I said it didn’t have an impact.” That’s how former FDA Commissioner Scott Gottlieb responded when asked last week at the BioPharma Congress in Washington, D.C., whether it matters if the FDA is led by an acting or a permanent Commissioner, even as reports swirl in Washington that […]
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March 6, 2019 — FDA Commissioner Scott Gottlieb, M.D., recently stated that he was not leaving the FDA, so news of his departure at the end of the month sent shock waves through FDA-regulated industry yesterday. Citing a need to spend more time with his family, Gottlieb tweeted that he is “immensely grateful for the […]
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Feb. 19, 2019 – In a move that “merits industry attention,” the Federal Trade Commission (FTC) announced last week that it had joined the Food and Drug Administration (FDA) in enforcement actions against three companies advertising that their products can treat diseases like Alzheimer’s, according to a Feb. 11 post by Lesley Fair, senior attorney, […]
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July 31, 2018 – Stating that the FDA’s “most fundamental obligation” is “providing patients with access to safe and effective medical products to meet their health care needs,” FDA Commissioner Scott Gottlieb, M.D., issued a statement July 30 warning women that the FDA has “serious concerns” about laser and energy-based devices cleared or approved for […]
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June 14, 2018 – Although they may not be perfect, the two final guidance documents issued this week by the FDA do provide more information and examples to help pharma companies navigate how they communicate with payors and how they ensure that their on-label communications are compliant. In a June 12 statement, FDA Commissioner Scott […]
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May 29, 2018 – As the dust settles on the Trump administration’s drug pricing blueprint, the pharmaceutical industry is facing a mixed bag of potential short- and long-term impacts, according to Kate Rawson, Senior Editor, Prevision Policy and The RPM Report. Rawson, who spoke May 23 at the Coalition for Healthcare Communication Rising Leaders Conference […]
Read more May 4, 2018 – A drug pricing initiative expected from the White House May 8 is likely to include a number of incremental steps on drug pricing to support a strategy that is trickling down from President Trump to Health & Human Services Secretary Alex Azar and FDA Commissioner Scott Gottlieb, M.D. This initiative may […]
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March 14, 2018 – The FDA has “prioritized a robust social and behavioral science research program” to help the agency understand “how consumers respond to prescription drug promotion,” according to FDA Commissioner Scott Gottlieb, M.D. This Office of Prescription Drug Promotion (OPDP) research “has provided key information to inform our policies related to the proper […]
Read more Jan. 15, 2018 – The FDA is delaying until further notice the effective date of a Jan. 9, 2017, final rule describing the types of evidence that may be considered in determining a medical product’s intended use so it can consider the comments and a citizen petition already received on that rule and collect additional […]
Read more Oct. 30, 2017 – FDA Commissioner Scott Gottlieb, M.D., is taking a strong leadership position in light of the nation’s opioid crisis, making a statement, in response to President Donald J. Trump’s declaration of the crisis as a public health emergency, that the FDA “has a vital role to play” on this issue, and telling […]
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