Feb. 23, 2021 – Amid a surge in opioid overdose deaths over the past year – due in part to the ongoing COVID-19 pandemic and its corresponding isolation and lack of employment and support services – the FDA’s Office of Prescription Drug Promotion (OPDP) has asserted the agency’s “ongoing commitment to combat inappropriate opioid use.” […]
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March 28, 2019 – “The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health,” the Food and Drug Administration (FDA) states in a new Warning Letter. “Therefore, FDA is taking measures to protect consumers from products that, without approval by FDA, claim to diagnose, mitigate, prevent, […]
Read more Feb. 23, 2018 – Companies, especially those that make opioid products, should make sure that promotional material displayed at conference exhibit booths clearly communicate their products’ risks and limitations of use, and that they heed advisory comments from the Office of Prescription Drug Promotion (OPDP), which issued an Untitled Letter to Collegium Pharmaceutical Inc. on Feb. […]
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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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Aug. 7, 2017 – In a 94-1 vote, the U.S. Senate on Aug. 3 passed FDA user fee reauthorization legislation that will revise and extend the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products through 2022. H.R. 2430, the FDA Reauthorization Act of 2017, was passed by the House […]
Read more Last week the FDA made a bold move by requesting that Endo Pharmaceuticals remove its opioid pain medication, reformulated OPANA® ER (oxymorphone hydrochloride), from the market, stating the agency’s concern that “the benefits of the drug may no longer outweigh the risks.” This action – the first time the FDA has taken steps to remove […]
Read moreOct. 17, 2016 – In a recent guest commentary in PM360, Coalition for Healthcare Communication Executive Director John Kamp praised Pfizer for its opioid agreement with the City of Chicago and called on the pharmaceuticals industry to engage now in the fight to help stem the tide of opioid addiction. In the PM360 piece, “In […]
Read moreJuly 8, 2016 – As organized medicine, politicians and the public seek to reverse the scourge of opioid addiction, Pfizer made a move that shows a good-faith effort to become a part of the problem’s solution. The company signed an agreement June 30 with the City of Chicago to follow a written code of conduct […]
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