Category: General

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2023 ACA Enrollment on Course to Surpass 2022 Record

2023 ACA Enrollment on Course to Surpass 2022 Record

Nov. 29, 2022 – Americans are enrolling in Affordable Care Act (ACA) marketplaces for 2023 at what appears to be a record-setting pace as healthcare becomes less of a political football. According to a report from President Joe Biden and Department of Health and Human Services (HHS) Secretary Xavier Becerra, nearly 3.4 million people have […]

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Clinical Trials Not Sufficiently Diverse – and Diversity Data Often Not Reported

Clinical Trials Not Sufficiently Diverse – and Diversity Data Often Not Reported

May 9, 2022 – New analyses of clinical trials conducted in the United States and in Europe on potential new drugs found that not only were study populations not as diverse as the general population, but that frequently no race or ethnicity data was included in the trial reports, and sometimes not even gender data. […]

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HHS: Pharmacists Can Administer COVID-19 Antivirals

HHS: Pharmacists Can Administer COVID-19 Antivirals

Nov. 29, 2021 –With little fanfare, the U.S. Department of Health and Human Services (HHS) recently moved to allow licensed pharmacists to dispense Food and Drug Administration (FDA)-authorized COVID-19 therapeutics directly to patients, without a physician prescription. This step, taken by publishing an amendment to a declaration under the Public Readiness and Emergency Preparedness Act, […]

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AMA To Tackle HCP Disinformation with New Policy

AMA To Tackle HCP Disinformation with New Policy

Nov. 22, 2021 – As the COVID-19 pandemic continues, the American Medical Association (AMA) is stepping up efforts to stop the dangerous spread of information, particularly when it comes from healthcare professionals (HCPs) who are using their licenses to validate the disinformation they are spreading. This scenario – where HCPs deliberately make false claims about […]

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PhRMA’s Updated Code for Industry Addresses Speaker Programs, Meals

PhRMA’s Updated Code for Industry Addresses Speaker Programs, Meals

Aug. 20, 2021 — The Pharmaceutical Research and Manufacturers of America (PhRMA) has “updated and enhanced” its voluntary code of ethics regarding how the drug industry can appropriately interact with U.S. health care professionals (HCPs) while marketing biopharma products in various ways, including speaker programs. PhRMA’s revised “Code on Interactions with Health Care Professionals,” last updated […]

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FTC Issues Unprecedented Number of Warning Letters for COVID-19 Claims

FTC Issues Unprecedented Number of Warning Letters for COVID-19 Claims

Aug. 17, 2020 – The Federal Trade Commission (FTC) recently issued 20 Warning Letters to companies making coronavirus claims for such products as zappers that use certain frequencies to kill viruses or remove pathogens from the body, virus-busting cards to hang around the collar, ozone therapies – including “intravenous ozone” – nasal sprays, and elderberry […]

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Amid COVID-19 Outbreak, Protecting 2020 Election Should Start Now

Amid COVID-19 Outbreak, Protecting 2020 Election Should Start Now

March 23, 2020 – As the United States grapples with the COVID-19 outbreak and its ongoing fallout, there is another pressing issue that is crucial to the American public: ensuring safe and fair elections between now and Nov. 3. “The Coalition believes it is important for all Americans to be active in the political process […]

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FTC Flexes Enforcement Muscles, Joins FDA in Cracking Down on Alzheimer’s Claims

FTC Flexes Enforcement Muscles, Joins FDA in Cracking Down on Alzheimer’s Claims

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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Guest Commentary: What Might a Part B IPI Model Do to Drug Innovation, Patient Care?

Guest Commentary: What Might a Part B IPI Model Do to Drug Innovation, Patient Care?

By Michael Parenti, Senior Engagement Strategist, Saatchi & Saatchi Wellness Feb. 1, 2019 — On Oct. 25, 2018, the Centers for Medicare and Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) to test whether phasing down the Medicare payment amount for selected Part B drugs to more closely align with international prices […]

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Top 10 Compliance Tips for Healthcare Communications Companies

Top 10 Compliance Tips for Healthcare Communications Companies

Jan. 3, 2019 – As healthcare communicators start off 2019, keeping an eye on the best ways to remain compliant is now a bit easier thanks to James N. Czaban, chair of the FDA and Medical Products Regulatory Practice at DLA Piper LLP in Washington, D.C. Speaking at the Coalition for Healthcare Communication’s Post-election Conference […]

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