Tag: Jon Bigelow

Jon Bigelow

Washington Focus

Marketing Tax, Pricing Limits, Other Measures May Pass as Add-ons to Omnibus Bills

Marketing Tax, Pricing Limits, Other Measures May Pass as Add-ons to Omnibus Bills

Jan. 5, 2021 – The just-enacted COVID-19 relief bill may be a harbinger of what is to come in 2021 for drug pricing and marketing tax proposals, according to Coalition for Healthcare Communication Executive Director Jon Bigelow. In a memo to Coalition members and industry leaders, Bigelow noted that it had been fairly clear weeks […]

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Regulatory/FDA

Myers: What the FDA Might Look Like Under Biden

Myers: What the FDA Might Look Like Under Biden

Dec. 21, 2020 – As President-elect Joe Biden takes office in January 2021, understanding what could change and what could remain the same at the FDA is important, according to Nancy Bradish Myers, president and CEO of Catalyst Healthcare Consulting Inc. Myers, who has held key positions at the FDA and in industry, spoke at […]

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Courts/First Amendment

U.S. Supreme Court Questioning Casts Some Doubt on Severability in ACA Case

U.S. Supreme Court Questioning Casts Some Doubt on Severability in ACA Case

Nov. 11, 2020 – In yesterday’s oral arguments before the U.S. Supreme Court in the case concerning the constitutionality of the Affordable Care Act (ACA), several conservative justices, including two added to the bench since the last time the Supreme Court affirmed the ACA – Justices Neil Gorsuch and Brett Kavanaugh – asked questions that […]

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Regulatory/FDA

OPDP Director Tom Abrams Retires, Leaving Mark on Drug Promotion Regulation

OPDP Director Tom Abrams Retires, Leaving Mark on Drug Promotion Regulation

Nov. 2, 2020 – After 27 years with the Office of Prescription Drug Promotion (OPDP) – formerly called the Division of Drug Marketing, Advertising, and Communication (DDMAC) – OPDP Director Tom Abrams retired from the agency on Oct. 23 as the primary force behind today’s regulation of prescription drug advertising and promotion. Abrams’ leadership shaped […]

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Data Privacy

California Seeks to Expand Data Privacy Protections

California Seeks to Expand Data Privacy Protections

Oct. 19, 2020 – Last week the California Department of Justice released a third set of proposed modifications to the regulations regarding the California Consumer Privacy Act of 2018 (CCPA) that went into effect on Aug. 14, largely aimed at making sure that consumers are able to easily opt out of allowing their personal data […]

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Washington Focus

Federal Government and FDA Operating under Continuing Resolution as FY 2021 Begins

Federal Government and FDA Operating under Continuing Resolution as FY 2021 Begins

Oct. 5, 2020 – Because Congress has not yet passed a budget, the federal government began fiscal year (FY) 2021 on Oct. 1 operating under a Continuing Resolution (CR). The CR sets a new deadline of Dec. 11 for passage of the full budget, but a further extension until February or March is very possible. […]

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Courts/First Amendment

Ginsburg’s Passing Heightens Concerns over ACA

Ginsburg’s Passing Heightens Concerns over ACA

Sept. 24, 2020 – As the U.S. Supreme Court prepares to hear a case about the constitutionality of the Affordable Care Act (ACA) soon, the passing of Supreme Court Justice Ruth Bader Ginsburg sharply increases the possibility that the ACA will be ruled unconstitutional, according to Coalition for Healthcare Communication Executive Director Jon Bigelow. The […]

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Washington Focus

Political Pressure on Federal Health Agencies Is Eroding Public Trust

Political Pressure on Federal Health Agencies Is Eroding Public Trust

Sept. 14, 2020 – As the COVID-19 pandemic persists and the race for a vaccine to prevent contracting the virus heats up, there is a great deal of misinformation circulating about treatments and the majority of Americans are concerned that political pressure from the Trump administration will lead the Food and Drug Administration to approve […]

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Washington Focus

Movement in White House-Pharma Industry Standoff on Drug Pricing?

Movement in White House-Pharma Industry Standoff on Drug Pricing?

Aug. 31, 2020 – Following the Democratic and Republican convention attacks on big pharma and President Trump’s acceptance speech for his party’s nomination for re-election – in which he claimed to have already taken effective action to lower prescription drug prices through Executive Orders  – the Pharmaceutical Research and Manufacturers of America (PhRMA) is making […]

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Regulatory/FDA

Despite COVID-19 Distractions, FDA Approving Drugs at Fast Pace

Despite COVID-19 Distractions, FDA Approving Drugs at Fast Pace

Aug. 20, 2020 – The Food and Drug Administration’s (FDA’s) ability to approve new drugs while juggling new responsibilities during the COVID-19 pandemic appears to be exceeding expectations, with the agency approving 36 novel drugs to date in 2020, an increase from the 24 new molecular entities (NMEs) approved by this date in 2019 (with […]

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