Tag: Congress

Congress

Legislative

Will Pasteur Act Finally Pass During Lame-duck Session?

Will Pasteur Act Finally Pass During Lame-duck Session?

Nov. 14, 2022 – The public health landscape has changed dramatically since the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act (Pasteur Act) – a bill that would address the significant and growing problem of antibiotic, antifungal and antiviral resistance – was introduced three years ago and every year since, but despite the ongoing need […]

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Washington Focus

FDA Funding Hangs in the Balance as Congress Struggles with FY 2023 Budget, User Fee Reauthorization

FDA Funding Hangs in the Balance as Congress Struggles with FY 2023 Budget, User Fee Reauthorization

Aug. 30, 2022 – When members of the House and Senate return to Washington Sept. 6 following the Labor Day holiday, they face competing priorities and tight timeframes to take action on the federal budget and user fees, which expire on Sept. 30. Failure to pass the fiscal year 2023 (FY 2023) budget and reauthorize […]

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Data Privacy

Data Privacy Regulation Efforts Heat Up, Abortion Issue Is Wild Card

Data Privacy Regulation Efforts Heat Up, Abortion Issue Is Wild Card

Aug. 22, 2022 – For years, the issue of regulating data privacy has been addressed largely by individual states, with little comprehensive action on the federal level. But that may be about to change in light of a more aggressive Federal Trade Commission (FTC), a new bipartisan proposal in Congress, and the U.S. Supreme Court’s […]

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CHC News

Carter: CHC Plays Vital Role in Protecting our Industry

Carter: CHC Plays Vital Role in Protecting our Industry

March 24, 2022 – By Jay Carter, EVP/Director of Business Development, AbelsonTaylor In remarks I made recently at the 2022 Medical Advertising Hall of Fame gala, I asked the following questions, which I think are especially applicable here: Do you work on communications to consumers or patients regularly? Do you work on digital initiatives as […]

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Legislative

Delays Add Pressure to User Fee Legislative Process

Delays Add Pressure to User Fee Legislative Process

Feb. 14, 2022 – Negotiations for prescription drug and medical device user fee legislation are running behind schedule and legislators are concerned about the timeline for the Prescription Drug User Fee Amendments VII (PDUFA VII), the Medical Device User Fee Amendments (MDUFA) and other user fee bills. Because the Food and Drug Administration (FDA) receives […]

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Regulatory/FDA

Myers: FDA Priorities Persist Amid Challenges

Myers: FDA Priorities Persist Amid Challenges

Jan. 24, 2022 – With the COVID-19 pandemic heading into year three, the Food and Drug Administration (FDA) faces ongoing challenges but continues to work on four primary agency priorities, according to Nancy Bradish Myers, president of Catalyst Healthcare Consulting, who spoke at a Jan. 21 Coalition for Healthcare Communication webinar, “A New Start for […]

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DTC Advertising

“List Prices in DTC Ads” Proposal Reintroduced After Aduhelm Pricing Decision

“List Prices in DTC Ads” Proposal Reintroduced After Aduhelm Pricing Decision

June 29, 2021 – In the wake of the FDA granting a controversial accelerated approval for Biogen’s aducanumab (Aduhelm) – and Biogen’s decision to set the list price for the drug for Alzheimer’s disease at $56,000 per year despite equivocal evidence of efficacy – members of Congress are introducing drug pricing legislation, calling for hearings, […]

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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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Legislative

Emergency Relief Package Yields Increased FDA Funding, OTC Revisions

Emergency Relief Package Yields Increased FDA Funding, OTC Revisions

March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […]

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Washington Focus

Holcombe: ‘Hill Staffers Are Incredibly and Shockingly Important’

Holcombe: ‘Hill Staffers Are Incredibly and Shockingly Important’

Aug. 19, 2019 – As presidential hopefuls discuss the possible merits of “Medicare for All” and other healthcare reforms, discourse in the nation’s capital has deteriorated to the point where “no one talks to each other,” according to Kay Holcombe, who recently retired as senior vice president for science policy at the Biotechnology Innovation Organization. […]

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