Elections

The RFK ‘Wild’ Card: Uncertainty For US FDA In A Second Trump Term

The RFK ‘Wild’ Card: Uncertainty For US FDA In A Second Trump Term

 

Republican presidential candidate Donald Trump says he will let Robert F. Kennedy Jr. “go wild on medicines” if he wins the White House. That could spell challenges for the US FDA in 2025.

PBMs, FTC and IRA: Experts Tackle Pharma’s Tough Acronyms At BioFuture Conference

PBMs, FTC and IRA: Experts Tackle Pharma’s Tough Acronyms At BioFuture Conference

 

Some of the industry’s biggest challenges, and potential solutions, were hot topics at the BioFuture conference in New York.

Déjà Vu: Revived Mifepristone Case Puts FDA And Pharma At Risk Again

Déjà Vu: Revived Mifepristone Case Puts FDA And Pharma At Risk Again

 

The outcome of the November presidential election may impact whether the government is willing to defend FDA's relaxation of the mifepristone REMS. The case poses risks for the broader drug approval process.

US Presidential Elections: Are Prescription Drug Pricing Reforms Losing Political Luster?

US Presidential Elections: Are Prescription Drug Pricing Reforms Losing Political Luster?

 
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Neither Kamala Harris nor Donald Trump mentioned drug pricing reforms in their presidential convention speeches.


FDA Disruption: If Trump Wins, Could Big Changes Be Coming?

FDA Disruption: If Trump Wins, Could Big Changes Be Coming?

 
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The agency is clearly on the radar of former President Trump and his new coterie of tech moguls.

UK Election Pledges: ‘Nimble’ Regulation, an MRA With the EU, Faster Access & More Efficient Trials

UK Election Pledges: ‘Nimble’ Regulation, an MRA With the EU, Faster Access & More Efficient Trials

 
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With the 4 July UK general election less than two weeks away, the Pink Sheet looks at the manifestos published by the major political parties and finds pledges to drive innovation, boost clinical trial activity and speed up regulatory procedures.

Biden vs Trump On Drug Pricing And Unfinished Business

Biden vs Trump On Drug Pricing And Unfinished Business

 
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While more significant reforms are less likely under a second Biden term unless Democrats control both chambers of Congress, former President Trump could look to put his stamp on drug pricing reform by resurrecting one of his former policies involving international reference pricing and Medicare Part B drugs. 

With Reform Efforts Persisting, PBM Trade Association Sets Lobbying Record

With Reform Efforts Persisting, PBM Trade Association Sets Lobbying Record

 
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Infographic details who gave what to whom as all segments of the US healthcare industry gear up for the presidential election cycle.


Biden’s Co-Pay Cap Is Silver Lining For Pharma In Drug Pricing Campaign

Biden’s Co-Pay Cap Is Silver Lining For Pharma In Drug Pricing Campaign

 
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President Biden’s call to expand the US Medicare price negotiation program is naturally making headlines from his campaign-year State of the Union Address. But his call for a national cap on co-pays could be an important opportunity for industry in the years to come.

Life Sciences In The Spotlight As UK Prepares For General Election

Life Sciences In The Spotlight As UK Prepares For General Election

 

The opposition Labour Party’s life sciences plan aims to make the UK a “frontier market” for innovative products, including cell and gene therapies. 

Biopharma’s Prospects Under A Second Trump Term: They Can’t Get Much Worse

Biopharma’s Prospects Under A Second Trump Term: They Can’t Get Much Worse

 
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Former Trump advisor Joe Grogan discusses what might be in store for the biopharma industry if the former president is re-elected in 2024.

Medicare And Lecanemab: House Republicans Lack ‘Proactive’ Plan For Ensuring Coverage

Medicare And Lecanemab: House Republicans Lack ‘Proactive’ Plan For Ensuring Coverage

 
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With a slim House majority, will Republicans wade into Medicare coverage policy for a promising Alzheimer’s drug and the new Medicare price negotiation program? Democratic Senate could offer ‘counter oversight’ hearings.


Pink Sheet Podcast: Election Fallout, IRA Impacting Product Development, Updated US FDA Expanded Access Policy

Pink Sheet Podcast: Election Fallout, IRA Impacting Product Development, Updated US FDA Expanded Access Policy

Pink Sheet reporters and editor discuss the impact of the midterm elections, the Inflation Reduction Act’s effects on drug development, and adjustments to FDA expanded access guidance.

Republican Leaders In Congress Want To Undercut Drug Pricing Law: What’s The Opportunity?

Republican Leaders In Congress Want To Undercut Drug Pricing Law: What’s The Opportunity?

 
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As Republicans expand their power in Congress, experts weigh in on prospects for significant changes to the Medicare price negotiation law and what the GOP might do to hamper implementation of the program.

What To Expect If Republicans Regain Majority: More Executive Actions, Focus On Costs

What To Expect If Republicans Regain Majority: More Executive Actions, Focus On Costs

 

Lobbyists discuss what will happen with the healthcare agenda if Republicans retake the House in the mid-term elections and the prospects for passing a prescription drug pricing bill before then.

US FDA Commissioner Race Shrinks And Widens: Biden Team Trying To Woo Reluctant Dems On Woodcock While Exploring New Options

US FDA Commissioner Race Shrinks And Widens: Biden Team Trying To Woo Reluctant Dems On Woodcock While Exploring New Options

 

White House is trying to overcome some Senate Democrats’ opposition to Janet Woodcock as FDA Commissioner, while also looking for other candidates for the job. Josh Sharfstein, long thought to be Woodcock’s main competition, is not a strong contender.


Trump’s Legacy Versus ‘March In’ Rights

Trump’s Legacy Versus ‘March In’ Rights

 
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Biden’s incoming Secretary of Health is a fan of ‘march in’ rights as a cost-containment tool for medicines. Two hold-overs from Trump Presidency may slow him down.

Biden Regulatory Freeze May Pause Sunset Rule, Medicare Rebate, Medicaid Line Extension Regs

Biden Regulatory Freeze May Pause Sunset Rule, Medicare Rebate, Medicaid Line Extension Regs

 
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Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.

Making The Case For A Legislative Deal On Drug Pricing

Making The Case For A Legislative Deal On Drug Pricing

 
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Drawing on 24 years as a legislator and another 16 years as a leading lobbyist for biopharma, Jim Greenwood sees an opportunity for industry to put drug pricing ‘behind us’ with a legislative compromise.

COVID-19 Vaccine Distribution Confusion Grows As Eligibility Widens

COVID-19 Vaccine Distribution Confusion Grows As Eligibility Widens

 

President-Elect Biden also adds David Kessler and Andy Slavitt to his COVID-19 response team, retains Francis Collins at NIH director.