“Status Quo” Election Means Stability in Administration Overseeing Rapid Change in Policy Climate

The re-election of Barack Obama injects some stability into a period of rapid change in regulatory and health policy. Most key health officials are expected to stay at least until 2014, and that is likely to include FDA Commissioner Margaret Hamburg. But there are plenty of big changes in key slots on Capitol Hill, and the implementation of health reform and PDUFA V will mean a lot is new even if the political lineups aren’t.

The re-election of Barack Obama as President coupled with a status quo outcome on Capitol Hill provides a sense of stability for the biopharma public policy climate at a time of important changes in the industry.

Even a “status quo” election ushers in a period of change, as key agency heads and Cabinet officers typically move...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Market Access

Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By 

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

Respiratory Treatments Hit Hardest By HTA Terminations In England

 
• By 

Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.

New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France

 

A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.

More from Pink Sheet

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

Infographic: Leqembi – A Geographical Comparison

 

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.