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Woodcock Nostalgia: GOP Rep. Bilirakis Wants CDER To Recapture Her Flexible Approach

 
• By Derrick Gingery

Energy and Commerce Committee member suggests CBER now is more flexible with rare disease product approval requirements than CDER, inviting the drug center to return to its approach under former director Janet Woodcock.

Rep. Gus Bilirakis
Republicans called for more use of accelerated approval during an Energy and Commerce Committee hearing. • Source: Screenshot of House of Representatives broadcast

Janet Woodcock’s tenure as director of the US Food and Drug Administration’s Center for Drug Evaluation and Research ended only three years ago, but some in Congress already are nostalgic for what they characterized as a bygone era.

Key Takeaways

  • House Republicans called for increased use of accelerated approval for rare disease treatments.

  • Rep. Gus Bilirakis encouraged CDER Director Patrizia Cavazzoni to embrace Janet Woodcock’s approach to the tool

House Republicans urged the directors of the drug and biologics centers during a 22 May Energy and Commerce Health Subcommittee hearing to use accelerated approval and regulatory

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Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By Kate Rawson

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

 
• By Francesca Bruce

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.

US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By Sue Sutter

The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.