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Cures 2.0 May Get Fast Tracked Due To COVID-19

 
• By Sarah Karlin-Smith

Follow-up bill to the 21st Century Cures Act looks to be more focused on reimbursement and delivery than the 2016 law, which centered on speeding drug development and approval. The bill's architects are working to get some of their provisions, including those around antibiotics, attached to the next COVID-19 relief legislation. 

Legislation on Direction Sign - Green Arrow on a Grey Background.
COVID-19 may give Cures 2.0 the push it needs to get over the finish line • Source: Shutterstock

Reps. Fred Upton, R-WI, and Dianna DeGette, D-CO, are exploring ways to include some of the ideas for their second iteration of the 21st Century Cures Act into legislation currently in the works to tackle the coronavirus epidemic, the pair said on call with reporters this week.

The bipartisan duo, which shepherded the 21st Century Cures Act into law in 2016 against the odds of getting any major FDA reform outside of a user fee reauthorization package, released a “concept paper” this week that outlines their plans for the follow-up legislation, which they first announced work on in November 2019

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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.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

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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.