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FDA Advisory Committees Would Get Patient Influence Under Hagan Bill

 
• By Derrick Gingery

Adjusting advisory committee conflict of interest rules has emerged as a high-priority issue in reauthorizing the drug user fee program, and several bills already propose loosen those rules. Sen. Kay Hagan’s draft FDA reform legislation may prove to be the most loosening proposed to date.

Sen. Kay Hagan’s draft FDA reform legislation includes several provisions aimed at expanding the pool of possible participants in agency advisory committees.

Adjusting conflict of interest rules for FDA advisory committees has emerged as a high-priority issue to be addressed by Congress in the reauthorization of the drug user fee program, and several bills already have been

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EU Shaping Biotech Act To Unleash SME Potential

 
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European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
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The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.

EU HTA Regulation: How Rare Disease Drug Makers Can Meet Worrisome JCAs Data Requirements

 
• By Francesca Bruce

In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.

House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
• By Sarah Karlin-Smith

The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

More from Pink Sheet

EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.