BIO's Suppport for the Reauthorization of the Prescription Drug User Fee Act (PDUFA V)

 

 

Dear Chairman Upton and Ranking Member Waxman:

On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our support for the Food and Drug Administration (FDA) user fee program legislation, which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA V). This bipartisan bill will incentivize the development of lifesaving therapies for patients and strengthen America’s global leadership in biomedical innovation. We commit to working with you in a collaborative fashion on remaining areas of interest in this legislation.

The bill will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. It also provides a transparent, predictable performance goals and a dedicated, independent funding stream to ensure that FDA can facilitate the development and evaluation of biosimilars products. BIO appreciates the inclusion of the enhanced accelerated approval pathway provision which will help expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases, while preserving robust standards for safety and effectiveness. In addition, BIO strongly supports the permanent reauthorization of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).  

 

Dear Chairman Upton and Ranking Member Waxman:

On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our support for the Food and Drug Administration (FDA) user fee program legislation, which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA V). This bipartisan bill will incentivize the development of lifesaving therapies for patients and strengthen America’s global leadership in biomedical innovation. We commit to working with you in a collaborative fashion on remaining areas of interest in this legislation.

The bill will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. It also provides a transparent, predictable performance goals and a dedicated, independent funding stream to ensure that FDA can facilitate the development and evaluation of biosimilars products. BIO appreciates the inclusion of the enhanced accelerated approval pathway provision which will help expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases, while preserving robust standards for safety and effectiveness. In addition, BIO strongly supports the permanent reauthorization of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).  

 

 

The bill will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. It also provides a transparent, predictable performance goals and a dedicated, independent funding stream to ensure that FDA can facilitate the development and evaluation of biosimilars products. BIO appreciates the inclusion of the enhanced accelerated approval pathway provision which will help expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases, while preserving robust standards for safety and effectiveness. In addition, BIO strongly supports the permanent reauthorization of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).