Chairman Harkin and Ranking Member Enzi Release HELP Drafts for Stakeholder Discussion

Today, Chairman Harkin and Ranking Member Enzi release a bipartisan Drug Approval and Patient Access Draft: Click here to view the pdf.

This discussion draft reflects bipartisan efforts to develop consensus policy proposals to accompany the FDA human medical product user fee legislation. Our goal is to solicit feedback on the policy merits, potential unintended consequences, and potential opportunities to improve the legislative language. We anticipate releasing additional drafts in other policy areas in the upcoming weeks. The discussion drafts will be available on the HELP Committee website.
Please submit your written comments to both Kathleen Laird (Kathleen_Laird@help.senate.gov) in Senator Harkin’s office and Grace Stuntz (Grace_Stuntz@help.senate.gov) in Senator Enzi’s office by April 11, 2012. We will try to meet with as many stakeholders as possible who have submitted written comments.  Written comments should accompany meeting requests.

Chairman Harkin and Ranking Member Enzi Release HELP Drafts for Stakeholder Discussion

Thursday, March 29, 2012

Today the bipartisan working group of Senators Harkin, Enzi, Alexander, Bennet, Blumenthal, Burr, Casey, Corker, Franken, Hagan, Isakson, Kirk, Klobuchar, Merkley, Mikulski, Murkowski, Murray, and Roberts release a bipartisan Prescription Drug Shortages Draft: Click here to view the pdf.

In addition, the bipartisan working group of Senators Harkin, Enzi, Alexander, Bennet, Blumenthal, Burr, Casey, Franken, Hagan, Hatch, Isakson, Kirk, Mikulski, and Roberts release a bipartisan Incentivizing New Antibiotic Development Draft: Click here to view the pdf.

These discussion drafts reflect bipartisan efforts to develop consensus policy proposals to accompany the FDA human medical product user fee legislation. The discussion drafts represent just that—draft language that should encourage discussion. These do not represent a completed product, but rather the start of bipartisan work that will hopefully lead to consensus language to be marked up. Our goal is to solicit feedback on the policy merits, potential unintended consequences, and potential opportunities to improve the legislative language. The discussion drafts will be available on the HELP Committee website. Please submit your written comments to both Kathleen Laird (Kathleen_Laird@help.senate.gov) in Senator Harkin’s office and Grace Stuntz (Grace_Stuntz@help.senate.gov) in Senator Enzi’s office by COB on April 9, 2012. We will try to meet with as many stakeholders as possible who have submitted written comments. Written comments should accompany meeting requests.

Chairman Harkin and Ranking Member Enzi Release HELP Drafts for Stakeholder Discussion

Tuesday, March 13, 2012

Today the bipartisan working group of Senators Harkin, Enzi, Bennet, Burr, Grassley, and Whitehouse release a bipartisan Drug Supply Chain Integrity Draft: Click here to view the pdf.

In addition, Chairman Harkin and Ranking Member Enzi release a bipartisan Medical Device Policy Draft: Click here to view the pdf.

These discussion drafts reflect bipartisan efforts to develop consensus policy proposals to accompany the FDA human medical product user fee legislation. The discussion drafts represent just that—draft language that should encourage discussion. These do not represent a completed product, but rather the start of bipartisan work that will hopefully lead to consensus language to be marked up. Our goal is to solicit feedback on the policy merits, potential unintended consequences, and potential opportunities to improve the legislative language. We and our staff anticipate releasing additional drafts in other policy areas in the upcoming weeks. The discussion drafts will be available on the HELP Committee website. Please submit your written comments to both Kathleen Laird (Kathleen_Laird@help.senate.gov) in Senator Harkin’s office and Grace Stuntz (Grace_Stuntz@help.senate.gov) in Senator Enzi’s office by April 1, 2012. Staff will try to meet with as many stakeholders as possible starting March 26, 2012, but will give priority to those that have submitted written comments.