H.R.1561 Overview
Enhancing Drug Safety and Innovation Act of 2007 (Introduced in House)
From the Senate version of S. 1082 The FDA Revitalization Act

May 24, 2007



H.R. 1561 Update

Specifically petition these Congresspersons listed below-Let Them Hear From You


The Energy and Commerce Health Subcommittee is preparing to markup several FDA bills in late June or thereafter. It is not clear if Senate bill S.1082, FDA Revitalization, will be used as a vehicle for Committee measures when being marked-up. H.R. 1561 on reforming FDA drug safety and post-marking processes includes the creation of the Reagan Udall Institute for Applied Biomedical Research.

The House bill language does not include the words "food and food ingredients" in the mission of the Foundation. The Senate added these words when it passed S.1082. The inclusion of this wording could open the door to the regulation of dietary supplements with the use of future risk-management practices, as prescription drugs or biological products in the future.

Congresspersons need to be lobbied to keep the current House bill language contained in H.R. 1561. NHF members who have any of the following Representatives especially need to send a Petition letter. These members will be the first to vote on legislation.

Democrats - Frank Pallone, Jr., NJ, Chairman Edolphus Towns, NY, Bart Gordon, TN, Anna Eshoo, CA, Gene Green, TX, Vice Chair Diana DeGette, CO Lois Capps, CA Tom Allen, ME Tammy Baldwin, WI Eliot L. Engel, NY Jan Schakowsky, IL, Hilda L. Solis, CA Mike Ross, AR, Darlene Hooley, OR, Anthony D. Weiner, NY, Jim Matheson, UT.

Republicans - Nathan Deal, GA, Ranking Member Ralph M. Hall, TX, Barbara Cubin, WY, Heather Wilson, NM, John B. Shadegg, AZ, Steve Buyer, IN, Joseph Pitts, PA, Mike Ferguson, NJ, Mike Rogers, MI, Sue Myrick, NC, John Sullivan, OK, Tim Murphy, PA, Michael C. Burgess, TX, Marsha Blackburn, TN.

As the oldest and best-respected health-freedom group on Capitol Hill, the NHF continues to be the credible source of objective assessment, and proactive actions on Congressional legislation and FDA matters impacting upon our freedom-of-health choices and our access to dietary supplements and nutritional foods.



Sample Petition Letter:



H.R. 1561
Enhancing Drug Safety and Innovation Act of 2007



The Honorable (Representative First and Last Name)

Dear Representative (Last Name);

The Energy and Commerce Health Subcommittee is preparing to markup several FDA bills in late June or thereafter. These relate to FDA prescription drug and medical device user fees, pediatric medical therapies, generic drugs, direct to consumer advertising, food safety, and H.R. 1561 on reforming FDA drug safety and post-marking processes.

It is not clear if the Senate bill S.1082, FDA Revitalization, will be used as a vehicle for these Committee measures when being marked-up. In either case, I am writing to support the House bill language in H.R. 1561 regarding the scope of the Reagan Udall Institute for Applied Biomedical Research.

The House bill language does not include the words "food and food ingredients" in the mission of the Foundation. The Senate added these words when it passed S.1082. Foods and, more importantly, dietary supplements are not prescription drugs and are not biological products. The inclusion of this wording could open the door to the regulation of dietary supplements, with the use of future risk-management practices, as prescription drugs or biological products. I am strongly opposed to this.

During Senate consideration, a colloquy between Senators Hatch and Harkin, and Kennedy and Enzi, the floor managers, expressed the Senate's intent that the activities of the Reagan Udall Institute should not apply to the Dietary Supplement Health and Education Act (DSHEA). The exclusion of the words "food and food ingredients" in the mission of the Foundation in the House bill will clearly address this issue.

I would appreciate your communicating this concern to your colleagues on the Committee.

Sincerely,