PRESS RELEASE
FDA Activity: Two More Strikes
By Lee Bechtel, NHF National Lobbyist
June 10, 2007
House Action on FDA "Reform"
House Energy and Commerce Health Subcommittee Chairman Frank Pallone (D-NJ) floated long-awaited discussion drafts of FDA reform bills that call for much stricter drug and medical-device controls than included in the Senate-passed FDA bill, S.1082.
These are included in nine "discussion drafts" released on June 6th. The nine drafts cover each of the following separately: drug user fees, device user fees, pediatric research incentives, pediatric research mandates, drug safety, clinical trial registry requirements, FDA advisory panel conflicts of interest, Reagan-Udall Institute for Applied Biomedical Research, and pediatric medical device research incentives. Download the Committee Memo from Pallone here.
The Committee mark-up draft for the creation of the Reagan-Udall Foundation does not include "food and food ingredients" in the research mission of the Foundation, which is different from the version included in S.1082. Download this here.
Pallone is seeking lawmakers’ input on the drafts in anticipation of marking up the bills starting on Thursday, June 14. Committee Chairman John Dingell (D-MI) plans to work these nine drafts into six FDA bills, rather than the omnibus bill S.1082, as passed by the Senate for full House consideration.
A food safety "discussion draft" will be considered later in the process. This could include the Durbin amendments to the Senate bill, or the creation of a new Food Safety agency, H.R.1148. Food-industry groups want the House to modify a food-safety provision included in the Senate's FDA reform bill that lays out requirements for notifying FDA of possible “adulterations” in the manufacturing process – standards the group feels are overly vague and cause concern. Consumers Union is lobbying House lawmakers to strike what it says is a loophole in the Senate’s FDA reform legislation that allows longer direct-to-consumer drug ads to avoid FDA scrutiny.
This is just the beginning of the process in the House. The Reagan-Udall Foundation is not, thus far, a dietary-supplement issue in the House version of the bill. However, creating a new Food Safety agency, as was the case with the Senate, still may be. Also unaddressed, thus far, is the reimportation of cheaper prescription drugs from Canada.
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Dietary Supplement Good Manufacturing Practices (GMPs)
The Congressional and FDA regulatory issue fronts are rife with matters impacting current and future health freedom of choice. Among these, the issuance of dietary supplement Good Manufacturing Practices (GMPs) should be at the top of the list.
As most people know, the FDA regulates the conditions under which foods and drugs are manufactured - GMPs. In November of 2005, the FDA sent its proposed GMP regulation for dietary-supplements to the Office of Management and Budget (OMB) for approval and release for public comment. At that time, supplement companies of all sizes, consumer groups, and several medical groups raised objections with how the requirements would impact small supplement companies.
Last month, the OMB cleared the final proposed GMP regulation. The latest development is that last week, just nine days after clearing the final GMP regulation, the OMB cleared an FDA Interim Rule just for dietary-supplement production standards impacting small manufacturers, as a subset of the broader final regulation.
So, there may be some public confusion since the Interim Rule and final GMP Regulation both have the same name. An Interim Rule takes effect immediately, but public comment will be solicited. The FDA can change an interim regulation. The broader Final Rule will also undergo a public comment period as well.
What does this mean for making changes, in the yet to be known specifics on both, to problems contained in both of these regulatory pronouncements? If, as is presumed, the broader final rule incorporates the Interim Rule, nothing in terms of the final outcome. However, depending upon the business compliance fiscal impact, either way, one can reasonably expect increased supplement production costs with increased cost for supplement users.
Either way, NHF members should be prepared to help the NHF respond to these GMP regulations, after full analysis is done, and formal reaction is warranted. Stay tuned for even more FDA interference into dietary supplement users' decisions and market product choices.
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About the National Health Federation
Established in 1955, the National Health Federation is a consumer-education, health-freedom organization working to protect individuals' rights to choose to consume healthy food, take supplements and use alternative therapies without government restrictions. With consumer members all over the world, and a Board of Governors and Advisory Board containing representatives from 6 different countries, the Federation is unique is being the only consumer health freedom organization in the world to enjoy official observer status with the Codex Alimentarius Commission.
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