The United States Senate Health, Education, Labor, and Pensions Committee (HELP) has released a discussion draft of its legislation to reauthorize FDA user fees for drugs, biologics, and medical devices package, which includes the controversialDurbin-Braun premarket approval conceptand more. The Natural Products Association (NPA) is cautioning that this would be damaging to the industry. (Full text of the draftcan be read here.) Dr. Daniel Fabricant, President and CEO, NPA, discusses the issue inthis episode of Health Quest Podcast.
From Dr. Fabricant:
"The NPA is significantly concerned with Chair Murray and Republican Leader Burr who failed to reject the radical and dangerous legislation from Senators Durbin and Braun that would require premarket approval for dietary supplements and weaken key privacy protections of the Bioterrorism Act, which protects the dietary supplement supply chain.
"Last time I checked, dietary supplements are not drugs, biologics, or medical devices, so why is Congress or anyone supporting non-germane legislation that will only add costs to consumers who are doing all they can to stay healthy is extremely troubling. Groups who have supported this legislation, have stated there are protections for technical disagreements with the FDA like those with hemp,CBD,NAC, and several other products. However if this legislation were to pass, it is abundantly clear these products would be eliminated from the market.
"The war is far from over. We need America’s health and wellness advocates to continue writing their members of Congress through the NPA Action Center, here. Grassroots involvement over the coming weeks is absolutely critical to defeating this radical and dangerous proposal."
ContactNPAnational.orgfor more information and to contact your representatives.
