07.18.22
Senator Richard Burr (R-NC), ranking member of the Senate HELP Committee, has taken a stand against the Food and Drug Administration Safety and Landmark Advancement (FDASLA) Act.
The Senate HELP Committee originally voted 13-9 to pass a recurring bill to reauthorize user fee agreements for drugs and medical devices which included FDASLA, an act which called for mandatory product listing (MPL) for dietary supplements. It would also make it a “prohibited act” to introduce and market a product as a dietary supplement that authorities determine does not meet the definitive criteria of a dietary supplement.
Burr has introduced a clean version of the reauthorization bill which doesn’t contain any of FDASLA’s provisions, following united opposition to the legislation in its current state from trade associations including the Council for Responsible Nutrition (CRN), the American Herbal Products Association, Natural Products Association, and Consumer Healthcare Products Association.
After initially voting against FDASLA, Burr panned the package as an innovation-killer.
“This legislation includes changes that would help strengthen oversight and accountability at the FDA. That includes creating a new Office of Critical Foods, imposing new timelines to help bring formulas to market faster, and requiring the agency work with industry to solve problems with inspections. It also takes important steps to enhance the accelerated approval pathway, support the development of generic and biosimilar drugs, advance innovation for rare diseases, and modernize the diagnostic testing framework,” Burr said.
“It’s a shame, then, that my colleagues have included amendments that would kill innovation, placing the entire bill in jeopardy. Senator Murray and I worked diligently to include commonsense provisions on some of the most difficult issues facing the FDA. Unfortunately, the amendments that were added during today’s mark-up take us backwards, making it more difficult to bring life-saving products, treatments, and cures to Americans. That goes against the entire purpose of this bill. It also undermines the bipartisan framework this Committee worked months to achieve. For these reasons, I have voted against the amended bill.”
Daniel Fabricant, president and CEO of the Natural Products Association, called for industry to rally behind Burr.
“Senator Burr is absolutely right that extraneous, unnecessary, and costly dietary supplement provisions have no place in this legislation, and should be applauded for this principled stance,” Fabricant said. “The dietary supplement provisions in the FDASLA would drive up the cost for consumers while preventing them from accessing certain products. As the nation faces record double-digit inflation, Congress should not be making it more expensive for Americans to stay healthy. Additionally, Congress has never required the nutritional supplement industry to pay user fees, and supplements are not prescription drugs, generic drugs, medical devices, or biosimilars, so including dietary supplement provisions was not only controversial but unprecedented.
“The legislation introduced today by Senator Burr represents an opportunity for the dietary supplement industry to rally behind Senator Burr and help ensure FDA keeps operations running without layoffs. It’s past time for dietary supplement stakeholders to come to the table and lend our support for Senator Burr’s proposal.”
The Senate HELP Committee originally voted 13-9 to pass a recurring bill to reauthorize user fee agreements for drugs and medical devices which included FDASLA, an act which called for mandatory product listing (MPL) for dietary supplements. It would also make it a “prohibited act” to introduce and market a product as a dietary supplement that authorities determine does not meet the definitive criteria of a dietary supplement.
Burr has introduced a clean version of the reauthorization bill which doesn’t contain any of FDASLA’s provisions, following united opposition to the legislation in its current state from trade associations including the Council for Responsible Nutrition (CRN), the American Herbal Products Association, Natural Products Association, and Consumer Healthcare Products Association.
After initially voting against FDASLA, Burr panned the package as an innovation-killer.
“This legislation includes changes that would help strengthen oversight and accountability at the FDA. That includes creating a new Office of Critical Foods, imposing new timelines to help bring formulas to market faster, and requiring the agency work with industry to solve problems with inspections. It also takes important steps to enhance the accelerated approval pathway, support the development of generic and biosimilar drugs, advance innovation for rare diseases, and modernize the diagnostic testing framework,” Burr said.
“It’s a shame, then, that my colleagues have included amendments that would kill innovation, placing the entire bill in jeopardy. Senator Murray and I worked diligently to include commonsense provisions on some of the most difficult issues facing the FDA. Unfortunately, the amendments that were added during today’s mark-up take us backwards, making it more difficult to bring life-saving products, treatments, and cures to Americans. That goes against the entire purpose of this bill. It also undermines the bipartisan framework this Committee worked months to achieve. For these reasons, I have voted against the amended bill.”
Daniel Fabricant, president and CEO of the Natural Products Association, called for industry to rally behind Burr.
“Senator Burr is absolutely right that extraneous, unnecessary, and costly dietary supplement provisions have no place in this legislation, and should be applauded for this principled stance,” Fabricant said. “The dietary supplement provisions in the FDASLA would drive up the cost for consumers while preventing them from accessing certain products. As the nation faces record double-digit inflation, Congress should not be making it more expensive for Americans to stay healthy. Additionally, Congress has never required the nutritional supplement industry to pay user fees, and supplements are not prescription drugs, generic drugs, medical devices, or biosimilars, so including dietary supplement provisions was not only controversial but unprecedented.
“The legislation introduced today by Senator Burr represents an opportunity for the dietary supplement industry to rally behind Senator Burr and help ensure FDA keeps operations running without layoffs. It’s past time for dietary supplement stakeholders to come to the table and lend our support for Senator Burr’s proposal.”
