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Aug 20, 2023

New FDA bill unveiled with no “dietary supplement” provisions

Josh Long | Jul 14, 2022 Sen. Richard Burr (R-N.C.) on Thursday introduced

Josh Long | Jul 14, 2022

Sen. Richard Burr (R-N.C.) on Thursday introduced legislation that funds FDA user fee programs, but excludes language that would require manufacturers to list their dietary supplement products with FDA.

The legislation is distinguishable from an FDA user fee bill passed recently by the Senate Committee on Health, Education, Labor and Pensions (HELP), the same committee where Burr is the ranking member.

Related: Rep. Duncan urging colleagues to strike dietary supplement language from FDA user fee bill

The latter bill, known as the FDA Safety and Landmark Advancements (FDASLA) Act, would create mandatory product listing (MPL) for manufacturers and distributors of dietary supplements and direct FDA to create and maintain a publicly accessible database of dietary supplement products. It also includes other dietary supplement components that industry trade groups have argued would be detrimental to industry.

FDA jobs at stake

Related: Industry laments Romney's failed tweaks to dietary supplement listing bill

An FDA user fee bill is considered a piece of must-pass legislation since without reauthorization of the fees that FDA is authorized to collect from regulated industries—including companies producing human drugs— thousands of FDA employees could be out of a job.

"While the user fee programs expire on Sept. 30, 2022, it is imperative that legislation reach the president's desk by August 1," Steven Grossman, executive director of the Alliance for a Stronger FDA, wrote in a Q&A published last month. "Otherwise, lay-off notices could be sent to thousands of FDA employees whose work is supported by expiring user fee programs."

In a July 12 fireside chat with the Alliance for a Stronger FDA, FDA Commissioner Dr. Robert Califf addressed the implications for his agency if user fee legislation isn't passed by August.

"There are enormous implications for the agency, as you know," Medtech Insight quoted Califf as saying. "On the medical products side, this is a very significant part of funding. And basically, we have to lay people off if the user fees don't go through. And even if we approach that cliff, we are very dependent right now on hiring people. We’re in the period of the Great Resignation."

Asked about the issues Thursday by Natural Products Insider, an FDA spokesperson said, "The user fee programs remain an essential part of FDA's mission to protect public health and accelerate innovation, therefore making the timely reauthorization of critical importance."

Reactions of lawmakers

In May, Burr and HELP Committee Chair Patty Murray (D-Wash.) introduced the FDASLA Act. But on Thursday, he criticized the bill voted last month by the HELP Committee, saying it would "undermine the very purpose of the user fee program" if enacted into law.

On June 14, the HELP Committee members voted 13-9 to pass the bill. Burr was among those who voted against the bill and objected to amendments that he said at the time "would kill innovation, placing the entire bill in jeopardy."

"The policies added to this bill endanger the development of drugs for rare diseases, imperil intellectual property rights, threaten Americans’ access to breakthrough treatments and cures, and deter private sector innovation," Burr said Thursday in a press release announcing his user fee bill. "In effect, this proposal would compromise the FDA's overall ability to keep pace with advancements in the industry it regulates. And Democrats’ recently released drug pricing proposal would further reduce private sector investment, making it more difficult for Americans’ to access new, lifesaving medicines."

Burr's new bill—dubbed the Food and Drug Administration Simple Reauthorization Act—creates further uncertainty over an MPL proposal rooted in a standalone bill introduced in the spring of 2022 by Sen. Majority Whip Dick Durbin (D-Ill.) and co-sponsored by Sen. Mike Braun (R-Ind.).

"Americans should not be forced to wait another 20 years for basic—and necessary—reforms that will improve the safety of their dietary supplement," Durbin said in email Thursday to Natural Products Insider, through a spokesperson. "The majority of Americans support requiring companies to register their products with the FDA. It's common sense and bipartisan legislation. I will keep working with my colleagues to get this bill across the finish line this Congress."

In the House of Representatives, lawmakers have already passed a user fee bill that does not include any dietary supplement provisions.

On Wednesday, POLITICO Pro quoted Burr as saying "it's doubtful" that riders to the user fee bill governing diagnostics, cosmetics and dietary supplements would remain in a final version of a user fee bill. The article also said Rep. Cathy McMorris Rodgers (R-Wash.)—ranking member of the House Energy and Commerce Committee—is advocating for a narrow user fee bill to be passed by Congress.

"Unless the Senate acts urgently to meet its deadline, FDA will be forced to issue reduction-in-force notices and furlough thousands of workers who ensure the safety and efficacy of medical products," McMorris Rodgers and Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-N.J.) said in a statement Thursday on bicameral negotiations to reauthorize the FDA user fee agreements. "Any delay is unacceptable, especially after the House passed the bipartisan Food and Drug Amendments of 2022 more than five weeks ago by an overwhelming vote of 392-28. We urge Senate leaders to bring our strong bipartisan package to the floor for a vote before August. There is no reason for the Senate to reject the strongest and best path forward to ensure this reaches the president's desk. For patients, it means lower health care costs, stronger supply chains, critical access to lifesaving prescription drugs, and more hope in the promise for new cures and treatments that will improve their quality of life."

Meanwhile, Murray has been in favor of modernization to the regulatory frameworks governing dietary supplements and cosmetics.

In a news release Thursday, she described the legislation that advanced out of her committee as "a strong, bipartisan bill that will make sure FDA has the tools and resources it needs to fulfill its mission and keep families safe and healthy, and that we have the accountability we need to know FDA is living up to that critical responsibility."

"Pink slips are unacceptable to me, and they should be unacceptable to all of us—that is why it makes absolutely no sense to back out of bipartisan negotiations now," Murray added in the release. "The fastest way to get this done is to move forward with the comprehensive bipartisan bill we have already advanced out of committee, and which includes so many desperately needed, long overdue and bipartisan policies. I urge Senator Burr to return to the table and finish what he started."

Industry responses

Natural Products Association (NPA) President and CEO Dan Fabricant responded to the latest development. NPA has been consistently and vigorously opposed to MPL, arguing it's unnecessary and would be misused by FDA to limit access to legitimate dietary supplement products.

"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 in a written statement. "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."

He further questioned the wisdom of including dietary supplement provisions in an FDA user fee bill considering dietary supplement companies are not required to pay user fees.

Burr's legislation "represents an opportunity for the dietary supplement industry to rally behind Senator Burr and help ensure FDA keeps operations running without layoffs," Fabricant added. "It's past time for dietary supplement stakeholders to come to the table and lend our support for Senator Burr's proposal."

American Herbal Products Association (AHPA) President Michael McGuffin also reacted to Burr's legislation.

Introduction of the Food and Drug Administration Simple Reauthorization Act, combined with Burr's recent vote on the FDASLA Act in the Senate HELP Committee, "are signals that he is looking for a different approach; one that does not include controversial riders such as MPL," McGuffin said in an email to Natural Products Insider.

He also referenced the statement issued Thursday by Pallone and McMorris Rodgers.

"What this means is there are now three congressional FDA user fee reauthorization bills in play (House-passed bill, FDASLA and the Burr bill)–and two of the three do not contain MPL," McGuffin said. "While it is hard to predict with any degree of certainty, these are seemingly positive developments for those who are advocating for a final measure that does not include MPL."

Earlier in the day, before Burr's proposal was unveiled, Council for Responsible Nutrition (CRN) President and CEO Steve Mister said, "We’re still at the negotiating table," when asked to comment on the developments reported Tuesday by POLITICO Pro. The trade group declined further comment, including a follow-up question asking what CRN was negotiating and with whom.

Other industry trade associations either declined comment or did not immediately respond to emails earlier Thursday requesting comment about the POLITICO Pro article, before Burr's bill was introduced.

Several industry trade groups—including CRN, the Consumer Healthcare Products Association (CHPA) and the United Natural Products Alliance (UNPA)—have been in favor of MPL generally. However, they have raised concerns about specific dietary supplement provisions or language in the FDASLA Act passed by the Senate HELP Committee.

Their concerns extend to a provision that would make it a "new prohibited act" to introduce into interstate commerce "any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under" federal law. Based on the current language in the Senate bill, FDA could leverage the threat of a criminal prosecution against companies in cases where industry and the agency disagree over whether a substance is a dietary ingredient or whether a disease claim is being made, Mister of CRN said in an article published last month.

In an email to Natural Products Insider after this story was first published, UNPA President Loren Israelsen said his organization continues "to work with the key [congressional] offices toward an acceptable MPL bill."

UNPA "will continue to seek an MPL process that resolves our four main concerns that led us to a ‘no support’ position," he added.

Sen. Mitt Romney (R-Utah) introduced an amendment in the Senate HELP Committee to alleviate industry's concerns, but the amendment was narrowly rejected by the committee in last month's vote to pass the FDASLA Act. A spokesperson for his office did not immediately respond to a request Thursday for comment.

NPA has expressed concerns that the bill would give FDA leverage to reject a product in a listing when there is a disagreement between industry and regulators regarding the legality of an ingredient, such as hemp-based CBD.

In an opinion piece published this week by The Hill and written by Durbin, the senator rejected that argument.

"To be clear: nothing in our proposal would require dietary supplement companies to receive FDA authorization to bring their products to market — despite the claims of some, and the wishes of others," Durbin proclaimed. "Our bill simply requires dietary supplement companies to provide FDA, and consumers, with basic information about their products."

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