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Posted On: 07/15/2022 9:31:31 PM
Post# of 148878
The current FDA User Fee program expires on September 30. The new user fee legislation is stalled in Washington, not only between Democrats and Republicans, but between different bills in the Senate and House. Failure to authorize a bill will result in layoffs and mass disruption at the FDA. The FDA does not need any distractions or interruptions, so hopefully, this is political grandstanding and something will pass before Washington leaves for their August recess. Here are a couple of brief summaries and a detailed article at the bottom of this post.
FDA User Fee Reauthorization. The Food and Drug Administration relies on user fees to review and approve applications for prescription drugs, medical devices, generic drugs, and biosimilars. The current programs expire on Sept. 30. On June 8 the House passed the Food and Drug Amendments of 2022 to extend these programs. On June 14 the Senate Health Education Labor and Pensions Committee passed a broader version of this legislation (the Food and Drug Administration Safety and Landmark Advancements Act). The House and Senate are now attempting to informally negotiate a compromise bill to increase the chances of quick passage by the full Senate.
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.
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.
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.”
The battle over what to include in this latest round of user fee legislation — the industry money that pays for all biopharma drug and biologic reviews at the FDA and has to be reauthorized every five years — is coming to a head as Congress looks to meet an August recess deadline before the FDA has to send out thousands of warnings to much-needed reviewers that they’ll be soon laid off.
Not only would the FDA be forced to send the pink slips, but all current PDUFA deadlines would grind to a halt as the agency would no longer have the staff to meet its review deadlines.
North Carolina Republican and Senate health committee ranking member Richard Burr yesterday introduced a blank version of the user fee legislation as an attempt to start over without any of the policy riders that made it out of the committee, like the accelerated approval pathway changes that would allow the FDA to require companies to begin postmarketing studies before granting the sped-up approvals.
“Unfortunately, the user fee package reported out of Committee would, if enacted, undermine the very purpose of the user fee program,” Burr said in a statement. “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. In effect, this proposal would compromise the FDA’s overall ability to keep pace with advancements in the industry it regulates.”
But Senate health committee chair Patty Murray (D-WA) fired back with her own statement yesterday afternoon, telling Burr, “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. 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.”
Burr, who’s not seeking reelection this year, has cautioned throughout the user fee legislation reauth process that Congress may not meet the end of September deadline necessary to keep the current drug, generic, biosimilar and medical device user fees going.
But some experts think this might be more bark than bite from the politicians.
Peter Pitts, former associate commissioner of FDA and president of the Center for Medicine in the Public Interest, told Endpoints News via email, “I think this will proceed on schedule. Political pressure notwithstanding, this is must-pass legislation and there’s a lot to do! I’m not hearing any serious talk of holding the FDA hostage for any specific reason. Talk is cheap and EC/HELP members are pretty responsible folks.”
But there are still major gaps between the House and Senate versions of the user fee bills, as the House included new clinical trial diversity measures, while the Senate included new responsibilities for the FDA to better regulate cosmetics and dietary supplements.
“Senator Burr and I have spent months negotiating bipartisan policies that will keep families safe, support innovation, bring down drug prices, and much, much more,” Murray added. “People want us to get this done—all of it.”
FDA commissioner Rob Califf recently made clear the importance of the timely reauths, noting that FDA reviewers would be laid off if it isn’t completed in time, and he noted that FDA’s commitment to its review timelines for sponsors won’t be met without those funds.
“This is a very significant part of funding” on the medical product side, and “even if we approach that cliff, we’re very dependent on hiring people, and we’re in the period of the great resignation,” Califf said. “Who wants to work at an organization if this job isn’t even going to exist? We really need to avoid that.”
Meanwhile, on the House side, there seems to be bipartisan agreement that the Senate needs to get its act together.
https://endpts.com/fda-user-fee-bill-deadline...tart-anew/
FDA User Fee Reauthorization. The Food and Drug Administration relies on user fees to review and approve applications for prescription drugs, medical devices, generic drugs, and biosimilars. The current programs expire on Sept. 30. On June 8 the House passed the Food and Drug Amendments of 2022 to extend these programs. On June 14 the Senate Health Education Labor and Pensions Committee passed a broader version of this legislation (the Food and Drug Administration Safety and Landmark Advancements Act). The House and Senate are now attempting to informally negotiate a compromise bill to increase the chances of quick passage by the full Senate.
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.
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.
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.”
The battle over what to include in this latest round of user fee legislation — the industry money that pays for all biopharma drug and biologic reviews at the FDA and has to be reauthorized every five years — is coming to a head as Congress looks to meet an August recess deadline before the FDA has to send out thousands of warnings to much-needed reviewers that they’ll be soon laid off.
Not only would the FDA be forced to send the pink slips, but all current PDUFA deadlines would grind to a halt as the agency would no longer have the staff to meet its review deadlines.
North Carolina Republican and Senate health committee ranking member Richard Burr yesterday introduced a blank version of the user fee legislation as an attempt to start over without any of the policy riders that made it out of the committee, like the accelerated approval pathway changes that would allow the FDA to require companies to begin postmarketing studies before granting the sped-up approvals.
“Unfortunately, the user fee package reported out of Committee would, if enacted, undermine the very purpose of the user fee program,” Burr said in a statement. “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. In effect, this proposal would compromise the FDA’s overall ability to keep pace with advancements in the industry it regulates.”
But Senate health committee chair Patty Murray (D-WA) fired back with her own statement yesterday afternoon, telling Burr, “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. 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.”
Burr, who’s not seeking reelection this year, has cautioned throughout the user fee legislation reauth process that Congress may not meet the end of September deadline necessary to keep the current drug, generic, biosimilar and medical device user fees going.
But some experts think this might be more bark than bite from the politicians.
Peter Pitts, former associate commissioner of FDA and president of the Center for Medicine in the Public Interest, told Endpoints News via email, “I think this will proceed on schedule. Political pressure notwithstanding, this is must-pass legislation and there’s a lot to do! I’m not hearing any serious talk of holding the FDA hostage for any specific reason. Talk is cheap and EC/HELP members are pretty responsible folks.”
But there are still major gaps between the House and Senate versions of the user fee bills, as the House included new clinical trial diversity measures, while the Senate included new responsibilities for the FDA to better regulate cosmetics and dietary supplements.
“Senator Burr and I have spent months negotiating bipartisan policies that will keep families safe, support innovation, bring down drug prices, and much, much more,” Murray added. “People want us to get this done—all of it.”
FDA commissioner Rob Califf recently made clear the importance of the timely reauths, noting that FDA reviewers would be laid off if it isn’t completed in time, and he noted that FDA’s commitment to its review timelines for sponsors won’t be met without those funds.
“This is a very significant part of funding” on the medical product side, and “even if we approach that cliff, we’re very dependent on hiring people, and we’re in the period of the great resignation,” Califf said. “Who wants to work at an organization if this job isn’t even going to exist? We really need to avoid that.”
Meanwhile, on the House side, there seems to be bipartisan agreement that the Senate needs to get its act together.
https://endpts.com/fda-user-fee-bill-deadline...tart-anew/
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