Senate HELP sends user fee reauthorization bill to floor vote

Regulatory NewsRegulatory News | 14 June 2022 |  By 

The US Senate Health, Energy, Labor and Pensions (HELP) committee advanced a bill that would reauthorize the Food and Drug Administration (FDA) to collect medical product user fees. It differs significantly from a sister bill recently passed in the House, meaning it would need to be reconciled in a conference if it is approved by the full Senate.
In a 13 to 9 vote, the HELP committee approved the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act on 14 June. (RELATED: All eyes on Senate after House passes user fee reauthorization bill, Regulatory Focus 9 June 2022).
It not only reauthorizes most of FDA’s medical products user fee programs, it also includes major provisions that are not in the House version such as the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would give FDA additional authorities to regulate in vitro diagnostics (IVD), including laboratory-developed tests (LDTs). If passed by the Senate, the two versions of the bill would have to be reconciled quickly in a conference before the current user fee programs expire at the end of September.
Sen. Tommy Tuberville (R-AL) proposed an amendment during the hearing that would exempt academic centers from the VALID Act. He said it would ensure access to care at academic centers would not be threatened and would protect them from undue bureaucratic red tape from FDA. He was supported by Sen. Bill Cassidy (R-LA) who argued academic institutions can produce tests faster than traditional diagnostic manufacturers and the issue was a matter of opportunity cost.
However, HELP Ranking Member Sen. Richard Burr (R-NC) noted that the act already states that it does not apply to test-makers who serve populations of 10,000 or less so he did not think the amendment was necessary.
Committee Chair Patty Murray (D-WA) agreed and said the language proposed by Tuberville and she ultimately tabled the amendment.
The most heated debate during the hearing was when Sen. Bernie Sanders (I-VT) offered four amendments intended to address high drug prices. The first amendment would allow wholesalers to import drugs from Canada and the UK, and after two years FDA could expand that to allow the import of drugs from other Organization for Economic Co-operation and Development (OECD) countries.
Sanders argued that price of prescription drugs in the US often costs ten times that of other countries and said FDA is beholden to pharmaceutical manufacturers because 73% of the funding to review drugs comes from user fees.
“We have talked about reimportation for a zillion years, this bill actually does it,” said Sanders. “It doesn’t wait for somebody in the bureaucracy to make it happen, we mandate it to happen.”
The Vermont senator argued that since 1998 the pharmaceutical industry has spent more than $5.1 billion in lobbying and over $531 million on campaign contributions. He said there are currently 15 paid lobbyists, many of them former republican and democratic leaders, working to ensure Congressional lawmakers don’t represent their constituents.
“It is not Congress that regulates the pharmaceutical industry, it is the pharmaceutical industry that regulates congress which is why we are where we are today,” Sanders argued.
An unlikely ally to speak up for the amendment was Sen. Rand Paul (R-KY) after Sanders made his impassioned speech.
“I’ve always wanted to go to a Bernie rally and now I feel like I’ve been there,” Paul said.
The Kentucky senator said he’s against price controls and worried about some of the consequences of price controls but agreed for the need to look at prescription prices in the US. He said Americans pay more because other countries don’t have free markets so manufacturers make up for the difference by charging Americans more.
Burr however pushed back against Sanders’ amendment, arguing that the regulations are different between the US and other countries, and the amendment risks FDA’s gold standard. He also argued that the high cost of drugs in the US is driven by the cost of research and development and bringing those drugs to the US first.
“I want to tell my colleagues, if you want to kill this bill do reimportations,” he said. “Bernie, you’re entitled to your own opinion, but you’re not entitled to your own set of facts, and just because you speak loudly does not mean what you say is in fact true.”
Sanders fired back urging lawmakers to approve his amendment even if they disagreed so that there can be a bigger debate on the Senate floor and called Burr’s concerns about potentially failing regulatory “gold standard” a “scare tactic.” He also said it was insulting to Canadians that their regulations were not good enough for American consumers.
Ultimately, Sen. Murray tabled the amendment because she said the manager’s amendment already requires FDA to issue regulations allowing the importation of drugs from Canada with safety provisions to prevent exacerbating the opioid epidemic. It also removes barriers for personal importation of drugs by requiring the agency to establish a program for personal importation that ensures imported drugs have same level of safety requirements and gives regulators the tools necessary to address any safety issues that arise from drug importation programs.
Murray also said she was concerned Sanders’ amendment did not have bipartisan support.
“Sen. Sanders, many of us want to do more but this bipartisan legislation is a huge step forward and it has the Republican support we need to pass legislation,” she said. “To my knowledge, this is the first time ever that a user fee reauthorization bill has included policy expanding the importation of prescription drugs.”
However, Murray did credit Sanders for working with her and Burr to develop the language in the manager’s amendment that has bipartisan support but decided not to relitigate the issue, though she agreed with much of Sanders’ amendments.
A number of riders however were successfully added to the final bill including an amendment proposed by Sens. Mike Braun (R-IN) and John Hickenlooper (D-CO) that would give FDA authority to allow predetermined change control plans for cleared and approved artificial intelligence/ machine learning (AI/ML) medical devices. (RELATED: User fee reauthorization bill advances in the House, Senate eyes different riders, Regulatory Focus 18 May 2022)
“Under current regulations, after a medical device is cleared or approved by the FDA, it typically cannot be changed or modified without a new submission to the agency and a subsequent review and decision,” Braun noted. He noted that his proposal saves FDA resources and prevents unnecessary reviews unless the device modifications are outside the scope of the predetermined change plan.
He also argued that patients would benefit since it ensures they will have the most effective and up-to-date devices.
However, not everyone agrees that FDA needs the authority. In a recent conversation with Regulatory Focus, Bradley Thompson, an attorney with Epstein, Becker and Green, said the agency already has the ability to set change parameters when they allow a product on the market. (RELATED: FDA should step in to help spur AI/ML standards: Expert, Regulatory Focus 13 June 2022)
The HELP committee also approved an amendment from Sen. Jacky Rosen (D-NV) that would require FDA to update its medical device cybersecurity guidances every two years instead of every four. It would also require providing public information on improving medical device cybersecurity including how to access support through the Cybersecurity and Infrastructure Security Agency (CISA) and require the Government Accountability Office to publish a report on challenges of cybersecurity and how federal agencies can better coordinate.
Sen. Braun also proposed an amendment with Sen. Maggie Hassan (D-NH) to waive annual establishment fees for small medical device makers stating they hurt the smallest companies most because they apply to all companies regardless of size. The amendment was approved.
Burr supported the amendment and said FDA’s budget has grown so much the agency wouldn’t be significantly affected by it.
“I say this for my colleagues in the appropriations committee, in a perfect world I would hope we would all be here lobbying that there would be no user fees paid to the FDA by anybody: devices, pharmaceuticals, generics, biologics,” he said. “That we’re actually … going to fund it [all] out of the appropriations process like it used to be.”
“Folks this is wrong,” Burr added. “When your regulator has the ability to sit down with you every five years and negotiate what you're going to pay them for you to do work on their applications, something's gravely broken.”
The committee also approved an amendment from Sens. Tina Smith (D-MN) and Braun that is intended to lower the cost of generic drugs by speeding their path to market by preventing drug parking. Parking is the practice of brand manufacturers agreeing not to sue generic drug makers who get first approval if they delay their drug from coming to market. The amendment would give 180-day exclusivity to subsequent generic drug fillers that disrupt that practice.


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