The focus of a recent hearing of Senate Health, Education, Labor and Pensions (HELP) was the FDA’s user fee agreements, or monies the agency receives from drug and medical device manufacturers to accelerate the review process.
But prior to the hearing, every Democratic member of the HELP committee signed a letter to Chair Lamar Alexander (R-Tenn.), requesting that he delay the hearing on user fees, and discuss the American Health Care Act (AHCA) instead.
That request was denied.
As a result, tensions were palpable during the hearing, as Alexander (R-Tenn.) and Patty Murray (D-Wash.), the ranking minority member, had the air of two people who’d just had a serious argument.
While FDA top brass stuck to the plan and answered questions on user fees, Democrats were less willing to play along, and Republicans stood their ground.
If Congress does not re-authorize four agreements — prescription drugs, generic drugs, biosimilars, and medical devices — before their expiration in September 2017, the FDA will lose the right to collect user fees, and be forced to send lay off notices to 5,000 employees, Alexander noted.
Inaction would “threaten biomedical industry jobs and American global leadership in biomedical innovation,” he added.
Alexander spoke of the passage of the 21st Century Cures Act, a bill whose goal was to speed the development and approval of drugs and get them to patients. The bill passed in November 2016 with broad bipartisan support, including that of President Obama and House Speaker Paul Ryan (R-Wis.).
Alexander stressed the need to press forward on the user free agreements in order to implement the goals of the act.
‘Step Back from the Precipice’
But Democrats were having none of it. Murray said she was appalled that HELP would not hold one hearing to debate “Trumpcare.” She noted that Senate Majority Leader Mitch McConnell (R-Ky.) has already declared his intention to push the ACHA vote directly to the Senate floor, after it leaves the House.
Glancing at Alexander, she stated “I hope that Republicans do the right thing, step back from the precipice, and work with us to strengthen our healthcare system not destroy it.”
Sen. Chris Murphy (D-Conn.) said it was “outrageous” to be holding a hearing on prescription drug user fee agreements rather than the repeal and replacement bill.
“We’re the health committee; we’re charged with overseeing the American healthcare system and we are acting as if this isn’t happening,” he said. “I get that we can make your job easier and speed more transformational drugs to market, but if you don’t have insurance to afford these drugs then nothing we do here … matters.”
The Senate could be asked as soon as next week to vote up or down on a bill that could cause millions to lose their health insurance, he continued, “and this committee will have nothing to say about it.”
Murphy then left the hearing without asking any questions of the FDA witnesses.
User Fee Talks Go On
In the limited discussion of the user agreements, some Republicans raised concerns about how user fee funding had been spent.
Sen. Richard Burr (R-N.C.) said the FDA hired 87% of the 129 staff it had pledged, alleging that money from user fees had been directed to construction and rent instead of solely to to the review of drugs.
But Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, said that rent was an “allowable cost.” She said she would look into the question of the construction funds.
Burr also asked how the generic user fee agreement had affected the review process. Woodcock called it a challenge, saying that it was “a python trying to… swallow a giant donkey.” Thousands of applications had been waiting to be reviewed before the first generic user fee agreement was enacted, she said.
The FDA now boasts a “predictable process” for industry and the 2,300 applications under review currently all have goal dates, Woodcock added.
Sen. Pat Roberts (R-Kan.) noted the combined 30% increase in fees for drug reviews and said he hoped the agency was prepared for “the increased workload.”
He asked why completion of the guidance on interchangeability for biosimilars was anticipated to take until 2020, nearly a decade after the biosimilar pathway was made law.
Peter Marks, PhD, director of the Center for Biologics Evaluation and Research, explained that the science of determining whether products were bioequivalent was complex; establishing scientific criteria for interchangeability was a challenge. The agency also has to solicit stakeholders’ feedback.
Murray asked how the FDA could help curb drug costs by advancing the approval of generic drugs and biosimilars.
Asked how many of the 2,300 drugs under review would serve as competition for brand-name drugs, Woodcock acknowledged there were only 15. Specifically, there are six drugs where the innovator patent had expired and generic competition is allowed, along with nine sole-source products for which NDAs are under review, an FDA representative explained after the meeting.
Murray noted that was only a small fraction of the total, adding that legislators would need to pursue other avenues to help bring down the costs of drugs. He mentioned the idea of allowing Medicare to negotiate drug costs, and that competition alone would not “solve the drug [cost] crisis.”
Several committee members pressed Woodcock and others on whether the Trump administration’s hiring freeze was hindering the agency’s work.
Woodcock said she couldn’t discuss budgetary issues, but she told reporters after the meeting that the agency was working with the U.S. Department of Health and Human Services on hiring issues.
On the Defensive
Throughout the hearing, Alexander defended the Republican leadership and his own decision not to discuss the AHCA.
He argued that Obamacare moved forward on different tracks when it was being approved, and the AHCA was following that same process.
With regard to the budget reconciliation, “there was no train that ran through the Congress faster than the Obama reconciliation bill,” he said arguing that the Democrats possessed “selective memory.”
In an emailed press statement, sent after the close of the hearing, Alexander’s office quoted the National Organization for Rare Diseases and Friends of Cancer Research: “Our request of the Committees of Jurisdiction and Congress as a whole is simple: please keep the user fee reauthorization process non-partisan, uncontentious, and focused on the patients FDA serves every day.”