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Holcombe’s E&C Testimony: PDUFA VI Will Take Patient-focused Drug Development to New Level

March 23, 2017 – In testimony before the House Energy and Commerce Committee’s Subcommittee on Health yesterday, Biotechnology Industry Organization Senior Vice President of Science Policy Kay Holcombe praised the success of industry user fees paid to the FDA to improve the drug review process and called on the subcommittee to reauthorize the Prescription Drug User Fee Act (PDUFA).

“Kay Holcombe is one of the unsung heroes of the PDUFA process, having represented FDA, Congress and now BIO across the history of this program,” said Coalition for Healthcare Communication Executive Director John Kamp. “We’re pleased that she is a featured speaker at the Coalition Rising Leaders meeting in D.C. on May 16 and can help us more fully understand PDUFA’s critical role in the FDA’s medical approval processes.”

“PDUFA VI builds on the proven premise that greater and more productive interaction between drug developers and FDA works,” Holcombe said. “It leads to better outcomes and to more efficient development programs.”

Holcombe reminded the subcommittee – which was instrumental in the 21st Century Cures Act legislation – that PDUFA VI, which needs to be reauthorized before its expiration in September 2017, “will take patient-focused drug development to a new level.”

According to Holcombe, “PDUFA VI will bring that patient voice to the forefront, changing it from a voice with a compelling story to a voice that provides evidence – verifiable, valid evidence that is appropriate for the drug label.”

She explained that “the message of those commitments is that the patient voice truly matters – in the beginning, when early studies show a promising treatment, and at the end, when FDA is making its decision about a product’s benefit and risk.” She added that “the vision of PDUFA VI is the vision of 21st Century Cures – put patient needs first.”

Further, predictable drug review and drug development timelines are integral to the livelihood of the biotechnology industry, Holcombe stated, because “predictability is critical for companies making investment decisions.” Although that predictability currently exists for drug review under PDUFA V, PDUFA VI would encourage greater predictability and transformation in the drug development arena by expanding expertise in diverse statistical methods, piloting innovative clinical trial designs and computer modeling and simulation, using biomarkers as surrogate endpoints, and utilizing real-world evidence/”big data.”

Holcombe also emphasized the importance of allowing the FDA to hire and retain the people it needs to carry out its PDUFA goals, even with a federal hiring freeze in place, because PDUFA is a carefully negotiated agreement that allocates the majority of user fee costs to FDA personnel. “In PDUFA VI, the annual hiring goals are included in the agreement,” according to Holcombe. “This allows the public a line of sight into whether goals may fall by the wayside as a result of an inability to hire. If this were to happen, fees could not be spent.”

To the relief of many FDA watchers, FDA recently received word from the White House that the federal hiring freeze would not apply to positions funded by industry user fees.

Responding to a question about the possible consequences of Congressional failure to pass PDUFA VI by early summer, Holcombe responded: “Titanic.” Delayed reauthorization would cause hundreds of FDA medical reviewers and other staff to be laid off, she said, crippling the drug review process.

To hear more from Holcombe, attend the Coalition for Healthcare Communication’s Rising Leaders Conference, to be held May 15-16 in Washington, D.C. Holcombe will be speaking on a panel of experts on the FDA, which will be moderated by Coalition Executive Director John Kamp. Joining them on the panel will be APCO Worldwide’s Wayne Pines, an FDA expert on crisis communication and medical marketing and also an FDA veteran; and Mit Spears, former General Counsel of both PhRMA and the Federal Trade Commission, who is on several lists for a senior policy position in the Trump administration. For more information or to register, contact John Kamp at