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Regulatory Focus – Woodcock, Industry Groups Tell House E&C Committee PDUFA Reauthorization Delays Could be Dire

Regulatory Focus – Woodcock, Industry Groups Tell House E&C Committee PDUFA Reauthorization Delays Could be Dire

Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI).


And, in her second straight day of testimony on user fees before Congress, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) detailed how the agency’s ability to effectively regulate drugs could be stymied if a deal is not reached soon.


In general, the committee seemed supportive of the agreement reached between FDA, industry and patients groups, though some members questioned the agency on particular issues, such as FDA’s oversight of generic drugs and its role in addressing the prescription opioid abuse epidemic.


However, despite support for the user fee agreements in Congress, uncertainties remain as to how President Donald Trump will approach the agreements, as his budget blueprint released last week called for recalibrating the agency’s fees.


In his opening statements, Rep. Gene Green (D-TX) said he was “disappointed” to see the administration hint at reopening the negotiation process for the agreements.

Woodcock’s Testimony

On Tuesday, Woodcock and the heads of FDA’s biologics and medical devices centers told members of the Senate Health, Education, Labor and Pensions Committee that the agency would experience major layoffs if a new deal is not reached before the current agreements expire in September 2017.


Today, Woodcock said that much of the staff the center would have to cut are highly specialized, and would be difficult to replace.


“Most of these are doctors and scientists, they’re almost all at the PhD or MD level. The physicians are generally sub-specialists…hard to find people,” Woodcock said.


She also warned that the agency’s performance could be affected well before notice of the layoffs occurs if the user fee reauthorizations were to stall.


“What we’d expect is the productivity would slow down as we approach the brink, tremendously. This has happened once before where we approached it, and we lose staff. Our people are heavily recruited into other jobs…and so I would expect we would start to lose people very early, before they got their notice,” Woodcock said, adding that filling those positions again would be difficult.


In their testimony, representatives from the Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Friends of Cancer Research (FOCR) called on Congress to reauthorize PDUFA.


“BIO strongly supports this PDUFA VI user fee agreement and its timely reauthorization,” said Kay Holcombe, senior vice president of science policy at BIO.


According to Holcombe, not passing the agreements on time would be devastating to drugmakers.


Review times at FDA, Holcombe said, represent “the tip of the iceberg” for the time it takes to get a new drug to market, and many of the provisions in PDUFA VI, such as innovative clinical trial design, biomarker qualification and enhancements to FDA’s breakthrough therapy program, promise to further reduce development times.


“It would absolutely disable any process that FDA has for talking to us during drug development about how to be more successful in our program,” Holcombe said.


Anne Pritchett, vice president of policy and research for PhRMA also cautioned that failing to reauthorize PDUFA could be a setback for US manufacturers.


“At a time when other countries are seeking to attract and grow their own biopharmaceutical presence due to its far reaching economic impacts, it is more critical than ever that we ensure that the US retains its competitive advantages, which includes a science-based, gold standard regulatory system in the FDA,” Pritchett said.


PDUFA VI also promises to further support patient involvement in the regulatory process. FOCR President Jeff Allen lauded the agreement. “The PDUFA VI agreement will further assist organizations and researchers in collecting patient experience data, create channels for providing such data to the FDA, and it will help develop methods for analyzing it,” said Allen.…