What Time Is It?

Time for generic pharma's leadership

By Steven Kuehn, Editor in Chief & Gary Ritchie, Contributing Editor

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Uhl explained that GDUFA basically changed the entire spectrum of the generic drug review process and the interaction between the Agency and the industry, and ultimately, puts tremendous responsibility on everyone. “It increases our responsibilities, our obligations, our commitments and also accountability — not just to each other, but to the American people.”

Uhl said GDUFA obviously causes substantial changes in the review process and communications both internal and external, and changes related to inspection and inspection parity. “GDUFA actually,” said Uhl, “… really forces us to define ‘What is the Generic Drug Program?” She noted to GPhA attendees that many people understood that the OGD is the FDA’s generic drug program, but that in reality that is not the case: “It is not just OGD,” said Uhl, “It is essentially every single component of CDER, as well as other Centers, such as devices, and potentially even biologics.” Regardless OGD is at the center of it all, she said, because it serves as the interface for industry applicants.

Uhl, addressing the audience frankly said, “Now we realize that you … have huge expectations. You’ve paid your money. You want services. We get it. We hear you and we are working very hard … [to provide service] … and that right now [the FDA is] really about instituting the appropriate operations that we need to meet … very aggressive metrics and the implementation of this program, and the success of this program really requires substantial changes at the FDA.”

Uhl characterized the Agency’s performance goals as a “Five-year program that is sequential and with progressive implementation.” The bottom line is that by 2017 the FDA’s OGD is obligating itself to approve ANDAs submitted electronically within 10 months. “Because that is our goal,” said Uhl, and “you will get action … [and] get an approval, tentative approval or a complete response — that’s the metric that we are headed for in year five.” Of particular note in her slide “GDUFA Review performance goals” is the FDA’s commitment to act on 90% of backlogged ANDA, amendment and PAS by the end of FY 2017.

In the name of efficiency (which is the point of FDA’s OGD reform after all), Uhl talked to a slide that outlined four primary categories of enhancements: ANDA and Type II DMF, Regulatory Science, Inspections and Systems and Electronic Standards. Within each of these categories the FDA proposes some very common sense means to increase the efficiency of the approval process, the issuance of complete response letters and the prioritization of inspections, tying them to ANDAs that are otherwise approvable or eligible for tentative approval.

Perhaps most vital to the FDA’s operational and structural efficiency actions is its proposed enhancements to IT systems and technology. This aspect of the FDA’s ANDA process improvement program includes the implementation of an “Integrated Regulatory Review Platform.” According to Uhl, it will provide great value to the OGD with its ability to measure progress against goal dates, real-time visibility into queue and status of applications and reviews, end-to-end support of the generic drug application review process, the reduction of manual and or duplicate entry and provide Agency access to searchable data and dynamic reporting as well as visibility when it comes to patent and exclusivity status, site inspection history and standardized communications documents. In other words, welcome to the modern world of IT functionality FDA!

Similarly, the IT enhancements program provides value to the industry as well, by improving planning and more accurate forecasting, consistent data and communications, structured reporting tools, the integration of process and technology and in general “Greater predictability and transparency of the generic drug review process.” Can we get an “Amen” for that Generic Pharma?

The GPhA’s keynote session included a panel discussion moderated by Marcie McClintic Coates, vice president and head of global regulatory affairs for Mylan. Among her panelists was Kate Beardsley, formerly U.S. regulatory counsel and someone who was on the ground floor of Hatch-Waxman. To kick off the discussion, Coates asked panelists if they recognized a link between Hatch-Waxman and GDUFA. Beardsley responded first. “It seems to me that GDUFA is in many ways … a culmination of Hatch-Waxman. Hatch-Waxman has been one of the most successful statutes … We have a huge and vibrant generic drug industry, we’re saving money for patients; everything that it was intended to do it has done and more.”

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