The Food & Drug Administration’s generic drug review activities are getting organizational status and a direct line to the top of FDA’s drug activities to reflect the new funding enacted by the FDA Safety & Innovation Act.

In a change announced September 7, Center for Drug Evaluation & Research Director Janet Woodcock made the generic review group one of five “super offices” in the CDER alignment, joining the Office of New Drugs, Office of Surveillance & Epidemiology (elevated in April 2011), Office of Compliance (elevated in June 2011), and Office of Medical Policy (elevated in September 2011).

The change in status for the Office of Generic Drugs is perhaps the most significant of the new Super Office designations. The reorganization pulls the generics operation out of the Office of Pharmaceutical Science and elevates it to a position with a direct line to Woodcock. ([A#29120911004])

That underscores the importance of the new Generic Drug User Fee program as a key element of FDASIA. OGD is slated to see its budget quadruple thanks to GDUFA, so an elevation in status seems appropriate.

A New Director With Brand Background

FDA acted quickly to have a new director of the Office of Generic Drugs in place within one week of the enactment of GDUFA on July 9.

Gregory Geba, a fifteen-year veteran of clinical development management at four large brandname companies, takes over the job of adding more reviewers (about 75 in the next two years) and embarking on a five-year plan to catch up on generic drug application backlogs.

Geba was introduced to the FDA staff during the week of July 9-13 with emphasis on his skills at managing a large organization in the pharma business. His first day on the job was July 16.

FDA’s internal announcement of Geba’s appointement noted that, in his previous position as deputy chief medical officer for the US operations of Sanofi , Geba “provided medical and scientific leadership and managerial direction to a staff of approximately 500 multidisciplinary scientific and regulatory professionals engaged in drug development activities.” Geba also worked for Merck & Co. Inc. for 6 years, Novartis AG for 5 years, and Medimmune/AstraZeneca PLC for two years.

Those management skills will be important because OGD is scheduled for a substantial influx of new reviewers, new funds from the $299 million in annual generic drug user fees, and more aggressive review schedules. FDA is committed to reducing the approximately 2,600-appplication backlog by 90% over the next five years with its new user fee resources. That’s a big simultaneous task of recruitment, training and ongoing operations improvement.

OGD Director Gregory Geba will deliver a keynote address during The RPM Report’s FDA/CMS Summit for Biopharma Executives Dec. 10-11 in Washington, D.C. Register now, via our website or by contacting Denise Struble (d.struble@elsevier.com; (908) 547-2067)

Geba’s scientific and development specialties (in pulmonary and immunology) are important as areas where FDA has faced difficulties assuring the equivalence criteria for generic versions of some leading inhaled and topical products. As someone with extensive experience on the brand development side in those areas, Geba will know the issues (and strategies) well. That eventually could help open up some blocked areas of generic drug development.

The agency has been stymied on the issue of assessing generic equivalence for major pulmonary inhaled products. Geba has regulatory experience with that class and, in fact, presented to an FDA advisory committee on the safety of a Novartis inhaled long-acting beta agonist, Foradil, in 2005.

At least one sponsor, Mylan NV , has projected a target generic application action for a product equivalent of GlaxoSmithKline PLC’s Advair (fluticasone propionate/salmeterol) by 2016. Under Geba’s leadership, OGD could be well prepared for an action in that area by then.

LidoDerm Offers Symbolic Start to New Era

The top management support for accelerating generic drug activities is reflected in the effort to show momentum on generics in several ways. For example, the approval for Allergan PLC’s generic version of Endo Pharmaceuticals Inc.’s LidoDerm on August 23 indicates a more decisive approach to lingering scientific issues.

Watson’s marketing of the patch is delayed by a previous settlement with Endo until September 2013, but the approval action itself is significant in the debate over FDA’s ability to determine bioequivalence for transdermal products. Just about two weeks before the FDA approval, Endo was telling Wall Street analysts that the company continued to see a “very high hurdle” for generic lidocaine patches coming to market and that Endo felt that its pending Citizen Petition was on generic approval issues was being taken “very seriously” by FDA.

The agency’s lidocaine approval may be a message on how the new generic review management will address blocking arguments like Endo’s. As such, it demonstrates a renewed willingness to take firm positions on challenged generic approval decisions.

Biosimilars, Anti-Infectives Next For Elevation?

FDA is not finished with reorganizations related to the new generic regulatory resources. In the September 7 announcement, Woodcock said CDER is “exploring” a further excision from the Office of Pharmaceutical Science (where OGD was previously located).

CDER is considering the creation of an Office of Product Quality. That would further address the intense public and Congressional attention to the quality of generic drug products and active ingredient sources. “I will also propose,” Woodcock said, “realigning some functions from the Office of Manufacturing & Product Quality (OMPQ) in the Office of Compliance into the new OPQ.” She noted that enforcement and compliance would “continue to reside in the Office of Compliance.”

FDA is reacting quickly to some of the different management challenges set by PDUFA V: the overlap in quality oversight and even the process of implementing the new Congressional objectives and deadlines.

To make it administratively more feasible to address the simultaneous challenges of organization growth and catching up on the backlog of applications in generics, for example, CDER is providing support to OGD on the functions of tracking and reporting on the generic user fee program within the Office of Executive Programs (outside the new generic super office). “Mary Beth Clarke, acting director of the Office of Executive Programs,” Woodcock said, “will continue to be the CDER lead of GDUFA implementation, working closely with OGD and other CDER components to implement this important program.”

Recent CDER reorganizations have done a good job of bringing the FDA organizations most directly in the view of Congress to higher positions reporting to Woodcock: first, elevating the drug safety office to emphasize symbolic equality with the new drug review group in CDER; then compliance (dealing with supply chain quality issues), medical policy (which plays a key role the developing biosimilars policy, post-market pharmacovigilance and drug promotion oversight) and now generic reviews.

That leaves biosimilars and anti-infective incentives as Congressionally-anointed priority areas with subsidiary profiles in FDA’s organization.

In both cases, the issues are covered by groups with good visibility within the agency: biosimilars by medical policy and new drug review (where most of the initial biosimilar application reviews are expected to take place) and for anti-infectives in the recently reorganized Office of Antimicrobial Products.

The biosimilar structure is likely to evolve over time. The current focus is on case-by-case product reviews where therapeutic area-specific decisions—guiding by the central policy oversight authority—is clearly appropriate. The relatively modest influx of funding for biosimilars (about $40 million in user fees plus appropriations, compared with $400 million for generics) also suggests a lower organizational status for the time being.

In fact, the elevation of OGD will allow the Office of Pharmaceutical Sciences to focus more attention on the critical role of analytics in the emerging biosimilar pathway. Also see "Biosimilars: Inverting the Innovator Development Model" - Pink Sheet, 1 February, 2012.

In anti-infectives, FDA is taking on an important new set of authorities under the GAIN Act provisions in FDASIA, including a new mechanism for extending exclusivity for qualifying infectious diseases. Also see "The Limitations of Antibiotic Incentives" - Pink Sheet, 9 May, 2012.

Getting Organized for GDUFA: FDA Elevates Generic Review Activities Under New Director Geba

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