Life Science Compliance Update

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January 03, 2013

FDA Center for Drug and Evaluation Research Exclusivity Board, Data Partnership and Neoadjuvant Therapies

Board meeting
According to a recent post from the FDA Law Blog, the Food and Drug Administration (FDA) recently announced that the Agency has established within the Center for Drug Evaluation and Research (“CDER”) an Exclusivity Board “to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency of decisions.”  “The CDER Exclusivity Board will oversee certain exclusivity determinations, including whether and what type of exclusivity should be granted and the appropriate scope of exclusivity grants,” according to the announcement.   

The Board will focus on 5-year new chemical entity (NCE) exclusivity, 3-year new clinical trial exclusivity, and exclusivity for biological products.  The Board will not review or make recommendations with respect to all exclusivity determinations in these areas, but will assist the Center in resolving certain matters, including issues that arise in the context of specific requests for exclusivity. 

The Board generally will not review 180-day generic drug exclusivity, 7-year orphan drug exclusivity, or 6-month pediatric exclusivity, but it will communicate with other groups within FDA responsible for addressing these exclusivity issues, as appropriate.  The Board also may evaluate and make recommendations regarding CDER’s policies and practices relating to exclusivity and maintain records of exclusivity determinations. 

The FDA Law Blog post, written by FDA Attorney Kurt R. Karst, explained that the CDER Exclusivity Board, “has been around for several months,” noting that back in April 2012, the Board rendered a decision with respect to the availability of 3-year exclusivity for an NDA supplement for VANCOCIN (vancomycin HCl) Capsules (NDA No. 050606).  In fact, Peter Pitts from the blog Drug Wonks, noted that the board began meeting in November 2011.  

Karst maintained that “the CDER Exclusivity Board was likely created in the wake of a February 2009 lawsuit against FDA over the Agency’s decision to grant NCE exclusivity for VYVANSE (lisdexamfetamine dimesylate) Capsules (NDA No. 021977).  (FDA ultimately issued a letter decision affirming the grant of NCE exclusivity, and both the DC District Court and the DC Circuit Court ruled in FDA’s favor.)  During the course of that litigation, FDA acknowledged that the Agency had mistakenly denied 5-year NCE exclusivity for another drug – EMEND (fosaprepitant dimeglumine) for Injection (NDA No. 022023) – and issued a letter decision that fosaprepitant dimeglumine should have been classified at the time of approval as an NCE and awarded 5-year exclusivity instead of 3-year exclusivity.   

The post notes that FDA did “not discuss the composition of the CDER Exclusivity Board; however, we understand that the Board is composed of members from various FDA components.  These FDA components include the Office of Chief Counsel, the Office of New Drugs, the Office of Regulatory Policy, and the Office of Generic Drugs.  It is possible that the Board may bring other FDA components as issues, such as biologics exclusivity, arises  .

Companies with questions regarding exclusivity matters may submit their queries by email to the CDER Exclusivity Board at

FDA Announces New Partnership 

In addition to this recent announced, CDER Director Janet Woodcock, M.D., recently posted on FDA’s Voice Blog that the agency has formed a new partnership.  The Clinical Data Interchange Standards Consortium (CDISC), and the Critical Path Institute (C-Path) was officially launched at the CDISC International Interchange in Baltimore. 

“This partnership, called the Coalition For Accelerating Standards and Therapies or CFAST, will bring together clinical data experts from the FDA, the pharmaceutical industry, and the information technology sector, to develop and maintain data standards tailored to individual diseases and therapeutic areas.” 

Woodcock noted how the agency is seeing “ever-increasing streams of data coming into the agency” and to address these challenges, FDA needs “to develop standardized definitions for individual diseases and the therapeutic approaches to treat them to be able to tap into this data stream.” 

Standardized data elements that are common to all clinical trials, such as age and gender, have been established using CDISC terminology.  However, data elements that are unique for a particular disease or therapeutic area still need to be developed so that the data from multiple trials can be more easily grouped for reporting and analysis.  To read more on data standards, Woodcock directed readers to:  CK Cooper et al. Drug Information Journal. 46(5) 521-22

In 2011, CDER identified a set of therapeutic areas that could benefit from further standardization, organizing them into three tiers of priority.  Several factors were considered at the time: (1) areas of particular medical need, (2) areas with existing data standardization projects underway, and (3) areas with greater drug development pipeline activity.  The number and ordering of these areas may change as stakeholder input and further analyses are considered. 

FDA has also established its own webpage for Priority Therapeutic Areas for Development, which includes links for a “Roadmap for Development” and a Table of Priorities. The roadmap below displays the TAs in priority groupings and suggests a series of standardization projects over time to achieve significant results by December 2017.  This roadmap assumes standardization projects for therapeutic areas are scoped narrowly enough to be accomplishable within a 12-month period, and that subsequent projects in those areas build on the results.  Periodically, updates to the timeline will be provided as progress, opportunity and additional information is available.   

Breaking Ground in Breast Cancer Treatment 

Another post on FDA’s blog in late October , written by Robert Justice, M.D., M.S., the director of the Division of Oncology Products 1 in the Office of Hematology and Oncology Products in CDER, discussed FDA’s recent efforts for helping accelerate approval of breast cancer drugs.  Many posts on FDA’s blog in October were dedicated to breast cancer in honor of Breast Cancer Awareness month.   

Justice explained that FDA has been “examining the use of novel anti-cancer therapies prior to surgery.”  This is known as neoadjuvant therapy, which FDA “believe[’s] has the potential to advance drug therapy for breast cancer even further, including the possibility of converting an inoperable breast cancer tumor into an operable one.  Preoperative therapy could also make it possible to identify—early in treatment—tumors that are resistant to chemotherapy, enabling doctors to discontinue ineffective therapy and better assess the likely course and outcome of the disease.” 

To evaluate this innovate approach, Justice noted that a new endpoint is needed — “an outcome from a clinical trial that FDA will accept as evidence that the drug will be effective.  This means some new ways of thinking about what kind of information from clinical studies constitutes enough evidence to consider a drug both safe and effective.”  He also pointed out how FDA recently shared its thoughts and views with the pharmaceutical industry on this subject via a document called a draft guidance, which discusses endpoints for clinical trials that may be considered when studying new drugs intended for neoadjuvant therapy. 

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