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Human Drugs Performance Detail FY 2012 OPA

Table of Contents FY 2012 OPA

Long Term Objective:  Advance Human Drug Safety and Effectiveness 

Measure

FY

Target

Result

223201: Percentage of Standard NDAs/BLAs within 10 months. (Output)

2012

90%

Nov 30, 2013

2011

90%

Nov 30, 2012

2010

90%

Nov 30, 2011

2009

90%

92%

(Target Exceeded)

2008

90%

84%

(Target Not Met)

2007

90%

88%
(Target Not Met)

223202: Percentage of Priority NDAs/BLAs within 6 months. (Output)

2012

90%

Nov 30, 2013

2011

90%

Nov 30, 2012

2010

90%

Nov 30, 2011

2009

90%

80%

(Target Not Met)

2008

90%

63%

(Target Not Met)

2007

90%

90%
(Target Met)

223205: The total number of actions taken on abbreviated new drug applications in a fiscal year. (Output)

2012

2000

Nov 30, 2012

2011

2000

Nov 30, 2011

2010

1900

2,079

(Target Exceeded)

2009

1900

2,006
(Target Exceeded)

2008

1780

1,934
(Target Exceeded)

2007

N/A

1,779
(Historical Actual)

 


Measure

Data Source

Data Validation

223201
223202 223101
223205

223207

Review performance monitoring is being done in terms of cohorts, e.g., FY 2009 cohort includes applications received from October 1, 2008, through September 30, 2009. CDER uses the Document Archiving, Reporting, and Regulatory Tracking System (DARRTS). FDA has a quality control process in place to ensure the reliability of the performance data in DARRTS. The Pediatric Exclusivity Database tracks all data regarding pediatric exclusivity as mandated by FDAMA and reauthorized by BCPA. Specifically, this database tracks the number of WRs issued and the number of products for which pediatric studies have been submitted and for which exclusivity determinations have been made. The Pediatric Page database captures all information regarding waivers, deferrals, and completed studies for applications that are subject to the Pediatric Research Equity Act. Published monographs that establish acceptable ingredients, doses, formulations, and consumer labeling for OTC drugs.

The Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) is CDER’s enterprise-wide system for supporting premarket and postmarket regulatory activities. DARRTS is the core database upon which most mission-critical applications are dependent. The type of information tracked in DARRTS includes status, type of document, review assignments, status for all assigned reviewers, and other pertinent comments. CDER has in place a quality control process for ensuring the reliability of the performance data in DARRTS. Document room task leaders conduct one hundred percent daily quality control of all incoming data done by their IND and NDA technicians. Senior task leaders then conduct a random quality control check of the entered data in DARRTS. The task leader then validates that all data entered into DARRTS are correct and crosschecks the information with the original document. CDER uses the Pediatric Exclusivity database and the Pediatric Research Equity Act Tracking System (PREATS) to track information such as number of written requests issued and the number of products for which pediatric studies have been submitted and for which exclusivity determinations have been made as well as information related to the PREA legislation.

 

Measure

FY

Target

Result

222303: Improve the safe use of drugs by patients and health care providers by reviewing safety labeling changes required under FDAAA within the timeframes established by FDAAA. (Output)

2012

80%

Nov 30, 2012

2011

80%

Nov 30, 2011

2010

80%

94%

(Target Met)

2009

N/A

75%

(Historical Actual)

2008

N/A

N/A

2007

N/A

N/A

222201: The Unit Cost associated with turning a submitted Adverse Event Report into a verified record in the database. (Efficiency)

2012

$10 per report

Nov 30, 2012

2011

$10 per report

Nov 30, 2011

2010

$12 per report

$7.35 per report

(Target Exceeded)

2009

$12 per report

$10.79 per report

(Target Exceeded)

2008

$13 per report

$10.59 per report
(Target Exceeded)

2007

$15 per report

$13.64 per report
(Target Exceeded)

222203: The percent of manufacturer submitted expedited adverse event reports received electronically compared to all expedited adverse event reports received from industry. (Outcome)

2012

90%

Nov 30, 2012

2011

90%

Nov 30, 2011

2010

80%

87%

(Target Met)

2009

N/A

83%

(Historical Actual)

2008

N/A

N/A

2007

N/A

N/A

292202:  Number of people for whom FDA is able to evaluate product safety through miniature Sentinel*pilots.  (Outcome)

2012

70 million

Oct 1, 2012

2011

70 million

Oct 1, 2011

2010

55 million

60 million

(Target Exceeded)

2009

N/A

35 million

(Historical Actual)

2008

N/A

N/A

2007

N/A

N/A

292203:  Number of safety analyses that are conducted using Medicare and Medicaid SafeRx* pilot.   (Output)

 

2012

13

Oct 1, 2012

2011

13

Oct 1, 2011

2010

10

15

(Target Exceeded)

2009

N/A

7

(Historical Actual)

2008

N/A

N/A

2007

N/A

N/A

 

Measure

Data Source

Data Validation

222201

222203

Drug Quality Reporting System (DQRS), Adverse Event Reporting System (AERS), OMB Form 300 on Drug Safety, UFMS cost data and published FDA CDER/CBER guidance for Industry, internet site http://www.fda.gov/cber/gdlns/barcode.htm.

AERS, UFMS, and OCIO quality control processes

292202

 

Automated Healthcare databases from Federal Partners' Collaboration  (i.e., CMS, DoD, VA)

 

Mini-Sentinel Pilot contractor (i.e., Harvard Pilgrim Health Care) automated Healthcare data from private sources (non-government)

Data validation is based on a review of the access to both publicly and privately available automated healthcare data.  Participating Federal Partners will verify patient population numbers that are accessible for evaluation of safety signals.  Harvard Pilgrim Health Care will verify patient population numbers accessible for evaluation of safety signals, to include all distributed partners within the contract.

292203

FDA Principal Lead for FDA-CMS Interagency Agreement to analyze safety signals from automated healthcare databases

 

Data validation is based on a review of the past period’s activities and verification by the CMS Contracting Officer's Technical Representative (COTR) that verifies workload on ongoing basis to monitor funding provided by FDA to CMS for this collaborative safety project. FDA provides guidance on which safety signals to investigate and collaboratively reviews the data.

 


 

Measure

FY

Target

Result

224201: Number of foreign and domestic high-risk human drug inspections.   (Output)

2012

750

December, 2012

2011

750

December, 2011

2010

700

705

(Target Exceeded)

2009

600

687

(Target Exceeded)

2008

500

534
(Target Exceeded)

2007

500

583
(Target Exceeded)

 



Measure

Data Source

Data Validation

224201

Field Data Systems.

ORA uses two main information technology systems to track and verify field performance goal activities: the Field Accomplishments and Compliance Tracking System (FACTS) and the Operational and Administrative System Import Support (OASIS). FACTS includes data on the number of inspections; field exams; sample collections; laboratory analyses; and, the time spent on each. OASIS, which is coordinated with U.S. Customs and Border Protection, provides data on what FDA regulated products are being imported as well as where they are arriving. It also provides information on compliance actions related to imports. FDA is currently developing the Mission Accomplishment and Regulatory Compliance Services (MARCS) system. MARCS will incorporate the capabilities of these two field legacy systems and include additional functionality.

 

Measure

FY

Target

Result

222302: Percentage of television advertisements requiring submission reviewed within 45 days.  (Output)

2012

30%

Dec 31, 2012

2011

Submit draft guidance & establish baseline

Dec 31, 2011

2010

Issue guidance & establish baseline

Guidance Drafted and Undergoing Review
(Target Not Met)

2009

N/A

N/A

2008

N/A

N/A

2007

N/A

N/A

 

1.   Percentage of Standard NDAs/BLAs and Priority NDAs/BLAs within 10 months.   (223201 and 223202)

 

Context:  This performance goal focuses primarily on improving the effectiveness and efficiency with which the FDA processes new drug and biologics licensing applications.  Central to that focus is FDA’s commitment to meeting PDUFA goals and requirements.  The Food and Drug Administration Amendments Act (FDAAA) of 2007 reauthorized collection of user fees to enhance the review process of new human drugs and biological products and established fees for applications, establishments, and approved products.  A key determinant in knowing if CDER is effective and efficient is to measure the time to “first action.”  The first action is the first regulatory action CDER takes (complete response, approvable, not approvable, or approval letter) at the end of the review of the original NDA/BLA submission (the first review cycle).  The “first action time” refers to the time it takes to review and take an action on the original submission.  This statistic is different from “total approval time” which is the time it takes from the original receipt of the application until it is approved, which may take more than one review cycle.  “Total approval time” includes time spent reviewing an application in each of the review cycles plus the time taken by the sponsor to respond to the issues raised in the complete response or approvable/not approvable letter(s) and to re-submit the application for review.  CDER’s featured targets under this performance goal are to measure time to first action for “priority” submissions and “standard” submissions.  Applications for drugs similar to those already marketed are designated standard, while priority applications represent drugs offering significant advances over existing treatments.  In FY 2012, FDA continues to maintain the target set for this goal in the PDUFA legislation. 

 

Performance:  CDER tracks performance to these review goals by fiscal year cohorts. If an application is submitted in September of 2009, it will be tracked in the FY 2009 cohort even though much of the review work associated with the application, and the goal action date, may occur in the following fiscal year. As such, the most recent available performance information is for the FY 2009 cohort.  CDER exceeded the review performance goal for standard reviews for the FY 2009 cohort by reviewing 92% of standard NDAs/BLAs within 10 months.  CDER did not meet the review performance goal for priority reviews for the FY 2009 cohort   Longer CDER priority review times for FY 2009 reflect the impact of several factors.  FDAAA reauthorized the Prescription Drug User Fee Act in FY 2008, and also added significant new authorities and requirements that have added or expanded tasks that must be performed within the process of human drug review.  As CDER was undertaking an aggressive effort to hire new staff to handle the existing scope and level of review work, the Center has also been implementing new requirements to be addressed within the review process.  This includes the increased use of advisory committees mandated under FDAAA—particularly for drugs receiving a priority review—coupled with a lengthier process to plan meetings using the more stringent advisory committee member screening process under FDAAA that allows significantly fewer waivers for conflicts of interest for otherwise qualified candidates.  Similarly, FDAAA Title IX risk management provisions add steps to the review to determine whether a Risk Evaluation and Mitigation Strategy (REMS) will be required at the time of new drug approval. These additional FDAAA-related processes have expanded the work required within review time goals that were established ten years earlier, under the Food and Drug Administration Modernization Act (FDAMA) of 1997.  To ensure a rapid and compliant process CDER is continuing to examine the expanded review process requirements, while training the significant number of newly-hired staff to enable them to achieve review expertise as rapidly as possible.

 

2.   The total number of actions taken on abbreviated new drug applications in a fiscal year. (223205)

 

Context:  Generics play an important and increasing role in providing safe, effective, and affordable drugs to the American public and thereby in controlling health care expenditures. The number of generic applications submitted to CDER’s generic drug program has grown considerably over the past decade – nearly three-fold since 2001 – outpacing the growth in program personnel. In order to manage the increasing workload CDER has launched initiatives to streamline and modernize the generic review program. The growing capacity of the program is measured in total actions taken on generic drug applications. An action is defined as any approval, tentative approval, not approvable, and approvable decision taken on a generic drug application. The target for FY 2009 and FY 2010 was 1,900 actions; the FY 2011 target is 2,000 actions, the FY 2012 target is to maintain 2,000 actions.

 

Performance:  In FY 2010 CDER’s generic program took 2,079 actions – exceeding the target measure by 179 actions.

 

3. Improve the safe use of drugs by patients and health care providers by reviewing safety labeling changes required under FDAAA within the timeframes established by FDAAA.  (222303)

 

Context:  CDER is implementing a policy of more transparency in ensuring patients and physicians have the most up-to-date and complete information necessary to make treatment decisions.  The FDA Amendments Act of 2007 (FDAAA) recognizes FDA’s critical role in assuring the safe and appropriate use of drugs after they are marketed.  FDAAA gives FDA substantial new resources for medical product safety, as well as a variety of regulatory tools and authorities to ensure the safe and appropriate use of drugs.   Congress, along with the recommendations made over the past two years by the Institute of Medicine, the Government Accountability Office (GAO), and a multitude of others, directed FDA to shift its regulatory paradigm to recognize that ensuring that marketed products are used as safely and effectively as possible is equally as important as getting new safe and effective drugs to market quickly and efficiently.  With increased focus and resources on post-marketing, CDER is establishing procedures and tools for tracking, managing, and monitoring safety issues in much the same way CDER tracks pre-market issues according to PDUFA requirements.  Consequently, CDER has determined that the previous measure (identifying priority postmarketing safety reviews and acting upon those reviews within an established timeframe) does not reflect current risk management practices following implementation of new authorities regarding postmarket safety of drugs with the 2007 enactment of FDAAA, particularly new authorities related to safety labeling changes. CDER has determined a more meaningful measure is the number of safety labeling change supplements reviewed within the timeframes established by FDAAA. This measure draws a direct connection to the safe use of drugs by Safe Use patients and health care providers by ensuring that the most up-to-date safety information is available in a timely manner as specified in FDAAA.

 

Performance:  In FY 2010, CDER reviewed 94% of safety labeling change supplements within the timeframe specified by FDAAA.

 

4.   The Unit Cost associated with turning a submitted Adverse Event Report into a verified record in the database. (222201)

 

Context:  The collection and analysis of data by FDA staff must occur throughout the entire life cycle of the product to identify unexpected safety risks associated with the use of a human drug that could not have been predicted by clinical trials and biostatistical analysis. Reports of these unexpected safety problems, called adverse events, are captured in the Adverse Event Reporting System (AERS), a critical component of FDA's post-marketing safety surveillance systems for all drug and therapeutic biologic products.  Information captured in AERS allows FDA scientists and statisticians to search for patterns that may indicate an emerging safety hazard, which is the first step in analyzing the potential causes and formulating an effective risk management response.  FDA is working to make AERS more efficient by improving the data entry work processes and reengineering the system to increase the percentage of electronic submissions, to reduce the amount of manual re-keying, along with other efficiencies.  These system improvements will allow the FDA to reduce the average cost and time associated with turning a submitted Adverse Event Report into a verified record in the database.  This improvement in efficiency will allow scientists and statisticians to access safety information sooner, and will free up resources that can be redirected to risk analysis activities that directly improve our ability to recognize and respond to drug safety problems.  The targets for FY 2012 and FY 2011 have been reduced to $10 per report.

 

Performance:  The average cost associated with turning a submitted Adverse Event Report into a verified record in the database has been decreasing since FY 2003 due to FDA efforts to streamline its business processes and improve the information systems that are used to process records.  In FY 2003, the cost per report was $21.91 per report.  In FY 2008, the actual cost per report was $10.59 per report. In FY 2009 the cost per report rose slightly to $10.79 per report but was still below the target of $12 per report.  In FY 2010, the cost per report was reduced to $7.35.  The overall savings to FDA from electronic submission continues to increase due the increasing numbers of received reports.  In the absence of electronic submissions, the program costs for manual data entry would be nearly double what they are today.

 

5.   The percent of manufacturer submitted expedited adverse event reports received electronically compared to all expedited adverse event reports received from industry.  (222202)

 

Context:  Drug manufacturers are required to submit to FDA reports of adverse events they receive related to their products. These reports provide crucial information to help enable CDER to monitor the post-market safety of drug products in use. Currently, manufacturers may submit these reports to CDER by mail, fax, or electronically through CDER’s MedWatch portal. As electronic reporting streamlines CDER processes, saves time and money, and ensures quicker reporting, CDER is committed to increasing the proportion of reports submitted electronically. FDA is currently developing an improved web-interface reporting system to be called MedWatch Plus. The MedWatch Plus portal will include a rational questionnaire which will help facilitate improved communication, ease of reporting, and enable more complete and higher quality reporting. This timelier and higher quality reporting will positively affect public heath by enabling improved scientific analysis of adverse event reporting and more timely and accurate detection of safety signals. CDER’s target for FY 2010 of 80% of all manufacturing reports submitted electronically was exceeded by 7%. The FY 2011 and FY 2012 targets are set at 90%.

 

Performance: The percentage of all reports submitted electronically (not limited to industry reports) grew from 33% in FY 2006 to 87% in FY 2010.  

 

6.  Number of people for whom FDA is able to evaluate product safety through multiple miniature Sentinel pilots.  (292202)

 

Context:   The goal of the Sentinel Initiative is to create a national, integrated, electronic system (the Sentinel System) for monitoring medical product safety.  The Initiative, which will be developed and implemented in stages, will ultimately enable FDA to leverage the capabilities of multiple, large databases (e.g., electronic health record systems, medical claims databases) to augment the Agency’s existing safety monitoring capability.  As currently envisioned, Sentinel will facilitate targeted queries, within the bounds of established privacy and security safeguards, across large remote data systems and be scalable to enable small or large queries using broad or narrowly focused data.  Sentinel, ultimately, will expand and strengthen FDA's ability to monitor the performance of a product throughout its entire life cycle and facilitate data mining and other research-related activities.

 

Performance: In FY 2010, miniature Sentinel pilots enabled FDA to reach 60 million patients. With the addition of a collaborative project with Federal partners, expectations are to be able to reach 70 million people by late FY 2011, and maintain that level of access in FY 2012.

 

7.  Number of safety analyses that are conducted using Medicare and Medicaid data through the SafeRx Project.  (292203)

 

Context:  Several projects are under way using Medicare and Medicaid data that are testing the ability to analyze safety on FDA-regulated products. The SafeRx project is using Medicare and Medicaid data to perform in-depth safety analyses. Analyses involve many types of active surveillance and epidemiology methodologies, which may last many months. Each analysis enables experts to test and evaluate tools necessary to perform almost real-time surveillance and also more thorough epidemiology studies.    

 

Performance: In FY 2010, 15 safety analyses were conducted through the SafeRx pilot.

8.  Number of foreign and domestic high-risk human drug inspections. (224201)

Context:  FDA is continuing to develop a more quantitative risk model to help predict where FDA’s inspections are most likely to achieve the greatest public health impact.  The Risk-Based Site Selection Model provides a risk score for each facility, which is a function of four component risk factors – Product, Process, Facility, and Knowledge. In the FY 2007 model, the Agency developed several enhancements and improvements and will continue to explore ways to enhance calculations of process risk and facility sub-scores in FY 2010.  As enhancements are made to FDA’s data collection efforts and to the Risk-Based Site Selection Model, FDA will improve its ability to focus inspections on the highest-risk public health concerns in a cost-effective way.  For FY 2010, the target was increased to 700 to reflect the FY 2009 Appropriations. In FY 2011, the target is being increased by 50 inspections for a new target of 750 inspections.  In FY 2012, the target is being maintained at the FY 2011 level.

 

Performance: FDA exceeded the FY 2010 goal of 700 by inspecting 705 high-risk foreign and domestic drug manufacturers.

 

 

9.   Percentage of television advertisements requiring submission reviewed within 45 days.  (222302)

 

Context: Under the Food and Drug Amendments Act of 2007 (FDAAA) FDA gained authority to require submission of television advertising for review 45 days before dissemination in order to protect the well-being of consumers and ensure advertising information remains consistent with prescribing information for the product under review. FDA is developing a risk-based set of standards to leverage limited resources in a manner that best protects the public health by assuring that TV ads accurately and effectively communicate key information about the product, including its major risks and its indications. These standards will focus reviews on products with particularly serious risks or at times when feedback on the risk and indication communication is critical, such as when a drug is first advertised on TV and after a drug has received significant safety labeling updates. The FY 2010 target of issuing draft guidance and establishing the baseline was not met as the draft guidance is still undergoing review.  The target for FY 2011 is to issue the draft guidance to industry on the program and receive submissions for pre-review. The FY 2012 target is 30% of reviews of TV ads completed within 45 days for advertising identified as meeting the high-risk criteria.

 

Performance: As this is a new authority, prior performance data does not exist.  

 

Next page: Biologics Performance Detail FY 2012 OPA