Department of Health and Human Services
 
OFFICE OF 

 
INSPECTOR GENERAL 

 
 
 
 
 
 
 
 
TH  E FOOD AND DRUG 

 
A  G
DMINISTRATION S  ENERIC 

 
 
D R P  
RUG  EVIEW  ROCESS 

 
 
 
 
 
 
 
Daniel R. Levinson 
  
Inspector General 

 
June  2008 

OEI-04-07-00280 
   
Office of Inspector General 

 
http://oig.hhs.gov 
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as  
amended, is  to protect the integrity of the Department of  Health and Human Services  
(HHS)  programs, as well as the health and welfare of beneficiaries  served by those 
programs.  This statutory mission  is  carried  out through  a nationwide network  of  audits, 
investigations, and inspections conducted by the  following operating components:  
Office of Audit Services 
The Office  of  Audit Services  (OAS) provides auditing services  for HHS, either by  conducting  
audits  with its own audit resources or by  overseeing  audit work done by others.  Audits  
examine the performance of HHS programs and/or its grantees and contractors in carrying  
out their respective responsibilities and are intended  to provide independent assessments of 
HHS programs and operations.  These assessments help reduce waste, abuse, and  
mismanagement and promote economy and efficiency  throughout  HHS. 
Office of Evaluation and Inspections  
The Office  of  Evaluation and Inspections (OEI)  conducts national evaluations to  provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
issues.  These evaluations focus on preventing fraud,  waste, or abuse  and promoting  
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving  program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations  
of  fraud and misconduct  related to HHS programs, operations, and beneficiaries.  With 
investigators working in all 50 States and the District of Columbia, OI  utilizes its resources 
by actively  coordinating with the Department  of Justice  and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to  criminal 
convictions, administrative sanctions,  and/or  civil monetary  penalties.  
Office of Counsel to the Inspector General 
The Office of Counsel to the  Inspector  General (OCIG) provides general legal services to 
OIG, rendering  advice and opinions on HHS programs  and operations and providing all 
legal support for OIGs  internal operations.  OCIG represents  OIG in all civil and 
administrative fraud and abuse cases involving HHS programs,  including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In  connection with these cases, OCIG 
also negotiates and monitors corporate integrity  agreements.  OCIG renders advisory 
opinions, issues compliance program  guidance, publishes fraud alerts, and provides other  
guidance  to  the health care industry concerning the anti-kickback statute and other  OIG  
enforcement authorities.    
   
  E X E C U T I V E   S U M M A R Y  
OBJECTIVES 
1. 	 To determine the percentage of new (i.e., original) generic drug 
applications approved, tentatively approved, or  disapproved by the 
Food and Drug Administration (FDA) in 2006. 
2. 	 To determine the extent to which FDA reviewed original generic 
drug applications within 180 days in 2006. 
3. 	 To identify factors that affected review times for original and  
amended generic drug applications in 2006.   
BACKGROUND 
Pharmaceutical companies must submit Abbreviated New Drug 
Applications (ANDA) to FDAs Office of Generic Drugs (OGD) and 
receive  FDAs approval before marketing new generic drugs.  Three  
OGD divisions review all ANDAs:  Chemistry, Bioequivalence, and 
Labeling. OGDs Microbiology division also reviews some ANDAs.   
In addition, OGD may consult with other FDA offices during ANDA 
reviews. All OGD divisions involved in the ANDA review contribute to 
approval, but disapproval is primarily determined by Chemistry.  
According to FDA, almost all original ANDAs contain Chemistry 
deficiencies  and are disapproved.   
OGD generally follows a first-in, first-reviewed policy for ANDAs. 
However, when Chemistry identifies no deficiencies in an ANDA  
(i.e., the ANDA is approvable by Chemistry), the other divisions assign 
high priority to the ANDAs review.  Pursuant to FDA policy, divisions 
should also assign high priority to ANDAs with minor deficiencies.   
In addition, some ANDA consults  are assigned high priority.   
FDAs timeliness in approving generic drugs has recently been a topic of 
scrutiny by both Congress and the media.  Federal law requires that 
FDA approve, tentatively approve, or disapprove original ANDAs within 
180 days of receipt. 
We examined review times for 989 original ANDAs under review during 
2006. We also surveyed OGD division reviewers assigned to a sample of 
105 ANDAs with review times greater than 180 days in at least one 
division. Finally, we conducted structured interviews with OGD 
officials to determine factors affecting ANDA review times. 
 
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FINDINGS 
The Food  and Drug Administration  approved or tentatively approved  
4 percent of original Abbreviated New Drug  Applications under 
review in 2006; the remaining 96 percent did not meet review  
standards and were disapproved. FDA approved 1 percent and 
tentatively approved 3 percent of original ANDAs under review in 2006. 
FDA disapproved 96 percent of original ANDAs under review in 2006 
because they contained Chemistry deficiencies.    
The Food and Drug Administration exceeded the 180-day  review  
requirement for nearly  half of original Abbreviated New Drug  
Applications under review in 2006  because Chemistry reviews 
exceeded 180 days.   In 2006, Chemistry did not review 46 percent of 
original ANDAs within 180 days as required by Federal law. For ANDAs  
taking more than 180 days for review, the median review time was 
217 days. Because almost all of these original ANDAs contained 
Chemistry deficiencies, Chemistrys delay in reviewing these ANDAs 
resulted in FDAs delay in disapproving them, regardless of the 
timeliness of the other divisions reviews. 
Microbiology, Bioequivalence, and  Labeling reviews of original  
Abbreviated New Drug  Applications generally  exceeded 180 days  in 
2006. In 2006, the percentages of ANDAs with review times exceeding 
180 days were 76 percent in Microbiology, 58 percent in Bioequivalence, 
and 56 percent in Labeling. For ANDAs taking more than 180 days to 
review, median review times were 361 days in Microbiology, 287 days in 
Bioequivalence, and 277 days in Labeling. 
Nearly 70 percent of sampled division reviews exceeding 180 days  
did not begin before the 180-day  review periods expired.   In a sample 
of 105 ANDAs with review times exceeding 180 days, reviews for          
69 percent did not begin within 180 days. Thus, the 180-day periods 
passed before division reviews began in most of the sample. 
The Food and Drug Administrations  prioritization practices affect 
Abbreviated New Drug  Application review times. FDA prioritization 
practices contribute to longer review times for ANDAs that are close to 
approval. 
 
 
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RECOMMENDATIONS 
We found that FDA disapproved most original ANDAs under review in 
2006 because they did not meet FDA review standards. Nearly half of 
Chemistry review times exceeded the 180 days required by Federal law. 
Moreover, many review times in other OGD divisions exceeded 
180 days. In addition, for a sample of ANDA reviews exceeding       
180 days, most reviews did not begin before the 180-day period expired.  
Finally, we found that FDA prioritization practices affect ANDA review 
times.    
The ANDA submissions have increased at more than double the rate of 
review resources in the last 5 years. To better manage FDAs current 
ANDA review resources and potentially improve ANDA review times, 
we recommend that FDA: 
Identify common original Abbreviated New Drug  Application  
deficiencies and offer more guidance to industry to decrease the  
percentage disapproved.    
Increase the percentage of original  Abbreviated New Drug  Applications  
reviewed by  all divisions within 180 days.   
Identify new prioritization practices to reduce  review times for 
Abbreviated New Drug  Applications close to approval.    
AGENCY COMMENTS 
In its comments to the draft report, FDA noted that it has already 
identified portions of the primary recommendations and is 
implementing process improvements that are the same as or similar to  
the recommendations. Specifically, FDA agreed  with our first 
recommendation but did not indicate whether it concurred with the two 
additional recommendations. However, FDA has taken actions that 
address our recommendations by providing guidance to assist industry 
in submitting more easily reviewed applications, developing a focused 
hiring program to increase staff and decrease review times, and 
prioritizing some ANDAs based on potential market entry date. 
We ask that, in its final management decision, FDA more clearly 
indicate whether it concurs with each  of our recommendations.  
 
 
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  T A B L E   O F   C O N T E N T S  
EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
  
 
 
I N T RO DUC T IO N  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1 
  
 
 
F I N D IN G S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  12 
  
  FDA disapproved most original ANDAs. . . . . . . . . . . . . . . . . . . . .  12 
  
  Chemistry reviews exceeded 180 days. . . . . . . . . . . . . . . . . . . . . .  13 
  
  Review times in other divisions exceeded 180 days. . . . . . . . . . . .  15 
  
  Sampled reviews did not start within 180 days. . . . . . . . . . . . . . .  16 
  
  ANDAs are not prioritized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  17 
  
   
R E C O MMEN D A T ION S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  21 

 
  Agency Comments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  23
  
   
 
APPENDIXES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  25 
  
  A:	  Additional Information on Methodology. . . . . . . . . . . . . . . . . .  25 
  
  B: 	2006 Chemistry Review Time Ranges . . . . . . . . . . . . . . . . . . .  28 
  
  C: 	2006 Microbiology, Bioequivalence, and Labeling
                           
Review Time Ranges. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  29 
  
  D: 	Frequency Distribution of Office of Generic Drugs              
Consults Pending as of June 2007 . . . . . . . . . . . . . . . . . . . . . .  30  
  E:	  Agency Comments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  31 
  
 
 
A C K NO WL E D G M E N T S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  36 
    
   
  I N T R O D U C T I O N  
 
OBJECTIVES 
1. 	 To determine the percentage of new (i.e., original) generic drug    
applications approved, tentatively approved, or  disapproved by the 
Food and Drug Administration (FDA) in 2006. 
2. 	 To determine the extent to which FDA reviewed original generic 
drug applications within 180 days in 2006. 
3. 	 To identify factors that affected review times for original and  
amended generic drug applications in 2006.   
BACKGROUND 
A generic drug is the same as a reference-listed (i.e., brand name) drug 
with respect to conditions of use, active ingredient(s), route of  
administration, dosage form, strength, and labeling.1  In addition, the 
generic drug must be bioequivalent to (i.e., perform in the same manner  
as) the brand name drug. 
A generic drug that is therapeutically equivalent is expected  to have the 
same clinical effect and safety profile as the brand name drug when 
administered under the conditions specified in the labeling. If generic 
drugs are determined to be therapeutically equivalent, physicians and  
pharmacists can substitute them for brand name drugs. 
Generic drug applications are referred to as Abbreviated New Drug 
Applications (ANDA).2  Pharmaceutical companies must submit ANDAs 
and receive FDAs approval before marketing new generic drugs.3    
 
 
 
 
1 21 U.S.C.  355(j)(2) ( 505(j)(2) of the Federal Food, Drug, and Cosmetic Act);              
21 CFR  314.92 and 314.105(c).  Some differences between generic and brand name drugs 
are permitted under 21 U.S.C.  355(j)(2).  See also Abbreviated New Drug Application 
(ANDA) Process for Generic Drugs, Center for Drug Evaluation and Research. Available 
online at http://www.fda.gov/cder/regulatory/applications/anda.htm. Accessed on       
November 29, 2007. 
2 The term abbreviated is used because FDA does not require generic drug  
manufacturers to submit the clinical studies necessary for brand name drug applications.  
Instead, the ANDA  must demonstrate that the generic drug is the same as a brand name 
drug.   
3 21 CFR  314.105(d).   
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FDAs timeliness in approving generic drugs has recently been a topic of 
scrutiny by both Congress and the media.4  5  6  Federal law requires that    
FDA approve or disapprove ANDAs within 180 days of receipt.7   
Abbreviated New Drug Application Review Components 
Three divisions within FDAs Center for Drug Evaluation and Research 
(CDER), Office of Generic Drugs (OGD), review all ANDAs:  the 
Division of Bioequivalence (Bioequivalence), the Division of Chemistry 
(Chemistry), and the Division of Labeling and Program Support 
(Labeling).8  9   In addition, the Microbiology team (Microbiology) reviews  
some ANDAs.10     
Other offices within CDER also review ANDAs in certain instances. For 
example, safety evaluations of inactive ingredients, labeling and  
bioequivalence protocol reviews, and statistical reviews of 
bioequivalence studies require OGD to consult other offices within 
CDER. According to OGD officials, OGD typically sends requests for 
such reviews (i.e., consults) to the CDERs Office of  New Drugs because 
it has expertise in these  areas.  CDER policy provides timeframes for 
 
4 The Generic Drug Maze:  Speeding Access to Affordable, Life Saving  Drugs.  Hearing 
of the United States Senate Special Committee on Aging.  July 20, 2006.  Available online 
at http://aging.senate.gov/hearing_detail.cfm?id=270735&. Accesssed on July 24, 2007. 
5 Appropriations for the Food and Drug Administration.  Hearing of the United States 
House of Representatives Appropriations Committee, Agriculture, Rural Development, Food  
and Drug Administration and Related Agencies Subcommittee.  February 16, 2006.   
6 Kaufman, Marc.  Generic Drugs Hit Backlog at FDA.  Washington Post.           
February 4, 2006, p. A01.  Available online at http://www.washingtonpost.com/wp
dyn/content/article/2006/02/03/AR2006020302598.html. Accesssed on July 25, 2007. 
7 21 U.S.C.  355(j)(5)(A); 21 CFR  314.101(f)(2).  An approval becomes effective on the 
date of the issuance of the approval letter, except for certain approvals that have delayed 
effective dates.   An approval with a delayed effective date is tentative and does not become  
final until the effective date.  21 CFR  314.105(d). 
8 A CDER organizational chart is available online at 
http://www.fda.gov/cder/cderorg.htm. CDER provides general information on the ANDA  
review process online at http://www.fda.gov/cder/ogd/. CDERs Manuals of Policies and 
Procedures (MaPP) provide official instructions  to CDER staff on the drug  review process.  
MaPP Chapter 5200 applies to OGD and is available online at 
http://www.fda.gov/cder/mapp.htm. Accesssed on January 3, 2008. 
9 In addition, the Office of Compliance evaluates the generic drugs manufacturing, 
packaging, and  testing facilities to determine whether they  meet current  Good  
Manufacturing Practices pursuant to 21 CFR  211.   
10 Microbiology reviews drugs administered as injections, inhalations, or solutions to 
ensure their sterility.  The Microbiology staff is officially  housed within the Immediate 
Office of the OGD Director.  When referring to  OGD divisions throughout this report, 
Microbiology is included.   
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OGD to receive consult results from other CDER offices.11  Policy 
timeframes  range from 15 to 90 days, based on the priority of the 
consult. A consults priority is based, in part, on how close the ANDA is 
to approval.   
Abbreviated New Drug Application Review Process 
OGD generally employs CDERs first-in, first-reviewed policy for 
ANDAs.12  However, OGD grants expedited reviews of ANDAs in special 
circumstances.13    
When an applicant submits an original ANDA, OGD first conducts a 
review to determine whether the application is sufficiently complete to 
permit a substantive review.14  OGD refers to this period as the filing 
review. The filing review takes approximately 60 days from the ANDAs 
receipt date to complete it. 
If OGD determines that an ANDA is sufficiently complete, it 
simultaneously assigns the ANDA to Bioequivalence, Chemistry, and  
Labeling, as well as Microbiology (if required).15  Each division begins 
its review when the ANDA reaches  the top  of the divisions waiting list 
(i.e., queue).  Regardless of the outcome of one divisions review, the 
other divisions generally review the ANDA independently.   
According to OGD officials, each division follows CDERs first-in,     
first-reviewed policy except when Chemistry determines that an ANDA  
contains no  Chemistry deficiencies.  In this case, divisions that have not  
finished reviewing the ANDA assign high priority to it and move it to 
the top  of their queues.    
 
11 CDER MaPP 5200.6.  Issuing and Tracking of Consults.  Available online at 
http://www.fda.gov/Cder/mapp/5200-6.pdf. Accesssed on January 11, 2007. 
12 CDER MaPP 5240.3.  Review Order of  Original ANDAs, Amendments, and 
Supplements. Available online at http://www.fda.gov/Cder/mapp/5240-3R.pdf. Accesssed  
on December 5, 2007.   
13 Ibid. Expedited reviews are granted for products that respond to current and 
anticipated public health emergencies; are under special review  programs, such as the 
Presidents Emergency Plan  for AIDS  Relief (PEPFAR); have been identified as nationwide  
shortages; and are first-generic drugs for which  there are no blocking  patents or 
exclusivities. First generics are drugs that have  never been approved before as generics 
and are generic products new to the market.   
14 21 CFR  314.101(b). 
15 An OGD official indicated that if an ANDA is not sufficiently complete, OGD rejects it 
and sends a refuse-to-file letter to the applicant.  OGD issued refuse-to-file letters for 
approximately 9 percent of ANDAs in fiscal year (FY) 2006.   
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In addition, Chemistrys review outcome determines OGDs response to 
the applicant.  According to FDA, Chemistry results are the primary 
consideration during the ANDA review because Chemistry determines  
pharmaceutical equivalence, which is a key concept in assessing a 
generics therapeutic equivalence to a brand name drug.  Chemistrys 
influence on OGDs response to the applicant and the review process in 
other divisions is explained in greater detail below.16  
The Office of Generic Drugs response and review process if Chemistry 
identifies deficiencies in the Abbreviated New Drug Application.  If an 
ANDA does not meet Chemistrys review standards (i.e., Chemistry 
finds deficiencies in the ANDA), OGD disapproves the ANDA and sends 
a not-approvable letter to the applicant.17  The not-approvable letter 
summarizes the Chemistry deficiencies.  According to OGD officials, 
most original ANDAs contain Chemistry deficiencies and are  
disapproved.18  19   
Even though OGD has issued a not-approvable letter and has 
disapproved the ANDA  based on Chemistry deficiencies, the other 
divisions continue processing it. If an ANDA does not meet other 
divisions review standards (i.e., other divisions find deficiencies in the 
ANDA), they issue deficiency letters directly to the applicant 
summarizing the deficiencies.    
 
16 FDA provides various overviews of the ANDA review process.  For example, the 
Generic Drug (ANDA)  Review  Process is a flowchart available online at 
http://www.fda.gov/cder/handbook/anda.htm.  Accesssed on January  3, 2008.  OGD officials 
indicated that the current review process is not accurately  reflected in many of these 
overviews.  We provide here our understanding  of the current review  process based on our 
contact with OGD officials.  Our description may be inconsistent with previous FDA 
overviews of the process.   
17 21 U.S.C.  505(j)(5)(A); 21 CFR  314.120(a). 
18 Remarks by Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs, 
FDA. Speech before the Annual Generic Drug Forum.  April 7, 2006.  Available online at 
http://www.fda.gov/oc/speeches/2006/genericdrug0407.html. Accesssed on October 9, 2007.  
According to these remarks, 98 percent of original ANDAs were disapproved in 2004 and   
93 percent were disapproved in 2005. 
19 FDA also refers to original ANDAs as ANDAs reviewed during the first review cycle.  
Throughout this report, our use of the term original ANDAs is synonymous  with ANDAs  
reviewed during the first review  cycle.  Most ANDAs contain Chemistry deficiencies and are 
disapproved during the first review cycle. 
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Applicants do not submit new ANDAs in response to not-approvable or  
deficiency letters.  Instead, applicants submit amendments to the 
appropriate division(s) to correct ANDA deficiencies.20    
OGD classifies amendments as major or minor.21   Major amendments 
contain significant new data.  Major amendments have the same review 
priority as original, unreviewed ANDAs and are reviewed according to 
CDERs first-in, first-reviewed policy.22  In contrast, minor amendments 
do not contain significant new data and often indicate that an ANDA is 
close to approval. When OGD receives a minor amendment, it assigns 
high priority to it.  The division places the minor amendment at the top  
of its queue, and the reviewer assigned to the ANDA reviews it upon 
completing his or her current assignment.   
The Office of Generic Drugs response and review process if Chemistry  
does not identify deficiencies in the Abbreviated New Drug  Application.  If 
Chemistry does not find  deficiencies  in an ANDA, the other divisions 
must review it and resolve any deficiencies before OGD sends an 
approval letter.  After each division  determines that the ANDA contains 
no deficiencies, it notifies Chemistry that the ANDA is approvable 
within that division. Unlike not-approvable letters, OGD sends an 
approval letter only when all division reviews are complete and the 
ANDA contains no deficiencies.23    
If other divisions find deficiencies in an ANDA but Chemistry does not,  
OGD does not disapprove the ANDA.  However, the applicant must 
resolve the deficiencies  before OGD will approve the ANDA. Therefore, 
when Chemistry does not identify deficiencies in an ANDA and is ready 
to approve it, the other divisions assign high priority to that ANDA.   
 
 
 
20 21 CFR  314.96(a). 

21 CDER, Guidance for Industry.  Major, Minor, and Telephone Amendments to 

Abbreviated New Drug Applications.  Available online at 
http://www.fda.gov/cder/guidance/4706fnl.pdf. Accesssed on December 13, 2006. 
22 Ibid. 
23 21 CFR  314.105(d). 
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According to CDER, 535 ANDAs (and  corresponding amendments) were 
approved in 2006.24 CDER indicates that median approval time for 
these ANDAs and amendments was nearly 17 months.25   
Abbreviated New Drug Applications With Valid Patents or Exclusivities 
In some cases, OGD can only tentatively approve an ANDA after all 
divisions have deemed the ANDA approvable.26  For example, OGD can 
only tentatively approve an ANDA  if valid patents or exclusive 
marketing rights (exclusivities) exist for brand name drugs.  
The tentative-approval letter instructs the applicant to notify OGD of 
any updates to the ANDA within 90 days prior to the patent or  
exclusivity expiration date. OGD confirms that the ANDA is approvable 
by all divisions and sends an approval letter to  the applicant once the 
patent or exclusivity expires.    
Patents on brand name drugs are granted by the U.S. Patent and 
Trademark Office and are typically valid for 20 years from the date on 
which the patent was submitted.27 Exclusivities are granted by FDA 
upon approval of a drug and may last up to 7 years.28 Generally, OGD 
does not prioritize ANDA reviews according to the dates on which the 
patents or exclusivities expire (i.e.,  market entry date). 
 
 
 
 
24 This includes ANDAs approved  with  delayed effective dates. FDA 2006 
Accomplishments: Thousands of Safe and  Effective Health Care Products Made  Available 
for Patients. Available online at http://www.fda.gov/oc/accomplishments/healthcare.html. 
Accesssed on May 5, 2008. 
25 Approval time is calculated from the time OGD receives the original ANDA to the time  
it is approved or tentatively approved. Approval time includes filing review time as well as 
the time necessary for applicants to prepare and submit, and for OGD to review and 
approve or tentatively approve, all amendments to the ANDA. Ted Sherwood, Office of  
Pharmaceutical Science in CDER at FDA. Generic Drugs: Overview of  ANDA  Review  
Process. Available online at.http://www.fda.gov/cder/ 
audiences/iact/forum/200704_sherwood.pdf. Accesssed on June 26, 2007. 
26 21 CFR  314.105(d) and 314.107. Although the term approval letters with delayed 
effective dates is cited in regulation, OGD officials referred to these letters as         
tentative-approval letters. 
27 U.S. Patent and Trademark Office. General Information Concerning Patents: Nature  
of Patent and Patent Rights. Available online at http://www.uspto.gov/go/pac/doc/general/. 
Accesssed on July 27, 2007. 
28 FDA, CDER. Frequently Asked Questions on  Patents and Exclusivity. Available 
online at http://www.fda.gov/cder/ob/faqs.htm. Accesssed on November 8, 2007. 
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The Food and Drug Administrations 180-Day Review  Requirement 
The Federal Food, Drug, and Cosmetic Act requires FDA to approve or  
disapprove an ANDA within 180 days of initial receipt.29 This 180-day 
period is called the review clock.30    
The 180-day review clock starts on the date on which OGD receives an 
ANDA (before the filing review) and stops on the date on which OGD 
sends an approval letter, a tentative-approval letter, or a 
not-approvable letter.31  32 If Chemistry identifies deficiencies in an 
original ANDA, OGD sends a not-approvable letter, and the 180-day 
review clock stops. If Chemistry identifies no deficiencies in the ANDA, 
OGD sends an approval or a tentative-approval letter once all 
remaining divisions deem the application approvable. According to 
OGD, Bioequivalence, Labeling, and Microbiology deficiency letters do 
not stop the 180-day review clock. 
Proposed rule requires all divisions to  meet the 180-day review clock.   FDA 
issued a proposed rule in 2004 that would require OGD to send a 
complete response letter to the applicant within 180 days of receipt if 
an ANDA contains deficiencies.33 The  proposed rule specifies that a 
complete response letter will describe all of the deficiencies that the 
applicant must address before OGD can approve the ANDA.   
According to current OGD practice, all divisions must meet the 180-day 
review clock if Chemistry finds no deficiencies in the original ANDA. 
However, if Chemistry finds deficiencies, only Chemistry is required to  
 
29 Section 505(j)(5)(A) of the Federal Food, Drug, and Cosmetic Act                                  
(21 U.S.C.  355(j)(5)(A)); 21 CFR  314.100. 
30 21 CFR  314.100(a). The law would permit the applicant and FDA to extend this 
180-day period by mutual agreement. However, OGD officials indicated that they do not 
extend the review clock. 
31 Ibid. If  OGD deems an ANDA to be sufficiently complete under 21 CFR  314.101(b), 
the 180-day review clock starts retroactively on the date of receipt. If OGD deems an 
ANDA not to be sufficiently complete, the 180-day review clock does not start. If OGD 
deems a revised and resubmitted ANDA to be sufficiently complete, the 180-day review 
clock retroactively starts on the date of the resubmission. 
32 Pursuant to 21 CFR  314.100(a), FDA may also send an approvable letter under 
21 CFR  314.110 to stop the 180-day review clock. However, OGD officials stated that they  
no longer send approvable letters. We confirmed this practice in OGDs  monthly statistics  
report, which  provides data on  OGD actions for original ANDAs in the past 5 years. 
According to this internal report, OGD has not sent an approvable letter since April 2004. 
Therefore, we did not include these letters in our review. 
33 Applications for Approval To Market a New Drug; Complete Response Letter; 
Amendments to Unapproved Applications, 69 Fed. Reg. 43352, 4335543356 (proposed 
July 20, 2004). 
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meet the 180-day review clock. Therefore, when OGD sends a          
not-approvable letter based on Chemistry deficiencies, the 180-day 
review clock stops. 
In contrast, to comply with the proposed rule, all divisions will need to  
meet the 180-day review clock regardless of whether Chemistry finds 
deficiencies  in the ANDA.34    
Review  Resources at the Food and Drug Administration 
The number of ANDAs submitted to  OGD has increased at more than 
double the rate of growth of OGDs review resources for ANDAs in the 
last 5 years. Despite this disproportionate growth, OGDs approval 
times have decreased.35  
Funding for the Generic Drugs Program has increased by 74 percent in 
the last 5 years, from $35.9 million in  FY 2001 to $62.6 million in        
FY 2006.36  37 The number of full-time-equivalent positions in OGD 
increased by 50 percent during this same time period, from 134 in    
FY 2001 to 201 in FY 2006.38    
In contrast,  according to CDER, the number of original ANDAs submitted 
between FYs 2001 and 2006 increased by 158 percent, from 307 to 793.39  40  
 
34 According to a recent Semiannual Regulatory Agenda published in the Federal 
Register, the Department of  Health and Human  Services estimated that it would  publish  
the final rule in October 2007 (72 Fed. Reg. 22490 (Apr. 30, 2007)). Available online at 
http://frwebgate.access.gpo.gov/ cgi
bin/getdoc.cgi?dbname=2007_unified_agenda_&docid=f:ua070408.wais. Accesssed on 
August 29, 2007. As of January 16, 2008, FDA had not published the final rule.  
35 Ted Sherwood, Office of Pharmaceutical Science in CDER at FDA. Generic Drugs: 
Overview of  ANDA Review Process. Available online at http://www.fda.gov/cder/ 
audiences/iact/forum/200704_sherwood.pdf. Accesssed on June 26, 2007. 
36 The Generic Drugs Program includes OGD and  other FDA offices associated with the 
generic drug review process, such as the Office of Regulatory Affairs and CDERs Office of 
Compliance, Office of Regulatory Policy, and Office of New Drugs.   
37 Generic Drugs Program budget figures were obtained from FDA officials in June 2007. 
38 Gary Buehler, OGD Director. Improving  Access to Generic Drugs. Testimony  before 
the United States Senate Special Committee on Aging. July 20, 2006. Available online at 
http://aging.senate.gov/events/hr161gb.pdf. Accesssed on July 25, 2007. 
39 Ted Sherwood, Office of Pharmaceutical Science in CDER at FDA. Generic Drugs: 
Overview of  ANDA Review Process. Available online at 
http://www.fda.gov/cder/audiences/iact/forum/200704_sherwood.pdf. Accesssed on                 
June 26, 2007. 
40 These 793 ANDAs were submitted to OGD in FY 2006. The number of ANDAs in our 
analysis989is greater than 793 because we included ANDAs that were submitted or 
were under review in calendar  year 2006. Our analysis also includes ANDAs submitted 
before 2006. 
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I N T R O D U C T I O N   
FDA continues to revise the ANDA  review process to improve approval 
times and has made progress since 2001.41  According to CDER, median 
approval time for ANDAs decreased nearly 2 months from 2001 to 2006.42    
Currently, congressional appropriations fund ANDA reviews.  To 
supplement FDAs budget, the Presidents proposed budget for FY 2009 
includes over $16 million for ANDA reviews funded through a new user fee 
program.43  User fees would support CDERs review by requiring 
applicants to pay fees when submitting original ANDAs.   
Related Office of Inspector General Work 
In 2003, the Office of Inspector General (OIG) reviewed the CDER 
Office of New Drugs management of the new drug application review 
process for brand name  drugs.44  OIG found that there were general 
workload concerns but that the review process had several strengths.  
OIG recommended ways for FDA to manage review resources, including 
assessing workload pressures and rejecting poor-quality applications.   
In 1989, OIG reviewed FDAs generic drug approval process.45 OIG 
concluded that the process for assigning ANDAs to reviewers was 
arbitrary and could permit favoritism to certain applicants.  OIG 
recommended that FDA consistently  apply its first-in, first-reviewed 
policy for reviewing ANDAs.  OIG also recommended that FDA 
uniformly apply and properly document exceptions to this policy. 
 
 
 
 
41 For example, FDA Announces Initiative To Bolster Generic Drug Program.       
October 4, 2007.  Available online at 
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01719.html. Accesssed on              
November 2, 2007.  This particular initiative was incorporated into CDERs MaPP 5240.3 
and became effective October 18, 2006. 
42 Ted Sherwood, Office of Pharmaceutical Science in CDER at FDA.  Generic Drugs:  
Overview of  ANDA Review Process.  Available online at 
http://www.fda.gov/cder/audiences/iact/forum/200704_sherwood.pdf. Accesssed on                  
June 26, 2007. 
43 FDA. Summary of FDAs FY 2009 Budget.  Available online at 
http://www.fda.gov/oc/factsheets/budget2009.html. Accesssed on February 28, 2008. 
44 FDAs Review  Process for New Drug Applications:  A Management Review,          
OEI-01-01-00590. 
45 Vulnerabilities in the Food and Drug Administrations Generic Drug Approval 
Process, A-15-89-00051. 
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METHODOLOGY 
Scope 
We examined review times for 989 original ANDAs that were approved, 
tentatively approved, disapproved, or pending (i.e., the ANDAs had not 
been reviewed or the reviews were not complete) during 2006.46  47 See 
Appendix A  for additional information about our methodology, including 
criteria for excluding ANDAs from our analyses.   
We surveyed OGD division reviewers and conducted structured 
interviews with OGD officials to determine factors that affect ANDA 
review times. 
Data Sources 
We obtained information about FDAs generic drug review process from 
the following sources: 
  FDA statutes, regulations, policies, procedures, and guidance 
documents; 
  FDAs Centerwide Oracle Management Information System 
(COMIS); 
  Surveys of OGD reviewers assigned to a sample of original ANDAs 
under review in 2006 with review times greater than 180 days; 
  Structured interviews with OGD officials involved in the generic 
drug review process; and  
  OGDs consult database. 
Data Collection and Analysis 
We reviewed FDA law, policies, procedures, and guidance documents to  
understand the generic drug review process.   We compared these 
documents with information obtained from OGD officials regarding 
OGD practices. In addition, we analyzed data obtained from COMIS to 
verify OGD practices.  
We analyzed 989 original ANDAs to determine review times in each 
division. Of the 989 original ANDAs, we identified those with review 
 
46 This includes ANDAs that were submitted in 2005 and were under review in 2006 or 
were submitted in 2006 but were reviewed or pending longer than 180 days in 2007. 
47 The term original refers to new, sufficiently complete  ANDAs. It does not include 
amendments. 
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times greater than 180 days in each division and selected a sample of 
105 ANDAs.     
We surveyed OGD reviewers responsible for reviewing the sample of 
105 ANDAs. We surveyed reviewers about factors contributing to 
original ANDA review times exceeding 180 days.    
We conducted structured interviews with 12 OGD officials involved in 
the administration of the generic drug review process to identify factors 
contributing to longer review times throughout the review process, from 
ANDA receipt to approval. 
Finally, we examined the OGD consult database to determine the 
number of and review times for pending consults. 
Limitations 
We did not independently verify the COMIS data or the OGD consult  
data to ensure their accuracy. 
Almost all original ANDAs are disapproved because Chemistry finds 
deficiencies. Therefore, we determined the extent to which original 
ANDA review times exceeded the 180-day review clock by analyzing 
Chemistry review times. We did not determine the extent to  which 
original ANDA review times exceeded the 180-day review clock in other 
divisions when Chemistry did not find deficiencies. 
The results from our sample of 105 ANDAs with review times greater 
than 180 days are not projectable. 
Shorter ANDA review times cannot be directly linked to faster market  
entry because of valid patents or exclusivities or applicants marketing 
decisions. For example, an ANDA  can be approvable by all divisions 
within 180 days, but valid patents or exclusivities prevent OGD from 
approving the ANDA.  OGD can only tentatively approve ANDAs before 
valid patents or exclusivities expire. Once OGD approves ANDAs, 
applicants marketing decisions may further delay or prevent drugs 
market entry.  
Standards 
We conducted this review in accordance with the Quality Standards for 
Inspections issued by the Presidents Council on Integrity and 
Efficiency and the Executive Council on Integrity and Efficiency. 
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  F I N D I N G S  
The Food and Drug Administration approved or  FDAs OGD approved 1 percent and 
tentatively  approved 4 percent of original  tentatively approved 3 percent of 
original ANDAs under review in 
Abbreviated New  Drug Applications under 
2006.48  49  OGD approves or  
review  in 2006; the remaining 96 percent did not 
tentatively approves ANDAs that 
meet review  standards and were disapproved  
meet each divisions review 
standards.50   If an ANDA does not meet all review standards (i.e., the 
ANDA contains deficiencies in at least one division), OGD cannot 
approve it.   
Generally, approval status (i.e., approved, tentatively approved, or  
disapproved) is based on whether (1) Chemistry identifies deficiencies in 
the ANDA and (2) valid patents or  exclusivities exist for the  
brand name drug. 
OGD approved 1 percent of original ANDAs (9 of 989) under review in 
2006. No OGD divisions found deficiencies in these ANDAs, and valid 
patents or  exclusivities did not exist for the brand name drugs.51   
Applicants could market these generic drugs as soon as OGD approved 
the ANDAs.   
OGD tentatively approved 3 percent of original ANDAs (34 of 989) 
under review in 2006. No divisions found deficiencies in these ANDAs, 
but valid patents or exclusivities existed for the  brand name drugs.52   
Applicants cannot market generic drugs until patents or exclusivities 
expire or are deemed invalid through litigation.   
OGD disapproved 96 percent of original ANDAs (946 of 989) under 
review in 2006. OGD disapproves ANDAs and sends not-approvable 
letters to applicants when ANDAs do not meet Chemistrys review 
standards. 
To correct the deficiencies noted in not-approvable or deficiency letters,  
applicants submit major or minor amendments.  OGD receives a large 
 
48 FDA approved a total of 535 ANDAs in 2006.  This included approved or tentatively 
approved original ANDAs and those requiring amendments.  In  contrast, our review  
included only original ANDAs. 
49 These original ANDAs were approved or tentatively approved during the first review  
cycle. 
50 21 CFR  314.105(d). 
51 If Bioequivalence, Labeling, or Microbiology found  deficiencies in these ANDAs, the 
deficiencies were resolved before OGD approved the ANDAs. 
52 If Bioequivalence, Labeling, or Microbiology found  deficiencies in these ANDAs, the 
deficiencies were resolved before OGD tentatively approved the ANDAs. 
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number of amendments because most ANDAs do not meet OGDs review  
standards and are initially disapproved.  For example, OGD received 
828 original ANDAs under review in  2006 but received 4,174 major or 
minor Chemistry amendments.53    
Major and  minor amendments compete for the  same review resources as  
original ANDAs.  Upon  receipt, major amendments are placed at the 
end of the same queue as original ANDAs.  Minor amendments are 
placed ahead of original ANDAs and major amendments in the queue.    
 
The Food and Drug Administration exceeded the  Forty-six percent of original ANDA 
180-day review  requirement for nearly half of  Chemistry reviews (456 of 989) 
original Abbreviated New Drug Applications  exceeded the 180-day requirement 
in 2006.54   For these ANDAs, the 
under review in 2006 because Chemistry reviews 
median review time was 217 days. 
exceeded 180 days   
Chemistry review time  ranges are  
presented in Appendix B.    
Table 1 (on the next page) provides the number of original ANDAs 
under review by FDAs OGD in 2006 as well as the number, percentage, 
and median review time  for ANDAs having review times greater than 
180 days. Table 1 presents these data by ANDA approval status. 
Because Chemistry found deficiencies in most original ANDAs under 
review in 2006 and stopped the 180-day review clock, Table 1 contains 
data for Chemistry only.55    
 
 
53 These 828 ANDAs were submitted to OGD in  2006.  The number of ANDAs in our 
analysis989is greater than 828 because we included ANDAs that were submitted or 
were under review in 2006.  Thus, our analysis includes ANDAs submitted before 2006.   
54 Our analysis of the number of original ANDAs exceeding the 180-day review clock is  
conservative. Because of limitations in the COMIS database, we calculated compliance with  
the 180-day review clock based on Chemistry review time (from the date on which OGD 
received the ANDA to the date on which Chemistry completed its review)  rather than OGD  
response time (from the date on which OGD received the ANDA  to the date on which OGD  
sent an approval letter, a tentative-approval letter, or a not-approvable letter).  For 
example, if Chemistry completed its review on Day 185 and found no deficiencies and OGD 
sent an approval letter on Day 210 (once other divisions deemed  the ANDA approvable), our 
calculation of Chemistry review time would  be 185 days.  In contrast, pursuant to   
21 CFR  314.100, the 180-day review clock would not stop until Day 210.   
55 One ANDA was pending longer than 180 days at the time we collected the data. FDA 
later indicated that this ANDA  was disapproved and provided the date on which Chemistry 
completed its review. We used this date to calculate review time for this ANDA, which was  
included in our analysis of Chemistrys ANDA  review times. 
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Table 1: 2006 Chemistry  Reviews of Original Abbreviated New  Drug Applications 
Number of  ANDAs  Percentage of   Median Review Time for 
Number of  ANDAs  With Review Time   ANDAs With Review   ANDAs With Review  
ANDA Approval  Status   Reviewed  > 180 Days   Time > 180 Days   Time > 180 Days  
Approved  9  5  56%  268 days  
Tentatively Approved  34  23  68%  300 days  
Disapproved  946  428  45%  214 days  
   All  989  456  46%   217 days  
Source:  OIG analysis of FDA COMIS  data, 2007.  
 
The percentage of ANDAs with review times longer than 180 days, and  
median review times for these ANDAs, varied according to  ANDA 
approval status: 
 	 Approved Abbreviated New Drug Applications.  Five of the nine original 
ANDAs approved in 2006 were not reviewed within 180 days.       
For these five ANDAs, applicants waited a median of 268 days    
(i.e., almost 3 months beyond the 180-day regulatory timeframe) 
before they  received OGDs approval and could  market the drugs.  
 	 Tentatively Approved Abbreviated New Drug Applications.  Reviews for  
23 of the 34 tentatively approved original ANDAs exceeded 180 
days. Applicants waited a median of 300 days (i.e., 4 months 
beyond the 180-day regulatory timeframe) for OGD to tentatively 
approve these ANDAs.  
  Regardless of whether OGD reviewed these tentatively approved 
ANDAs within 180 days, applicants could not market these drugs 
immediately because of valid patents or exclusivities.  For example, 
even though OGD tentatively approved 11 of the 34 ANDAs within 
180 days, the patent expiration dates for the brand name drugs 
ranged from 11 months to 12 years after the date of OGDs tentative 
approval.56  57  58  
 
56 The earliest expiration date was November 22, 2007, but OGD tentatively approved 
this ANDA on December 29, 2006 (i.e., 11 months before the patent expired).  The latest  
expiration date was November 14, 2018, and OGD tentatively approved this ANDA on 
November 6, 2006 (i.e., 12 years before the patent expired).   
57 Applicants for 2 of the 11 ANDAs were challenging the validity of the patents or 
exclusivities. 
58 Five of these ANDAs were expedited PEPFAR applications.  Although patents prevent 
marketing these drugs in the United States, applicants can  market them internationally.    
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 	 Disapproved Abbreviated New Drug Applications.  Reviews for            
428 disapproved original ANDAs exceeded 180 days.  For these 
ANDAs, applicants waited a median of 214 days (i.e., more than      
1 month beyond the expiration of the 180-day review clock) before 
OGD notified them of the ANDA disapproval.   
 
Microbiology, Bioequivalence, and Labeling  In 2006, 77 percent of original 
reviews of original Abbreviated New  Drug  ANDAs (760 of 989) had review 
times exceeding 180 days in 
Applications generally exceeded 180 days      
divisions other than Chemistry.  
in 2006 
Of ANDAs taking more than          
180 days to review, median review times were 361 days in Microbiology, 
287 days in Bioequivalence, and 277 days in Labeling. Review time 
ranges in each division are presented in Appendix C.      
OGD does not hold these other divisions (i.e., Microbiology, 
Bioequivalence, and Labeling) to the 180-day review clock if Chemistry 
finds deficiencies in the original ANDA.  However, FDAs proposed rule  
will require all divisions to complete reviews within 180 days, 
regardless of whether Chemistry finds deficiencies.59      
Table 2 (on the next page) provides,  by division, the number of original 
ANDAs under review in Microbiology, Bioequivalence, and Labeling in 
2006 as well as the number, percentage, and median review times for 
ANDAs having review times greater than 180 days.60      
 
59 Applications for Approval To Market a New Drug; Complete Response Letter; 
Amendments to Unapproved Applications, 69 Fed. Red. (proposed July 20, 2004).  
60 Data are not available in COMIS to determine the review outcome (i.e., approvable or 
deficient) in divisions other than Chemistry.  
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F I N D I N G S  

Table 2: 2006 Microbiology, Bioequivalence, and Labeling Reviews of Original Abbreviated 
New Drug Applications 
Number of  ANDAs  Percentage of   Median Review Time for 
Total  Number of ANDAs   With Review Time   ANDAs With Review   ANDAs With Review  
OGD Division  Reviewed  > 180 Days   Time > 180 Days*   Time > 180 Days**  
Microbiology  229  175  76%  361 days  
Bioequivalence  989  576  58%  287 days  
Labeling  989  556  56%  277 days  
* Some ANDAs had reviews that exceeded 180 days in multiple divisions. 
** Median review times may be underestimated because review times for pending ANDAs in  these divisions were accruing when we obtained the 
data.  Of ANDAs with review times greater than 180 days, the percentages that were pending at the time we obtained the data were:  73 percent  
for Microbiology (127 of 175 ANDAs), 3 percent  for Bioequivalence (16 of 576 ANDAs), and 32 percent  for Labeling (178 of 556 ANDAs).   
Source:  OIG analysis of FDA COMIS  data, 2007.  
 
In our sample of ANDAs with
Nearly 70 percent of sampled division reviews  
review times exceeding 180 days,  
exceeding 180 days did not begin before the 
69 percent (72 of 105) of original 
180-day review periods expired  
ANDAs were in the queue longer 
than 180 days.61 Thus, the 180-day 
periods passed before division reviews began in most of our sample of  
105 original ANDAs. 
Review time in each division is calculated from the date on which OGD 
receives an  ANDA to the date on which each division completes its 
review of the original ANDA.  Review times can be further divided into 
two components:  the amount of time the ANDA waited in the queue 
(i.e., queue time) and the amount of time each division took to  
determine whether the ANDA met the divisions review standards  
(i.e., division review time).62    
Figure 1 (on the next page) compares medians for queue time and 
division review time for the sample  of 105 ANDAs having review times 
greater than 180 days in each division. 
 
61 These data are available for the sample of 105 ANDAs only.  The dates on which 
reviewers start their reviews (i.e., the dates on which ANDAs leave the queue) are not 
provided in the COMIS; reviewers in our sample provided these dates in their survey  
responses.   
62 Queue time consists of both the filing  review time and the time the ANDA awaits  
review in the division queue.   
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    Queue Time 
FIGURE 1 
Comparison    Chemistry  149  74  Division Review Time 
Between Queue 
 
Time and  
 
Division Review 
Bioequivalence  227  21 
 
Time by  Division 
 
 
  Labeling  237  9 
 
 
 
Microbiology  264  37 
 
 
  0  180 
Number of Days 
 
  Source: OIG analysis of FDA COMIS  data and OGD reviewer responses, 2007. 
 
The Food and Drug Administrations  FDA prioritization practices 
prioritization practices affect Abbreviated New   contribute to longer review times  
for ANDAs close to approval. 
Drug Application review times 
ANDAs that are close to approval 
include those that (1) have high-priority consults; (2) do not have valid 
patents or exclusivities, or have patents or exclusivities that will expire 
in the near future; (3) are deemed approvable in multiple divisions; or 
(4) contain only minor deficiencies.   
The Food and Drug Administration does not review  consults  within policy  
timeframes   
FDAs CDER policy indicates that OGD should receive consult results 
for highest-priority consults within 15 days and lowest-priority 
consults within 90 days. Consult priority is based, in part, on how 
close the ANDA is to approval. In practice, however, consult results 
generally are not returned to OGD within the timeframes specified in 
policy, which prolongs ANDA review times. 
For the 100 pending OGD consults, days pending ranged from 3 to 
882.63 Of these pending consults, 78 percent (78 of 100) were not 
 
63 These consults were pending as of June 22, 2007, the date on which  we received the 
OGD consult data. 
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F I N D I N G S  
returned to OGD within 90 days (i.e., the longest period of time 
specified by CDER policy).  Sixty-eight percent (68 of 100) were not 
returned within 180 days.  The number of days pending for all        
100 consults is presented in Appendix D. 
The Food and Drug Administration does not consider market entry date 
when  prioritizing Abbreviated New Drug Applications 
FDAs OGD generally maintains a first-in, first-reviewed policy for 
reviewing ANDAs.  FDA grants exceptions to this policy, such as for 
first generic drugs that do not have  valid patents or exclusivities at the 
time of submission.64    
However, FDA does not grant exceptions to this policy for ANDAs of 
non-first generic drugs without patents or exclusivities (i.e., ANDAs 
that are close to approval rather than tentative approval).65   Thus, OGD 
reviews ANDAs with valid patents or exclusivities while ANDAs that 
can immediately enter the market wait in the queue.    
Twenty-nine percent (291 of 989) of original ANDAs under review by 
OGD in 2006 could not immediately enter the market because of valid 
patents or exclusivities.  Chemistry  reviewed nearly 60 percent of  
these ANDAs (168 of 291) within 180 days.   
In contrast, 71 percent (698 of 989) of original ANDAs under review in 
2006 could enter the market as soon as OGD approved them.66   
Chemistry reviewed only 52 percent of these ANDAs (365 of 698) 
within 180 days. 
The Food and Drug Administration prioritizes Abbreviated New  Drug 
Applications differently across divisions 
FDAs OGD prioritizes ANDAs with approvable reviews differently 
across divisions.  Divisions also classify and prioritize amendments 
differently. Differences in prioritizing ANDAs affect ANDA review 
times, as described below. 
 
64 First generics are drugs that have never been approved before as generics and are new  
to the market. 
65 According to FDA, the second  and subsequent  generic drugs to enter the market effect 
the greatest cost savings.  First generic drugs are priced only slightly lower than brand  
name drugs.  Available online at http://www.fda.gov/cder/ogd/generic_competition.htm. 
Accesssed on February 18, 2008.  
66 This includes ANDAs in which the applicants are challenging the validity of the 
patents or exclusivities.   
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F I N D I N G S  
Divisions in the Office of Generic Drugs do not consistently assign high 
priority to approvable Abbreviated New Drug Applications. Other OGD 
divisions assign high priority to an ANDA after Chemistry deems the 
ANDA approvable.  However, Chemistry maintains CDERs first-in, 
first-reviewed policy and does not change the priority of ANDAs deemed  
approvable by other divisions.   
For example, if Chemistry deems an ANDA approvable before other  
divisions, the ANDA is designated as high priority and reviewed ahead 
of other ANDAs in divisions queues.67  In contrast, if all three            
non-Chemistry divisions deem an ANDA approvable, Chemistry does  
not assign high priority to the ANDA.  Rather,  Chemistry reviews the 
ANDA according to CDERs first-in, first-reviewed policy.   
Divisions in the Office of Generic Drugs do not consistently classify and 
prioritize amendments. Federal regulation recognizes that 
amendments that contain significant new data will require significant 
additional review time.68   Pursuant to CDER guidance, these major 
amendments have the same review priority as original, unreviewed 
ANDAs.69  CDER guidance also directs OGD to classify all other 
amendments as minor.  When minor amendments are received, 
divisions should assign high priority to them to  expedite the review of 
ANDAs that are near approval.70    
  According to FDA, only Chemistry classifies amendments as major or  
minor.71  72  In addition, during our structured interviews, an OGD 
official stated that amendments in non-Chemistry divisions are 
treated as minor amendments and prioritized ahead of original 
 
67 The other divisions also assign high priority to any amendments they receive for the 
ANDA. 
68  21 CFR  314.96(a). 
69 CDER, Guidance for Industry.  Major, Minor, and Telephone Amendments to 
Abbreviated  New Drug Applications.  Available online at 
http://www.fda.gov/cder/guidance/4706fnl.pdf. Accesssed on December 13, 2006. 
70 Ibid. 
71 For example, see Ted Sherwood, Office of Pharmaceutical Science in CDER at FDA.   
Generic Drugs:  Overview of ANDA Review Process.  Available online at 
http://www.fda.gov/cder/audiences/iact/forum/200704_sherwood.pdf. Accesssed on                 
June 26, 2007. 
72 We confirmed this OGD practice by examining COMIS data.  A COMIS data field 
tracks major and minor amendments for Chemistry.  Codes in  other divisions do not 
designate amendments as major or minor.    
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ANDAs in the queue, regardless of the significance of the data 
contained in the amendment.    
  Not classifying amendments as major or minor may place ANDAs 
with more deficiencies ahead of those with fewer.  This may dilute the 
effectiveness of the amendment prioritization process by delaying 
reviews of amendments that are truly minor and original ANDAs.     
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  R E C O M M E N D A T I O N S  
 
Generic drugs are generally thought of as one way to rein in increasing 
health costs.  FDAs timeliness in approving generic drugs has recently 
been a topic of scrutiny by both Congress and the media.  Federal law 
requires that FDA approve or disapprove original ANDAs within       
180 days of receipt.    
We found that FDA disapproved most original ANDAs under review in 
2006 because they did not meet FDA review standards.  Nearly half of 
Chemistry review times exceeded the 180 days required by Federal law.  
Moreover, many review times in other OGD divisions exceeded  
180 days. In addition, for a sample of ANDA reviews exceeding          
180 days, most reviews did not begin before the 180-day periods expired.  
Finally, we found that FDA prioritization practices affect ANDA review 
times.  
The ANDA submissions have increased at more than double the rate of 
review resources in the last 5 years.  To better manage OGDs current  
ANDA reviews and to potentially increase the number of ANDAs 
reviewed and approved within 180 days, we recommend that FDA: 
Identify Common Original Abbreviated New  Drug Application Deficiencies 
and Offer More Guidance to Industry To Decrease the Percentage 
Disapproved 
Without lowering review standards, FDA should identify ways to decrease 
the percentage of disapproved original ANDAs.  Disapproving fewer 
original ANDAs would reduce the number of amendments that FDAs 
OGD receives and reviews.  If OGD received fewer amendments, the queue 
would become smaller, and OGD could allocate more resources to review 
original ANDAs within 180 days. 
To decrease the percentage of ANDAs originally disapproved, we suggest  
that OGD examine deficiency letters to identify common deficiencies in 
original ANDAs.  The types of deficiencies that occur most frequently 
indicate the areas in which applicants need  more  guidance.  FDA should  
create or revise guidance to address these problem areas.  Expanded  
guidance may improve the quality of the ANDAs submitted to OGD and 
increase the percentage of original ANDAs approved within 180 days. 
 
 
  OEI-04-07-00280   THE  FOOD AND DRUG  ADMINISTRATIONS GENERIC  DRUG  REVIEW PROCESS   21   
   
R E C O M M E N D A T I O N S  
Increase the Percentage of Original Abbreviated New  Drug Applications 
Reviewed by All Divisions Within 180 Days  
Federal regulation requires that FDA approve or disapprove original 
ANDAs within 180 days of receipt.  In addition, FDAs proposed rule 
would require that all divisions review ANDAs within the 180-day 
regulatory requirement, regardless  of whether Chemistry identifies 
deficiencies  in the original ANDAs.   
In light of the current regulation and proposed rule, FDA should  
continue to revise the ANDA review process to reduce review times in  
all divisions.  Because queue times in our sample of ANDAs were longer 
than division review times and the 180-day period passed while most of 
our sample  waited in the queue, FDA should focus on reducing queue  
times.  
Identify New Prioritization Practices To Reduce Review  Times for 
Abbreviated New Drug Applications Close to Approval 
ANDAs that are close to  approval include those that have high-priority 
consults, have no valid patents or exclusivities (or have patents or 
exclusivities that expire soon), are deemed approvable in multiple 
divisions, or contain only minor deficiencies.   
We recommend that FDA assign priority to and meet review timeframes 
for consults based on whether the ANDAs are close to approval, 
according to CDERs consult policy.  In addition, FDA should  identify 
ANDAs close to approval and improve the prioritization process to  
reduce review times for these ANDAs.  These new prioritization 
processes would generate exceptions to CDERs first-in, first-reviewed 
policy for reviewing ANDAs.  If implemented, OGD would need to 
uniformly apply and properly document these  exceptions. 
Evaluate the consultation process to meet review timeframes specified by 
Food and Drug Administration policy.  FDAs CDER policy defines high- and         
low-priority consults based, in part, on whether  the ANDA is close to  
approval.  The policy also establishes review timeframes based on the 
consults priority.  However, we found that, in practice, consult results 
generally are not returned to OGD within specified timeframes, regardless 
of the consults priority.   
FDA should  examine the ANDA consultation process to determine how 
consults can be returned to OGD within the timeframes specified in CDER 
policy, particularly consults for ANDAs close to approval.  Obtaining 
consults within designated priority timeframes may reduce the number of 
ANDAs exceeding the 180-day regulatory requirement.   
  OEI-04-07-00280   THE  FOOD AND DRUG  ADMINISTRATIONS GENERIC  DRUG  REVIEW PROCESS   22   
   
RR EE CC OO MM MM EE NN DD AA TT II OO NN SS  
Identify and assign high priority to Abbreviated New Drug Applications close to 
approval. Assigning high priority to some ANDAs will reduce review times 
for these ANDAs but will also delay reviews for lower-priority ANDAs. In 
light of this, we offer the following options to FDAs OGD for identifying 
ANDAs that are close to  approval and improving the ANDA  prioritization 
process.   We also recognize that there may be additional options to  
improve the prioritization process. 
 	 Prioritize Abbreviated New Drug Applications based on potential market 
entry date.   OGD could review ANDAs for generic drugs without 
valid patents or exclusivities ahead of those with them. OGD could 
assign high priority to and reduce review times for ANDAs that can 
be approved and marketed immediately (i.e., ANDAs without valid  
patents or exclusivities) or in the near future (i.e., ANDAs with 
valid patents or exclusivities expiring soon). However, OGD should 
not delay ANDA reviews if the delay violates current FDA policy 
(e.g., ANDAs expedited under the PEPFAR program or expedited 
first generic drugs). 
 	 Assign high priority to Abbreviated New Drug Applications with 
approvable reviews in multiple divisions.  OGD could prioritize 
ANDAs based on the number of divisions with approvable reviews. 
As a result, ANDAs with few deficiencies across divisions (i.e., 
ANDAs approvable by multiple divisions and, thus, close to  
approval) would be reviewed more quickly. 
 	 Classify amendments according to Food and Drug Administration policy 
and assign high priority to Abbreviated New Drug  Applications with only 
minor deficiencies.   OGD could follow or revise amendment policies 
so that divisions classify and prioritize amendments similarly. In 
all divisions, OGD could assign high priority to ANDAs with minor 
deficiencies  (i.e., ANDAs close to approval) and review them before  
ANDAs with major deficiencies.   
AGENCY COMMENTS 
In its comments to the draft report, FDA noted that OGD and CDER 
staff have already identified portions of the primary recommendations, 
and FDA is implementing process improvements that are the  same as or 
similar to the recommendations. Specifically, FDA agreed with our first 
recommendation but did not indicate whether it concurred with the two 
additional recommendations. 
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R E C O M M E N D A T I O N S  
FDA agreed  that increasing the number of original ANDAs approved  
(i.e., in the first review cycle) would help streamline the review process  
by decreasing the number of amendments and subsequent review 
cycles.  FDA has provided guidance to assist industry in submitting 
more  easily reviewed applications and indicated that the development of  
guidance is a continually evolving process.  
Although FDA did not indicate whether it concurred with the second 
recommendation, FDA  noted that it continues to alter its review process  
with the goals of reducing queue times and reviewing original ANDAs 
within 180 days. FDA has developed a focused hiring program to 
increase staff and anticipates that additional reviewers will eventually 
decrease review times.  In addition, FDA is developing other approaches  
to increase review efficiency, including shifting responsibilities to the 
Project Management staff.   
FDA also did not indicate whether it concurred with the last 
recommendation.  FDA  stated that a variety of external forces can affect  
an applications review and approval, which makes determining 
whether an ANDA is close to approval difficult.  FDA also expressed 
some concerns about the options presented in our recommendation.  
However, it appears that FDA has taken some actions to address this 
recommendation.  FDA noted that it prioritizes some ANDAs based on 
potential market entry date and may consider further revisions to this 
process.  In particular, FDA indicated that a possible consideration 
would be to delay reviews for ANDAs  with patents that expire far into 
the future.  However, FDA noted that such a process would require a 
thorough examination of all related issues and policy changes within 
OGD. 
FDA also provided several technical comments to the report.  We have 
incorporated these comments into the report, as appropriate. 
We ask that, in its final management decision, FDA more clearly 
indicate whether it concurs with each of our recommendations.  For the 
full text of FDAs comments, see Appendix E. 
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  A P P E N D I X ~ A
ADDITIONAL INFORMATION ON METHODOLOGY 
Below we provide additional information about the methodology used to  
accomplish our objectives.  
Food and Drug Administration Policies, Procedures, and Guidance 
We reviewed the Food and Drug Administrations (FDA) Center for 
Drug Evaluation and Research (CDER) policies, procedures, and 
guidance on  the: 
  issuance and tracking of consults in the Office of Generic Drugs 
(OGD), 
  review order of original Abbreviated New Drug Applications 
(ANDAs) and amendments, and 
  classification of major and minor amendments.   
We compared these documents to  information gathered about ANDA 
review practices from OGD officials as well as data obtained from FDAs 
Centerwide Oracle Management Information System (COMIS), surveys  of 
OGD reviewers, and structured interviews with OGD officials.  We 
identified generic drug review practices that deviated from CDER policies, 
procedures, or guidance.  We also identified policies and practices that 
affected ANDA review times (e.g.,  OGD does not prioritize ANDAs based 
on potential market entry date).      
Centerwide Oracle Management Information System Data 
We obtained COMIS data from FDA to assess each divisions review 
times for ANDAs under review in 2006.  We defined ANDAs as under 
review if they contained a date between January 1 and           
December 31, 2006, in any of the following COMIS fields: 
  the date on which the ANDA was addressed to OGD,  
  the date on  which at least one division completed its review  of the  
ANDA, or  
  the date on which Chemistry acted on the ANDA. 
We obtained COMIS data for all ANDAs meeting at least one of the 
above criteria. Although we received data from FDA for 1,619 original 
ANDAs, we analyzed review times for 989 original ANDAs.   
We removed data for 37 ANDAs because they did not meet our criteria 
of being submitted, in the review queue, under review, or reviewed by at 
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A P P E N D I X ~ A  
least one division in 2006. Additional records were removed from the 
data set if at least one of the following criteria was met: 
  The ANDA was closed administratively or not assigned to divisions 
based on the results of the filing review (116 ANDAs), 
  COMIS did not contain data for the ANDA in all three divisions 
that review each ANDA  (Bioequivalence, Chemistry, and Labeling; 
393 ANDAs), and 
  The ANDA had been pending fewer than 180 days and Chemistry 
had not completed its review (84 ANDAs). 
The COMIS data were analyzed using SAS, a statistical analysis 
program.  ANDA review times were  calculated for each of the four 
divisions by subtracting the date on which OGD received the ANDA 
from the date on which each division completed its review. If an 
ANDA was currently pending in a division for more than 180 days, we 
entered the date on which we obtained the COMIS data from FDA 
(April 2, 2007) as the review completion date and assigned a pending 
code to the record.   
In some cases, an ANDA contained multiple records for a division 
(e.g., Bioequivalence has multiple COMIS division codes that all 
reflect the Bioequivalence review).  To capture the total time  for a 
division to complete the ANDA review, the last date on which a 
review was completed in the division was used as the review stop 
date. 
For cases in which one record for an ANDA within a division 
contained a review stop date but another record within the same 
division and ANDA contained no stop date, the last stop date was 
used. A review stop date indicates that the review is complete, and 
we did not classify these cases as pending.   
Office of Generic Drugs Reviewers 
From the COMIS data, we identified ANDAs with review times greater 
than 180 days and selected a sample of 105 ANDA reviews.  To obtain 
this sample, we identified reviewers assigned to a subset of recently  
submitted ANDAs within each division.  We sampled from ANDAs in 
which the 180-day review clock would have expired in the 4 months 
prior to the date on which we requested the data from FDA.   These  
ANDAs were submitted from June through September 2006.   
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A P P E N D I X ~ A  
We randomly selected 25 tentatively approved, disapproved, or pending 
ANDAs within each division.  In each division, we randomly selected  
one ANDA review per reviewer until each reviewer was sampled once  or 
until 25 ANDA reviews were selected.  If we did not obtain 25 ANDA 
reviews within a division after each reviewer was sampled once, we 
randomly selected additional ANDA reviews in the division,  1 per 
reviewer, until we obtained 25 ANDAs within the division.   
We also selected all ANDAs that were approved  but had review times  
greater than 180 days. This added five ANDA reviews to Chemistry 
and one ANDA review to Labeling for our sample.   
Therefore, we collected data from reviewers for a total of 106 ANDA 
reviews:  30 Chemistry,  25 Bioequivalence, 26 Labeling, and                 
25 Microbiology.  However, one Labeling reviewer indicated that the 
COMIS data for his review were wrong and the ANDA was reviewed 
within 180 days. We removed this ANDA review from our sample.  
Thus, our analysis of reviewer data was based on 105 ANDA reviews.   
Reviewers survey responses indicated the date on which their review of  
each ANDA began as well as the factors that contributed to the ANDA 
reviews exceeding 180 days within their division.   
Office of Generic Drugs Officials 
We conducted structured interviews with a division director (in all 
divisions except Microbiology), team leader, and project manager from  
each of the divisions as well as the Director of OGD.  We asked these   
12 individuals open-ended questions concerning factors that contribute 
to longer review times throughout the generic drug review process.    
We used reviewers and officials responses to understand ANDA review 
practices and to identify factors that contribute to ANDA review times  
exceeding 180 days. In addition, data from reviewers and officials 
provided the basis for collecting and analyzing additional FDA data.  
For example, reviewers and officials responses prompted us  to examine 
the OGD consult data and to compare review times for ANDAs affected 
by valid patents or exclusivities with those that could enter the market 
immediately.    
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  A P P E N D I X ~ B
 
 
 
2006 Chemistry Review Time Ranges  
ANDA  Approval Status  Review Time Range for ANDAs With Review Time > 180 Days  
Approved  246306 days 
Tentatively Approved  187667 days 
Disapproved  181816 days 
   All  181816 days  
Source:  Office of  Inspector General analysis of FDA COMIS data, 2007.  
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  A P P E N D I X ~ C
 
 
2006 Microbiology, Bioequivalence, and Labeling Review  Time Ranges 
 
OGD Division  Review Time Range for ANDAs With Review Time > 180 Days* 
Microbiology  181651 days 
Bioequivalence  181610 days 
Labeling  181627 days 
* Review time ranges may be underestimated because review times for pending ANDAs in these divisions were 
accruing when we obtained  the data.  For ANDAs with review times greater  than 180 days, the  percentages that  
were pending at  the time we obtained the data were:  73  percent  for Microbiology (127 of 175 ANDAs), 3 percent 
for Bioequivalence  (16 of 576 ANDAs), and 32 percent for Labeling (178 of 556 ANDAs).  
Source:  Office of  Inspector General analysis of FDA COMIS data, 2007.  
  OEI-04-07-00280   THE  FOOD AND DRUG  ADMINISTRATIONS GENERIC  DRUG  REVIEW PROCESS   29   
   
  A P P E N D I X ~ D
 
   
  25 
 
Frequency 

Distribution of
     
Office of Generic    20
Drugs Consults     s 
t
Pending as of    ul
s15 
June 2007  n
  o
C
  of 
r 
  e10 
b
m
  u
N
 
5 
 
 
0   
0  0  0  0  0  0  0  0  0  0 
9 8 7 6 5 4 3 2 1 0
0 11 12 13 14 15 16 17 18 19
9 18 27 36 45 54 63 72 8 1
Number of Days Pending 
  Source: Office of  Inspector General analysis of FDAs consult data, 2007. 
 
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  A P P E N D I X ~ E
 
 
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A P P E N D I X ~ E  

 
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A P P E N D I X ~ E  

 
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A P P E N D I X ~ E  

 
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A P P E N D I X ~ E  

 
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  A C K N O W L E D G M E N T S
 
This report was prepared under the  direction of  Robert A. Vito, Acting 
Regional Inspector General for Evaluation and Inspections in the 
Atlanta regional office, and Dwayne F. Grant, Deputy Regional 
Inspector General.    
Jaime Durley served as the lead analyst for this study.  Other principal 
Office of Evaluation and Inspections staff from the Atlanta regional 
office who contributed to this report include Sarah Ambrose and Mina 
Zadeh; central office staff who contributed include Ayana Everett, Kevin 
Farber, Rob Gibbons, and Mark Richardson; Joyce Greenleaf from the 
Boston regional office also contributed.    
 
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