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CDER Data Briefing 1996-2006
Accessible Version
CDER Facts and Figures, U.S.
Department of Health and Human Services, Food and Drug
Administration Center for Drug Evaluation and Research, Steven
Galson, M.D., MPH, Center Director, August 3, 2007
CDER Mission: Promote and
protect the public health by assuring that safe and effective drugs
are available to Americans
Notes page information:
What we do
Review drugs before marketing. A drug company seeking to
sell a drug in the United States must first test it. The company
then sends us the evidence from these tests to prove the drug is
safe and effective for its intended use. If the drug is effective
and we are convinced its health benefits outweigh its risks, we
approve it for sale.
Watch for drug problems. Once a drug is approved for sale
in the United States, our consumer protection mission continues. We
monitor the use of marketed drugs for unexpected health risks. If
new, unanticipated risks are detected after approval, we take steps
to inform the public and change how a drug is used or even remove it
from the market. We evaluate reports about suspected problems from
manufacturers, health-care professionals and consumers.
Monitor drug information and advertising. Accurate and
complete information is vital to the safe use of drugs. We regulate
information that accompanies or is displayed with an
over-the-counter drug. In the past, drug companies promoted their
products almost entirely to physicians.
Protect drug quality. In addition to setting standards for
safety and effectiveness testing, we also set standards for drug
quality and manufacturing processes. We monitor changes in
manufacturing to make sure they won’t adversely affect safety or
efficacy.
Priority NDA and BLA
Approvals--Median times and approvals by calendar year, including
therapeutic biologics starting in 2004:
- In 1996, there were 29 approvals with a median FDA review time
of 7.8 months and a median total approval time of 7.8 months.
- In 1997, there were 20 approvals with a median FDA review time
of 6.2 months and a median total approval time of 6.4 months.
- In 1998, there were 25 approvals with a median FDA review time
of 6.2 months and a median total approval time of 6.4 months.
- In 1999, there were 28 approvals with a median FDA review time
of 6.1 months and a median total approval time of 6.1 months.
- In 2000, there were 20 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2001, there were 10 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2002, there were 11 approvals with a median FDA review time
of 13.8 months and a median total approval time of 19.1 months.
- In 2003, there were 14 approvals with a median FDA review time
of 7.7 months and a median total approval time of 7.7 months.
- In 2004, there were 29 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2005, there were 22 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2006, there were 21 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
Notes page information:
New drug applications. NDAs are the formal submissions of
data that sponsors send us when they are seeking approval to market
a “new drug” in the United States. Some NDAs are NMEs; however, “new
drugs” can also include an active substance previously sold in a
different form.
Biologic license applications. BLAs are the formal
submissions of data that sponsors send us when they are seeking
approval to market a biologic in the United States. A “new BLA” is a
biologic that has never been approved for marketing in the United
States.
Review and approval times. Review time represents the time
that we spend examining the application. Approval time represents
our review time plus industry’s response time to our requests for
additional information.
Priority approvals. These products represent significant
improvements compared with marketed products. We have a goal of
reviewing 90 percent of these applications within six months.
Median times. Our charts show review and approval times as
“medians.” The value for the median time is the number that falls in
the middle of the group after the numbers are ranked in order. It
provides a truer picture of our performance than average time, which
can be unduly influenced by a few very long or short times.
Priority NDA and BLAs--Filings,
actions and approval percentages by calendar year, including
therapeutic biologics starting in 2004:
- In 1996, there were 26 filings, 44 actions and a 66 percent
approval percentage.
- In 1997, there were 32 filings, 35 actions and a 57 percent
approval percentage.
- In 1998, there were 27 filings, 46 actions and a 54 percent
approval percentage.
- In 1999, there were 31 filings, 43 actions and a 65 percent
approval percentage.
- In 2000, there were 21 filings, 41 actions and a 49 percent
approval percentage.
- In 2001, there were 7 filings, 27 actions and a 37 percent
approval percentage.
- In 2002, there were 19 filings, 18 actions and a 61 percent
approval percentage.
- In 2003, there were 18 filings, 26 actions and a 54 percent
approval percentage.
- In 2004, there were 31 filings, 42 actions and a 69 percent
approval percentage.
- In 2005, there were 29 filings, 36 actions and a 61 percent
approval percentage.
- In 2006, there were 26 filings, 38 actions and a 55 percent
approval percentage.
Notes page information:
Actions and filings. An application is “filed” when we
determine it is complete and accept it for review. We make a filing
decision within 60 days of receiving an application. Approval is one
of the actions that we can take once an application is filed. Other
actions include seeking more information from the sponsor.
There is no direct connection between applications filed in one
year and actions in the same year.
Priority NME and new BLA
Approvals--Median times and approvals by calendar year, including
therapeutic biologics starting in 2004:
- In 1996, there were 18 approvals with a median FDA review time
of 7.7 months and a median total approval time of 9.6 months.
- In 1997, there were 9 approvals with a median FDA review time
of 6.4 months and a median total approval time of 6.7 months.
- In 1998, there were 16 approvals with a median FDA review time
of 6.2 months and a median total approval time of 6.2 months.
- In 1999, there were 19 approvals with a median FDA review time
of 6.3 months and a median total approval time of 6.3 months.
- In 2000, there were 9 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2001, there were 7 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2002, there were 7 approvals with a median FDA review time
of 13.8 months and a median total approval time of 16.3 months.
- In 2003, there were 9 approvals with a median FDA review time
of 7.7 months and a median total approval time of 6.7 months.
- In 2004, there were 21 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2005, there were 15 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2006, there were 10 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
Notes page information:
New molecular entities. NMEs contain an active substance
that has never before been approved for marketing in any form in the
United States. Because of high interest in truly new medicines, we
report approvals of NMEs and “new BLAs.”
The charts for all NDAs and all BLAs include NMEs and new BLAs.
Priority NMEs and new BLAs--Filings by
calendar year, including therapeutic biologics starting in 2004:
- In 1996, there were 16 filings.
- In 1997, there were 16 filings.
- In 1998, there were 15 filings.
- In 1999, there were 14 filings.
- In 2000, there were 14 filings.
- In 2001, there were 5 filings.
- In 2002, there were 10 filings.
- In 2003, there were 16 filings.
- In 2004, there were 17 filings.
- In 2005, there were 17 filings.
- In 2006, there were 7 filings.
Standard NDA and BLA
Approvals--Median times and approvals by calendar year, including
therapeutic biologics starting in 2004:
- In 1996, there were 102 approvals with a median FDA review
time of 15.1 months and a median total approval time of 17.8
months.
- In 1997, there were 101 approvals with a median FDA review
time of 14.7 months and a median total approval time of 15.0
months.
- In 1998, there were 65 approvals with a median FDA review time
of 12.0 months and a median total approval time of 12.0 months.
- In 1999, there were 55 approvals with a median FDA review time
of 12.0 months and a median total approval time of 13.8 months.
- In 2000, there were 78 approvals with a median FDA review time
of 12.0 months and a median total approval time of 12.0 months.
- In 2001, there were 56 approvals with a median FDA review time
of 12.0 months and a median total approval time of 14.0 months.
- In 2002, there were 67 approvals with a median FDA review time
of 12.7 months and a median total approval time of 15.3 months.
- In 2003, there were 58 approvals with a median FDA review time
of 11.9 months and a median total approval time of 15.4 months.
- In 2004, there were 90 approvals with a median FDA review time
of 11.9 months and a median total approval time of 12.9 months.
- In 2005, there were 58 approvals with a median FDA review time
of 11.8 months and a median total approval time of 13.1 months.
- In 2006, there were 80 approvals with a median FDA review time
of 12.0 months and a median total approval time of 13.0 months.
Notes page information:
Standard approvals. These products have therapeutic
qualities similar to those of already marketed products. We have a
goal of reviewing 90 percent of these applications within 10 months.
Standard NDAs and BLAs--Filings,
actions and approval percentages by calendar year, including
therapeutic biologics starting in 2004:
- In 1996, there were 90 filings, 225 actions and a 45 percent
approval percentage.
- In 1997, there were 92 filings, 200 actions and a 51 percent
approval percentage.
- In 1998, there were 87 filings, 153 actions and a 42 percent
approval percentage.
- In 1999, there were 101 filings, 147 actions and a 37 percent
approval percentage.
- In 2000, there were 87 filings, 197 actions and a 40 percent
approval percentage.
- In 2001, there were 88 filings, 143 actions and a 39 percent
approval percentage.
- In 2002, there were 79 filings, 154 actions and a 44 percent
approval percentage.
- In 2003, there were 89 filings, 139 actions and a 42 percent
approval percentage.
- In 2004, there were 75 filings, 162 actions and a 56 percent
approval percentage.
- In 2005, there were 82 filings, 107 actions and a 54 percent
approval percentage.
- In 2006, there were 90 filings, 158 actions and a 51 percent
approval percentage.
Standard NME and new BLA
Approvals--Median times and approvals by calendar year, including
therapeutic biologics starting in 2004:
- In 1996, there were 35 approvals with a median FDA review time
of 14.6 months and a median total approval time of 15.1 months.
- In 1997, there were 30 approvals with a median FDA review time
of 14.4 months and a median total approval time of 15.0 months.
- In 1998, there were 14 approvals with a median FDA review time
of 12.3months and a median total approval time of 13.4 months.
- In 1999, there were 16 approvals with a median FDA review time
of 14.0 months and a median total approval time of 16.3 months.
- In 2000, there were 18 approvals with a median FDA review time
of 15.4 months and a median total approval time of 19.9 months.
- In 2001, there were 17 approvals with a median FDA review time
of 15.7 months and a median total approval time of 19.0 months.
- In 2002, there were 10 approvals with a median FDA review time
of 12.5 months and a median total approval time of 15.9 months.
- In 2003, there were 12 approvals with a median FDA review time
of 13.8 months and a median total approval time of 23.1 months.
- In 2004, there were 15 approvals with a median FDA review time
of 16.0 months and a median total approval time of 24.7 months.
- In 2005, there were 5 approvals with a median FDA review time
of 15.6 months and a median total approval time of 23.0 months.
- In 2006, there were 12 approvals with a median FDA review time
of 12.5 months and a median total approval time of 13.7 months.
Standard NDA and new BLAs--Filings by
calendar year, including therapeutic biologics starting in 2004:
- In 1996, there were 29 filings.
- In 1997, there were 25 filings.
- In 1998, there were 28 filings.
- In 1999, there were 22 filings.
- In 2000, there were 12 filings.
- In 2001, there were 25 filings.
- In 2002, there were 13 filings.
- In 2003, there were 12 filings.
- In 2004, there were 16 filings.
- In 2005, there were 19 filings.
- In 2006, there were 17 filings.
Priority New or Expanded Use
Approvals--Median times and approvals by calendar year, including
therapeutic biologics starting in 2004:
- In 1996, there were 7 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 1997, there were 4 approvals with a median FDA review time
of 4.4 months and a median total approval time of 4.4 months.
- In 1998, there were 13 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 1999, there were 9 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2000, there were 18 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2001, there were 6 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2002, there were 19 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2003, there were 21 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2004, there were 48 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2005, there were 36 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
- In 2006, there were 39 approvals with a median FDA review time
of 6.0 months and a median total approval time of 6.0 months.
Notes page information:
Applications for a new or expanded use, often representing
important new treatment options, are formally called “efficacy
supplements” to the original new drug application biologics license
application.
We have a goal of reviewing standard supplements in 10 months and
priority supplements in six months.
Priority New or Expanded
Uses--Actions and approval percentages by calendar year, including
therapeutic biologics starting in 2004:
- In 1996, there were 9 actions and a 78 percent approval
percentage.
- In 1997, there were 7 actions and a 57 percent approval
percentage.
- In 1998, there were 13 actions and a 100 percent approval
percentage.
- In 1999, there were 19 actions and a 47 percent approval
percentage.
- In 2000, there were 23 actions and a 78 percent approval
percentage.
- In 2001, there were 10 actions and a 60 percent approval
percentage.
- In 2002, there were 36 actions and a 53 percent approval
percentage.
- In 2003, there were 33 actions and a 64 percent approval
percentage.
- In 2004, there were 64 actions and a 75 percent approval
percentage.
- In 2005, there were 52 actions and a 69 percent approval
percentage.
- In 2006, there were 52 actions and a 75 percent approval
percentage.
Standard New or Expanded Use
Approvals--Median times and approvals by calendar year, including
therapeutic biologics starting in 2004:
- In 1996, there were 111 approvals with a median FDA review
time of 12.6 months and a median total approval time of 14.8
months.
- In 1997, there were 104 approvals with a median FDA review
time of 11.9 months and a median total approval time of 12.0
months.
- In 1998, there were 111 approvals with a median FDA review
time of 11.9 months and a median total approval time of 12.0
months.
- In 1999, there were 88 approvals with a median FDA review time
of 11.0 months and a median total approval time of 11.3 months.
- In 2000, there were 116 approvals with a median FDA review
time of 10.0 months and a median total approval time of 10.0
months.
- In 2001, there were 85 approvals with a median FDA review time
of 10.7 months and a median total approval time of 11.3 months.
- In 2002, there were 133 approvals with a median FDA review
time of 10.0 months and a median total approval time of 10.0
months.
- In 2003, there were 110 approvals with a median FDA review
time of 10.0 months and a median total approval time of 10.0
months.
- In 2004, there were 99 approvals with a median FDA review time
of 10.0 months and a median total approval time of 10.0 months.
- In 2005, there were 105 approvals with a median FDA review
time of 10.0 months and a median total approval time of 10.0
months.
- In 2006, there were 98 approvals with a median FDA review
time of 9.9 months and a median total approval time of 9.9
months.
Standard New or Expanded
Uses--Actions and approval percentages by calendar year, including
therapeutic biologics starting in 2004:
- In 1996, there were 187 actions and a 59 percent approval
percentage.
- In 1997, there were 182 actions and a 57 percent approval
percentage.
- In 1998, there were 160 actions and a 69 percent approval
percentage.
- In 1999, there were 165 actions and a 53 percent approval
percentage.
- In 2000, there were 182 actions and a 64 percent approval
percentage.
- In 2001, there were 203 actions and a 42 percent approval
percentage.
- In 2002, there were 237 actions and a 56 percent approval
percentage.
- In 2003, there were 178 actions and a 62 percent approval
percentage.
- In 2004, there were 161 actions and a 61 percent approval
percentage.
- In 2005, there were 171 actions and a 61 percent approval
percentage.
- In 2006, there were 133 actions and a 74 percent approval
percentage.
Pediatric Drug Development--Calendar year
data:
- In 1999, there were 98 written requests issued, 3 pediatric
exclusivity labeling changes granted and 12 pediatric exclusivity
determinations made.
- In 2000, there were 45 written requests issued, 11 pediatric
exclusivity labeling changes granted and 17 pediatric exclusivity
determinations made.
- In 2001, there were 69 written requests issued, 12 pediatric
exclusivity labeling changes granted and 23 pediatric exclusivity
determinations made.
- In 2002, there were 21 written requests issued, 19 pediatric
exclusivity labeling changes granted and 20 pediatric exclusivity
determinations made.
- In 2003, there were 24 written requests issued, 15 pediatric
exclusivity labeling changes granted and 23 pediatric exclusivity
determinations made.
- In 2004, there were 19 written requests issued, 25 pediatric
exclusivity labeling changes granted and 17 pediatric exclusivity
determinations made.
- In 2005, there were 10 written requests issued, 25 pediatric
exclusivity labeling changes granted and 15 pediatric exclusivity
determinations made.
- In 2005, there were 22 written requests issued, 14 pediatric
exclusivity labeling changes granted and 18 pediatric exclusivity
determinations made.
Notes page information:
The Best Pharmaceuticals for Children Act of 2002 renewed our
authority to grant six months of additional marketing exclusivity to
manufacturers who conduct and submit pediatric studies in response
to our written requests.
As of April 30, 2007, we had received 504 proposed pediatric
study requests from manufacturers, issued 341 written requests, made
149 exclusivity determinations, granted exclusivity to 136 drugs and
added new pediatric information to 127 labels.
OTC New Approvals and New Uses--Calendar
year data:
- In 1995, there were 9 new approvals or Rx-to-OTC switches and
1 new use.
- In 1996, there were 20 new approvals or Rx-to-OTC switches and
1 new use.
- In 1997, there were 9 new approvals or Rx-to-OTC switches and
1 new use.
- In 1998, there were 8 new approvals or Rx-to-OTC switches and
7 new uses.
- In 1999, there were 5 new approvals or Rx-to-OTC switches and
3 new uses.
- In 2000, there were 8 new approvals or Rx-to-OTC switches and
3 new uses.
- In 2001, there were 6 new approvals or Rx-to-OTC switches and
1 new use.
- In 2002, there were 13 new approvals or Rx-to-OTC switches.
- In 2003, there were 1 new approval or Rx-to-OTC switch and 2
new uses.
- In 2004, there were 5 new approvals or Rx-to-OTC switches and
3 new uses.
- In 2005, there were 5 new approvals or Rx-to-OTC switches.
- In 2006, there were 13 new approvals or Rx-to-OTC switches and
1 new use.
Notes page information:
Over-the-counter drugs are available for purchase without a
prescription. They are available to treat common ailments that
people can diagnose and treat themselves.
We regulate OTC drugs to ensure they are safe, effective and
properly labeled. We publish monographs that establish acceptable
ingredients, doses, formulations and consumer labeling for OTC
drugs. Products that conform to a final monograph may be marketed
without prior FDA clearance.
Drugs also can be approved for OTC sale through the new drug
review process.
Generic Drug Approvals--Number
of approvals and median approval times by calendar year data:
- In 1996, there were 212 approvals in a median time of 23.0
months.
- In 1997, there were 273 approvals in a median time of 19.3
months.
- In 1998, there were 225 approvals in a median time of 18.0
months.
- In 1999, there were 186 approvals in a median time of 18.6
months.
- In 2000, there were 244 approvals in a median time of 18.2
months.
- In 2001, there were 234 approvals in a median time of 18.1
months.
- In 2002, there were 321 approvals in a median time of 18.3
months.
- In 2003, there were 263 approvals in a median time of 17.0
months.
- In 2004, there were 380 approvals in a median time of 15.7
months.
- In 2005, there were 344 approvals in a median time of 16.4
months.
- In 2006, there were 371 approvals in a median time of 17.5
months.
A generic drug is a chemical copy of a brand-name drug. There are
generic versions of prescription and over-the-counter drugs.
Generics are not required to repeat the extensive clinical trials
used in the development of the original, brand-name drug. For many
products such as tablets and capsules, the generics must show
bioequivalence to the brand-name reference listed drug.
This means that the generic version must deliver the same amount
of active ingredient into a patient’s bloodstream and in the same
time as the brand-name reference listed drug. The rate and extent of
absorption is called bioavailability. The bioavailability of the
generic drug is then compared to that of the brand-name. This
comparison is bioequivalence.
Brand-name drugs are subject to the same bioequivalency tests as
generics when their manufacturers reformulate them.
Generic Drug Tentative
Approvals--Calendar year data:
- In 1996, there were 25 tentative approvals.
- In 1997, there were 40 tentative approvals.
- In 1998, there were 40 tentative approvals.
- In 1999, there were 56 tentative approvals.
- In 2000, there were 61 tentative approvals.
- In 2001, there were 73 tentative approvals.
- In 2002, there were 63 tentative approvals.
- In 2003, there were 101 tentative approvals.
- In 2004, there were 65 tentative approvals.
- In 2005, there were 108 tentative approvals.
- In 2006, there were 164 tentative approvals.
Notes page information:
The only difference between a full approval and a tentative
approval is that the final approval of these applications is delayed
due to an existing patent or exclusivity on the innovator drug
product.
While tentative approvals represent a full workload for us, they
are only displayed in our approvals chart once they are converted to
full approvals. For example, some of the approvals in 2005 represent
conversions of tentative approvals granted in 2004 or previous
years.
Tentative approval is a key regulatory mechanism to support the
availability of drugs for the President’s Emergency Plan for AIDS
Relief.
Generic Drug Applications
Received (workload in future years)--Calendar year data:
- In 1996, there were 307 applications received.
- In 1997, there were 330 applications received.
- In 1998, there were 345 applications received.
- In 1999, there were 296 applications received.
- In 2000, there were 365 applications received.
- In 2001, there were 320 applications received.
- In 2002, there were 392 applications received.
- In 2003, there were 479 applications received.
- In 2004, there were 635 applications received.
- In 2005, there were 777 applications received.
- In 2005, there were 828 applications received.
The dramatic increase in receipts of generic drug applications
makes it imperative that we process generic drug applications more
efficiently.
We are taking steps aimed at improving the content and
completeness of generic drug applications and assuring that the
applications contain the needed information to be evaluated
successfully in one cycle.
More Generic Competition Lowers
Drug Prices--Analysis of 1999-2004 retail sales data from IMS Health
- With 1 generic manufacturer, the average relative price per
dose is 94 percent of the brand-name price.
- With 2 generic manufacturers, the average relative price per
dose is 52 percent of the brand-name price.
- With 3 generic manufacturers, the average relative price per
dose is 44 percent of the brand-name price.
- With 4 generic manufacturers, the average relative price per
dose is 39 percent of the brand-name price.
- With 5 generic manufacturers, the average relative price per
dose is 33 percent of the brand-name price.
- With 6 generic manufacturers, the average relative price per
dose is 26 percent of the brand-name price.
- With 7 generic manufacturers, the average relative price per
dose is 23 percent of the brand-name price.
- With 8 generic manufacturers, the average relative price per
dose is 21 percent of the brand-name price.
- With 9 generic manufacturers, the average relative price per
dose is 20 percent of the brand-name price.
- With 10 generic manufacturers, the average relative price per
dose is 26 percent of the brand-name price.
- With 11 generic manufacturers, the average relative price per
dose is 22 percent of the brand-name price.
- With 12 generic manufacturers, the average relative price per
dose is 20 percent of the brand-name price.
- With 13 generic manufacturers, the average relative price per
dose is 24 percent of the brand-name price.
- With 14 generic manufacturers, the average relative price per
dose is 15 percent of the brand-name price.
- With 15 generic manufacturers, the average relative price per
dose is 13 percent of the brand-name price.
- With 16 generic manufacturers, the average relative price per
dose is 11 percent of the brand-name price.
- With 17 generic manufacturers, the average relative price per
dose is 9 percent of the brand-name price.
- With 18 generic manufacturers, the average relative price per
dose is 8 percent of the brand-name price.
- With 19 generic manufacturers, the average relative price per
dose is 6 percent of the brand-name price.
Notes page information:
The entry of a second generic competitor brings about the largest
price reduction. We concluded this from our analysis of IMS retail
sales data for single-ingredient brand-name and generic drug
products sold from 1999 through 2004.
Inspections of Clinical
Research--Calendar year data:
- In 1998, there were 635 inspections for data quality and
research risks that included 246 U.S. clinical investigators; 64
foreign clinical investigators; 184 institutional review boards; 4
sponsors, monitors or contract research organizations; 54 good
laboratory practices; and 83 in-vivo bioequivalence.
- In 1999, there were 700 inspections for data quality and
research risks that included 293 U.S. clinical investigators; 61
foreign clinical investigators; 191 institutional review boards;
10 sponsors, monitors or contract research organizations; 54 good
laboratory practices; and 91 in-vivo bioequivalence.
- In 2000, there were 650 inspections for data quality and
research risks that included 296 U.S. clinical investigators; 49
foreign clinical investigators; 155 institutional review boards;
28 sponsors, monitors or contract research organizations; 47 good
laboratory practices; and 75 in-vivo bioequivalence.
- In 2001, there were 574 inspections for data quality and
research risks that included 258 U.S. clinical investigators; 38
foreign clinical investigators; 139 institutional review boards;
28 sponsors, monitors or contract research organizations; 50 good
laboratory practices; and 61 in-vivo bioequivalence.
- In 2002, there were 589 inspections for data quality and
research risks that included 276 U.S. clinical investigators; 30
foreign clinical investigators; 166 institutional review boards;
15 sponsors, monitors or contract research organizations; 32 good
laboratory practices; and 70 in-vivo bioequivalence.
- In 2003, there were 728 inspections for data quality and
research risks that included 324 U.S. clinical investigators; 44
foreign clinical investigators; 154 institutional review boards;
17 sponsors, monitors or contract research organizations; 87 good
laboratory practices; and 102 in-vivo bioequivalence.
- In 2004, there were 730 inspections for data quality and
research risks that included 242 U.S. clinical investigators; 82
foreign clinical investigators; 178 institutional review boards;
18 sponsors, monitors or contract research organizations; 74 good
laboratory practices; and 136 in-vivo bioequivalence.
- In 2005, there were 652 inspections for data quality and
research risks that included 284 U.S. clinical investigators; 70
foreign clinical investigators; 122 institutional review boards;
31 sponsors, monitors or contract research organizations; 56 good
laboratory practices; and 89 in-vivo bioequivalence.
- In 2006, there were 648 inspections for data quality and
research risks that included 313 U.S. clinical investigators; 95
foreign clinical investigators; 71 institutional review boards;
32 sponsors, monitors or contract research organizations; 31 good
laboratory practices; and 106 in-vivo bioequivalence.
Notes page information:
When obtaining data about the safety and effectiveness of drugs,
sponsors rely on high quality laboratory studies and human
volunteers to take part in clinical studies. Protecting volunteers
from research risks is a critical responsibility for us and all
involved in clinical trials.
We perform on-site inspections to protect the rights and welfare
of volunteers and verify the quality and integrity of data submitted
for our review. We inspect domestic and foreign clinical trial study
sites; institutional review boards; sponsors, monitors and
organizations conducting research; laboratories that obtain data;
and sites performing bioequivalence studies in humans and
preclinical studies in animals.
2006 Inspections of Clinical
Research
- In 2006, there were 648 inspections for data quality and
research risks that included 313 U.S. clinical investigators; 95
foreign clinical investigators; 71 institutional review boards;
32 sponsors, monitors or contract research organizations; 31 good
laboratory practices; and 106 in-vivo bioequivalence.
Letters Issued on Drug
Promotion Compliance--Calendar year data:
- In 1996, there were 159 initial letters citing violations and
61 follow-up letters citing violations.
- In 1997, there were 154 initial letters citing violations and
91 follow-up letters citing violations.
- In 1998, there were 158 initial letters citing violations and
79 follow-up letters citing violations.
- In 1999, there were 115 initial letters citing violations and
56 follow-up letters citing violations.
- In 2000, there were 80 initial letters citing violations and
37 follow-up letters citing violations.
- In 2001, there were 71 initial letters citing violations and
34 follow-up letters citing violations.
- In 2002, there were 29 initial letters citing violations and 9
follow-up letters citing violations.
- In 2003, there were 25 initial letters citing violations and
17 follow-up letters citing violations.
- In 2004, there were 23 initial letters citing violations and
33 follow-up letters citing violations.
- In 2005, there were 29 initial letters citing violations and
31 follow-up letters citing violations.
- In 2005, there were 22 initial letters citing violations and
48 follow-up letters citing violations.
Notes page information:
We oversee advertising of prescription drugs, whether to
physicians or consumers. We pay particular attention to broadcast
ads that can be seen by a great many consumers. The Federal Trade
Commission regulates advertising of over-the-counter drugs.
Advertisements for a drug must contain a truthful summary of
information about its effectiveness, side effects and circumstances
when its use should be avoided.
Drug advertising and promotion must be truthful, fair, balanced
and not misleading. We issue letters to ensure compliance with our
regulations when asked or as a result of our own surveillance.
We issue regulatory action letters to companies for prescription
drug promotions determined to be false, misleading, lacking in fair
balance of risks and benefits or that promoted a product or
indication before approval. These were either “untitled” letters for
violations or “warning” letters for more serious or repeat
violations. Examples of violative promotions include exhibit hall
displays, oral representations, Internet sites, plus traditional
materials such as journal advertisements, sales brochures and TV
ads.
Advisory Drug Promotion Letters
--Calendar year data:
- In 1996, there were 558 launch campaign advisory letters.
- In 1997, there were 539 launch campaign advisory letters.
- In 1998, there were 399 launch campaign advisory letters.
- In 1999, there were 350 launch campaign advisory letters and
773 other advisory letters.
- In 2000, there were 276 launch campaign advisory letters and
515 other advisory letters.
- In 2001, there were 178 launch campaign advisory letters and
597 other advisory letters.
- In 2002, there were 186 launch campaign advisory letters and
465 other advisory letters.
- In 2003, there were 185 launch campaign advisory letters and
510 other advisory letters.
- In 2004, there were 184 launch campaign advisory letters and
571 other advisory letters.
- In 2005, there were 158 launch campaign advisory letters and
470 other advisory letters.
- In 2006, there were 197 launch campaign advisory letters and
333 other advisory letters.
Notes page information:
When requested, we review advertisements and other promotional
materials before drug companies launch marketing campaigns that
introduce either new drugs or new indications or dosages for
approved drugs.
Percentage of Drug Promotion Letters
Concerning DTC Ads--Calendar year data:
- In 1997, 31 percent of drug promotion letters concerned
direct-to-consumer promotion.
- In 1998, 44 percent of drug promotion letters concerned
direct-to-consumer promotion.
- In 1999, 19 percent of drug promotion letters concerned
direct-to-consumer promotion.
- In 2000, 24 percent of drug promotion letters concerned
direct-to-consumer promotion.
- In 2001, 22 percent of drug promotion letters concerned
direct-to-consumer promotion.
- In 2002, 27 percent of drug promotion letters concerned
direct-to-consumer promotion.
- In 2003, 34 percent of drug promotion letters concerned
direct-to-consumer promotion.
- In 2004, 27 percent of drug promotion letters concerned
direct-to-consumer promotion.
- In 2005, 30 percent of drug promotion letters concerned
direct-to-consumer promotion.
- In 2006, 28 percent of drug promotion letters concerned
direct-to-consumer promotion.
Adverse event reporting --Calendar year
data:
- In 1996, there were 191,865 reports of suspected drug-related
adverse events that included 15,262 MedWatch reports directly from
individuals; 26,315 manufacturer 15-day (expedited) reports;
and 150,288 manufacturer periodic reports.
- In 1997, there were 212,978
reports of suspected drug-related adverse events that included
16,217 MedWatch reports directly from individuals; 37,849
manufacturer 15-day (expedited) reports; and
158,912 manufacturer
periodic reports.
- In 1998, there were 247,607
reports of suspected drug-related adverse events that included
15,279 MedWatch reports directly from individuals; 71,584
manufacturer 15-day (expedited) reports; and 160,744 manufacturer
periodic reports.
- In 1999, there were 278,266
reports of suspected drug-related adverse events that included
16,205 MedWatch reports directly from individuals; 81,625
manufacturer 15-day (expedited) reports; and 180,436 manufacturer
periodic reports.
- In 2000, there were 266,978
reports of suspected drug-related adverse events that included
16,137 MedWatch reports directly from individuals; 95,030
manufacturer 15-day (expedited) reports; and 155,807 manufacturer
periodic reports.
- In 2001, there were 285,101
reports of suspected drug-related adverse events that included
19,311 MedWatch reports directly from individuals; 115,014
manufacturer 15-day (expedited) reports; and 150,776 manufacturer
periodic reports.
- In 2002, there were 322,692
reports of suspected drug-related adverse events that included
20,442 MedWatch reports directly from individuals; 128,874
manufacturer 15-day (expedited) reports; and 173,376 manufacturer
periodic reports.
- In 2003, there were 370,898
reports of suspected drug-related adverse events that included
22,951 MedWatch reports directly from individuals; 144,316
manufacturer 15-day (expedited) reports; and 203,628 serious
manufacturer periodic reports.
- In 2004, there were 423,030
reports of suspected drug-related adverse events that included
21,661 MedWatch reports directly from individuals; 162,097
manufacturer 15-day (expedited) reports; and 239,972 manufacturer
periodic reports.
- In 2005, there were 464,065 reports of suspected drug-related
adverse events: 25,325 MedWatch reports directly from individuals;
213,537 manufacturer 15-day (expedited) reports; and 230,455
manufacturer periodic reports.
- In 2006, there were 471,679 reports of suspected drug-related
adverse events: 20,979 MedWatch reports directly from individuals;
220,245 manufacturer 15-day (expedited) reports; and 230,455
manufacturer periodic reports.
Notes page information:
A powerful drug safety tool is the Adverse Event Reporting
System, known as AERS. This computerized system combines the
voluntary adverse drug reaction reports from MedWatch and the
required reports from manufacturers. These reports often form the
basis of “signals” that there may be a potential for serious and
unrecognized drug-associated events. When a signal is detected,
further testing of the hypothesis is undertaken using various
epidemiological and analytic databases, previously published studies
or other instruments and resources.
Report types
Direct reports from MedWatch. An individual, usually a
health-care practitioner, notifies us directly of a suspected
serious adverse event.
15-day (expedited) reports. Manufacturers report serious
and unexpected adverse events to us as soon as possible but within
15 days of discovering the problem.
Manufacturer periodic reports. These report all other
adverse events, such as those less than serious or described in the
labeling. These are submitted quarterly for the first three years of
marketing and annually after that. Nonserious reports are displayed
separately starting with 1998.
2006 Adverse Event Reports
- In 2006, there were 471,679 reports of suspected drug-related
adverse events: 20,979 MedWatch reports directly from individuals;
220,245 manufacturer 15-day (expedited) reports; and 230,455
manufacturer periodic reports.
Adverse Event Electronic
Submissions--Calendar year data
- In 2000, there were 2,571 adverse event reports submitted
electronically, including 2,571 manufacturer 15-day (expedited) reports
and 0 manufacturer periodic reports.
- In 2001, there were 15,644 adverse event reports submitted
electronically, including 13,839 manufacturer 15-day (expedited) reports
and 1,805 manufacturer periodic reports.
- In 2002, there were 22,937 adverse event reports submitted
electronically, including 21,623 manufacturer 15-day (expedited) reports
and 1,314 manufacturer periodic reports.
- In 2003, there were 42,375 adverse event reports submitted
electronically, including 29,843 manufacturer 15-day (expedited) reports
and 12,532 manufacturer periodic reports.
- In 2004, there were 81,099 adverse event reports submitted
electronically, including 55,227 manufacturer 15-day (expedited) reports
and 23,872 manufacturer periodic reports.
- In 2005, there were 136,211 adverse event reports submitted
electronically, including 109,452 manufacturer 15-day (expedited) reports
and 0 manufacturer periodic reports.
- In 2006, there were 157,667 adverse event reports submitted
electronically, including 122,272 manufacturer 15-day (expedited) reports
and 35,395 manufacturer periodic reports.
Notes page information:
Electronic submission of adverse event reports permits more
timely receipt and evaluation at a considerable cost savings for
both the FDA and industry. As of the end of 2006, 38 sponsors were
submitting their 15-day reports electronically, and seven were
submitting their periodic adverse event reports electronically.
Drug Recalls--Fiscal year data:
- In 1996, there were 226 recalls of prescription drugs and 53
recalls of over-the-counter drugs.
- In 1997, there were 248 recalls of prescription drugs and 34
recalls of over-the-counter drugs.
- In 1998, there were 176 recalls of prescription drugs and 88
recalls of over-the-counter drugs.
- In 1999, there were 352 recalls of prescription drugs and 72
recalls of over-the-counter drugs.
- In 2000, there were 316 recalls of prescription drugs and 156
recalls of over-the-counter drugs.
- In 2001, there were 248 recalls of prescription drugs and 72
recalls of over-the-counter drugs.
- In 2002, there were 354 recalls of prescription drugs and 83
recalls of over-the-counter drugs.
- In 2003, there were 254 recalls of prescription drugs and 88
recalls of over-the-counter drugs.
- In 2004, there were 215 recalls of prescription drugs and 71
recalls of over-the-counter drugs.
- In 2005, there were 401 recalls of prescription drugs and 101
recalls of over-the-counter drugs.
- In 2006, there were 240 recalls of prescription drugs and
121
recalls of over-the-counter drugs.
Notes page information:
In some cases, a drug product must be recalled due to a problem
occurring in the manufacture or distribution of the product that may
present a significant risk to public health. These problems usually,
but not always, occur in one or a small number of batches of the
drug. Manufacturers or distributors usually implement voluntary
recalls in order to carry out their responsibilities to protect the
public health when they need to remove a marketed drug product that
presents a risk of injury to consumers or to correct a defective
drug product. A voluntary recall of a drug product is more efficient
and effective in assuring timely consumer protection than an
FDA-initiated court action or seizure of the product.
Safety-Based Withdrawals--NMEs
approved Jan. 1, 1971, to March 31, 2007, and BLAs approved Oct. 1,
2003, to March 31, 2007:
- For the pre-PDUFA receipt period there were 16 withdrawals
(3.3 percent) of 488 medicines.
- For the PDUFA receipt period there were 13 withdrawals (3.6
percent) of 363 medicines.
Notes page information:
In some cases, there is an intrinsic property of a drug that
makes it necessary to withdraw the drug from the market for safety
reasons. The rates of safety-based withdrawals of new molecular
entities are similar for an earlier period before we collected user
fees and for the period, beginning Oct. 1, 1992, when we collected
user fees. Our time periods are based on when we received an
application rather than when we approved it.
Drug Quality Reports--Fiscal year
data:
- In 1999, there were 2,020 MedWatch drug quality reports and
296 field alerts.
- In 2000, there were 2,125 MedWatch drug quality reports and
281 field alerts.
- In 2001, there were 2,469 MedWatch drug quality reports and
299 field alerts.
- In 2002, there were 2,800 MedWatch drug quality reports and
413 field alerts.
- In 2003, there were 2,864 MedWatch drug quality reports, 447 field alerts,
and 4 biologic product deviation reports.
- In 2004, there were 3,064 MedWatch drug quality reports,
374 field alerts, and 25 biologic product deviation reports.
- In 2005, there were 2,864 MedWatch drug quality reports,
325 field alerts, and 15 biologic product deviation reports.
- In 2006, there were 2,332 MedWatch drug quality reports, 311 field alerts,
and 27 biologic product deviation reports.
Notes page information:
Drug Quality Surveillance Systems
Our reporting tools help us rapidly identify significant health
hazards and quality problems associated with the manufacturing and
packaging of medicines. Problems that may affect a medicine’s
safety, purity or potency may occur during manufacturing,
processing, packing, labeling, storage or distribution.
We evaluate reports and FDA field inspections to identify
specific firms with manufacturing quality problems with the most
potential impact on public health. We target these candidates for
inspection and further product sampling and laboratory analysis. We
recommend appropriate corrective actions based upon our analysis of
the findings. We may take enforcement action in some cases.
Reported Drug Quality
Defects--Fiscal year 2006 data:
- In 2006, the types of product defects and their percentages of
the total were formulation/substitution, 24 percent; labeling,
13 percent; other, 12 percent; delivery, 13 percent; fill
problem, 5 percent; packaging, 6 percent; and product defect, 27
percent.
President’s Emergency Plan for AIDS
Relief
PEPFAR generic drugs:
- 4 fully approved
- 44 tentatively approved
Notes page information:
Through guidance and an active outreach program to the
pharmaceutical industry, we actively encourage any sponsors
worldwide to submit U.S. marketing applications for single entity,
fixed dose combination and co-packaged versions of previously
approved antiretroviral therapies--even if there are still patent or
exclusivity market protections for the product in the United States.
International Information-Sharing
Agreements
- 13 foreign nations
- 2 international organizations:
- European Medicines Agency
- World Health Organization
Notes page information:
Because of enhanced cooperation among regulators around the
world, FDA has entered into international agreements in which we
play a critical implementation role. We have a growing number of
regulatory partners worldwide with whom we can pursue more open
dialogue on emerging issues as well as exchange routine information
on scientific review, policy development and enforcement.
Export Certificates Issued--Fiscal
year data:
- In 1996, there were 4,499 export certificates issued.
- In 1997, there were 4,378 export certificates issued.
- In 1998, there were 4,382 export certificates issued.
- In 1999, there were 3,973 export certificates issued.
- In 2000, there were 4,197 export certificates issued.
- In 2001, there were 4,544 export certificates issued.
- In 2002, there were 4,762 export certificates issued.
- In 2003, there were 5,509 export certificates issued.
- In 2004, there were 4,491 export certificates issued.
- In 2005, there were 5,207 export certificates issued.
- In 2006, there were 6,420 export certificates issued.
Notes page information:
Export certificates attest that U.S. drug products are subject to
inspection by FDA and are manufactured in compliance with current
good manufacturing practices. These certificates enable American
manufacturers to export their products to foreign customers and
foreign governments. The demand for certificates remains high due to
expanding world trade, ongoing international harmonization
initiatives and international development agreements.
Public Meetings & Workshops 2006
- 22 Advisory Committee Meetings
- 3 public workshops
- 5 public meetings
- 1 teleconference
- 1 satellite TV broadcast
- 2 forums for international regulators
Communications outreach 2006
- General information inquires:
- ~30,000 phone calls 618 letters
- ~67,000 e-mails
- Trade press: >2,200
- Compliance information requests: >6,400
- Videoconferences: 348
- Contacts with FDA field offices: >1,800
Rx label outreach 2006
- Revised format for prescription drug labeling:
- Teleconference
- “CDER Live” satellite broadcast
- Workshop
Notes page information:
Our 2006 requirement provides that labels for new and recently
approved prescription drugs and new uses be presented in a format
that is better understood, more easily accessible and more memorable
for physicians.
Average Monthly Use of CDER Internet Site--Calendar year data:
- In 1997, there were 30,000 visitors and 500,000 hits.
- In 1998, there were 200,000 visitors and 3 million hits.
- In 1999, there were 200,000 visitors and 3 million hits.
- In 2000, there were 400,000 visitors and 7 million hits.
- In 2001, there were 500,000 visitors and 9 million hits.
- In 2002, there were 800,000 visitors and 14 million hits.
- In 2003, there were 1 million visitors and 17 million hits.
- In 2004, there were 1.4 million visitors and 24 million hits.
- In 2005, there were 1.4 million visitors and 35 million hits.
- In 2006, there were 2.8 million visitors and 53 million hits.
Notes page information:
User sessions on our Web site in 2006 accounted for 43 percent of
the total FDA user sessions, and hits on our Web site accounts for
33 percent of total FDA hits.
Where to find more information
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