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Letter Concerning FDA's Freedom of Information Office

May 1, 2001

Janet Woodcock, M.D.
Director, Center for Drug Evaluation and Research (CDER)
Food and Drug Administration
5600 Fishers Lane
Rockville MD, 20857  

Dear Dr. Woodcock:

One of our major functions at Public Citizen's Health Research Group is to monitor new drug approvals, analyze the data, and pass along this information to our members and subscribers as well as the public in general. We also monitor approved drugs that may become of interest because of adverse effects or a new indication for use. The major sources of our information are the FDA's web site and the Freedom of Information (FOI) Office which we rely upon to provide us with letters, memos, labels, drug reviews, and advisory committee transcripts.

Our success in obtaining this material has been steadily declining: the FOI office has become increasingly unresponsive to our requests and the CDER New and Generic Drug Approvals web site has been months to years behind in posting reviews. In fact, of the 27 new molecular entities approved in the year 2000[1], only one (Lotronex) had a review posted on the FDA web site[2] as of April 3, 2001.

In order to further quantify the problem, we have looked at the FDA web site postings, as of that April 3 date, and quantitated some of the missing elements. We have also tabulated responses to our own FOI requests as well as looking at the total number of drugs with NDAs and supplemental NDAs for the period 1998-2001 that had documents posted on the FDA web site. We analyzed the letters A-H (as a random sample of the whole) and tabulated the percentages that had a letter, label, and reviews posted (see Table 1).

Table 1. CDER New and Generic Drug Approvals (1998-2001;A-H)[3]

 

Letter Not Posted 

Label Not Posted 

Reviews Not Posted 

NDAs* (A-H)

19/116 (16%)

27/116 (23%)

84/116 (72%)

sNDAs** (A-H)

29/107 (27%)

62/107 (58%)

62/107 (58%)

  *New Drug Approvals
**Supplemental New Drug Approvals (new indications or formulations)

We also tabulated a non-random sample of 25 specific drugs approved between 1998 and 2001 that are lacking posted reviews and that are of special interest because they are either widely prescribed, promoted in direct-to-consumer advertising, or otherwise the focus of public attention. Appendix 1 illustrates that for these drugs, approval letters, labels, and reviews are often not present. In fact, not a single review was posted for this group of drugs, an inexcusable omission since by definition the review is completed well before the approval letter and label.

Not only are reviews (and sometimes labels and letters) missing but long periods of time may elapse between posting the different elements of the table. For example, the time between the approval date and the approval letter for Tamiflu was two months; for Singulair, seven months. Long periods can also elapse between posting the letter and the label: examples include Singulair (three months) and Tasmar (five months). We do not understand why all reviews are not posted promptly on the CDER web site: this would lighten the burden on the FOI office and provide the early availability of information that is needed by the public. Indeed, the whole purpose of the Electronic Freedom of Information Act Amendments of 1996 was to make these important documents available.

The public access that is expected through the FOI act is not occurring with the long times between requests and responses: we have been waiting for over a year for the Approval Package for Protonix and for more than 8 months for those for Glucovance and Vaniqa (Appendix 2). At a teleconference between Public Citizen and Dr. Woodcock in the spring of 1999, we were told that we should expect a reply to our FOI requests within two or three weeks. Clearly, this has not happened and response times have actually been increasing. Public Citizen looks forward to a prompt reply to the issues raised in this letter.

Sincerely, 

Elizabeth Barbehenn, Ph.D.
Research Analyst 

Peter Lurie, M.D.
Deputy Director 

Sidney M. Wolfe, M.D.
Director
Public Citizen's Health Research Group

cc: Bernard Schwetz, Ph.D., D.V.M.
Jane A. Axelrad, M.D.

ENDNOTES

[1] http://www.fda.gov/rdmt/nmecy2000.htm

[2] http://www.fda.gov/cder/approval

[3] http://www.fda.gov/cder/approval


Appendix 1.

A sampling of important approved drugs (1998-2001) (lacking letter, label, and/or reviews on the FDA web site) [3]

DRUG NAME

APPROVAL DATE

APPROVAL LETTER POSTED

LABEL POSTED

REVIEW POSTED

Actonel (Supp 1-4)

4/14/00

4/24/00

Missing

Missing

Allegra (fexofenadine hydrochloride) Tablets, 30, 60, and 180 mg.

2/25/00

2/29/00

2/29/00

Missing

Allegra/pseudoephedrine (fexofenadine 60 mg/pseudoephedrine 120 mg) Extended Release Tablets

2/25/00

Missing

Missing

Missing

Arava (leflunomide) Tablets, 10 mg, 20 mg, and 100 mg

9/10/98

9/17/98

9/17/98

Missing

Comtan (entacapone) Tablets, 200 mg

10/19/99

12/30/99

12/30/99

Missing

Detrol LA Capsules, 2 and 4 mg extended release

12/22/00

1/9/01

1/9/01

Missing

Exelon (rivastigmine tartrate) Capsules, 1.5, 3 mg, 4.5, & 6 mg.

4/21/00

4/24/00

Missing

Missing

Fosamax S-021, S022 (35 and 70 mg)

10/20/00

10/30/00

Missing

Missing

Glucophage XR (metformin HC1 extended-release) Tablets 500, 850, & 1000 mg

10/13/00

10/20/00

10/20/00

Missing

Glucovance (glyburide and metformin) Tablet

7/31/00

8/4/00

8/4/00

Missing

Meridia (sibutramine hydrochloride monohydrate) Capsule

2/16/01

Missing

Missing

Missing

Nexium (esomeprazole magnesium) Delayed-Release Capsules, Rx

2/20/01

Missing

Missing

Missing

Nolvadex (tamoxifen citrate) /S046

6/29/00

7/14/00

7/6/00

Missing

Protonix (pantoprazole sodium) Delayed-Release Tablets

2/2/00

2/3/00

2/7/00

Missing

Reminyl (galantamine hydrobromide) Tablets

Missing

Missing

Missing

Missing

Singulair (Montelukast Sodium) Tablets, 10 mg

2/20/98

9/10/98

12/8/98

Missing

Solaraze (diclofenac sodium) Gel

10/16/00

10/20/00

10/20/00

Missing

Starlix (nateglinide) Oral Tablets, 60 and 120 mg.

12/22/00

1/9/01

1/9/01

Missing

Tamiflu (oseltamivir phosphate) Oral Suspension

12/14/00

12/15/00

12/14/00

Missing

Tamiflu (oseltamivir phosphate) 75 mg Capsule

10/27/99

12/30/99

12/30/99

Missing

Tikosyn (dofetilide) Capsules

10/4/99

10/4/99

Missing

Missing

Trileptal (oxcarbazepine) Tablets

1/10/99

1/19/00

1/19/00

Missing

Tri-Nasal (triamcinolone acetonide), Nasal Spray

2/4/00

2/4/00

2/14/00

Missing

Vaniqa (eflornithine hydrochlorine) Cream

7/27/00

8/3/00

8/3/00

Missing

Ziprasidone HCI Oral Capsules

2/5/01

2/12/01

2/12/01

Missing

Zoloft (sertraline hydrochloride) Oral concentrate,  20 mg/ml

12/7/99

12/28/99

12/28/99

Missing

Appendix 2.

Response Times to Public Citizen Information Requests

DRUG 

REQUEST DATE 

RECEIVED DATE 

NO. OF MONTHS UNTIL RECEIPT 

Prevacid SBA#

1/6/00

8/4/00

7

Prilosec SBA

1/31/00

3/7/00

1

Cisapride deaths

2/22/00

3/31/00

1

Risedronate SBA

3/13/00

3/15/00

 

Prevacid AC##

3/15/00

10/24/00

7

Prilosec AC

3/15/00

6/20/00

3

Protonix SBA

4/3/00

Not received (>13 months)

 

Lotronex SBA

4/7/00

6/14/00

2

Tikosyn SBA

4/10/00

6/15/00

2

Lotronex AEs

7/18/00

8/1/00

0.5

Glucovance SBA

8/7/00

Not received (>8 months)

 

Vaniqa SBA

8/28/00

Not received (>8 months)

 

Exelon SBA

9/15/00

Not received (>7 months)

 

Actonel supplements

10/31/00

Not received (>6 months)

 

Aricept SBA

12/5/00

Not received (>4 months)

 

Glitazone memos

1/25/01

Not received (>3 months)

 

#Summary Basis of Approval
##Advisory Committee

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