Letter Concerning FDA’s Freedom of Information Office
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