Mr. Luther called at 4:07 P.M. He asked me if any decision had been made here with regard to the injunction recommendation we had received from the Buffalo District. I told him it is still under review. He asked me if, in the event that the recommendation is forwarded to the General Counsel, I would call him and let him know that in order that he might appeal against our decision to the General Counsel. I told him I would not call him if the matter is referred to the General Counsel. I said that if he calls me and the matter is out of my hands, i.e., it has been forwarded to the General Counsel, or it has been referred back to the District, I will let him know that it is out of my hands, but not what disposition we have made of it.

I advised Mr. Luther that our press office has advised us that they have heard a story that there are FDA agents all over the Rensselaer plant. I asked if there are any FDA inspectors in the plant today. He said no. He said there was a reporter who called and said he had heard a rumor that FDA was going to close up the Rensselaer facility. He said as a result of that, the firm will have to, because it is news, let the press know what they have been doing, and that report to the press will cover the things that he talked about in his mailgram to the Pirector of the Buffalo District.

Mr. Luther asked me what I thought he could do further to avert the injunction. I said this is something he would have to work out with the Director of the District. I asked him what contacts he had had

with the District since he sent the mailgram. He said none. I suggested that if I were the Executive of the firm dealing with the District, I would be in touch with the Director and I would ask him what further could be done, or what further needed to be done.

CC:

NYK-FO (HFR-21)
BUF-DO (HFR-2200)
HFD-300 R/F

HFD-320 R/F
HFA-226

BTLoftus:zr:1/5/75

Bernard T. Loftus
Director

Division of Drug Manufacturing
Bureau of Drugs

We have evaluated a portion of Dr. Rotstein's work with investigational
drug products and find that he has repeatedly violated the conditions of
our regulations and has submitted to the sponsors of his investigations
false information in required reports.

Specifically, we find instances of identically named individuals reported
to be subjects of more than one study during the same time period with
differences in clinical courses reported to the sponsors. We have been
unsuccessful in our attempts to confirm that reported laboratory data
represent work actually performed. Further, Dr. Rotstein's office
records are generally too scanty to support a conclusion that data
submitted to FDA represent actual studies performed or actual results

obtained.

Therefore, in accord with section 312.1(c) of the New Drug Regulations,
you are notified that Dr. Rotstein is no longer eligible to receive
investigational new drugs. In the absence of validating information,
we cannot consider Dr. Rotstein's work in support of claims of safety
or efficacy of such drugs.

You should, therefore, review all INDs and NDAs supported by Dr. Rotstein's
Work to determine whether, after the presumably unreliable data are removed
from consideration, the data remaining are adequate to justify continuation
of clinical trials with products covered by IRDS and RIDAS. Please let us
have a report of your findings.

You should recall any of your investigational drugs that are in Dr. Rotstein's possession.

CC: ORL-DO NYK-DO

HFA-228 HF-1(2) HFM-1

HFD-1 HFD-2

FDA TRAC NO. 7502485

HFD-100/MJFinkel

HFD-108(2)

Sincerely yours,

AM. Schmidt.

Alexander M. Schmidt, M.D.

HFD-108/ABLisook/10/31/75/12/2/75/ Commissioner of Food and Drugs

I have reviewed the transcript of the Informal Hearing of October 21,
1975, conducted by Dr. John Jennings, At the hearing you were unable
to offer any explanation for the discrepancies found in your study case
reports as exemplified by the cases cfted in Dr. Leventhal's April 15,
1975, letter. In addition, although you have hean afforded ample
opportunity to provide documentation of the laboratory work questioned
in Dr. Leventhal's letter, you have not done so.

Accordingly, there being no information which would mitigate a
determination that you have repeatedly violated the conditions of
Investigational drug regulations, in accord with 21 CFR 312.1(c),
I find you no longer eligible to receive investigational-use drugs.

The sponsors of your work with investigational drugs have been notified
and a specimen letter sent to them is enclosed.

The above complaint was received by YK-DO on 11/17/75. The complainant
Ms. Monserrate Estevez, Director Reg. Pharmacy, Regional Medical Center
Mayaguez, Puerto Rico, reported finding ampoules in the lot of Demerol HCL
without labeling on the glass ampoule, some ampoules were empty or with crystals
outside the ampoule but within the blister pack. The defective ampoules

had been turned over to Ir. Porfirio Gutierrez-Yantin of the Department
of Servicios Contra La Adiccion, Division for Control of Drugs and Harcotics,
Rio Piedras, Puerto Rico, to be picked up by FDA, San Juan. The items were
destroyed by ihr Gutierrez-Yantin according to info provided by San Juan DO.
On 12/1/75 I visited the offices of Winthrop Labs at 90 Park Ave, New York
N.Y 10016/ Credentials were presented and a written Notice of ins; ection
issued to Dr. C.R. Willis, Associate Directors of Drug Regulatory Affairs.
According to Dr Willis the firm had not received this or similar complaints.
The drug is manufactured by Winthrop labs at their plant im Rensselaer, N.Y?
The glass ampoules are received by the firm and are cold printed at Rensselaer.
Dr Willis stated that occasionally the print my be rubbed off during the various
processing steps but that due to the various inspection points he could not
understand why the ampoules were unlabeled or empty. Each ampoule is then blister
packed and this packaging bears complete labeling.

The 00410 lot of the drug was involved in a problem at the firm in that

5 blister packed ampoules of lot 004L0O were fudd packed in a 25 ampoule carton conting of 5strips of 5 ampoules cach all of whoch vre supposed to be Deacrol 50 mg, lot #007L0 . A recall of lot 007Lo was instituted by the firm in 11/75 and is being monitored by FDA Puffalo, H.Y.