Mr. Kasperson said that Abbott could go off the market for a month,
but if they do that, it would create a serious medical problem in
the hospitals. I said that option does not have to be considered,
and that Abbott can replace the ampules in the field. He said no,
that puts Abbott in a product liability suit situation which he
cannot endorse, and Abbott's doctors cannot endorse the idea of
non-sterile ampules going into the operating room. He said the
hospitals would have to sterilize the ampules on the outside by
wrapping and putting them through a sterilizer. Then they would
have to unwrap it in the operating room, and the dirty nurse would
do it. They are not at all satisfied with that type of a situation.

He said that Abbott will have all the replacement stocks of the other kit components in about one month, and at that time will be willing to "eat" about two and one half to three month's supply, but they can not see how they can recall now because of the medical need, and they do not now wish to agree to replacement of the drug components at the hospitals.

Following discussion of the problem among Mr. Kous tenis, Mr. Katz, Mr. Bryant, and Mr. Loftus, Mr. Kous tenis and Mr. Loftus telephoned Mr. Owen Lamb in the Chicago District. Mr. Lamb said that he had received a tlephone call from Mr. Kasperson. We exchanged information. One of the points Mr. Lamb brought out was that Mr. Kasperson would not recall or do the replacements in the field unless he received a written order or communication of some sort from FDA. took the position that Mr. Lamb should call Mr. Kasperson and tell him that we cannot accept his argument that the sterilization of the replacement material was more of a risk than the use of the Sterling drug, when it is known that there is a possibility the Sterling drug in the kit may not be sterile.

I

Mr. Lamb reported back that Mr. Kasperson would not effect the recall unless it were an FDA initiated recall. Accordingly, it was agreed between us that the Chicago District would submit a recommendation for an FDA initiated recall of the Abbott Kits with the assurance that HFD-320 would concur and submit the recommendation to the Associate Commissioner for Compliance with a recommendation for approval.

This is in reply to your two letters of December 18 and 29, 1975, in
which you promised correction of CHP problems at Sterling's Rensselaer,
New York, facilities.

FDA staff candidly told representatives of your company on November 21,
1975, that there was an injunction recommendation before me and that
in it the District urged a plant closedown pending corrections. Since
that date, your representatives and ours have been in continual contact
with a view to resolution of Sterling's CMP problems as quickly as
possible in the interest of the public health.

We reinspected the plant on January 19-23, 1976, to audit the perfor-
mance of commitments made by you in your letters, and of commitments
made subsequently by your staff. My review of the report of that
inspection has been completed.

I have concluded that Sterling has substantially complied with both
your personal commitments and those of your staff. There have been
massive improvements.

I believe that since January 23, 1976, the Rensselaer facility has
operated in essential compliance with the Current Good Manufacturing
Practice Regulations. You should not, however, conclude that this degree
of compliance is all that Sterling needs to accomplish. Frankly, I
au still concerned about the firm, and I have instructed the Deputy
Regional Director in FDA a Buffalo District to maintain strict surveil-
lance to assure that there is no backsliding.

There is no way that FDA's investigators can--or should--operate as
consultants to drug manufacturers. We are never antisfied that manufac-
turers correct only what we point out to then. We cannot see everything
during inspections. Every manufacturer must assure himself that his
control systers are all working, and working well at all times. I ask
that you personally assure yourself that all of your control systems
neet FDA's CMP regulations.

I have been kept continually advised of developments in this matter, and I intend to remain personally appraised of FDA's efforts to assure the quality of drugs that come out of Rensselaer. I have abated the injunction recommendation because I believe FDA has received, throughTM your personal intervention in this matter, as much compliance to this date as we might have obtained through a court order. A further reason for my decision was your voluntary/recall of certain products and your agreement to effect corrections as suggested by our staff.

I am still concerned lest our succeeding inspections unearth more major problems. I ask that you maintain vigilance that this does not happen.

I am writing this letter at the suggestion of your local liaison person to apprise you of a very serious situation confronting our hospital.

The problem centers around Winthrop Laboratories, 90 Park Avenue, New York, 10016, and their inability to supply us with certain drugs, It has been difficult for me to ascertain the facts in this dilemma. However, it appears to be the clash between the company and the FDA relating to Current Good Manufacturing Practices.

Those of us in hospital pharmacy are accustomed to drug shortages developing from time to time as the FDA institutes product recalls for various reasons. The reason we are so concerned now is the fact that some of these items we are unable to obtain are life-saving and inthrop is the sole source of supply. One example is Levonhed, a potent vasopressor which is a life-saving drug in shock. Another is Seo Synephrine Injection, essential in many types of operations, including open heart surgery.

-

We believe the drugs that are in short supply as a result of the FDA's actions should be produced by Winthrop with as much speed as possible in their facility as it now exists. We also feel the FDA has a responsibility to the health care needs of the people and should expedite this phase of production and distribution. these needs are met, they can work out their differences.

When

render in

We would certainly appreciate any assistance you can this most difficult situation. If you need further information, please call me or call our Chief of Anesthesiology, Dr. Truett Guffin.

WS/h1

Thank you.

Sincerely,

༧་༥ ་མཐོང

Wayne Smith, Director
Pharmacy Services