We have evaluated a portion of Dr. Balin's work with investigational
drug products and find that he has repeatedly violated the conditions of
our regulations.

We find instances of overstatement of study duration; of data recording
in absence of patient visits; instances where doubt exists concerning
the identification of the product under investigation; and instances of
non-reporting of the occurrence of pregnancies during the course of a
contraceptive study.

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

You should, therefore, review all INDs and NDAS supported by Dr. Balin's
work to determine whether after the presumably unreliable data are re-
moved from consideration, the data remaining are adequate to justify
continuation of clinical trials with products covered by INDs and
adequate to establish the safety and effectiveness of products covered
by NDAS. Please let us have a report of your findings.

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

Should Dr. Balin be reinstated as an investigator éligible to receive
investigational drugs, we will inform you.

We have evaluated a portion of Dr. Balin's work with investigational
drug products and find that he has repeatedly violated the conditions of
our regulations.

We find instances of overstatement of study duration; of data recording
in absence of patient visits; instances where doubt exists concerning
the identification of the product under investigation; and instances of
non-reporting of the occurrence of pregnancies during the course of a
contraceptive study.

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

You should, therefore, review all INDS and NDAs supported by Dr. Balin's
work to determine whether after the presumably unreliable data are re-
moved from consideration, the data remaining are adequate to justify
continuation of clinical trials with products covered by INDS and
adequate to establish the safety and effectiveness of products covered
by NDAS. Please let us have a report of your findings.

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

Sponsors

FICE

Re: Howard Balin, M.D.
1601 Walnut Street
Philadelphia, PA 19102

Gentlemen:

We have evaluated a portion of Dr. Balin's work with investigational
drug products and find that he has repeatedly violated the conditions of
our regulations.

We find instances of overstatement of study duration; of data recording in absence of patient visits; instances where doubt exists concerning the identification of the product under investigation; and instances of hon-reporting of the occurrence of pregnancies during the course of a contraceptive study.

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

You should, therefore, review all INDs and NDAs supported by Dr. Balin's
work to determine whether after the presumably unreliable data are re-
moved from consideration, the data remaining are adequate to justify
continuation of clinical trials with products covered by INDs and
adequate to establish the safety and effectiveness of products covered
by NDAs. Please let us have a report of your findings.

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

Should Dr. Balin be reinstated as an investigator eligible to receive investigational drugs, we will inform you.

Sincerely yours,

Alexander M. Schmidt, M.D.
Commissioner of Food and Drugs

A specimen letter is enclosed for your information.

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

MAR 19 1975

HFA-228

By letter of February 10, 1975, I offered you the opportunity for an
informal hearing in my office if you disputed the Bureau of Drugs'
recommendation that you be found ineligible to receive investigational
use drugs. Not having received a reply to that letter, your office vas
called on March 3, 1975, and Ms. Hoffmann, your administrative secretary,
said that you had received my letter; that you did not think that a
response was necessary; and that you did not desire the proffered informal
hearing.

Therefore, in accord with part 312.1(c) of our regulations, I am informing the following sponsors of your work with investigational drugs that you are no longer eligible to receive such drugs: