Inspections, Compliance, Enforcement, and Criminal Investigations
[Federal Register: August 1, 1994]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93N-0349]
Satish R. Shah; Denial of Hearing and Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is denying a hearing
for and is issuing a final order under section 306(a)(2) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 335a(a)(2))
permanently debarring Mr. Satish R. Shah, #28858-037, L.S.C.I.
Allenwood, P.O. Box 1500, White Deer, PA 17887, from providing services
in any capacity to a person that has an approved or pending drug
product application. FDA bases this order on a finding that Mr. Shah
was convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of a drug product and relating to the regulation of a drug
product under the act.
EFFECTIVE DATE: August 1, 1994.
ADDRESSES: Application for termination of debarment to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Tamar S. Nordenberg, Center for Drug
Evaluation and Research (HFD-366), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-2041.
Mr. Satish R. Shah, a former research and development supervisor in
Par Pharmaceutical, Inc.'s (Par), Research and Development Department,
was sentenced on April 30, 1993, for his conviction of, among other
counts, one count of making a false statement to a Federal agency, a
felony offense under 18 U.S.C. 1001. The basis for this conviction was
Mr. Shah's material false statement to FDA regarding the formulation
and the bioequivalency and stability testing of Par's generic drug
product Triamterene 75 milligram (mg)/Hydrochlorothiazide 50 mg
In a certified letter received by Mr. Shah on October 22, 1993, the
Deputy Commissioner for Operations offered Mr. Shah an opportunity for
a hearing on the agency's proposal to issue an order under section
306(a) of the act permanently debarring Mr. Shah from providing
services in any capacity to a person that has an approved or pending
drug product application. The proposal was based on a finding, under
section 306(a) of the act, that Mr. Shah was convicted of a felony
under Federal law for conduct relating to the development, approval,
and regulation of a drug product.
The certified letter informed Mr. Shah that his request for a
hearing could not rest upon mere allegations or denials but must
present specific facts showing that there was a genuine and substantial
issue of fact requiring a hearing. The letter also notified Mr. Shah
that if it conclusively appeared from the face of the information and
factual analyses in Mr. Shah's request for a hearing that there was no
genuine and substantial issue of fact, FDA would enter summary judgment
against him, making findings and conclusions, and denying his request
for a hearing.
Mr Shah requested a hearing in a letter dated November 23, 1993.
However, Mr. Shah has not submitted any information or analyses to
justify a hearing. Mr. Shah's failure to raise any issues of fact, and
his failure to submit information or analyses in support of his hearing
request, constitute a waiver of his opportunity for a hearing and a
waiver of any contentions concerning his debarment (21 CFR 12.22).
II. Denial of Hearing
Because he failed to present any arguments or information to show
why he should not be debarred, FDA finds that Mr. Shah has failed to
identify any genuine and substantial issue of fact requiring a hearing.
Accordingly, pursuant to 21 CFR 12.28, the agency denies Mr. Shah's
request for a hearing.
III. Findings and Order
Therefore, the Acting Deputy Commissioner for Operations, under
section 306(a) of the act and under authority delegated to her (21 CFR
5.20), finds that Mr. Satish R. Shah has been convicted of a felony
under Federal law for conduct: (1) Relating to the development or
approval, including the process for development or approval, of a drug
product (21 U.S.C. 335a(a)(2)(A)); and (2) relating to the regulation
of a drug product (21 U.S.C. 335a(a)(2)(B)). Specifically, Mr. Shah's
felony conviction under 18 U.S.C. 1001 was for making a false statement
to FDA by submitting false pilot batch records for a drug product.
Pilot batch records are used by FDA in its determination of whether to
approve a generic drug product based, among other things, on
bioequivalence with its name brand counterpart. Because a showing of
bioequivalence is a prerequisite to drug approval, the actions for
which Mr. Shah was convicted affected the drug approval process.
As a result of the foregoing findings, Mr. Satish R. Shah is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application under
sections 505, 507, 512, or 802 of the act (21 U.S.C. 355, 357, 360b, or
382), or under section 351 of the Public Health Service Act (42 U.S.C.
262), effective (insert date of publication in the Federal Register)
(21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 321(ee)). Any
person with an approved or pending drug product application who
knowingly uses the services of Mr. Shah, in any capacity, during his
period of debarment, will be subject to civil money penalties. If Mr.
Shah, during his period of debarment, provides services in any capacity
to a person with an approved or pending drug product application, he
will be subject to civil money penalties. In addition, FDA will not
accept or review any abbreviated new drug applications submitted by or
with the assistance of Mr. Shah during his period of debarment.
Any application by Mr. Shah for termination of debarment under
section 306(d)(4) of the act should be identified with Docket No. 93N-
0349 and sent to the Dockets Management Branch (address above). All
such submissions are to be filed in four copies. The public
availability of information in these submissions is governed by 21 CFR
10.20(j). Publicly available submissions may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: July 18, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-18624 Filed 7-29-94; 8:45 am]
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