• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

08/01/1994

[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.

 

ACTION: Notice.

 

-----------------------------------------------------------------------

 

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.

 

SUPPLEMENTARY INFORMATION:

 

I. Background

    

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

tablets.

 

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]

BILLING CODE 4160-01-F