The Food and Drug Administration will hold a public hearing on Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox, a carcinogenic new animal drug used in swine feed. The public hearing will be held virtually on March 10, 2022, via Zoom from 1:00 to 5:00 p.m. ET.
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| Greenwood Ice Cream, LLC | Office of Human and Animal Food Operations – East Division 3 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | ||||
| 10 Days Inc d/b/a Pod Juice | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Wadina Distribution LLC dba Gost Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| International Golden Foods Inc | Office of Human and Animal Food Operations East-VI | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | ||||
| Hubei Kangzheng Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| Etomic LLC d/b/a Rogue Liquids | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Tropic Trading Co. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Aroma Imports, Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
U.S. Attorney’s Office
NEWARK, N.J. – A former sales representative today admitted his role in a scheme to defraud New Jersey state health benefits programs, U.S. Attorney Philip R. Sellinger announced.
Scott Shekitka, 42, formerly of Westwood, New Jersey, pleaded guilty by videoconference before U.S. District Judge John Michael Vazquez to an information charging him with conspiracy to commit health care fraud.
According to documents filed in this case and statements made in court:
Compounding is a practice in which a pharmacist or physician combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. The Food and Drug Administration does not approve compounded drugs and thus does not verify the safety, potency, effectiveness, or manufacturing quality of compounded drugs. Generally, a physician may prescribe compounded drugs when an FDA-approved drug does not meet the health needs of a particular patient.
Between June 2014 and February 2016, Shekitka worked as a sales representative for a marketing company that marketed and sold compounded drugs, including pain and scar creams, metabolic supplements and vitamins. Shekitka recruited patients, including family members, who had prescription drug coverage under the New Jersey State Health Benefits Program and the New Jersey School Employee’s Health Benefits Program, to obtain medically unnecessary prescriptions for compounded drugs. Shekitka paid certain patients he recruited to obtain these medically unnecessary prescriptions and directed patients to telemedicine companies that were paid by the marketing company or its affiliates. The prescribing physicians at the telemedicine companies would then write the prescriptions without performing any examination or after deliberately conducting cursory examinations that were insufficient to legitimately deem a compounded drug medically necessary.
The marketing company directed the medically unnecessary prescriptions to certain compounding pharmacies that then paid the marketing company a percentage of the health care benefit reimbursement payments they received for each prescription that Shekitka referred. The marketing company, in turn, paid Shekitka based on the compounded prescriptions he generated.
The conspiracy to commit health care fraud charge carries a maximum penalty of 10 years in prison and a $250,000 fine, or twice the gain or loss from the offense. As part of his plea agreement, Shekitka must forfeit $329,639 in criminal proceeds and pay restitution of at least $1.39 million. Sentencing is scheduled for May 12, 2022.
U.S. Attorney Sellinger credited special agents of the FBI, under the direction of Special Agent in Charge George M. Crouch Jr. in Newark, with the investigation leading to today’s plea.
The government is represented by Assistant U.S. Attorney Adam Baker of the U.S. Attorney’s Office’s Opioid Abuse Prevention and Enforcement Unit in Newark.