Day: August 24, 2013

Seven oncologists charged with importing unapproved Drugs

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FOR IMMEDIATE RELEASE

Aug. 13, 2013

Seven Ohio oncologists were charged with importing cancer medications that had not been approved by the Food and Drug Administration, said Steven M. Dettelbach, United States Attorney for the Northern District of Ohio.

The doctors were charged with causing the shipment of misbranded drugs, a misdemeanor violation of the Food, Drug and Cosmetic Act. Their names, ages and the city where they practiced medicine are:

  1. Ranjan Bhandari, 56, Liverpool.
  2. Timmappa Bidari, 68, Parma.
  3. David Fishman, 62, Euclid.
  4. Su-Chiao Kuo, 60, Brunswick.
  5. Marwan Massouh, 54, Westlake.
  6. Poornanand Palaparty, 62, Cleveland.
  7. Hassan Tahsildar, 55, Euclid.

“These doctors used drugs that had not been approved by the FDA,” Dettelbach said. “Our office is committed to working with our partners to make sure patients are getting medicine that has been properly inspected.”

“FDA’s regulatory standards are designed to ensure the safety and quality of the medical devices and drugs distributed to American consumers,” said Antoinette V. Henry, Special Agent in Charge, FDA’s Office of Criminal Investigations. “We will continue to work to investigate all persons, including medical professionals, who disregard regulatory requirements and jeopardize the public health by participating in the distribution of misbranded products.”

The doctors are accused of obtaining drugs, including Zometa, Kytril, Taxotere, Gemzar, Eloxatin and others, from outside the United States, where the drugs were not approved by the FDA, according to the charges.

A drug may be considered misbranded even if it is identical in composition to an FDA-approved drug (that is, a drug labeled and packaged in compliance with the FDA’s standards) and even if it was made by the same manufacturer in the same facility as the FDA-approved version.

If convicted, the doctors face up to one year in prison and fines up to $100,000. Their sentences will be determined by the court after reviewing factors unique to this case, including the defendant’s prior criminal record, if any, the defendant’s role in the offense and the characteristics of the violation.  In all cases the sentence will not exceed the statutory maximum and in most cases it will be less than the maximum.

These cases are being prosecuted by Assistant U.S. Attorney Michael L. Collyer following investigations by the FDA – Office of Criminal Investigations and the Department of Health and Human Services – Office of Inspector General.

Anyone suspecting health care fraud, waste or abuse can report it by calling the U.S. Department of Health and Human Services, Office of Inspector General at 800-447-8477.  To learn more about health care fraud prevention and enforcement go to http://www.stopmedicarefraud.gov

A charge is not evidence of guilt. The defendants are entitled to a fair trial in which it will be the government’s burden to prove guilt beyond a reasonable doubt.

Eleven Charged In Alleged Illegal Pharmacological Import

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FOR IMMEDIATE RELEASE

August 7, 2013

ALEXANDRIA, Va. – Seven arrests have been made in a coordinated operation spanning several states, related to the unsealing of a 17-count indictment and criminal complaint involving Gallant Pharma International Inc., an allegedly unlicensed company that is accused of distributing misbranded prescription drugs from its headquarters in Crystal City, Virginia, and an office in Springfield, Virginia. The individuals arrested were:

  • Syed “Farhan” Huda, 38, of Arlington, Virginia;
  • Deeba Mallick, 36, of Arlington, Virginia;
  • Anoushirvan R. Sarraf, 47, of Rockville, Maryland;
  • Talib Khan, 42, of Montreal, Canada, and Barbados;
  • Harvey Whitehead, 67, of Troy, Michigan;
  • Lisa Coroniti, 46, of Devon, Pennsylvania; and
  • Robert J. Sparks, 30, of Springfield, Virginia.

Munajj Rochelle, 36, a dual U.S.-Canadian citizen, is currently incarcerated in Montreal, Canada, on unrelated charges. Arrest warrants have been issued for the remaining three defendants, Robert Wachna of Ottawa, Canada, Mirwaiss Aminzada, 43, of Montreal, Canada.

Neil H. MacBride, United States Attorney for the Eastern District of Virginia, Antoinette V. Henry, Special Agent in Charge, FDA’s Office of Criminal Investigations, Gary Barksdale, Inspector in Charge of the Washington Division of the United States Postal Inspection Service, and Special Agent in Charge John P. Torres, U.S. Immigration and Customs Enforcement (ICE), Homeland Security Investigations (HSI) Washington, made the announcement after the four defendants arrested in the Eastern District of Virginia – Huda, Mallick, Sarraf, and Sparks – made their initial appearances before Judge John F. Anderson.

According to the 17-count indictment unsealed today, Khan and Huda were principals of Gallant Pharma, which allegedly began illegally importing prescription drugs, including intravenous chemotherapy drugs and injectable cosmetics, into the United States in or around August 2009. Gallant Pharma represented itself as a “Canadian company” and told potential customers that it sold drugs from Canada. The indictment alleges, however, that Khan, with the assistance of Huda, Mallick, Aminzada, and others, acquired drugs from other parts of the world, including India, Switzerland, and Turkey. These drugs were allegedly not manufactured and packaged in accordance with FDA requirements and, in some cases, were not approved by the FDA for use in the United States. The indictment states that Gallant Pharma imported the drugs with the assistance of co-conspirators in Canada and the United Kingdom, including Aminzada, who broke large shipments into many small packages, mislabeled the contents of packages, and addressed deliveries to Dr. Sarraf at his medical practice in McLean, Virginia, in order to lessen scrutiny by Customs and Border Protection. Initially, Gallant Pharma allegedly operated out of the apartment of Huda and his wife, Mallick, in Crystal City, where Huda is alleged to have served as the day-to-day head of Gallant Pharma in the United States and Mallick had primary responsibility for processing sales invoices and customer payments. Until June 2013, Gallant Pharma allegedly stored the misbranded drugs at an office in Springfield, Virginia.

According to the indictment, Gallant Pharma was not licensed to distribute prescription drugs in the United States. Nonetheless, Gallant Pharma is alleged to have sold drugs to doctors, hospitals, and medical practices across the United States, generating more than $8.6 million in revenue since August 2009.

Gallant Pharma allegedly employed a cadre of sales representatives with dedicated sales territories across the United States.

The defendants are charged with the following offenses: conspiracy to commit importation fraud, introduction of misbranded drugs into interstate commerce, unlicensed medical wholesaling, wire fraud, and to defraud the FDA, each of which is punishable by a maximum term of imprisonment of five years; importation contrary to law, which is punishable by a maximum term of imprisonment of twenty years; introduction of misbranded drugs into interstate commerce, which is punishable by a maximum term of imprisonment of three years; unlicensed medical wholesaling, which is punishable by a maximum term of imprisonment of three years; wire fraud, which is punishable by a maximum term of imprisonment of twenty years; and monetary transactions with criminally derived proceeds, which is punishable by a maximum term of imprisonment of ten years.

The investigation was conducted by FDA Office of Criminal Investigations, Drug Enforcement Agency Group 33 Diversion Task Force, Department of Homeland Security Office of Immigration and Customs Enforcement, the United States Postal Inspection Service, with assistance from the Arlington County Police Department. Assistant United States Attorneys Lindsay A. Kelly, Alexander T.H. Nguyen, and Ryan K. Dickey are prosecuting the case on behalf of the United States.

Criminal indictments are only charges and not evidence of guilt. A defendant is presumed to be innocent until and unless proven guilty.

A copy of this press release may be found on the website of the United States Attorney’s Office for the Eastern District of Virginia at
http://www.justice.gov/usao/vae.
Related court documents and information may be found on the website of the District Court for the Eastern District of Virginia at
http://www.vaed.uscourts.gov or on
https://pcl.uscourts.gov