CORPUS CHRISTI, Texas – Dr. Mohamad Ayman Ghraowi has entered a guilty plea on behalf of Corpus Christi-based South Texas Comprehensive Cancer Centers PLLC (STCCC) to a violation of the federal Food, Drug and Cosmetic Act (FDCA), announced U.S. Attorney Kenneth Magidson announced.
STCCC was charged with causing the introduction into interstate commerce of misbranded prescription cancer drugs worth more than $900,000, between Feb. 22, 2010, and Jan. 17, 2012. STCCC was a professional association existing under Texas state law with clinics located within the Southern District of Texas, which provided care and treatment for patients with cancer and blood diseases.
In 2012, the Food and Drug Administration (FDA) received information from the United Kingdom Medicines and Healthcare Products Regulatory Agency regarding the appearance of counterfeit versions of the cancer drug Avastin. Regulators determined that some of these counterfeit drugs may have been illegally imported into the U.S. FDA investigators tracked the counterfeit drugs to a distributor offering numerous misbranded foreign drugs for sale to cancer clinics in the U.S. STCCC was determined to be one of the clinics purchasing misbranded foreign drugs from the distributor.
The FDA is responsible for protecting the health and safety of the American public by ensuring, among other things, that drugs are safe and effective for their intended uses and that the drugs bear labeling that contains true and accurate information. FDA's responsibilities include regulating the manufacture and distribution of drugs, including prescription drugs, shipped or received in interstate commerce, as well as the labeling of such drugs. FDA carries out its responsibilities by enforcing the FDCA and other pertinent laws and regulations.
One of the goals of the FDCA has been to ensure the integrity of America's drug supply. Congress determined that the public interest in the purity of prescription drugs and pharmaceutical products distributed to American consumers is so great as to warrant imposition of the highest standard of care on those who distribute those products to the public. Under the FDCA, the responsibility for maintaining the quality and safety of drugs is not placed on the innocent public that purchases drugs but rather on those who sell and distribute drugs. Under the FDCA, consumers have a right to expect that drug distributors will be vigilant and responsible in matters that affect the public health.
While the U.S. wholesale distribution market is highly regulated, many other markets around the world are not. Pharmaceutical distributors who circumvent U.S. law and illegally import foreign pharmaceuticals into the United States put American consumers at risk for receiving counterfeit, misbranded or adulterated drugs.
Following the guilty plea, U.S. Magistrate Judge B. Janice Ellington ordered the corporation to serve five years of probation and forfeit $900,000, an amount equivalent to the purchase price of the misbranded drugs.
The case was investigated by FDA - Office of Criminal Investigations, U.S. Department of Health and Human Services – Office of Inspector General, Defense Criminal Investigative Service and the Texas Attorney General's Office – Medicaid Fraud Control Unit. The case is being prosecuted by Assistant United States Attorney (AUSA) Robert D. Thorpe Jr. and Special AUSA Brittany Jensen.