US Department of Justice (DOJ) officials indicted 11 people on 17 different charges related to the illegal importation and distribution of non-Food and Drug Administration (FDA)-approved drugs into the US. These individuals operated or worked for Gallant Pharma International Inc., an entity with headquarters in Virginia that represented itself as a Canadian company and “told potential customers that it sold drugs from Canada,” indicates a DOJ news release. The company allegedly imported drugs from India, Turkey, and Switzerland and mislabeled the contents of the packages to lessen scrutiny by US Customs and Border Protection, explains DOJ. The DOJ indictment indicates that the company was not licensed to distribute drugs in the US; however, it allegedly sold drugs to doctors, hospitals, and medical offices throughout the country. The scheme began in August 2009 and netted more than $8.6 million over three years. Of the 11 indicted, seven were arrested.
FDA advises that health care providers should purchase prescription drugs either directly from the manufacturer or from wholesale drug distributors licensed in the US and provides a list of state agencies for assistance in verifying licensure. Another way that pharmacies can be assured of the legitimacy of a wholesale distributor is to look for NABP’s Verified-Accredited Wholesale Distributors® (VAWD®) Seal. Those wholesale distributors that achieve VAWD accreditation are in compliance with state and federal laws and NABP's VAWD criteria. Wholesale distributers that display the VAWD Seal as part of their accreditation have undergone a criteria compliance review, including a rigorous review of their operating policies and procedures, licensure verification, survey of facility and operations, background checks, and screening through the NABP Clearinghouse. Accredited facilities are reviewed annually and undergo an on-site survey every three years. Created in 2004, the accreditation program plays a pivotal role in preventing counterfeit drugs from entering the US drug supply.
quoted from NABP
1 comment:
The physicians who bought drugs from this illegal outfit were not "duped". No, they were willing accomplices to this racketeering organization just because they wanted better profit margins on the Botox, Juvederm, and Chemotherapy they injected into their patients. They knew (or should have known) that this outfit was not licensed to do business in the United States. Their "willing disregard of" the laws and rules of the U.S and State government makes them culpable as well.
What does the Florida Department of Health donwhen complaints are filed against physicians (including one acupuncturist who has nomlegal right to purchase these drugs nor inject them into patients)? Nothing other than to whitewash the complaints by saint "probable cause was not found" - even though they have a letter from the FDA to these licensees saying, "we have records proving you obtained these contraband drugs illegally; do not administer them to your patients"
Crazy!
Kenneth Woliner, MD
www.holisticfamilymed.com
Post a Comment