Three California men and a Minnesota company were charged in an indictment today in the Southern District of Ohio for their roles in a massive prescription drug diversion scheme.
The indictment alleges that David Jess Miller, 50, of Santa Ana, California; Artur Stepanyan, 38, and Mihran Stepanyan, 29, both of Encino, California, and Minnesota Independent Cooperative Inc. (MIC) engaged in a conspiracy to sell prescription drugs from illegal, unlicensed sources to wholesalers and pharmacies throughout the United States. The 12-count indictment charges the defendants with conspiracy to commit mail and wire fraud, multiple counts of mail fraud, and conspiracy to distribute prescription drugs without a license and to make false statements.
Principal Deputy Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division, U.S. Attorney Carter M. Stewart of the Southern District of Ohio, Director George M. Karavetsos of the U.S. Food and Drug Administration (FDA)’s Office of Criminal Investigations and Assistant Inspector in Charge Christopher White of the U.S. Postal Inspection Service (USPIS) announced the charges.
According to the indictment, from 2007 through April 2014, David Miller and his company, MIC, of Eagan, Minnesota, purchased prescription drugs from a network of illegal and unlicensed sources in New York, Florida and California. Artur Stepanyan and Mihran Stepanyan, worked together to sell drugs from illegal sources to Miller and MIC. Artur and Mihran Stepanyan, using a variety of company names, including Panda Capital Group, Red Rock Capital Group, Trans Atlantic Capital Group and GC National Wholesale, were Miller’s largest source of illegal drugs. During the course of the conspiracy, Miller and MIC paid the Stepanyans approximately $160 million for these prescription drugs.
“American consumers should be able to rely on the prescription drug supply chain,” said Principal Deputy Assistant Attorney General Mizer. “Prescription drug diversion schemes like the one charged in this indictment undermine that supply chain and increase the risk that counterfeit, adulterated, misbranded, sub-potent or expired drugs will be sold to patients and consumers.”
To hide the true, illegal sources of their prescription drugs, David Miller and MIC falsified so-called drug pedigree documents. Pedigrees are documents required by law that show the source of drugs. For most of the conspiracy, the fraudulent pedigrees falsely listed B&Y Wholesale, a company located in Puerto Rico and co-owned by co-conspirator Yusef Yassin Gomez (Yassin) as the source of the drugs. The pedigree documents also falsely stated that Yassin’s company was an authorized distributor of the drugs. On Feb. 19, 2014, Yassin pleaded guilty in U.S. District Court for the Southern District of Ohio to conspiracy to engage in the wholesale distribution of prescription drugs without a wholesale license. In connection with his guilty plea, Yassin admitted the he agreed to allow Miller and MIC to use his company’s name on pedigree documents to hide the true drug sources. In exchange, Miller and MIC paid Yassin a commission on all of the drug sales.
“Once a prescription drug is diverted outside of the regulated distribution channels, it becomes difficult, if not impossible, for regulators, law enforcement and end-users to know whether the prescription drug package actually contains the correct drug or the correct dose,” said U.S. Attorney Stewart. “We will aggressively prosecute individuals and companies that ignore the law and sell illegally diverted prescription drugs to pharmacies, and ultimately, to American consumers.
“We are committed to protecting the integrity of the pharmaceutical supply chain, especially as criminals go to more extreme measures to subvert it,” said FDA’s Office of Criminal Investigations Director Karavetsos. “We will continue to pursue these criminals and work to bring them to justice.”
“The Postal Inspection Service is proud to partner with the FDA Office of Criminal Investigations to bring to bear our mail fraud expertise to help the fight against drug diversion,” said USPIS Assistant Inspector in Charge White.
Throughout the course of the conspiracy charged in the indictment, using these fraudulent pedigree documents, Miller and MIC sold approximately $393 million worth of prescription drugs to wholesalers and retail pharmacies throughout the United States, including to multiple customers in the Southern District of Ohio.
In addition to Yassin, two of Miller’s other illegal drug suppliers, Peter Kats and Joseph Dallal, previously pleaded guilty to conspiracy to commit mail and wire fraud for their sales of illegally-diverted prescription drugs to Miller and MIC.
This matter is being investigated by the FDA and USPIS. Assistant U.S. Attorneys Anne L. Porter and Christy Muncy of the Southern District of Ohio and Trial Attorney John W. Burke of the Civil Division’s Consumer Protection Branch are prosecuting this case.
David Miller, Artur Stepanyan, and Mihran Stepanyan were charged amongst 30 other individuals in the Northern District of California in a separate indictment on charges including federal Racketeer Influenced and Corrupt Organizations (RICO) Act; conspiracy to commit identity theft; conspiracy to commit access device fraud; conspiracy to commit mail, wire, and bank fraud; money laundering conspiracy; and conspiracy to distribute prescription drugs without a wholesale license.
This information is according to the Department Of Justice website.
The charges in the indictment are merely allegations, and do not constitute proof of guilt. Every defendant is presumed to be innocent unless and until proven guilty.
Showing posts with label dangerous drugs. Show all posts
Showing posts with label dangerous drugs. Show all posts
Sunday, May 10, 2015
Monday, March 16, 2015
Pharmaceutical Companies Contradicting Official Safety Warnings
According to The Washington Post The Food and Drug Administration is proposing to allow pharmaceutical companies to contradict official safety warnings in sales presentations to customers.
Though an FDA warning can scare off buyers, the new proposal would allow drugmakers to present customers with information that undermines official warnings as long as it comes from a peer-reviewed journal article.
The proposal is supported by the manufacturers, who argue the policy would allow them to give doctors and hospitals the benefits of the latest research.
But the proposal is drawing criticism from public-health advocates, who argue that because individual studies can differ widely in their results, a drug company could easily mislead customers - and possibly endanger patients - by presenting only a selection of new research.
The proposal "seriously undermines FDA authority," Sidney Wolfe, founder of Public Citizen's Health Research Group, wrote the agency. "Its main supporters are drug companies and their associations, all of which would benefit from being allowed and encouraged to sell more drugs by making them seem safer than FDA has judged them to be."
Under the proposal, the FDA would not "object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling." Studies must be "well-designed" and "at least as informative as the data sources" the FDA used in generating the official warning.
For example, a drugmaker could present evidence that the severity or frequency of a side effect is less than that suggested by the FDA-approved label. Or it could question whether the drug causes the side effect at all.
Exactly what drugmakers can tell customers has been the subject of regulation and sometimes - when the side effect has led to heart attacks, cancer, or suicide - billion-dollar penalties. But the industry has pushed back in recent years, arguing that under First Amendment, the government cannot curtail their right to disseminate information.
The proposal seems bound to increase drug sales because it is explicitly geared toward undermining the FDA warnings, rather than enhancing them, critics said. The proposal allows the dissemination of information that "rebuts or mitigates" the risk identified by the FDA, or information that "refines" the risk as long as it "does not indicate greater seriousness of the risk."
In a letter to the FDA, the pharmaceutical industry's chief lobbying group, PhRMA, said that while the agency has an "important role in evaluating the safety and efficacy of new medicines . . . we also must recognize the critical need for health-care professionals to receive the most current, accurate and comprehensive scientific information."
"The Constitution's protection of an open and robust exchange of ideas . . . limits FDA's ability to regulate scientific communication," according to the letter signed by PhRMA vice president Jeffrey K. Francer. "PhRMA respectfully submits that FDA should give additional consideration to these First Amendment limitations in issuing final guidance."
Wednesday, March 11, 2015
Specialty Compounding Distributing Adulterated Drugs!
The U.S. District Court for the Western District of Texas entered a consent decree of permanent injunction against Specialty Compounding LLC, Raymond L. Solano III and William L. Swail to prevent the distribution of adulterated and misbranded drugs, the Department of Justice announced today.
The department filed a complaint in the U.S. District Court for the Western District of Texas on Feb. 23, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, Specialty Compounding manufactured both sterile and non-sterile drugs at a facility in Cedar Park, Texas, and distributed the company’s drugs to hospitals, surgery centers and health clinics in Texas and throughout the United States. As noted in the complaint, Solano is Specialty Compounding’s pharmacist-in-charge and co-owner, and Swail is Specialty Compounding’s Managing Partner and co-owner.
The complaint alleges that Specialty Compounding manufactured a sterile injectable drug product that tested positive for bacterial growth. In addition, according to the complaint, in August 2013, FDA received reports from two Texas hospitals that 17 patients had developed bacterial infections caused by Rhodococcus equi after receiving infusions of calcium gluconate manufactured by Specialty Compounding. Specialty Compounding ceased sterile drug manufacturing operations in August 2013, and recalled all lots of its unexpired sterile drug products distributed since Feb. 1, 2013.
“Specialty Compounding’s manufacturing practices posed a serious risk to the public health,” said Acting Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division.
“The American public needs to have the confidence that pharmaceutical drugs on the market are safe and effective.”
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a permanent injunction. As part of the settlement, the company and its owners have committed to implementing corrective actions before resuming production of sterile drugs. Specifically, the injunction prohibits Specialty Compounding and its owners from manufacturing, holding or distributing sterile drugs until they comply with the federal Food, Drug, and Cosmetic Act and its regulations. The permanent injunction also provides the defendants cannot resume distribution of sterile drug products until they receive written approval from the FDA that they are in compliance with the remedial provisions of the permanent injunction.
As described in the complaint, the FDA inspected Specialty Compounding’s Cedar Park facility in August and September 2013, and found insanitary conditions and numerous violations of the current good manufacturing practice requirements for drug products. Among other observations, the FDA found that the company was distributing some of their drugs without receiving a valid prescription for an identified individual patient and was introducing into interstate commerce unapproved new drugs and misbranded drugs. In addition, as alleged in the complaint, analyses of samples of a drug product collected by the FDA found bacterial contamination in one of the company’s drugs. The company initiated a recall of all injectable drugs on Aug. 9, 2013.
The government is represented by Trial Attorney Jessica Gunder of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel Melissa Mendoza of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
The department filed a complaint in the U.S. District Court for the Western District of Texas on Feb. 23, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, Specialty Compounding manufactured both sterile and non-sterile drugs at a facility in Cedar Park, Texas, and distributed the company’s drugs to hospitals, surgery centers and health clinics in Texas and throughout the United States. As noted in the complaint, Solano is Specialty Compounding’s pharmacist-in-charge and co-owner, and Swail is Specialty Compounding’s Managing Partner and co-owner.
The complaint alleges that Specialty Compounding manufactured a sterile injectable drug product that tested positive for bacterial growth. In addition, according to the complaint, in August 2013, FDA received reports from two Texas hospitals that 17 patients had developed bacterial infections caused by Rhodococcus equi after receiving infusions of calcium gluconate manufactured by Specialty Compounding. Specialty Compounding ceased sterile drug manufacturing operations in August 2013, and recalled all lots of its unexpired sterile drug products distributed since Feb. 1, 2013.
“Specialty Compounding’s manufacturing practices posed a serious risk to the public health,” said Acting Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division.
“The American public needs to have the confidence that pharmaceutical drugs on the market are safe and effective.”
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a permanent injunction. As part of the settlement, the company and its owners have committed to implementing corrective actions before resuming production of sterile drugs. Specifically, the injunction prohibits Specialty Compounding and its owners from manufacturing, holding or distributing sterile drugs until they comply with the federal Food, Drug, and Cosmetic Act and its regulations. The permanent injunction also provides the defendants cannot resume distribution of sterile drug products until they receive written approval from the FDA that they are in compliance with the remedial provisions of the permanent injunction.
As described in the complaint, the FDA inspected Specialty Compounding’s Cedar Park facility in August and September 2013, and found insanitary conditions and numerous violations of the current good manufacturing practice requirements for drug products. Among other observations, the FDA found that the company was distributing some of their drugs without receiving a valid prescription for an identified individual patient and was introducing into interstate commerce unapproved new drugs and misbranded drugs. In addition, as alleged in the complaint, analyses of samples of a drug product collected by the FDA found bacterial contamination in one of the company’s drugs. The company initiated a recall of all injectable drugs on Aug. 9, 2013.
The government is represented by Trial Attorney Jessica Gunder of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel Melissa Mendoza of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
Thursday, February 26, 2015
Ketoconazole-Anti Fungal Medication Should Not Be Distributed
A consumer advocacy group has asked the FDA to immediately withdraw oral formulations of a decades-old fungal medicine over concerns that serious liver damage outweighs “questionable” benefits. And to reinforce its assertion, the consumer group cites an internal FDA memo in which agency staffers two years ago wrote that they did not view the risks associated with ketoconazole as “tolerable.”
The medicine was approved in 1981 to treat various fungal infections and several generic versions are currently available, although the original brand-name medicine is no longer sold. In its petition to the FDA, however, Public Citizen notes the FDA required a so-called black box warning – the most serious safety alert – for the drug in 1983 due to potentially fatal liver damage.
By July 2013, growing concerns prompted the FDA to issue a safety notice that removed several approved uses from the product labeling because of the risk of liver injury, adrenal gland dysfunction and troubling interactions with other medicines. The agency allowed oral versions of the drug to remain available for five fungal infections in the event other treatments fail or are not tolerated.
On the same day, though, the European Medicines Agency recommended all oral formulations be removed from the market over concerns about liver damage. The EMA review committee “could not identify a fungal infection where the level of hepatotoxicity of the drug could be balanced by an adequately substantiated benefit,” according to its report.
What was not previously known is that in January 2013, 14 staffers in the FDA Office of Surveillance and Epidemiology wrote a memo that the “overall benefit-risk assessment… is negative in the context of all of the drug’s labeled indications.” The 48-page review was undertaken after French regulators in 2011 suspended marketing authorization for the tablets due to safety concerns.
“The FDA’s own experts concluded that ketoconazole was too dangerous to remain on the market for any of its approved uses, yet the agency continues to allow hundreds of thousands of prescription for the medication to be filled each year,” says Sammy Almashat of Public Citizen in a statement. The consumer group says 462,000 prescriptions were written in 2014, citing IMS Health data.
An FDA spokeswoman would only say that the agency “will review the petition and respond directly to the petitioner.” We asked the three generic drug makers that sell ketoconazole in the U.S. – Teva Pharmaceuticals, Mylan Laboratories and Taro Pharmaceuticals – for comment, but no one has responded.
Monday, September 15, 2014
Drug Shortages Happening So What's the Solution?
A recent trend in drug shortages resulting from manufacturers “experiencing product quality problems” and a lack of supply chain alternatives. Valerie Jensen, associate director of the FDA’s drug shortage program, announced the agency is temporarily leveraging foreign suppliers to alleviate supply constraint. Could this be one of the reasons why we have had so many problems with medication goof ups lately?
Am I the only one concerned about this? So if I am understanding the facts correctly we are in short supply of some meds-so we are going to trust other countries (possibly with some ties to unsavory political choices?) to supply us with them? Why are we then shipping so many medications to other countries again if it only causes us a shortage? Are we just setting ourselves up to be vulnerable to a terror attack through medications?
This is a scary reality they have so many shortages just check it out at : http://www.accessdata.fda.gov/scripts/drugshortages/
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