Selling drugs online to doctors allows companies to bypass FDA approval process. In law school we learned never to make unproven assumptions because when you assume anything you make an ass of me (or something like that.).
Pharma companies allegedly selling fake and unapproved cancer drugs
Turkish drug company Ozay Pharmaceutical Co. is at the center of an FDA investigation into how counterfeit cancer drugs ended up in the hands of U.S. doctors, endangering the lives of American cancer patients. In January, two men involved with Ozay, Ozkan Semizoglu and Sabahaddin Akman, were indicted for one count of conspiracy and three counts of smuggling illegal drugs into the U.S. Each smuggling charge carries up to 20 years in prison and/or a fine of up to $250,000.
It comes down to this: drug companies are powerful and cancer patients aren’t. Drug companies are in a position to make money, and cancer patients are desperate to do anything to live.
Ozay, based in Istanbul, bills itself as “an exporter of drugs, cosmetics and medical devices” to 70 countries. According to the FDA, some of the drugs Ozay shipped to U.S. doctors contained mold and water, but no active ingredients. Some other drugs Ozay shipped to the U.S. were legitimate drugs but allegedly not licensed for sale in the U.S. Prosecutors say that Ozay agents smuggled many drug shipments into the U.S. in small parcels, and that the agents falsely declared the shipments as gifts, documents, and product samples. The January indictments were apparently the culmination of an elaborate setup by the FDA and several international law enforcement bodies to lure Ozay agents into extradition friendly jurisdictions.
Doctors administer many cancer drugs to patients themselves and then seek reimbursement from insurers. This has allowed drug companies to market directly to doctors, bypassing more typical drug distribution networks. In 2012, the FDA investigated Winnipeg-based company Canada Drugs, which the year before had sold two batches of counterfeit Avastin, a cancer drug, to U.S. doctors. It comes down to this: drug companies are powerful and cancer patients aren’t. Drug companies are in a position to make money, and cancer patients are desperate to do anything to live. When a drug company cuts corners and sells a counterfeit or unapproved medication, it might mean that the patient administered that drug is given false hope and deprived of actual treatment. That patient could die as a result.
The FDA keeps careful watch over suspected counterfeit drugs cases. People can report problems with drugs or unlawful sales of drugs here and the FDA provides a guide to determine the safety of online pharmacies here, providing information to both consumers and physicians. Fraud.org has a handy guide as well. Patients treated with drugs administered by doctors should be comfortable communicating freely with their doctors to make sure their drugs come from a reputable source.
Because the FDA is not in a position to regulate international drug companies directly, and because the internet makes it easy for these companies to market directly to consumers and physicians, individuals have to take responsibility for themselves and do research on the drugs they are prescribed. If you think you’ve been administered a counterfeit drug, you need to tell your doctor as soon as possible, and consider reporting it to the FDA.
Client Reminder: Always keep the drugs you have questions about. Do not throw the drugs away. Store them in a plastic bag in the original container. Without the drugs we have no case. So keep them!
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I like to say to my clients, "Help me to help you." If we can help you call the Lombardi Law Firm to speak with attorneys Steve Lombardi and Katrina Schaefer. We can be reached at 515-222-1110 or by emailing us at [email protected] and [email protected] We look forward to your call.