The FDA has sent a warning letter to one of the most prolific Internet drug providers from Canada, which reports have tied to an investigation of counterfeits of the cancer drug Avastin that were sold to physician practices in the U.S. this year.The agency this week posted a warning letter sent to a lawyer in Manitoba claiming that hundreds of websites it identified, including CanadaDrugs.com, were offering for sale drugs made at unapproved facilities. It said the sites were even offering domperidone, which it said is no longer approved for sale in the U.S. because of dangers to breastfeeding women.
A similar warning letter regarding "Arkadiy Kisin/White Forest Solutions" was also sent to a series of email addresses and lists dozens of Internet pharmacy sites offering contraceptives and "unapproved drugs" including Accutane, which it says has not been approved for sale in the U.S. since 2010.
An investigation this year by The Wall Street Journal tied the owner of CanadaDrugs.com, Kris Thorkelson, to a probe by federal authorities into companies that the FDA said supplied counterfeit Avastin to U.S. doctors. It said subpoenas sent to physicians asking for information about where they obtained the drugs named Thorkelson. The warning letter says, the "FDA is taking this action against your firm because of the inherent risk in buying unapproved and misbranded new drugs." It gives the companies 10 days to respond.The FDA in February and April discovered the counterfeit cancer drugs. Some of the recovered boxes were labeled Altuzan, which is the brand name for Avastin in Turkey. Tests, however, determined that there was no active ingredient in the counterfeits. So far, there have been no reports of problems related to the drugs, according to the FDA and Genentech, the Roche ($RHHBY) unit that makes the cancer treatment.The letter came only days after the agency launched a new campaign it hopes will discourage the practice of buying drugs online, or at least, teach consumers how to determine what sites are potentially legit. The agency last week launched BeSafeRx, to warn against the dangers.- here's the warning letter to CanadaDrugs.com
- here's the letter to Arkadiy Kisin/White Forest SolutionsRelated Articles:
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Fajardo, Puerto Rico-Birth Control Pills-Fda Warning Letter-Test Specification-Ethinyl Estradiol
In what appears to be another pregnancy risk to women taking birth control pills, the FDA has sent a warning letter to Warner Chilcott ($WCRX) saying that for 5 years the potency of its Ovcon pills has been in question.The letter follows an inspection last summer of the company's manufacturing plant in Fajardo, Puerto Rico. The FDA says that from 2006 until a recall in June 2011, "7 of 9 lots of Ovcon (Norethindrone (NE) 1 mg and Ethinyl Estradiol (EE)) 50 mcg tablets, laced on stability, failed to meet the assay test specification for Ethinyl Estradiol (EE) at different stability testing intervals." Because of this situation, the pills may not last until the expiration date, the FDA says.The company has told the FDA that it didn't take action because it believes that another test on stability condition was a more appropriate indicator. However, the FDA says Warner is required to see that a drug passes both tests. The company also has said new packaging should help, but the FDA letter says a batch in the new packaging also failed a test.This disclosure comes shortly after Glenmark Generics recalled 7 lots of norgestimate and ethinyl estradiol tablets manufactured in India, because the pills are rotated 180 degrees in the card. That announcement came about a month after Pfizer ($PFE) recalled a million packages of Lo/Ovral-28 pills and their generic counterparts for a similar packaging mishap. That event already has attorneys trolling for clients. In both cases, it was a consumer who noticed that something was wrong with the packaging.- check out the FDA warning letterRelated Articles:
Birth control redux: Glenmark Generics pulling mixed-up pills
Pfizer suspects 30 packs of contraceptives mispackaged; pulls 1 million just in case read more..