Unapproved Drugs Prompt FDA Alert To 5 Connecticut Doctors

Five Connecticut physicians have received letters from the U.S. Food and Drug Administration (FDA) alleging that they may have purchased unapproved drugs that put patients at risk of adverse health consequences, documents obtained by C-HIT show. The FDA documents show the five doctors were alerted as part of a wide-reaching federal probe involving Gallant Pharma International Inc., which sold more than $12.4 million in unapproved chemotherapy and injectable cosmetic drugs in the United States before the government shut down the operation in 2013. The letters to the doctors, dated April 1, 2015, say that “In addition to putting patients at risk, receiving misbranded or adulterated drugs and devices in interstate commerce and delivering or offering to deliver those drugs and devices to (or use on) others violates federal law.”

None of the doctors has been charged with wrongdoing, and only one acknowledged receiving the letter from the FDA. The case comes to light as drug companies and pharmacies are urging Congress and law enforcement officials to crack down on an increasing number of dangerous unapproved and counterfeit drugs being sold to doctors and consumers nationwide. Sales of counterfeit drugs and drugs not approved by FDA have soared into a multi-billion dollar industry with the growth of the Internet, and drug companies say efforts by governments to tackle illegal online drug sales are not sufficient.

Tainted Dietary Supplements Frequently Hit The Market

Every week for the past 7½ years, the U.S. Food and Drug Administration has identified an average of two dietary supplements being sold to consumers that were “tainted” and “potentially hazardous,” a C-HIT analysis of data reveals. The supplements contained prescription drug ingredients, controlled substances or untested pharmaceutical ingredients, which is prohibited by federal law and “can pose considerable dangers to consumers,” including stroke, liver damage, kidney failure and death, according to the FDA. C-HIT’s analysis of FDA data reveals 615 dietary supplements that were identified as tainted since Jan. 1, 2008. In the first half of this year alone, 59 tainted dietary supplements were posted on the FDA’s site.