Archive for August 2017

Bioworld: Importation a cliché, not a CAPA

Mari Serebrov, the regulatory editor for biotechnology news site BioWorld, offered this opinion about drug importation on August 4, 2017.  

“On the surface, importing drugs from Canada seems like a no-brainer,” she writes, “especially when the Canadian version is virtually the same drug as the one approved by the FDA for the U.S. market – except a whole lot cheaper. But there’s the rub. How can Congress ensure that drugs imported from Canada are all that they claim to be?

While more than 40 countries have or are implementing security measures to protect their drug supply chain, Canada’s not one of them, Brian Daleiden, vice president of industry marketing at Tracelink Inc., told BioWorld. That puts importation – from Canada, at least – on a collision course with the U.S. Drug Supply Chain Security Act (DSCSA), which Congress passed in 2013 as part of the Drug Quality and Security Act.”

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Physician: Sanders’ drug proposal comes with serious costs

The Daily Herald published this editorial by Dr. Terry Sellers about the shortcomings of drug importation as policy on July 25th, 2017. Sellers is a Utah-based physician specializing in addiction.

“… price is not the same as cost,” he writes, “In this case, cheaper prices will impose tremendous costs that would adversely affect the future of medicine for generations to come.” 

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Former Director of the U.S. FDA’s Office of Criminal Investigations Warns Against Allowing Drug Importation

More than 60,000 Americans died from drug overdoses last year. Fentanyl, a synthetic opioid 100 times more powerful than morphine, caused one-fifth of those fatalities. Local law enforcement and health professionals are working at a feverish pace to prevent fatal overdoses, yet at the same time, some federal lawmakers have proposed legislation that would make it legal to import drugs that are not approved by the Food and Drug Administration into the United States from questionable sources. Such legislation would provide a gateway for international criminal organizations to import counterfeit prescription drugs and deadly illegal opioids, including fentanyl…

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Update On Fentanyl in Georgia

Image courtesy of the Georgia Poison Center The August newsletter from the National Drug Early Warning System (NDEWS) News describes how the Georgia Poison Center (GPC) played a crucial role in the early detection of deadly, fentanyl-laced fake Percocet in Georgia. NDEWS describes how a call from an emergency-room doctor triggered the process of identifying…

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Former Florida AG: Importing prescription drugs could worsen opioid crisis

Bill McCollum, former attorney general of Florida and member of Congress, wrote about the dangers of drug importation on August 8, 2017:

“Opening the door to increased prescription drug importation will just make it easier for smugglers to ship this dangerous opioid into the United States. For years, we have asked police officers and prosecutors to do more with less. There are few signs that austerity will end. Changing laws to encourage importation of drugs would only add to that burden.”

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Georgia Sheriff: Keep Dangerous Foreign Opioids Out Of Georgia

Terry W. Deese, Peach County, Georgia Sheriff and president of the Georgia Sheriffs’ Association, wrote this editorial for the Macon Telegraph. It was published on July 27, 2017.

“Georgia’s law-enforcement professionals and health officials are scurrying to stop the spread of these harmful pills. But in Washington, Congress may soon make it easier for counterfeit drugs like these — along with illicit prescription medicines — to enter the United States.

This effort doesn’t make any sense. Loosening restrictions on drug importation will worsen the opioid crisis.”

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Oncologist Who Bought Cancer Drugs from Fake Drug Sellers Sentenced to Six Years in Prison

Dr. Diana Anda Norbergs, a Florida oncologist convicted in November 2016 of importing misbranded, non-FDA approved cancer drugs from unlicensed suppliers, has been sentenced to almost six years in federal prison, according to a report in the Tampa Bay Times. The Department of Justice (DOJ) indictment alleged that Norbergs purchased prescription cancer treatments from unlicensed foreign…

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