Importation
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.”
[...]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.”
[...]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…
[...]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.”
[...]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.”
[...]AIDS Drug Assistance Advocate: Drug importation policy is a hard pill to swallow
Brandon Macsata, the CEO of the AIDS Drug Assistance Program Advocacy Association, writes about the dangerous unreliability of imported medicines. (Originally published in the The Washington Blade and the ADAP blog.)
[...]Shepherd M (2018) U.S. Drug Importation: Impact on Canada’s Prescription Drug Supply. Health Econ Outcome Res Open Access 4: 146.
This research paper is an update to The Effect Of U.S. Pharmaceutical Drug Importation On The Canadian Pharmaceutical Supply, published in 2010.
[...]This Just In: Law Enforcement Groups Oppose Drug Importation Proposals
This Just In: Law Enforcement Groups Oppose Drug Importation Proposals Drug importation endangers patients and the American drug supply and worsens the opioid crisis “[T]he IACP is gravely concerned about the dangers law enforcement personnel and their canine drug detecting partners are subject to each time they come into contact with fentanyl [..] the IACP…
[...]National Sheriffs’ Association Opposes Legislation On Drug Importation
The National Sheriffs’ Association passed a resolution at their conference opposing pending drug importation proposals. The resolution highlighted multiple reasons why drug importation is a bad idea for everyone…
[...]Kansas Woman Convicted of Tax Evasion Also Faces Counterfeit Drug Charges
Example of counterfeit Botox courtesy USFDA. The former owner of a Leawood, Kansas business, Midwest Medical Aesthetics, has been charged with importation of misbranded drugs. Kathleen Stegman has been charged with illegally importing $194,000 worth of non-FDA approved “Botox,” Dysport,” “Restylane,” “Perlane,” and “Sculptra,” according to the Food and Drug Administration (FDA). Stegman is currently…
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