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Omnibus Bill Empowers FDA to Confiscate Imported Drugs

The recently signed appropriations or “omnibus” bill to fund the federal government includes an additional $94 million (Section 778) for the FDA to screen and stop drug imports at international mail facilities (IMFs). That could mean fewer people receiving their prescription medications that they have ordered from Canadian or other international pharmacies.

As I wrote a couple of weeks ago, the FDA’s coming crackdown against opioids could be a cover for greater import refusals and destruction of imported medications. This new appropriation of $94 million is a lot of money. In the case of drug importation, that money could be used for good (intercepting opioid ingredients en route to drug dealers or addicts) or evil (refusing and destroying prescribed medication en route to a patient who can’t afford the drug here).

You can read the section of the bill showing the appropriation and what it’s for at the end of this post. It states that the money is for “necessary expenses of processing opioid and other articles imported or offered for import through international mail facilities of the U.S. Postal Service.” Those “other articles” include prescription medications from pharmacies in Canada and other countries. Since the FDA considers those imports illegal, at least under most circumstances, it can refuse them and even destroy them – but must first alert the patient who ordered them giving them due process to defend their prescription order. (more…)

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New FDA Tests Indicate Imported Drugs Are Safe

 

FDA Testing Lower-Cost Imported Medications

Tens of millions of people have bought medications from foreign pharmacies – despite the technical illegality of importing those medications. According to reporting by Kaiser Health News last month, the FDA tested imported medications, apparently to see if what Americans are doing is safe. All medications the FDA tested “contain[ed] the ingredients matching the medicines ordered.”

The Kaiser Health News reporting was focused on international pharmacy options offered by local governments and school. While that’s interesting, it’s not breaking news (I mentioned it here). The FDA testing imports and saying the medications are safe, albeit begrudgingly, is breaking news. (more…)

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Legalize it; don’t criticize it – prescription drug importation

In 1976, reggae legend, Peter Tosh, released his song “Legalize It” – calling for the legalization of marijuana. In it, he sings “legalize it, don’t criticize it.” Needless to say, that’s already becoming our reality in the U.S. where, to varying degrees, many states have made pot legal. The federal government has begrudgingly accepted dissension in the ranks of states. Yes, there are rumblings that under Attorney General Jeff Sessions things are going to change. We’ll see.

This week, journalist and pharmaceutical industry analyst, Ed Silverman, from Stat News, published an opinion article called “It’s time to make it legal for Americans to order prescription drugs from abroad.” Unlike the downpour of op-eds against importation sponsored by drug companies, Silverman has no financial interest in this.

To be intellectually honest, Silverman’s call to action is qualified. He seems to be saying to “legalize it,” but he’s not necessarily advising that we not “criticize it.” There are real threats from counterfeit and otherwise substandard drugs that need to be addressed in reforming the law. Dr. Aaron Kesselheim, professor of medicine at Harvard, offers his own thoughts in Silverman’s piece: “We should be able to address this safety issue…To not have the conversation and instead say there’s no way to import medicines safely is a cop-out.” (more…)

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