You can't miss the stories in the news these days - more and more Americans are going across the borders and overseas to get their prescription drugs for cheaper prices. To date, while the response of the current administration to date has been mildly stern, the FDA has not gone after any jurisdictional area for what they’ve deemed illegal drug sales and it’s stuck in a tough public policy spot. On the one hand, there are the FDA regulations and other consumer protection laws in effect regarding the quality of drugs sold in this country, and the FDA has a responsibility to protect American citizens against "bad" drugs. On the other hand, the administration can't really look like they are bullying sick people into spending their entire life savings just to survive.
In the last couple days, Illinois announced to it will start a program on the Internet to help its citizens buy drugs not just from Canada (the general fave for this) but also Britain and Ireland. And the government has come out with its sternly worded concerns about such a plan. When other states, such as Minnesota, and cities, such as Boston, have come forward and started such programs, they were also met with the harsh glare and disapproval from the FDA, and Vermont’s request to have a similar program was denied by the FDA.
And also today, we see that the FDA might be getting more comfortable with the importation of drugs, at least from Canada and "drug stores [it has] some experience with." FDA Commissioner Lester Crawford recently stated in an interview that the FDA " will take a lighter hand" against some cities and states who are enacting these programs. Despite its prior actions (like stopping the buses of senior citizens and going after Canadian pharmacies who sell to the US), it now seems to be willing to find some middle ground with the state and cities.
It still remains to be seen, of course, how much the FDA will press the issue. Will it bring an action against a municipality? Will it wait until, say, January 22nd? Or will it draw ire from the pharmaceutical companies and allow for the sale of imported drugs under certain circumstances (proper testing of the drugs beforehand, inspection and testing of the pharmacies or manufacturing plants)? My bet today is that there will be cautionary tones expressed through the end of this year, the FDA will wait and see how many people really use the new programs and whether there are problems with drug quality, and then next year we’ll see a spate of action of express regulation and oversight of the overseas pharmacies and distributors (unless, of course, the FDA's hand is forced by Vermont, which is suing the FDA because of the rejection of its plan to import drugs). While it needs to protect American citizens from bad drugs, it also would be really embarrassing to have parades of seniors marching on its offices because of the financial bind they find themselves in when trying to get their needed medications. Not to make the FDA the bad guy here ... they're the easy target at the moment for a number of ills that affect our entire health care system (the attempted legislative reforms in the past year notwithstanding). But the battle that is sure to come with the FDA may help create the roadmap for the grander reforms that are likely necessary and that are sure to create years of debate among patients, health care providers, pharma & tech companies and the government.
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