This week, FDA Commissioner Scott Gottlieb announced that inspections by drug regulatory authorities of foreign manufacturing plants that export pharmaceuticals to the U.S. are sufficient to ensure the integrity of those products: meaning the FDA doesn’t also need to inspect them. The countries identified are Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom. All are currently members of the European Union (the UK is soon Brexiting).
Although this has made headlines as an unprecedented practice, the FDA relying on inspections from foreign regulators is not an entirely new development. The FDA does not inspect all foreign plants that export medicine to the U.S. even though most pharmaceuticals sold in the U.S. are foreign-made.
So what’s with the big announcement then?
I think the significance here is the much greater degree that the FDA is willing to now forgo inspecting foreign drug plants if already inspected by its regulatory counterparts. This is a smart move because it’s a waste of time and money for the FDA to inspect a plant in the UK that its counterpart, the Medical and Health Products Regulatory Agency, has recently inspected for Good Manufacturing Practices – and vice versa. It also, as noted in the announcement, frees up resources to focus on inspections in higher risk markets like China and India. Hooray for efficiency.
What does this say about prescription drug importation?
To keep it simple, let’s just focus on the UK.
With the FDA’s warm embrace of the UK’s ability to regulate pharmaceutical production, why on earth will it still be technically against the law for Americans to import medication from a pharmacy in the UK to fill their prescriptions? The medication is the same. The same plant that exports medications from the UK to the U.S. make those same medications sold in the UK. What’s the difference? The packaging and price.
Pharma lackeys will argue that the problem is safe distribution from – not manufacture in – the UK. Really? Pharmacies in the UK are lawfully permitted to ship medications to people in other countries, albeit with caveats. It’s called mail-order pharmacy. On our side of the pond, a large slice of pharmacy dispensing is already via mail-order across long distances. The UK and the U.S. have the same language and of course Americans are already buying medications from the UK via online pharmacies. As I’ve recently discussed, Walgreens owns pharmacies in the UK. Enough said.Tagged with: FDA Commissioner, foreign made, Scott Gottlieb