In a letter to Sen. Sam Brownback (R-KA), FDA Commissioner Margaret Hamburg expresses doubts that her agency could properly regulate or guarantee the safety of drugs imported from other countries. The Senate is once again discussing reimportation--a measure supporters say could significantly lower rising drug costs. The Obama Administration supports reimportation, "assuming that safety concerns... [can] be addressed," according the The Hill
"...[A]s currently written, the resulting structure would be logistically challenging to implement and resource intensive. In addition, there are significant safety concerns," Hamburg writes in her letter. She also notes that the FDA can't oversee foreign supply chains, which would limit the agency's ability to ensure drugs brought in from other countries are safe. But Sen. Byron Dorgan (D-ND), who submitted the bill, maintains that Hamburg's concerns are bogus, given that the European Union has had success with its version of reimportation, called parallel trading.
Ken Johnson, PhRMA's senior vice president, pointed out that the EU's system isn't without its flaws, as Europe has had to deal with counterfeit medicines infiltrating its system. PhRMA, of course, strongly opposes reimportation. The issue will be debated in the Senate today or Thursday.
- here's the WSJ article
- read the item from The Hill