US Drugs Czar may Propose Drug Import Plan

29.11.2019 -

US Department of Health and Human Services Secretary Alex Azar will soon release a drug importation plan that will do more to keep prices under control than one proposed by the Democratic Party, US president Donald Trump asserted this week.

No details of a new plan have been revealed, but Trump said the Democrats’ proposals published in September “don’t do the trick,” as they deliver fewer new drugs.

Among other things, proposals presented by Democrat Nancy Pelosi, Speaker of the House of Representatives, call for senior health care program Medicare to be able to negotiate drug prices, as well as an international pricing index and potential fines for drugmakers gouging prices.

In the Senate, lawmakers are pushing for less wide-sweeping rules but have leaned toward simplifying Medicare Part D, an out-of-pocket cap for Part D patients, as well as tweaks to Medicare Part B and more transparency for pharma “middlemen. “

The Pelosi plan has not been welcomed by the pharmaceutical industry, but the topic of importation is also anathema to it, with producers suggesting this could threaten a secure drug supply chain, and observers said it is hard to see how  any proposals by Azar, a former executive at Eli Lilly, could  change their views.

Following in the footsteps of predecessor Scott Gottlieb, FDA commissioner nominee Stephen Hahn said during his Senate confirmation hearing that he believes the drug approval agency can have an “indirect” role in drug pricing by stimulating competition.

Somewhat unusually compared with its stance in the past, the American Medical Association (AMA) in a recent report voiced support for an arbitration process to bring US drug costs down. The process would be managed by independent, “informed mediators,” who would choose bids by either pharma companies or payers in areas of high drug prices and limited competition.

AMA noted that the status quo allows drug manufacturers to set prices unilaterally, without regard to patient access and affordability. An arbitration process would provide "incentive for drug manufacturers and payers to arrive at a negotiated price,” the physicians’ grouping said.