Rachel Cohrs December 18, 2019
The Trump administration on Wednesday moved
forward with two regulatory actions that would allow states and drugmakers to
import prescription drugs, a top healthcare priority for the president's 2020
re-election campaign.
The Food and Drug Administration issued a
proposed rule that would allow states to pursue pilot programs to import drugs
from Canada and a draft guidance that would allow drugmakers to import their
own products and sell them under different drug codes.
Several states are already preparing importation
program applications, and Florida and Vermont have already submitted concept papers
to HHS. Florida's Republican Gov. Ron DeSantis has been a key figure in pushing
President Donald Trump to allow drug importation, and he signed a state law
creating an importation program in June.
Vermont, Colorado and Maine have also passed
drug importation laws, and HHS officials said they worked with New Hampshire's
governor on the regulatory action.
It could be years before patients would actually
see imported drugs even if all steps of the plan proceed, but HHS Secretary
Alex Azar said the administration is moving as quickly as possible to finalize
the regulatory actions.
States wouldn't be allowed to import biologics
including insulin, but drugmakers could under the second regulatory avenue
detailed in the draft guidance. Azar said the guidance could potentially move
faster than the proposed rule.
The second pathway would allow drugmakers to
import their own FDA-approved drugs intended for sale in any foreign country,
not just Canada. The policy would allow drugmakers to import the medicines
under different drug codes, which allows manufacturers to circumvent rebate
agreements with pharmacy benefit managers and offer their drugs at lower list
prices. Azar said drugmakers had asked for a way to offer drugs without
rebates.
"We will have to see if drug companies live
up to it," Azar said.
Azar, a former executive at Eli Lilly, is a
well-known opponent of rebates in the prescription drug supply chain, and
championed a failed policy to pass
all rebates to consumers at the point of sale.
The draft guidance only applies to brand drugs,
but HHS will solicit comments on providing guidance on a similar importation
approach for generic drugs.
HHS is legally allowed to approve importation programs
as long as the agency can certify that the program would present no additional
safety risk and would save consumers money. It remains unclear from preliminary
analyses whether prescription drug importation programs will save substantial
amounts of money, and Azar hinted on a call with reporters Tuesday evening that
HHS has several options in how it defines the cost savings requirement.
"We will seek comment on how that should be
interpreted," Azar said.
Azar has done a dramatic about-face on drug imports
in the past year, and called importation from Canada "just a gimmick"
in 2018. Azar changed his tune after Trump made importing prescription drugs
from Canada a healthcare priority.
Critics of drug importation have voiced concerns
about how imported drugs will comply with track-and-trace standards Congress
created to ensure the security of the prescription drug supply chain. Former
FDA Commissioner Scott Gottlieb, who now serves on Pfizer's board of directors,
said the protections were implemented to keep counterfeit drugs from being able
to penetrate the drug supply.
"While other solutions are harder to
achieve politically, they offer more enduring relief to consumers, without
risks that come from weakening (or attempting to waive) controls erected as a
result of bipartisan legislation passed in response to significant public
health concerns," Gottlieb tweeted Tuesday night.
Amid reported tensions between Azar and CMS
Administrator Seema Verma, the administration expedited its timeline for
releasing the proposed rule and draft guidance, as Modern Healthcare previously
reported.
FDA Commissioner Stephen Hahn was sworn in
Tuesday evening, but former Acting Commissioner Dr. Brett Giroir is promoting
the importation policy. Giroir is an Azar ally and served as the Assistant
Secretary for Health before he was tapped to temporarily fill in at the helm of
FDA.
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