Press Conference on HHS Plan for Importation of Prescription Drugs

By Paul Henry / in , , , , , , /

Well good morning, thank you for being here. I want to thank Secretary Azar, Assistant
Secretary for Health Giroir for traveling to Tallahassee to share our exciting news
this morning. When I came into office obviously we had a
lot of things on the agenda. One of the things was more affordable access
to healthcare but particularly for prescription drugs. This was a priority for the Speaker of the
House Jose Oliva and I want to thank him for what he did. I also want to thank Senator Galvano for moving
the bill through the legislature in the Senate but we look to figure out what options do
we have to do this and obviously as many of you know the prescription drugs is heavily
regulated by the federal government like the states can just do whatever the heck they
wanted but we were able to identify a law that was passed almost 20 years ago that did
provide an avenue for the importation of safe and affordable drugs from Canada. And so the legislature moved forward and I
spoke with the president and he was supportive of us moving forward and then once we passed
our legislation, my folks were working with Secretary Azar’s folks to try to figure out,
you know, what would this look like if we go forward and so today the Secretary is announcing
that the draft rule, the proposed rule has been issued. They’ll obviously be a comment period but
they obviously work closely with my administration to get a good template and so I’m excited
when you think about it, you know, this is only one step and I’ve always said you know,
there’s no silver bullet with this but this is a step that no one’s been willing to take
for almost 20 years. All the way back to 2003 you’ve had presidents
of both parties you’ve had secretaries of both parties and yet until now we haven’t
done it so I think that this is a big step forward obviously we’re going to be engaged
as the rulemaking process goes through both you think about it now we. Passed this legislation and I signed it I
think in May and you know we work with Secretary Azar and sometimes people are like oh when
is this going to happen but I mean this is not easy stuff and for them to be here now
you know they’ve worked to work really hard on this so so we’re really excited and we
want to thank us secretaries are for choosing to come down to Florida to make the announcement
so it’s my honor to be able to introduce him to explain to ya’ll what HHS is doing. Good morning, everyone, and thank you for
joining us. Thank you, Governor DeSantis, for having us
here today, and thank you for your bold leadership on lowering healthcare costs for Floridians. It’s been a pleasure to work with you. President Trump has made lowering drug prices
and increasing access to safe, effective, and affordable prescription drugs a top priority. We know this is a real challenge for many
Americans, including many Floridians. Premiums for Medicare Part D prescription
drug plans have dropped steadily under President Trump. But the average Floridian on Medicare is still
paying $367 a year out-of-pocket for the drugs they need. Nearly 240,000 Floridians on Medicare have
drug spending that pushes them into the catastrophic coverage phase of Part D, meaning they could
be spending as much as $5,000 or more out-of-pocket on drugs they need each year. President Trump has made it a top priority
to lower these costs. The
importation proposals being announced today are a historic step forward in the President’s
efforts. We’re announcing two actions today. First, the FDA is proposing to authorize states
to develop programs that would allow importation of certain prescription drugs from Canada. We know Florida has expressed interest in
that pathway, and I’m pleased to have discussed this possibility a great deal with Governor
DeSantis. We’ve also seen interest and leadership on
this issue from a number of other governors from both parties, including Governor Mills
of Maine, Governor Polis of Colorado, Governor Scott of Vermont, and Governor Sununu of New
Hampshire. Second, we are publishing a draft guidance
that drug manufacturers can follow to facilitate importation of FDA-approved drugs into the
U.S. This would potentially allow for the sale
of these drugs at lower prices than currently offered to American consumers, giving drug
makers new flexibility to reduce prices. There has been a longstanding debate about
the role importation can play in a safe drug supply chain, and there have always been questions
about how effective it can be at lowering costs. Over time, the drug pricing marketplace has
changed, and we’ve seen improvements to supply chain safety, as well. Under President Trump, we have arrived at
commonsense solutions that we believe can deliver results and keep patients safe. That is why, for the first time in history,
HHS and FDA are open to importation as a means to lower drug prices. I’m proud to work for a President who has
been bold enough to recognize the opportunities we have on importation, and President Trump
is now delivering solutions. We’ll continue to explore all avenues for
lowering drug prices while protecting incentives for innovation and maintaining standards of
safety, effectiveness, and quality. We’re also driving competition through historic
levels of generic drug and biosimilar approvals, we’ve banned pharmacy gag clauses, and we’ve
allowed Medicare Advantage plans to negotiate more effectively against drug companies. Under President Trump, retail prescription
drug prices dropped in 2018 for the first time in more than 40 years, and prescription
drug price inflation saw the biggest decrease in June in more than 50 years. We are committed to producing more results,
by introducing more competition, tougher negotiation, better incentives, and lower out-of-pocket
costs throughout our drug pricing system, and we look forward to working with leaders
like Governor DeSantis to do it. So thank you again to Governor DeSantis for
welcoming us here, and thank you everyone for joining us today. For some more details on this announcement,
I now want to hand things over to HHS Assistant Secretary for Health and Acting FDA Commissioner,
Admiral Brett Giroir. Admiral Giroir? Thank you Secretary Azar, thank you all for
being here, thank you Governor DeSantis for having us here today and for your leadership
on this and so many other issues. The FDA continues to further the Trump Administration’s
efforts to reduce drug prices and improve access to medicines for all Americans by promoting
competition in the drug marketplace. While the FDA does not regulate drug prices
the agency has worked to examine solutions to this challenge and has been making concerted
efforts across the agency. This, today’s landmark actions set forth the
plan for importing safe and effective prescription drug and biological products into the United
States with the ultimate goals of increasing access and lowering costs for Americans. As the Secretary noted, the FDA took the first
step, today, in implementing a provision of federal law that would allow for the importation
of certain prescription drugs from Canada under specific conditions to ensure the process
imposes no additional risk to the public’s health and safety while also resulting in
a significant reduction in cost of covered products to the American consumer. The proposed rule, if finalized, would allow
states and certain other non-federal government entities to submit importation program proposals
to the FDA for review and authorization for the importation of certain prescription drugs
from Canada. The programs would be required to ensure the
importation poses no additional risk to the public’s health and safety and that it would
result in significant reductions in cost of covered products to the American consumer. The FDA today also issued a draft guidance
which describes a pathway for drug manufacturers that could facilitate the importation to the
United States of an FDA approved drug product they originally manufactured and intended
to sell in any foreign country in a way that importantly also protects the public’s health
and safety. The products imported under this pathway described
in the draft guidance could be available to patients in a variety of settings including
hospitals, health care providers’ offices and licensed U.S. pharmacies. We look forward to receiving public comment
on these proposals as we work to finalize the proposed rule and proposed guidance as
quickly as possible. In closing I would like to state our ultimate
policy objective and that is; to provide pathways for the importation of drugs that would afford
lower prices while also maintaining the high quality Americans expect. The FDA will also continue to assess and act
on multiple opportunities to promote competition that can in turn, also help reduce drug prices
and improve access to medicines for Americans. Thank you. Does anyone have any questions for the Secretary
or for me? Governor, a number of Democrats voted against
making this request of the federal government, arguing that there were, um lack of FDA style
safe guards in the Canadian system, you mentioned a couple of minutes ago that this plan today
would allow for essentially those same type type of safe guards. How would that work? Well, yeah, so I don’t think that’s and Alex
can expound upon it but I think the way we’ve talked about it with the Secretary is, you
know the FDA does a good job in the U.S. we have a great system where inside that you
get safe drugs. Canada has a good system where inside that
they get safe drugs so we’re trying to do is build a pipeline between the Canadian system
and our system understanding that there are risks if you go outside that with safety and
that’s not anything we’re trying to do there’s a lot of sophistication out there there’s
a lot of bogus things. But if we take what’s in Canada and we leverage
that with, with what’s in the U.S. then then we saw the problem. Obviously they could not issue this rule under
the statute if there wasn’t a way to do it safely that was a requirement and we were
never looking to do anything other than that so it’s not going to be like you know you
just go on some website that’s hosted in like you know, Thailand or something and start
buying that’s not it’s going to be. I mean it is going to be oversight but I’ll
let Alex say a few more things. Yes, thank you thank you Governor. So I think it is an important clarification. For years people have said, ‘Canadians go
into drug stores in Canada their drugs are safe.’ Canadians aren’t dying from getting drugs
in Canada of course they’re not, the Canadian drug distribution system is very safe. The American drug distribution system is very
safe, it’s the gold standard around the world both are hermetically sealed, closed systems
of distribution. For years the challenge has been how could
we possibly connect those two systems up in a way that would not allow foreign entities
or unauthorized entities to bring adulterated, counterfeit, unapproved products into that
close system. That’s really what’s unique about and historic
about today’s announcement is we believe we have figured out an approach, given how the
supply chain is developed you now have bigger more global supply chains, global wholesale
distributors that operate you have now large global pharmacies that now operate. And so the way this would work in practice
under the proposal is a state would come forward with a plan where they say we’re working with
a wholesaler or a pharmacy and they in Canada will take direct control of the product from
a manufacturer in Canada of the same product that would be in America, product that’s identical
except it happens to have a Canadian label on it except an American label. These are products coming off the same production
lines as American pharmaceuticals currently they just get a different Canadian label slapped
on it when it rolls off the production line, that’s the only difference. Take direct control of that, ship into the
United States that product with then be relabeled for the United States it would receive track
and trace numbering on it. It would be inspected for purity by, by sent
by appropriate sampling and then it would go into the U.S. distribution system at a
lower cost available for patients. So think of it as a business to business connecting
these two, excellent drug distribution systems together. What it is not, what it is not is saying that
people can or should go online and buy from unauthorized so called Canadian pharmacies
to get drugs. Your taking your life in your own hands when
you do that. You are not buying drugs that are the same
necessarily as what a Canadian gets when they walk in to a Canadian pharmacy. These are drugs that often their only connection
if at all, is that they waved at Canada on their way to your mailbox from some other
country. They could be sub potent, counterfeit, adulterated,
contain very dangerous inactive or active ingredients. There are of course authorized, U.S. online
pharmacies. But what so many people have been beguiled
into using these are not safe what the Governor and I and other Governors and the President
are working on is a system to connect to the safe Canadian system with the safe American
system to bring savings for the American patient. (Cross Talk)
I’ll let the Governor moderate. Secretary Azar, you called importation a gimmick
during your confirmation hearing and back in 2004 I believe, you wrote a paper in which
you suggested that this entire plan was unworkable. So can you sort of explain your evolution
here going from saying this just couldn’t work at all to why you think now it should
work and should we just view this a political situation? So what happened is we, in part of the urging
of Governor DeSantis and the energy of the President on this we at the FDA and myself
we examined the supply channel I’ve spent a lot of time dealing with the drug supply
chain I actually used to work in the drug industry between my roles at HHS. And what we, what we examined was just how
that supply chain has developed as I said the increase in size, the vertical and horizontal
integration in the globalization of these large pharmacy chains as well as the very
large wholesale distributors with operations in Canada and elsewhere, we believe this creates
this opportunity for a business to business connectivity between the Canadian and the
American systems that wasn’t there in 2003 when the legislation was passed, that wasn’t
there in 2004 and frankly we hadn’t examined as closely until recently at the Governor’s
and the President’s urgings. This for the FDA is a very historic step to
be willing for the career officials at FDA to be willing to say we believe there’s an
approach that could connect the Canadian and American systems together with safe importation
of drugs through this business to business type approach is a very historic day and it’s
a result of very careful evaluation that’s why that has taken some time. Governor, what about the politics of this? As mentioned, the fact that this announcement,
somewhat incremental step is being announced on the same day that the impeachment is going
forward in the Congress. Well I think it’s a good. (Inaudible question) No, this is just what
we wanted to do obviously if they would have had this ready last month we’d have done it
last month. But I think my, you know my what I’ve tried
to do since I’ve been Governor is just focus on things that matter to people obviously
the prescription drugs has been a big issue for a lot of people throughout the country
but particularly in Florida. We were as I said limited in really what as
a state we could do we found this one pathway which obviously requires the federal government’s
approval so we went ahead and charged through and now we’re taking a, you know in the grand
scheme of things I mean this is just one step but if you look in recent history I mean this
is a major, major change from where the agencies had been and I think that this is the beginning
of a lot of re-evaluation of some of the policy so that we can get Americans to be treated
similar to other I mean you literally have people spending so much money here and all
these other countries you know it’s much less, so, so we want to have some equity. What about reality that this might actually
be a couple of years before this comes to fruition, concerned might oversell this now
and get people frustrated because it doesn’t come to fruition right away? We’re not, well first of all, I mean both
the Secretary and myself have said you know that it’s not like this is a silver bullet
this is one things of many when I signed the bill I said this is just kind of one step
in a long process, we’ve got to go through and obviously we in Florida don’t control
it all. But the fact that this is going today, there
will be a comment period I think you know I’ve only been able to kind of briefly get
a review, I got a brief from the Secretary they, they could not give us because of some
of the restrictions on what they’re allowed to do anything that can move the markets they
could not brief us you know far in advance. So we’ll look more at it but it but it seems
like you know this is a really, really good approach and maybe they’ll be some changes
with the comment period but I think we’re going to go forward on a similar track to
what’s being proposed so that we’re ready to go and, and hopefully we’re able to see
but you know Secretary Inch is here you know just for corrections a quarter of their healthcare
budget is prescription drugs. So even if you get some modest savings out
of this for them you know that could be tens of millions of dollars in savings for the
state of Florida and then obviously those are resources that can be used more productively
at that point. So this is one step, it’s an important step
we’ve got more ways to go but I’m glad, I’d much rather be here moving forward then just
being on the sidelines chirping and saying oh why doesn’t somebody do something about
it at least we’re trying to do something about it. So the timeline here, the proposals going
out they’ll be a 75 day comment period because we need this very complex it’s been terrific
work we’ve got. We’re joined here by, where is little Schiller? There we go. Little Schiller from our Principal Associate
Commission for Food and Drugs and his team just did heroic work at FDA to to get this
done in in speedy time but will we want to be open minded we have to hear comment on
different approaches to how we’re doing this. We will get our comments in and will be processed
those processing those comments as quickly as possible and then if we finalize the rule
we will finalize that as quickly as possible with any modifications we need to make, and
then go and implementation. And as the Governor said we hope that governors
like Governor DeSantis, Governor Mills, Governor Scott, Governor Polis, Governor Sununu and
others will be looking at the proposal and perhaps even starting to work on implementation
planning so that we’re ready to hit the ground on day one as soon as as soon as we have a
system in place. I talked to the President just this morning
at 8 am he is excited about this he is excited that we’ve gotten this out but his first message
to me was get it done fast. He wants this to happen quickly and I know
the Governor definitely feels that also. (question inaudible) You know I’ve said on
the same thing, I think I think we everyone in this room knows how this is ultimately
going to end I mean so and I think that’s why it has he has lost support with the public
and it’s not something that’s really energizing a lot of a lot of folks in the middle so you
know it is what it is. But I think the fact that we’re doing this
shows that the administration is pushing forward on doing things we obviously, I’m going to
be on Friday for a space launch and I’m going to have the Vice President down in Florida
at the space center so we’re looking forward to doing that so you know we’re just going
to keep charging ahead keep working on to find stuff in Florida and then continuing
to work constructively with the administration. I think they you know we’re getting Everglades
money which is which is great we obviously have the prescription drug they’ve had a lot
of help with us with infrastructure if you look at different things whether it’s Tamiami
trail whether it’s some of the other programs with the U.S. DOT. You know we’ve really appreciated the support
we’ve had from secretary Azar, from Secretary Chao obviously from the President. I mean when I talk with him he will always
mention the drug the Canadian drugs I mean it’s really important for him, he really wants
to make headway on drug prices that’s why the Secretary they’ve been able to do a lot
they are actually the Secretary was giving us a rundown beyond just the Canadian, you
know they’re certifying or approving these generics at a much faster rate so obviously
you know when you get a generic in there that really puts a downward pressure on the price
and that’s very good for consumers. One thing that we dealt with in Congress that
they’re now working on too is you know sometimes the generics when they’ve been on the market
for so long become so cheap that people exit the market they don’t even produce them anymore. So then all of a sudden you get one person
they go and have a monopoly on a generic and they can jack up the prices on people. So some of the old generics get so they’re
working on that too which is a very significant thing. So I think, you know, I think that there’s
just a lot of headway being made and you know Rome wasn’t built in a day but I really commend
the Secretary and I commend the President for focusing on this issue. Because it really does matter to the people
in Florida and throughout the country. (question inaudible) So obviously the Canadians
are going to be looking out for Canadians just as for the President and myself and Governor
DeSantis we’re here to put American patients first. And so we hope they’ll work with us. I think they’re obviously concerned about
their own their own system but as long as they’re getting lower prices as long as they
are free riding off of American investment in innovation the President and I are committed
to ending foreign freeriding that we’re committed to bringing lower price discount products
to the United States. If the drug companies are willing to give
discounts to other countries that are similarly positioned economically to the United States
then the United States where we have, where we are the largest pharmaceutical market in
the world, we ought to be getting deals like that, and that’s what we’re driving towards
with this as well as other plans that we have done and will continue to keep working on
for the benefit for the American people. President Trump and I, we’re just not going
to be distracted by this silly partisanship on the sidelines, we’re bringing transparency
to pricing in our health care system. We’ve got U.S. MC as you just mentioned getting
approved, we have historic appropriations across the government gotten through. We’re driving ahead with bringing basically
a personalized affordable patient centric health care system to the American people
that puts the patient at the center and then treats them like a human being not a number. And we’re just not going to be distracted
by any other nonsense that’s going on in Washington because the people’s business is simply too
important and this is one really important example of that. And I just want to thank Governor to DeSantis’
whole team for their partnership and in making this is a really historic day for health care
happen today. Thank you. Thank you everyone, thank you, appreciate

Leave a Reply

Your email address will not be published. Required fields are marked *