Washington, DC…Thank you very much. This is a very big announcement — the biggest ever, concerning drugs and drug pricing. So, today, I have to tell you it’s a great honor for me to announce that my administration is issuing two groundbreaking rules to very dramatically lower the price of prescription drugs for the American people, especially for our cherished seniors.

We’re pleased to be joined on this occasion by Secretary of Health and Human Services Alex Azar, and Administrator of the Center for Medicare and Medicaid Services, Seema Verma. Thank you both. Thank you both. And thank you all for being here. Appreciate it.

The unprecedented reforms we’re completing today are the direct result of the historic drug pricing executive orders I signed in July. Statutorily, we had to go through a very long process, and we got it done. I was very proud to have gotten this done. We were pushing it very hard, as we did with the vaccines and other things.

The first action will save American seniors billions of dollars by preventing middlemen — the famous middlemen, they call them — from ripping off Medicare patients with high prescription prices.

Currently, drug companies provide large discounts on the price of prescription medicines, including nearly $40 billion in rebates to Medicare Part D plans last year alone. Yet often, middlemen stop those discounts from going to the patients — which is what we’re interested in; not the middlemen — who need it the most. So the patients are going to be now getting the benefit, instead of these very wealthy individuals.

Patients pay very high prices, and they have for many years — although we brought it down; first time in 51 years — with the costs adding up to hundreds or even thousands of dollars per year, per patient.

Today’s action ends this injustice and requires that these discounts go directly to the people. These are the people that need it. This will save patients up to 30 percent. It could be 40 percent, could be 50 percent, could be much higher than that. These are numbers that nobody has ever even contemplated, and that doesn’t include lifesaving drugs like insulin, which will be even higher. Insulin was destroying lives and destroying families because the cost was so high, and now it’s at a level that nobody can even believe.

Is that correct, Seema?

ADMINISTRATOR VERMA: Thirty-five dollars a month.

THE PRESIDENT: Thirty-five dollars a month from many times that number.

The second rule we are finalizing today will transform the way the U.S. government pays for drugs to end global freeloading on the backs of American citizens and American patients.

Until now, Americans have often been charged more than twice as much for the exact same drug as other medically advanced countries. We would be having a drug — identical drug, same company — and we’d pay many times the price of what that drug would sell for in certain countries.

In case after case, our citizens pay massively higher prices than other nations pay for the same exact pill, from the same factory, effectively subsidizing socialism aboard [abroad] with skyrocketing prices at home. So we would spend tremendous amounts of money in order to provide inexpensive drugs to another country. And when I say the price is different, you can see some examples where the price is beyond anything — four times, five times different.

For example, Medicare Part B recipients are forced to spend five times more for a common breast cancer medication than patients in other countries. So, five times more. And we have other examples that are substantially higher than that.

To address this unfairness and to lower prices for Americans, we’re finalizing the Most Favored Nation rule. Remember that name. Most Favored Nation rule. Nobody has ever done this. The drug companies don’t like me too much, but we had to do it. It took a long time before we were able to do this because, statutorily, we had to go through a process. But they’ll — there’ll never be anything like this. I just hope they keep it. I hope they have the courage to keep it, because the powerful drug lobby — big pharma — is putting pressure on people like you wouldn’t believe.

Medicare will now look at the price that other developed nations pay for their drugs. And instead of paying the highest price on that list — and we are substantially higher than any other country in the world — we will pay the lowest price. In other words, we take the lowest price, and we match whatever the lowest price is, leading to colossal savings for all Americans. And we’re talking about savings of 50, 60, 70 percent, 80 percent — different drugs, different prices.

In addition, today, we’re taking one more historic action to hold down drug prices. In the past, drug companies have been allowed to identify certain very old generic drugs that have been widely available for decades and exploit a misguided program called “Unapproved Drugs Initiative — that’s “Unapproved Drugs Initiative,” a program that has been around for a long time and hasn’t been too good for the people that were supposed to benefit — to obtain market exclusivity on these medicines.

So we are doing something that nobody thought anybody would do. The savings is going to be incredible. Then they’ve jacked up the prices by as much as 1,000 to 5,000 percent on this product. This program has also caused shortages of important medicines.

Today, I am announcing that we are ending the Unapproved Drugs Initiative program to put a stop to this unfair practice. So prices are lifted by 1,000 percent to 5,000 percent. In one or two cases, even more than that. And we’re ending this. We are putting an end to it.

Together, these reforms will save American patients many, many billions of dollars every single year. For generations, the American people have been abused by big pharma and their army of lawyers, lobbyists, and bought-and-paid-for politicians. But I’ve [never] been loyal to the special interests; I have been loyal to our patients and our people that need drugs — prescription drugs — and devoted myself completely to fighting for the American people. You see that. This is not an easy thing to do.

Big pharma ran millions of dollars of negative advertisements against me during the campaign — which I won, by the way. But, you know, we’ll find that out. Almost 74 million votes. We had big pharma against us. We had the media against us. We had big tech against us. We had a lot of dishonesty against us.

But big pharma alone ran millions and millions of dollars in ads. In fact, I looked at it, and I said, “Who is it? Are they — I’ve never seen anything quite like it.” Because I told them, “I’m going to have to do this.” You know, I was put here to do a job. And Pfizer and others were way ahead on vaccines. You wouldn’t have a vaccine, if it weren’t for me, for another four years because FDA would’ve never been able to do what they did — what I forced them to do.

And Pfizer and others even decided to not assess the results of their vaccine; in other words, not come out with a vaccine until just after the election. That’s because of what I did with favored nations and these other elements, instead of their original plan to assess the data in October. So they were going to come out in October, but they decided to delay it because of what I’m doing, which is fine with me, because frankly, this is just a very big thing. A very big thing. What I’m doing here — I don’t know if anybody is going to appreciate it. These people can’t even believe it. Alex, even you can’t believe it, can you? Look at you.

So they waited and waited and waited. And they thought they’d come out with it a few days after the election. And it would’ve probably had an impact. Who knows? Maybe it wouldn’t have. I’m sure they would’ve found the ballots someplace — the Democrats and the group.

These corrupt games will not deter us from doing what is right for the American people. And I will always put American patients first, and I think it could never be shown better than what I’m doing today.

Already, we’ve successfully lowered drug prices for the first time in 51 years. In September, we finalized a rule allowing states, wholesalers, and pharmacies to safely and legally import drugs from Canada. Career politicians have promised to institute this reform for decades, and we got it done.

The reason Canada — and this is going to be, I think, just a short-term fix, because until we have the favored nations fully ready, which we hope to have — be in January 1st. I think a very important thing is say January 1st — that’s right around the corner.

But I’m giving governors the right to go to Canada because they’ll pray — pay approximately 50 percent less for their drugs for — that they buy for their states. So the governors buying drugs for their states go to Canada. They buy the drugs for very, very much less, and they’ll be able to pass that on to the people of Florida. Ron DeSantis was the first one to ask, but others are asking also. And it’s a great thing. I mean, you’ll save 50 percent. They’re going to buy a lot from Canada initially, and I think, ultimately, they’ll be comparing prices. You’ll get the lowest price anywhere in the world, so you won’t need to buy from Canada.

In a few weeks, my administration will also finalize rules requiring federally funded health centers to pass drug company discounts on insulin and EpiPens directly to patients. And the EpiPen price has come way down. We remember those horrible stories about EpiPen. Well, the price has now come way, way, way down. We capped insulin costs for many seniors at just $35 a month, as I said, saving them an average of nearly $500 to $1,000 a year just on insulin. Saving $1,000 a year on insulin.

Since I took office, we’ve reduced Medicare Part D premiums by 12 percent, putting nearly $2 billion back in seniors’ pockets. Now, 12 percent is great by any standard, but 12 percent is peanuts compared to what we’ve done with favored nations. It’s — I think it’s probably the biggest story that we’ve ever had relative to drug prices. There’s never been anything like this. This is something that has been talked about for many years, but nobody had the courage to do it because of the power of big pharma.

We ended the gag clauses that prevented pharmacists from telling patients how to buy less expensive drugs. As you know, pharmacists could not talk to patients about how to buy drugs. How about that one? Think that’s right? And now they can and should.

We approved a record number of affordable generic drugs for three years in a row. And we put a very hemph- — a very heavy emphasis on generic drugs. And the pricing there has become very good, but that pricing will also go down very substantially.

No administration has ever fought harder or achieved more for our patients and for our seniors but for America, when you think of it. For America. Because other countries were paying a fraction of what we were paying; in some cases, a small fraction. I mean, it was — it was what — the numbers were just staggering, the difference between going to — I won’t name nations, but I could name five of them right off the top of my head that it is so incredible to think about, for years, what was happening. We’ve been working on this for two years. Statutorily, we had to go through a process.

But when you think that our nation, for the exact same pill out of the exact same box, often made in the exact same factory, same company — and you take a look at the — the cost was so much more. Many, many, times more.

In four short years, we’ve instituted the most dramatic series of drug pricing reforms in decades, and you’ll see that. It all comes to fruition right now, starting on January 1st. And the American people will benefit from our actions for many, many decades. And it should be very immediate. Now, I presume they’ll sue, but it’s a sue that they should never be able to win. They should never, ever be able to win.

So now I’d like to ask Secretary Azar to provide some more details as to the action. And then, Seema, I’d like to have you come up and say a word — few words. And great job. We appreciate it. Thank you.

Secretary? Go ahead, please.

SECRETARY AZAR: Well, thank you, Mr. President. What an extremely exciting day for American healthcare. On top of the news that you just made, today, Pfizer will be filing an application for an emergency use authorization with the FDA for their COVID-19 vaccine that appears to be 95 percent effective. Within weeks, we could have a decision from FDA, and within 24 hours of that, we will have started distributing millions of doses of safe and effective vaccine to begin protecting our most vulnerable across America.

You know, the President mentioned his passion for getting drug prices down. And I can tell you, I’ve seen that firsthand. When I become Secretary in January 2018, the very first meeting we had in the Oval Office was to put together our plan for tackling drug prices. It was — the number-one priority, the President said, for us was getting drug prices down. And in that meeting, we came up with the idea for Most Favored Nations status and for insuring that the discount prices that big pharma was giving to middlemen would get passed on to America’s seniors at the pharmacy counter.

And almost two and half years ago, in May, the President laid out the most comprehensive vision for reforming drug pricing in American history. The President’s blueprint was clear: We need to put American patients first, and our drug pricing system too often puts them last. The system had to change. The blueprint called for tackling foreign freeriding, for bringing down high list prices, for reducing out-of-pocket costs, and for better negotiation by our government programs. That’s what the President has delivered over the last two years already, and that’s what the President is delivering today with these new, historic reforms.

We’re ending a broken system of shadowy kickbacks that drove prices higher and higher every single year and left so many patients shocked at the out-of-pocket costs that they owe at the pharmacy. We’re replacing that system with up-front discounts in Medicare, delivered straight to the patient at the pharmacy counter.

We’re bringing negotiation to the way we pay for the most costly drugs in Medicare, fixing a system where the government just took the price that drug companies offered, paying about twice as much as comparable countries. We’re ending a program that’s been used by drug companies to jack up prices on older drugs.

The President’s actions today, boldly take on the big drug companies, take on the middlemen, and take on foreign countries freeriding off of Americans.

If you don’t believe how fiercely special interests have fought these efforts, you must not have watched any TV in Washington over the last couple of years. Special interest have run millions of dollars in ads against the President’s drug pricing initiatives.

Mr. President, they underestimated me and they sure as the devil underestimated you. About two years ago, just over in the Roosevelt Room, the President signed legislation to ban pharmacy gag clauses, alongside me and his drug pricing advisors.

That included my friend and colleague Dan Best, who passed away two years ago this month. And he devoted his life to lowering drug costs for American patients, putting them at the center of our healthcare system, just as President Trump has done. And he was one of the key driving forces behind the rules that we are announcing today. I wish Dan could have been here today, Mr. President, but today’s actions are a lasting legacy for him and for you.

The President’s historic actions will transform drug pricing forever and build the system that American — the American people deserve, a system that puts American patients first.

Thank you so much, Mr. President, for making today possible.

THE PRESIDENT: Thank you, Alex, very much. Thank you.

Seema, please.

ADMINISTRATOR VERMA: Masks and hoop earrings don’t work well. (Laughter.)

Thank you, Mr. President, for your leadership. And let me take a moment to give some context for today’s announcement. From day one, President Trump made it very clear that he wanted to make healthcare more affordable and accessible to every American. And the most important thing is that he wasn’t afraid to take on the special interest groups to get this goal accomplished.

And in the absence of any meaningful legislative support, this administration has delivered real, tangible results. Premiums down in Medicare by 34 percent, the lowest in 14 years. And some areas saw declines almost as much as 60 percent. We stabilized the exchange, lowering premiums for the first time, and brought back more plan choices.

We have set forth a pathway to make the American healthcare system work more efficiently to deliver better quality and lower costs, tackling longstanding problems that no other administration had the guts to do.

And the list is long: price transparency so that patients know what they’re getting charged before they get their care; portable, digital health records, so patients have their complete medical history right on their phones; reducing regulatory burden so that doctors can spend more time with patients. The healthcare system will work better because of what this administration and President Trump has accomplished.

And as the President noted, our achievements on drug pricing are no less sweeping and unprecedented. Thanks to regulatory changes in 2017, the Part D premiums have dropped to some of the lowest rates in seven years, saving beneficiaries over $1.9 billion in premiums.

And we’re also bringing price transparency to Medicare so that doctors and patients have pricing information when drugs are prescribed so that patients can get the best deal.

The President’s Senior Savings Model has our Medicare beneficiaries cheering this year as they are selecting plans in this year’s open enrollment. They have over 1,600 plans that are offering insulin for just $35 a month or less. And that is a massive 66 percent savings.

Today’s announcement is about Part B, where the Medicare program has been nothing but a powerless price taker, and the problem is simple. While there are market forces and negotiations that serve to reduce cost in other parts of the healthcare system, it just doesn’t exist in Part B, which pays for drugs that you get in a doctor’s office: cancer drugs and other infusions.

In Part B, American seniors and taxpayers pay whatever drug companies want to charge. And doctors also get paid a percentage add-on. So the higher the drug costs, the more they get paid, giving an overt incentive to prescribe higher-priced drugs and for manufacturers to increase those prices. And so it’s no wonder that American seniors are paying twice as much as what other countries are paying.

And because of this, over the past five years, Medicare spending for Part B drugs has gone up by 55 percent on average. And drug spending in Part B is responsible for over a third of the premiums that our seniors pay. So the bottom line is: Higher drug costs lead to higher premiums and higher copays. Doctors do well, drug companies do well, but patients pay more. This effort is going to save over $85 billion over seven years, and saving seniors over $28 billion as well.

And so I want to thank the President for being a problem solver, willing to be — to think big and to act boldly on behalf of the American patients. His record of success over the last four years is a testimony to that mentality.

Thank you.

THE PRESIDENT: Thank you, Seema. Thank you very much.