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Much has happened since President Joe Biden, then a candidate, made a campaign-trail pledge to lower drug costs. He said in a Nov. 2, 2020, speech that he would "lower prescription drugs by 60%, and that's the truth."
He followed up on that promise early in his term, with a July 2021 executive order that gave a road map of how his administration planned to do it. At the time, drug pricing experts said these actions might help, but they warned that legislation was necessary to move closer to keeping that campaign promise.
Then, last summer, following a long partisan fight, Congress adopted wide-ranging legislation called the Inflation Reduction Act, part of which targeted prescription drug costs. It passed with no Republican votes. Biden signed it into law Aug. 16. But has any of this moved the needle toward Biden's promise?
Experts say the new policies could move closer to the 60% mark, but with caveats.
Through this law, "there are people who are going to save thousands, either because they are taking many drugs or certain high-cost drugs," said Matthew Fiedler, senior fellow at the USC-Brookings Schaeffer Initiative for Health Policy. Unless the law is repealed, "those reductions in prices will eventually happen."
But the big picture is murkier, he and other experts said.
It isn't clear, for example, whether the 60% reduction Biden promised was aimed at drug costs for individuals, lower prices across many drugs, or a spending drop of that size in the overall national prescription drug tab.
If Biden was aiming for a 60% reduction in the cost of drugs across the U.S., then the inflation reduction measure "is not going to meet that target," Fiedler said. "This is a big change in government policy. But it's not a 60% change."
What else does the law do?
Its drug provisions are varied. One, which went into effect in October, increases payment incentives for physicians to prescribe what are called biosimilars, which are lower-cost alternatives to expensive brand-name biologic drugs. And, as of January, Medicare enrollees' insulin prices are capped at $35 a month.
But what's gotten much more attention are the changes to Medicare. In addition to the insulin cap, the law allows Medicare for the first time to negotiate prices with drug manufacturers. It starts small — with 10 drugs that don't have generic or biosimilar competitors — in 2026. More will be added to the list each year. No one knows yet which drugs' prices will be the first to be negotiated, though they must be selected from among the 50 drugs with the highest Medicare spending.
Those provisions are estimated to save $98.5 billion over 10 years for Medicare, according to the Congressional Budget Office.
A provision that goes into effect this year requires drugmakers to rebate Medicare if their prices rise faster than inflation, with an estimated government savings over 10 years of $63.2 billion.
Another change affects how much Medicare enrollees must pay out-of-pocket annually toward their drugs. Those changes start to take effect in 2024 — and let's just describe them as complex. Bottom line: Medicare beneficiaries who use a lot of drugs or very expensive drugs will see their share of the costs lowered and capped, to $2,000 a year by 2025, and rising after that by a specific index.
KFF estimated 1.4 million Medicare members enrolled in Part D of the program had out-of-pocket drug costs that exceeded $2,000 in 2020, averaging about $3,355 each. Likely more will benefit from the provision by the time it goes into effect, the September report noted. (Kaiser Health News is an editorially independent program of KFF.)
Unlike some other provisions in the Inflation Reduction Act, the CBO estimated that the Medicare out-of-pocket-cap will cost the federal government — about $30 billion over 10 years.
A few other provisions also affect drug costs and access. All told, the CBO said, the legislation will reduce the federal deficit by $237 billion over 10 years.
So how to rate Biden's promise?
"Congress passed a law, and the president signed that piece of legislation, which will significantly lower prices of some drugs for some people in the future," said Ippolito.
But it isn't just what people pay as their share of the cost of some drugs, he emphasized. Biden seemed to promise a 60% reduction, but whether that is for some individuals, the prices manufacturers set in the first place, or total national spending on drugs is unclear.
"One of the specific things about Biden's statement was the 60% reduction, and we don't know if that's going to be the case or for how many drugs because we don't know how the agencies will implement the law," Ippolito said.
That's one reason he considers the promise as "a work in progress." It's also uncertain just how Medicare will set the maximum prices allowed in the program for those drugs that will be selected for the effort.
Fiedler, however, thought Biden's promise was partly achieved, in that significant changes have been accomplished that will substantially lessen costs for some people or for some prescriptions, but fall short of a 60% reduction when the number is applied across the pharmaceutical marketplace.
"Has the administration taken big steps on prescription drugs that will substantially reduce prices? The answer is yes," said Fielder. But he also said it would take time before "these price reductions fully materialize" and there is "a meaningful reduction in what the U.S. pays for drugs."
Some provisions are just now taking effect, and the groundwork is set for more.
Savings will start to be seen by some Americans this year under the insulin out-of-pocket cap and potentially through the incentives for doctors to prescribe lower-cost biosimilars. Several big-ticket items — the out-of-pocket spending cap for enrollees in Medicare, and the drug price negotiations — will play out over the next three years. Those changes may lead to consumers and the federal treasury saving hundreds of billions of dollars over the next decade.
Still, because it will take time to see how these reductions come to fruition, and whether they reach a 60% mark, our rating on the promise remains In the Works.
Telephone interview with Matthew Fiedler, senior fellow at the USC-Brookings Schaeffer Initiative for Health Policy, Dec. 16, 2022
Telephone interview with Benedic Ippolito, senior fellow in economic policy studies at the American Enterprise Institute, Dec. 19, 2022
PolitiFact, "Biden Takes Steps to Lower Drug Prices, but Odds Are Long for Achieving His Promised 60% Reduction," July 15, 2021
Rev.com transcript, Joe Biden campaign event speech, Pittsburgh, Nov. 2, 2020
The White House, Executive Order on Promoting Competition in the American Economy, July 9, 2021
U.S. Senate, "Roll Call 117th Congress, 2nd Session vote summary," accessed Dec. 21, 2022
U.S. House of Representatives, "Roll Call 420/Bill Number: H.R. 5376," accessed Dec. 21, 2022
Fierce Pharma, "Nearing a 'Watershed' Year, Biosimilar Industry Gets a Boost From Inflation Reduction Act," Oct. 6, 2022
KFF, "Explaining the Prescription Drug Provisions in the Inflation Reduction Act," Sept. 22, 2022
Congressional Budget Office, "Estimated Budgetary Effects of Public Law 117-169," Sept. 7, 2022
President Joe Biden's executive order issued July 9 marked an official step toward making good on a key campaign-trail promise.
"I'm going to lower prescription drugs by 60%, and that's the truth," Biden said during a November 2, 2020 speech.
The recent executive order outlined the president's vision for how he wants to proceed.
The order included an initiative designed to shore up the approval framework for generic drugs and biosimilars, working with the Federal Trade Commission to address efforts to impede competition for these types of drugs and to help Medicare and Medicaid incorporate new payment models to cover them.
It also calls for a report to be issued within 45 days outlining the specific efforts that should be implemented to reduce prescription drug prices. More details will emerge when that document becomes available.
Experts so far have offered measured reactions.
The administrative actions outlined in this executive order do have the potential to reduce prescription drug prices, said Matthew Fiedler, a fellow with the USC-Brookings Schaeffer Initiative for Health Policy. But it's dependent on more than just what the executive order says.
"In each of these areas, whether prices actually fall will depend on the details of the proposals the administration ultimately puts forward," Fiedler wrote in an email. "However, these are all areas where there are opportunities to make changes that would have a meaningful impact."
It's also important to note that the FTC is an independent agency, so Biden's principle means of influencing drug policy would come from his appointments to the agency, said Fiedler. It does seem likely, though, he added, that the newly appointed FTC chair would be sympathetic to cracking down on market conduct that delays the entry of generic drugs or biosimilars.
Still, to actually reduce drug prices by 60% would require legislation, said Benedic Ippolito, senior fellow in economic policy studies at the American Enterprise Institute.
"And the most disruptive drug pricing reforms — those that could even sniff that kind of price reduction — are also the most unlikely to pass," Ippolito wrote in an email. "In short, I suspect that this executive order isn't going to make much headway in achieving this goal."
Former President Donald Trump also promised that he would lower drug prices by 60% last year on the campaign trail, after repeatedly promising to reduce medication costs during his four years in office. However, little progress was made toward accomplishing the overarching goal despite issuing several, drug-pricing executive orders in 2020.
While Biden's executive order has a different focus than most of the Trump-era drug-pricing orders, the Biden administration has signaled they may still be open to embracing some of those policies.
Trump's directives focused on rebates paid to pharmacy benefit managers being rerouted to beneficiaries, reducing the cost of insulin by compelling federally qualified health centers to make the drugs available at low prices to low-income people, importing drugs from Canada and tying the prices of drugs to the prices of those drugs in other countries.
Three of the Trump-era proposed rules that are a result of his executive orders are still being kept around by the Biden administration — at least for the time being. One is called the "Most Favored Nation Model." This rule is supposed to match U.S. prices for a certain class of drugs with the lower amount paid in countries which negotiate drug prices.
According to Politico, the Biden administration's regulatory office received the rule last week, which means there may be a new public comment period and finalization of the rule — though it's likely this would take some time to complete.
Another rule that was finalized during the Trump administration would allow states to import drugs from other countries with the Food and Drug Administration's permission. But Pharmaceutical Researchers and Manufacturers of America sued the Trump administration to get it overturned and it is still tied up in court.
No other Trump drug-pricing efforts made much headway. Instead, they drew a fair amount of industry pushback.
And it remains to be seen whether Biden's directives will fare any better. His executive order is just the first step in a long line of steps to try to reduce the cost of prescription drugs. When the prescription drug pricing plan comes out, more will be known. Plus, issuing rules and allowing time for public comment takes time.
But experts agreed that most likely congressional action would be needed to achieve a 60% reduction in drug prices. With over three years left in office for Biden, who knows what could still happen on this issue.
For now, we rate this promise In the Works.
Email interview with Benedic Ippolito, senior fellow in economic policy studies at the American Enterprise Institute, July 9, 2021
Email interview with Matthew Fiedler, a fellow with the USC-Brookings Schaeffer Initiative for Health Policy, July 9, 2021
Email interview with Rachel Sachs, Treiman professor of law, Washington University of St. Louis, July 9, 2021
Kaiser Health News, "Trump Again Claims He's Bringing Down Drug Prices, But Details of How Are Skimpy," August 26, 2020
Politico Prescription Pulse, "Pfizer to seek OK for third dose," July 9, 2021
Rev.com, Joe Biden Campaign Event Speech Transcript Pittsburgh, PA November 2, Nov. 2, 2020
The White House, Executive Order on Promoting Competition in the American Economy, July 9, 2021