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Biden Administration Takes Historic Step to Lower Cost of Prescription Drugs for Medicare, Medicaid

For the first time, thanks to President Biden’s Inflation Reduction Act – the historic law lowering health care costs – Medicare is able to negotiate the prices of prescription drugs. HHS released the list of the first 10 drugs that it will negotiate prices for.When implemented, prices on negotiated drugs will decrease for up to 9 million seniors. These seniors currently pay up to $6,497 in out-of-pocket costs per year for these prescriptions. In addition, the nonpartisan Congressional Budget Office reports that this will save taxpayers $160 billion by reducing how much Medicare pays for drugs through negotiation and inflation rebates. © Karen Rubin/news-photos-features.com

In the immortal words of President Biden as VP when President Obama signed the Affordable Care Act (Obamacare) into law, this is a big f—kg deal.

For the first time, thanks to President Biden’s Inflation Reduction Act – the historic law lowering health care costs – Medicare is able to negotiate the prices of prescription drugs.

Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced the first 10 drugs covered under Medicare Part D selected for negotiation. The negotiations with participating drug companies will occur in 2023 and 2024, and any negotiated prices will become effective beginning in 2026. Medicare enrollees taking the 10 drugs covered under Part D selected for negotiation paid a total of $3.4 billion in out-of-pocket costs in 2022 for these drugs. 

“For far too long, pharmaceutical companies have made record profits while American families were saddled with record prices and unable to afford life-saving prescription drugs. But thanks to the landmark Inflation Reduction Act, we are closer to reaching President Biden’s goal of increasing availability and lowering prescription drug costs for all Americans,” said HHS Secretary Xavier Becerra. “Although drug companies are attempting to block Medicare from being able to negotiate for better drug prices, we will not be deterred. The Biden-Harris Administration will continue working to ensure that Americans with Medicare have access to innovative, life-saving treatments at lower costs.”

The Biden-Harris Administration has made lowering prescription drug costs and improving access to innovative therapies a key priority. Alongside other provisions in the new law that increase the affordability of health care and prescription drugs, allowing Medicare to negotiate prescription drug prices will strengthen the program’s ability to serve people with Medicare now and for generations to come. The negotiation process will consider the selected drug’s clinical benefit, the extent to which it fulfills an unmet medical need, and its impact on people who rely on Medicare, among other considerations, such as costs associated with research and development as well as production and distribution for selected drugs. As a result of negotiations, people with Medicare will have access to innovative, life-saving treatments at lower costs to Medicare.

The selected drug list for the first round of negotiation is:

  • Eliquis
    • Jardiance
    • Xarelto
    • Januvia
    • Farxiga
    • Entresto
    • Enbrel
    • Imbruvica
    • Stelara
    • Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill

These selected drugs accounted for $50.5 billion in total Part D gross covered prescription drug costs, or about 20%, of total Part D gross covered prescription drug costs between June 1, 2022 and May 31, 2023, which is the time period used to determine which drugs were eligible for negotiation. CMS will publish any agreed-upon negotiated prices for the selected drugs by September 1, 2024; those prices will come into effect starting January 1, 2026. In future years, CMS will select for negotiation up to 15 more drugs covered under Part D for 2027, up to 15 more drugs for 2028 (including drugs covered under Part B and Part D), and up to 20 more drugs for each year after that, as outlined in the Inflation Reduction Act.

“We’ve reached this milestone because of the Inflation Reduction Act– one of the most significant laws ever enacted, and one that passed with the leadership of Democrats in Congress,” President Biden stated. “We took on Big Pharma and special interests, overcoming opposition from every Republican in Congress, and the American people won.”

When implemented, prices on negotiated drugs will decrease for up to 9 million seniors. These seniors currently pay up to $6,497 in out-of-pocket costs per year for these prescriptions. In addition, the nonpartisan Congressional Budget Office reports that this will save taxpayers $160 billion by reducing how much Medicare pays for drugs through negotiation and inflation rebates.

“This plan is a key part of Bidenomics, my economic vision for growing the economy from the middle out and the bottom up – not the top down. And it’s working.,” Biden stated. “That’s why Big Pharma has already filed eight lawsuits against my Administration, and spent nearly $400 million last year to try to stop our progress. Let me be clear: I am not backing down. There is no reason why Americans should be forced to pay more than any developed nation for life-saving prescriptions just to pad Big Pharma’s pockets. For many Americans, the cost of one drug is the difference between life and death, dignity and dependence, hope and fear. That is why we will continue the fight to lower healthcare costs – and we will not stop until we finish the job.”

HHS Announces First Set of Drugs Selected for Medicare Price Negotiation

For the first time ever, HHS announced ten drugs selected for Medicare drug price negotiation:
 

Drug NameCommonly Treated ConditionsTotal Part D Gross Covered Prescription Drug Costs from June 2022-May 2023Number of Medicare Part D Enrollees Who Used the Drug from June 2022-May 2023Average Part D Covered Prescription Drug Costs Per Enrollee
EliquisPrevention and treatment of blood clots$16,482,621,0003,706,000$4,448
JardianceDiabetes; Heart failure$7,057,707,0001,573,000$4,487
XareltoPrevention and treatment of blood clots; Reduction of risk for patients with coronary or peripheral artery disease$6,031,393,0001,337,000$4,511
JanuviaDiabetes$4,087,081,000869,000$4,703
FarxigaDiabetes; Heart failure; Chronic kidney disease$3,268,329,000799,000$4,091
EntrestoHeart failure$2,884,877,000587,000$4,915
EnbrelRheumatoid arthritis; Psoriasis; Psoriatic arthritis$2,791,105,00048,000$58,148
ImbruvicaBlood cancers$2,663,560,00020,000$133,178
StelaraPsoriasis; Psoriatic arthritis; Crohn’s disease; Ulcerative colitis$2,638,929,00022,000$119,951
Fiasp; Fiasp FlexTouch; Fiasp PenFill;
NovoLog; NovoLog FlexPen; NovoLog PenFill
Diabetes$2,576,586,000777,000$3,316

 
[Source: CMS, https://www.cms.gov/files/document/fact-sheet-medicare-selected-drug-negotiation-list-ipay-2026.pdf]

These ten drugs are among those with highest total spending in Medicare Part D – $50 billion in total part D gross covered drug cost s- or 20% of total part D gross covered drug costs june 1, 2022, may 31, 2023. More than 8 million Part D enrollees depend on these vital treatments to treat life-threatening conditions including diabetes, heart failure, and cancer, but many struggle to access their medications because of prohibitive costs.

Medicare drug price negotiation will result in lower out-of-pocket costs for seniors and will save money for American taxpayers. Negotiations for the first group of selected drugs will begin in 2023, with negotiated prices going into effect in 2026.

Out-of-Pocket Costs for Drugs Covered Under Part D Selected for Drug Price Negotiation, by State

Today HHS also released a report showing that 9 million Medicare Part D enrollees took the drugs covered under Part D selected for negotiation and paid a total of $3.4 billion in out-of-pocket costs for these drugs in 2022.  For enrollees without additional financial assistance, average annual out-of-pocket costs for these drugs were as high as $6,497 per enrollee in 2022.

To view a state-by-state breakdown of the number of Medicare enrollees who use the prescription drugs selected for negotiation and their out-of-pocket costs, visit HHS’s website.

Continuing to Lower Prescription Drug Costs

Every day, millions of seniors are saving money on prescription drug costs because of the Biden Administration’s actions. People with Medicare are saving an average of $70 in out-of-pocket costs on vaccines like shingles and Tdap because President Biden’s Inflation Reduction Act made recommended vaccines free for beneficiaries starting this past January. Nearly four million seniors and others on Medicare with diabetes started to see their insulin costs capped at $35 per month this past January, saving some seniors hundreds of dollars for a month’s supply. And some seniors taking drugs covered under Part B for which manufacturers have hiked prices faster than inflation are saving up to $449 in lower coinsurance this quarter thanks to the new Medicare inflation rebates.

People with Medicare will continue to see their prescription drug costs go down as more provisions of the Inflation Reduction Act go into effect in the coming years. Part D enrollees will no longer pay 5% co-insurance when they reach the catastrophic phase of their benefit starting in 2024. Nearly 19 million seniors and other Part D beneficiaries are projected to save $400 per year on prescription drugs when the out-of-pocket cap drops to $2,000 in 2025, and 1.9 million enrollees with the highest drug costs will save an average of $2,500 per year. And the lower prices negotiated for the high-spend drugs selected today will go into effect in 2026.

The President’s Budget for Fiscal Year 2024 builds upon the Inflation Reduction Act to continue lowering the cost of prescription drugs. For Medicare, this includes further expanding the newly established negotiation authority by extending it to more drugs and bringing drugs into negotiation sooner after they launch. The Budget also includes proposals to curb inflation in prescription drug prices and cap the prices of insulin products at $35 for a monthly prescription in the commercial market to lower drug costs for all Americans.

The ability to negotiate drug prices is historic. For decades, Big Pharma lobbyists (three for every one member of Congress) and Congressional Republicans stopped Medicare from saving taxpaying, hardworking families money by negotiating lower drug costs.

The result of that blockade was that Americans were forced to pay the highest prices for medicines in the world, despite the fact that taxpayers subsidize Big Pharma’s research and development.

“This is a game-changer for Americans who are being overcharged for medicines they need and a game-changer for Medicare because it will spend less taxpayer money to deliver the same benefits,” stated Deputy Press Secretary and Senior Communications Adviser Andrew Bates.

“This comes after President Biden also beat Big Pharma by capping the price of insulin at $35 per month for Medicare recipients. Big Pharma has spent nearly $400 million lobbying to stop these reforms.”

However, as the Biden Administration takes these newest historic actions to lower drug costs for Americans and strengthen Medicare, Congressional Republicans continue to side with Big Pharma’s price gouging and cuts to Medicare benefits instead.

Not only do congressional Republicans want to take the new benefits being announced today away from Americans with repeal legislation (just as they spent years trying to repeal the Affordable Care Act – Obamacare) – they are even siding with Big Pharma’s lawsuits to stop them in their tracks, Bates said.

Congressman Morgan Griffith endorsed their suits, saying, “every drug manufacturer probably ought to sue because it is, on its face, an unconstitutional taking.”

And reporters have frequently noted that in their opposition to this breakthrough for seniors, congressional Republicans are parroting Big Pharma’s talking points and “echoing arguments the pharmaceutical industry has made for years.”  

After unsuccessfully voting to block President Biden’s plan to let Medicare negotiate lower drug costs, Congressional Republicans have sought to repeal it, in alignment with Big Pharma. In the midterms, they campaigned on repealing Medicare’s new power but shut their ears to voters’ message back to them.

This summer alone, the Republican Study Committee, which represents over three quarters of House Republicans, unveiled yet another repeal plan.

The handouts Congressional Republicans are pursuing for Big Pharma would explode our deficit, weaken Medicare, and subject more American seniors and families to price gouging for life-saving medicines, Bates said. 

“Across the board, the hallmark of congressional Republicans’ trickle-down economic agenda is to increase costs and financial burdens shouldered by hardworking Americans in exchange for welfare payoffs to the super rich and multinational corporations. In this case, Big Pharma.

“Their philosophy is the polar opposite of Bidenomics, which is based on rewarding hard work and growing our economy by growing the middle class. Not leaching off the middle class for an extreme rightwing scheme to redistribute income upward.   

“We should be bolstering Medicare’s ability to lower drug costs for families, instead of trying to erase them.

“This fight is far from over. President Biden is pushing to expand Medicare’s capacity to negotiate lower drug costs, which he released a concrete plan for in his budget,” Bates said.

FACT SHEET: Biden Takes Action to Lower Health Care and Prescription Drug Costs for Americans

President Biden Signs Executive Order Directing HHS to Explore Additional Actions to Lower Prescription Drug Costs

Starting this January, seniors and other Medicare beneficiaries will begin to see the benefits of these cost-saving measures. Because of the Inflation Reduction Act: a month’s supply of insulin will be capped at $35; Medicare beneficiaries will pay $0 out of pocket for recommended adult vaccines covered by their Part D plan, including the shingles vaccine – which costs seniors up to $200; Prescription drug companies that try to raise their prices faster than inflation will be required to pay Medicare a rebate © Karen Rubin/news-photos-features.com

This fact sheet about actions that President Biden is taking to lower health care and prescription drug costs was provided by the White House:

To mark the start of Medicare Open Enrollment season, President Biden is highlighting how seniors can take advantage of the Inflation Reduction Act’s cost-saving provisions as they shop for new health insurance plans. The President  also signed an Executive Order directing the Department of Health and Human Services to explore additional actions it can take to lower prescription drug costs to build on his Administration’s work lowering costs for working and middle-class families.

Americans are squeezed by the cost of living – that’s been true for years and is a key reason the President ran. Health care costs in particular are driving inflation. Too many Americans face challenges paying for prescription drugs. On average, Americans pay two to three times as much as people in other countries for prescription drugs, and one in four Americans who take prescription drugs struggle to afford their medications. Nearly three in ten American adults who take prescription drugs say that they have skipped doses, cut pills in half, or not filled prescriptions due to cost. 

The Inflation Reduction Act – which President Biden and Congressional Democrats delivered – tackles that problem and locks in on average $800 per year lower health care premiums for 13 million families, lowers seniors’ prescription drug prices, and caps their out of pocket expenses for prescription drugs at $2,000 per year. The Inflation Reduction Act protects Medicare beneficiaries from catastrophic drug costs by phasing in a cap for out-of-pocket costs at the pharmacy, establishing a $35 monthly cap per prescription of insulin, requiring companies who raise prices faster than inflation to pay Medicare a rebate, and allowing Medicare to negotiate prices for high-cost prescription drugs for the first time ever. Republicans in Congress, meanwhile, have said their top priority is to repeal the Inflation Reduction Act, ending these cost-saving provisions and raising prices for tens of millions of Americans. 

To further lower health care costs, earlier this week, the Treasury Department took action to fix the so-called “family glitch” rule that was making it harder for families to afford health care coverage for their spouse or child. About 1 million Americans will either gain coverage or see their insurance become more affordable as a result of the new rule.

Lowering Medicare Costs This Open Enrollment Season

Starting this January, seniors and other Medicare beneficiaries will begin to see the benefits of these cost-saving measures. Because of the Inflation Reduction Act:

• A month’s supply of insulin will be capped at $35 starting on January 1, 2023. 

• Medicare beneficiaries will pay $0 out of pocket for recommended adult vaccines covered by their Part D plan, including the shingles vaccine – which costs seniors up to $200. 

• Prescription drug companies that try to raise their prices faster than inflation will be required to pay Medicare a rebate. 

Earlier this year, HHS released a report showing that the price of 1,200 prescription drugs rose faster than inflation in just the last year. For example, one manufacturer of a drug used to treat high blood pressure and heart failure, used by millions of Medicare beneficiaries, increased the drug’s price by nearly 540 percent in 2022. Another drug used to treat autoimmune conditions increased by $1000 just this year.

During Medicare Open Enrollment – running from October 15 to December 7 – seniors and other beneficiaries will be able to choose drug coverage that reflects these new cost-savings, putting money back into their pockets. 

Medicare beneficiaries should visit Medicare.gov or call 1-800-MEDICARE to review their options for the coming year, and make sure their health and prescription drug coverage is right for them.  

Using HHS’ Innovation Center to Further Bring Down Costs

As the Biden-Harris Administration works to implement the Inflation Reduction Act, President Biden signed an Executive Order directing the Department of Health and Human Services to consider additional actions to further drive down prescription drug costs. That includes leveraging the “Innovation Center” at HHS, created by the Affordable Care Act, which has authority to test new ways of paying for Medicare services thatimprove the quality of care while lowering costs.  

Under Executive Order XX, HHS will have 90 days to submit a formal report outlining any plans to use the Innovation Center’s authorities to lower drug costs and promote access to innovative drug therapies for Medicare beneficiaries. This action would build on the Inflation Reduction Act’s landmark drug pricing reforms and help provide additional breathing room for American families.

Reining in Big Pharma – or Why Capitalism Doesn’t Work With Life-Saving Drugs

How much is your child’s life worth? Big Pharma is betting it is priceless © 2016 Karen Rubin/news-photos-features.com
How much is your child’s life worth? Big Pharma is betting it is priceless © 2016 Karen Rubin/news-photos-features.com

By Karen Rubin, News & Photo Features

How much is it worth to you to save your child’s life? $1 million? $10 million? How much is it worth it to you to have the medication that will prolong your mother’s life from Multiple Myeloma, $10,000 a month? (That’s what the medication cost.)

The issue was most recently dramatized by Mylan, the drug company that has a monopolistic control over the EpiPen syringe, and over the course of but a few years, increased the price for an item that can mean the difference between a child surviving a severe allergic response from $57 to $600 (did I mention it has a year-long shelf life?)

The cost of the actual medication, epinephrine, that can stop potentially fatal anaphylactic shock that’s in the EpiPen dispenser? $1.

It’s not just families who are held up, in much the same way as a gun-wielding robber (“Your money or your life”), but school districts, volunteer fire departments and municipalities who can face a severe budgetary crunch.

And it’s not as if Mylan hasn’t already squeezed the profit out of its drug technology – as rapidly as the price has risen, so have the salaries and bonuses paid to its executives.

The steep increase in prices started when drug company Mylan acquired the rights to the EpiPen nearly a decade ago (the company did not even invest in its development). As they hiked the prices, the salaries of their top executives skyrocketed:  From 2007 to 2015, Mylan CEO Heather Bresch’s total compensation went from $2.5 million to 3,456 to $18,9 million, a mind-blowing 671% increase.

“I am a for-profit business. I am not hiding from that,” Bresch declared. Indeed, Mylan also dodges paying taxes in America, by using the insidious “inversion” loophole.

In other words, Mylan charges more because it can. Its sole aim is to maximize return for management and investors.

About 40 million Americans have severe allergies to spider bites, bee stings and foods like nuts, eggs and shellfish. Last year, more than 3.6 million U.S. prescriptions for two-packs of EpiPens were filled, earning Mylan nearly $1.7 billion.

What was Mylan’s CEO’s response to the outcry?  Mylan said it would expand eligibility for patient assistance, with a $300 savings card.

Mylan is only the latest example. A year ago, the rage was focused on Martin Shkreli, the founder and former chief executive of Turing Pharmaceuticals, who raised the cost of a life-saving drug (which had been available for years from a company he acquired) from an affordable $13.70 a tablet to $750 per tablet.

Another company, Valeant Pharmaceuticals International similarly raised prices of many of its drugs exponentially, including two heart medications, Nitropress and Isuprel used to treat cardiac arrest, and another to treat Wilson’s disease, a rare genetic disorder.

The cynical way they dodge this despicable behavior is to suggest that the consumers don’t actually pay the sticker price – health insurance or Medicare Part D does, or in some cases (as the advertisements like to scream), they offer some relief to the poorest patients. But the upshot is that the rest of us (“society,” if you will) still do pay because of higher premiums. Also, because insurance premiums are so costly, people are opting for cheaper policies that have higher deductibles, so a family might be out-of-pocket to begin with until insurance kicks in.

What is more, the ones who are hurt the most are those who can least afford it: “One of the cruelties of drug pricing is that the burden falls most heavily on those least able to pay it. Uninsured patients often must pay the list price of a drug, and an increasingly large share of insured customers are being asked to pay a percentage of the list price,” writes Katie Thomas in the New York Times. She quotes Pembroke Consulting’s Adam J. Fein, “We soak the poor.”

Not to mention the “donut hole” that many seniors find themselves in. Seniors are finding their costs rising by double digits, 10% in 2015 and 12% in 2014.

There are laws against price-gouging– for food, water, gasoline. There are regulations that keep utility prices – for water, water treatment, electricity – in check, where price hikes have to be justified. Why are there no checks on drug companies, beyond public shaming (which does not seem to work).

The argument is that it costs millions, even a billion dollars and years to research, develop, test and bring a drug to market and many drugs never win approval so never make it to market at all. Well, it also costs millions, even billions, to create a utility system. What is more, taxpayers already pay for a lot of that research, funding programs through universities. (My idea is that taxpayers should be shareholders in the company and get reimbursed through a percentage of the profits on the drug.)

President Obama can use his executive authority to help break Big Pharma’s monopoly power. The FDA controls whether companies can offer alternatives to products like EpiPens, and the National Institutes of Health can prevent new ones from being granted.

Medicare should be allowed to negotiate drug prices (presently inexplicably prohibited under George W. Bush era legislation written by Big Pharma). The Centers for Medicare & Medicaid Services has proposed 6 pilot projects to test possible reforms to how prescription drugs are reimbursed and how the “value” of a drug is measured under Medicare Part B.

Meanwhile, in Congress, Senator Bernie Sanders and Rep. Elijah Cummings of Maryland have introduced bills that would authorize the Secretary of Health and Human Services to negotiate drug prices and reduce barriers to the importation of lower-cost drugs from Canada and other countries.

Another measure being floated in Congress would require a drug company to show justification for any annual price hike greater than 10% (consider that the inflation rate has been running 2%).

But in the absence of Congressional action, California is proposing The California Drug Price Relief Act, which would prohibit the state from paying more for a prescription drug than the lowest price paid for the same drug by Veterans Affairs, which already negotiates lower prices for pharmaceuticals.

“It is no surprise that the pharmaceutical industry already has dedicated $50 million to defeat this ballot initiative,” Sanders said. “Their greed has no end.”

Prices for prescription medicine in the United States soared last year more than 10 percent – the third consecutive year of double digit price increases. One out of five adults between the ages of 18 and 64 – more than 35 million Americans (that’s one out of five)– cannot afford the medications that their doctors prescribe.

Price gouging on life-saving drugs is only one glaring example of why it is an absurdity to operate the health care system as a purely capitalistic, free-market commodity – and yet, this is exactly what is presented by candidates Donald Trump, who vows to repeal Obamacare and the Libertarian Gary Johnson, who thinks that what is wrong with health care system is that there isn’t enough free market forces at work, while Green Party candidate Jill Stein, an actual doctor, has said that the science on childhood vaccinations isn’t definitive.

Hillary Clinton actually has a detailed policy prescription:

Building upon the comprehensive plan she offered earlier in the campaign last year, Clinton is calling for action to protect consumers from unjustified prescription drug price increases by companies that are marketing long-standing, life-saving treatments and face little or no competition. (See: Hillary Clinton Announces Aggressive New Plan to Address Unjustified Price Hikes in Life-Saving Drugs)

 

Clinton would convene representatives of Federal agencies charged with ensuring health and safety and fair competition, and create a dedicated group charged with protecting consumers from outlier price increases. They will determine an unjustified, outlier price increase based on specific criteria including: 1) the trajectory of the price increase; 2) the cost of production; and 3) the relative value to patients, among other factors that give rise to threatening public health.

Should an excessive, outlier price increase be determined for a long-standing treatment, Clinton’s plan would make new enforcement tools available including:

  • Making alternatives available and increasing competition: Directly intervening to make treatments available, and supporting alternative manufacturers that enter the market and increase competition, to bring down prices and spur innovation in new treatments.
  • Emergency importation of safe treatments: Broadening access to safe, high-quality alternatives through emergency importation from developed countries with strong safety standards.
  • Penalties for unjustified price increase to hold drug companies accountable and fund expanded access: Holding drug makers accountable for unjustified price increases with new penalties, such as fines – and using the funds or savings to expand access and competition.

As it is the system is designed to impede research and development into new drug treatments for ailments and diseases that would not have a big enough pay-back (for example, rarer diseases).

The Obama Administration has supported an initiative which focuses on precision medicine – that is, matching appropriate treatments to genetic make up (it’s why certain asthma treatments are less effective for African-Americans and Hispanics than Caucasians), and how certain cancer treatments (such as envisioned in Biden’s Cancer Moonshot) can be much more targeted.

The Health Care Industrial Complex, however, is not designed to prevent or cure, but prolong the stream of profits.

________________________________

© 2016 News & Photo Features Syndicate, a division of Workstyles, Inc. All rights reserved. For editorial feature and photo information, go to www.news-photos-features.com, email [email protected]. Blogging at www.dailykos.com/blogs/NewsPhotosFeatures.  ‘Like’ us on facebook.com/NewsPhotoFeatures, Tweet @KarenBRubin

Hillary Clinton Announces Aggressive New Plan to Address Unjustified Price Hikes in Life-Saving Drugs

Hillary Clinton announced a new plan to protect Americans from unjustified price hikes of long-available prescription drugs with limited competition, like EpiPens and pyrimethamine, the drug for a disease related to AIDS that Turing Pharmaceuticals raised the price of by more than 5,000% © 2016 Karen Rubin/news-photos-features.com
Hillary Clinton announced a new plan to protect Americans from unjustified price hikes of long-available prescription drugs with limited competition, like EpiPens and pyrimethamine, the drug for a disease related to AIDS that Turing Pharmaceuticals raised the price of by more than 5,000% © 2016 Karen Rubin/news-photos-features.com

Hillary Clinton has announced a new plan to protect Americans from unjustified price hikes of long-available prescription drugs with limited competition, like EpiPens and pyrimethamine, the drug for a disease related to AIDS that Turing Pharmaceuticals raised the price of by more than 5,000%.  After speaking out against excessive prices for prescription drugs throughout the campaign and, last week, calling for Mylan to lower its EpiPen price, Clinton believes that Mylan’s recent actions have not gone far enough to remedy their outrageous price increase. So today, Clinton is proposing a new set of strong tools – including a consumer protection group – that will let the government take effective action in such cases where public health is put at risk by an unjustified, outlier price increase for a treatment long available on the market with limited competition.

“Over the past year, we’ve seen far too many examples of drug companies raising prices excessively for long-standing, life-saving treatments with little or no new innovation or R&D,” Clinton said. “It’s time to move beyond talking about these price hikes and start acting to address them. All Americans deserve full access to the medications they need — without being burdened by excessive, unjustified costs. Our pharmaceutical and biotech industries are an incredible source of American innovation and revolutionary treatments for debilitating diseases. But I’m ready to hold drug companies accountable when they try to put profits ahead of patients, instead of back into research and innovation.”

Today, building off the comprehensive plan she offered earlier in the campaign last year, Clinton is calling for action to protect consumers from unjustified prescription drug price increases by companies that are marketing long-standing, life-saving treatments and face little or no competition. She’ll start by convening representatives of Federal agencies charged with ensuring health and safety, as well as fair competition, to create a dedicated group charged with protecting consumers from outlier price increases. They will determine an unjustified, outlier price increase based on specific criteria including: 1) the trajectory of the price increase; 2) the cost of production; and 3) the relative value to patients,among other factors that give rise to threatening public health.

Should an excessive, outlier price increase be determined for a long-standing treatment, Clinton’s plan would make new enforcement tools available including:

  • Making alternatives available and increasing competition: Directly intervening to make treatments available, and supporting alternative manufacturers that enter the market and increase competition, to bring down prices and spur innovation in new treatments.
  • Emergency importation of safe treatments: Broadening access to safe, high-quality alternatives through emergency importation from developed countries with strong safety standards.
  • Penalties for unjustified price increase to hold drug companies accountable and fund expanded access: Holding drug makers accountable for unjustified price increases with new penalties, such as fines – and using the funds or savings to expand access and competition.

Her plan will establish dedicated consumer oversight at our public health and competition agencies.  They will determine an unjustified, outlier price increase based on specific criteria including: 1) the trajectory of the price increase; 2) the cost of production; and 3) the relative value to patients, among other factors that give rise to threatening public health.

In combination with her broader plan – which addresses the costs facing consumers from both long-standing and patented drugs – these new tools to address price spikes for treatments available for many years will lower the burden of prescription drug costs for all Americans.

This plan would impact the many examples we’ve seen over the past year of drug companies raising prices excessively for drugs that have been available for years – from Turing raising the price of pyrimethamine for AIDS patients by over 5,500 percent, to Mylan raising the price of the EpiPen by more than 400 percent. This is not an isolated problem: Between 2008 and 2015, drug makers increased the prices of almost 400 generic drugs by over 1,000 percent. Many of these companies are an example of a troubling trend—manufacturers that do not even develop the drug themselves, but acquire it and raise the price.

The immediate protections she is offering today build on her broader plan to lower prescription drug costs for all Americans that she released last year.

The full fact sheet is available here.