(Reuters) – U.S. President Donald Trump on Friday said it was issuing two new rules that are aimed at lowering drug prices for the Medicare program, including one aimed at making sure pharmacy benefit managers pass after-market rebates onto seniors.
The second rule is aimed at aligning the prices paid in the United States to those paid in foreign countries, he said.
(Reporting by Caroline Humer, Editing by Franklin Paul)
WASHINGTON (Reuters) – U.S. President Donald Trump on Thursday will sign an executive order aimed at boosting American drug manufacturing and lowering drug prices, White House trade adviser Peter Navarro said as the administration continues to grapple with the novel coronavirus outbreak.
The order, first reported by USA Today, “establishes Buy American rules for government agencies, strips away regulatory barriers to domestic pharmaceutical manufacturing, and catalyzes the Advanced Manufacturing technologies needed to keep drug prices low,” Navarro tweeted.
It will allow the Department of Health and Human Services to use a 1950 law to procure certain “essential” medicines and other equipment from U.S. companies, although it does not list specific products, USA Today reported, citing the White House.
The order also directs the U.S. Food and Drug Administration and the Environmental Protection Agency to give priority status to U.S. drug ingredient manufacturers during their regulatory review process, and addresses counterfeit medicines sold by third-party sellers, according to the report.
So far, more than 157,000 people in the United States have died from COVID-19 – about 1,000 each day – with 4.8 million known COVID-19 cases.
Trump is expected to sign the order later on Thursday, USA Today said. The Republican president is scheduled to travel to Ohio to visit a Whirlpool manufacturing plant and hold a fundraiser for his re-election campaign before traveling to his New Jersey golf resort for the weekend, according to the White House.
Representatives for the White House did not immediately respond to a request for comment.
(Reporting by Susan Heavey; editing by Jonathan Oatis)
(Reuters) – Shares of U.S. drugmakers fell on Friday, ahead of executive orders by President Donald Trump aimed at lowering drug prices.
With a re-election race underway and the coronavirus pandemic raging in the country, the White House is looking to bring down drug prices by reportedly considering tying them to what consumers outside the United States pay.
The S&P 500 was down 1.3%, with drugmakers such as Regeneron Pharmaceuticals Inc. and Pfizer Inc. weighing on the index. The declines were in line with a fall in broader markets.
Given that the speculation of an executive order on drug pricing surfaced roughly a month ago, stocks in the healthcare sector are unlikely to take a hit in the near term, Jefferies analyst Jared Holz said.
The administration’s move would likely be viewed more as political posturing than a critical moment for the pharmaceutical industry, Holz added.
Trump, who had previously urged lawmakers to rein in drug costs, will deliver remarks and sign the executive orders at 3 p.m. EDT (1900 GMT) on Friday, according to the president’s schedule issued by the White House on Thursday.
Drugmakers often negotiate rebates or discounts on their list prices in exchange for favorable treatment from insurers and other healthcare payers. As a result, insurers and covered patients rarely pay the full list price of a drug.
Elimination of rebates is likely not included in the orders, Politico reported on Thursday.
Such an order would be positive for health insurers UnitedHealth Group Inc, Cigna Corp and CVS Health, said Mizuho analyst Ann Hynes.
Cigna and CVS were among the handful of healthcare movers in the black.
Drugmakers Johnson & Johnson and Merck & Co Inc were trading down in morning trading.
(Reporting by Manas Mishra in Bengaluru; Editing by Shinjini Ganguli)
By Jeff Mason
WASHINGTON (Reuters) – U.S. President Donald Trump will unveil an executive order on Thursday aimed at strengthening the Medicare health program for seniors, seeking to improve its fiscal position and offer more affordable plan options, administration officials said.
The order, which Trump will discuss during a visit to a retirement community in Florida known as the Villages, is the Republican president’s answer to some Democrats who are arguing for a broad and expensive expansion of Medicare to cover all Americans, proposals that Republicans reject.
It follows measures rolled out in recent months by the administration designed to curtail drug prices and correct other perceived problems with the U.S. healthcare system, though policy experts say those efforts are unlikely to slow the tide of rising drug prices in a meaningful way.
The Medicare program covers Americans who are 65 and older and includes traditional fee-for-service coverage in which the government pays healthcare providers directly and Medicare Advantage plans, in which private insurers manage patient benefits on its behalf.
Seniors are a key political constituency in America because a high percentage of them vote, and Florida is a political swing state that both parties woo in presidential elections.
The order is designed to show Trump’s commitment to keeping Medicare focused on seniors, administration officials said ahead of the announcement.
The order pushes for Medicare to use more medical telehealth services, which is care delivered by phone or digital means.
One administration official, who described the order to Reuters, said that would reduce costs by cutting down on the number of expensive emergency room visits by patients; lower costs would help strengthen the program’s finances.
The order directs the government to work to allow private insurers that operate Medicare Advantage plans to use new plan pricing methods, such as allowing beneficiaries to share in the savings when they choose lower-cost health services.
It also aims to bring payments for the traditional Medicare fee-for-service program in line with payments for Medicare Advantage.
Trump’s plans contrast with the Medicare for All program promoted by Bernie Sanders, a Democratic socialist who is running to become the Democratic Party’s nominee against Trump in the 2020 presidential election.
Sanders’ proposal, backed by left-leaning Democrats but opposed by moderates such as former Vice President Joe Biden, would create a single-payer system, effectively eliminating private insurance by providing government coverage to everyone, using the Medicare model.
“Medicare for All is Medicare for none,” said Seema Verma, the administrator of the U.S. Centers for Medicare and Medicaid Services, on a conference call with reporters, calling the proposal a “pipe dream” that would lead to higher taxes.
Sanders has argued that Americans would pay less for healthcare under his plan.
The White House is eager to show Trump making progress on healthcare, an issue Democrats successfully used to garner support and take control of the House of Representatives in the 2018 midterm elections. Trump campaigned in 2016 on a promise to repeal and replace the Affordable Care Act, his predecessor President Barack Obama’s signature healthcare law also known as “Obamacare,” but was not successful.
In July, the U.S. Department of Health and Human Services (HHS) said it would propose a rule for imports of cheaper drugs from Canada into the United States. A formal rule has not yet been unveiled.
The administration also issued an executive order in June demanding that hospitals and insurers make the prices they charge patients more transparent, as well as another in July encouraging novel treatments for kidney disease.
Trump considered other proposals that did not reach fruition.
A federal judge in July shot down an executive order that would have forced drugmakers to display their list prices in advertisements, and Trump scrapped another planned order that would have banned some of the rebate payments drugmakers make to payers.
The administration is also mulling a plan to tie some Medicare reimbursement rates for drugs to the price paid for those drugs by foreign governments, Reuters reported.
(Reporting by Jeff Mason; Additional reporting by Caroline Humer and Carl O’Donnell; Editing by David Gregorio)
By Susan Cornwell and Michael Erman
WASHINGTON/NEW YORK (Reuters) – The top Republican and Democrat on the U.S. Senate Finance Committee announced a proposal to lower prescription drug prices on Tuesday that could save $100 billion in costs to government healthcare programs, and said the committee would vote on the legislation on Thursday.
The committee’s chairman, Senator Chuck Grassley, and its leading Democrat, Senator Ron Wyden, said in a statement that they have been working on the bipartisan plan to “address the broken prescription drug supply chain” for six months.
“This legislation shows that no industry is above accountability,” Grassley and Wyden said.
It is not clear how much support this, or any other drug pricing measure proposed in Congress, will receive ahead of 2020 presidential elections. But the cost of U.S. healthcare is sure to be a top campaign issue.
The proposal aims to keep drug prices down – for both Medicare patients and those in the commercial market – by forcing pharmaceutical companies to pay rebates to Medicare if they raise prices of drugs more than the rate of inflation.
Those rebates would be equal to the difference between the price increases and the inflation rate.
It also includes a cap on out-of-pocket costs for drugs covered under Medicare’s Part D, which is for self-administered prescription drugs, as well as changes to the program’s Part B, which covers physician-administered drugs.
The senators said the proposal would save taxpayers $100 billion from the Medicare and Medicaid programs. Beneficiaries would save $27 billion in out-of-pocket costs.
The Trump administration and Democrats in the House of Representatives have been working on their own plans to lower the cost of medicines for U.S. consumers.
U.S. President Donald Trump, a Republican, has struggled to deliver on a pledge to lower drug prices before the November, 2020 election. His administration is currently working to push through a rule that would tie some Medicare drug prices to the lower prices paid in other countries.
The Trump administration earlier this month scrapped an ambitious policy that would have required health insurers to pass billions of dollars in rebates they receive from drugmakers to Medicare patients.
Also in July, a federal judge struck down a Trump administration rule that would have forced pharmaceutical companies to include the wholesale prices of their drugs in television advertising.
(Reporting by Susan Cornwell in Washington and Michael Erman and Carl O’Donnell in New York; Editing by Susan Thomas, Steve Orlofsky and Bill Berkrot)
By Yasmeen Abutaleb and Michael Erman
WASHINGTON/NEW YORK (Reuters) – U.S. senators called drug pricing practices “morally repugnant” and told drug company executives they do not want to hear them blame others for the high prices, taking an aggressive stance at a Senate hearing on the rising costs of prescription medicines.
Senators took aim in particular at Abbvie Inc Chief Executive Richard Gonzalez and his company’s rheumatoid arthritis drug Humira – the world’s top-selling prescription medicine.
Executives from AstraZeneca PLC, Sanofi SA, Pfizer Inc, Merck Co, Johnson & Johnson and Bristol-Myers Squibb Co also answered questions from members of the U.S. Senate Finance Committee.
The executives pointed to their companies’ records of developing lifesaving medications, saying profits generated in the lucrative U.S. market help them fund expensive research and development of future treatments.
“American research-based companies are leading the next wave of biomedical innovation to help patients whose diseases cannot be adequately treated with today’s medicines. We should work to ensure policies that support and reward these investments,” said Bristol-Myers CEO Giovanni Caforio.
The executives also voiced support for plans to reform the industry-wide system of rebates that pharmacy benefit managers (PBMs) and health insurers receive from drugmakers in exchange for preferential coverage of their medicines.
In his opening statement, Senator Ron Wyden, the Finance Committee’s top Democrat, tore into each company one-by-one for “profiteering and two-faced scheming.”
“Drugmakers behave as if patients and taxpayers are unlocked ATMs full of cash to be extracted, and their shareholders are the customers they value above all else,” Wyden said.
Senators from both parties targeted AbbVie’s Gonzalez, with Wyden noting that the CEO’s bonus was partially tied to Humira sales, which reached nearly $20 billion globally last year. Republican Senator John Cornyn criticized the company’s web of more than 130 patents that protects Humira’s exclusivity.
The drug has a list price of more than $60,000 a year, nearly double what it was in 2014, according to Rx Savings Solutions, which helps health plans and employers seek lower cost prescription medicines.
“I support drug companies recovering a profit based on their research and development and development of innovative drugs. But at some point, that patent has to end, that exclusivity has to end, to be able to get it at a much cheaper cost,” said Cornyn, the No. 2 Senate Republican from Texas.
Cornyn suggested that the powerful Senate Judiciary Committee should examine the U.S. patent system under which drug companies protect the exclusivity of their medicines.
Congress has already held several hearings on rising prescription drug prices in both the Democrat-controlled House of Representatives and the Republican-led Senate, but Tuesday’s hearing is the first time drug company executives, most of them CEOs, will face lawmakers in more than two years.
U.S. President Donald Trump has said drugmakers are “getting away with murder,” and his administration has made bringing down prescription medicine costs for U.S. consumers a top priority.
The U.S. Department of Health and Human Services (HHS) last year rolled out a plan to lower drug prices and has introduced several modest proposals to curb medicine costs, but Democrats have said the Trump administration is not doing enough.
HHS has proposed a rule to eliminate rebates for drugs paid for by Medicare and Medicaid, the government health insurance programs.
Several drugmakers temporarily froze price increases last year after criticism from Trump, but they raised prices on more than 250 prescription drugs at the start of this year, albeit at lower levels than in years past.
(Reporting by Yasmeen Abutaleb; editing by Jonathan Oatis and Bill Berkrot)
By Yasmeen Abutaleb
WASHINGTON (Reuters) – U.S. Senator Bernie Sanders plans to send a letter to Catalyst Pharmaceuticals on Monday asking it to justify its decision to charge $375,000 annually for a medication that for years has been available to patients for free.
The drug, Firdapse, is used to treat Lambert-Eaton Myasthenic Syndrome (LEMS), a rare neuromuscular disorder, according to the letter, made available to Reuters by the senator’s office. The disorder affects about one in 100,000 people in the United States.
The government is intensifying its scrutiny of the pharmaceutical industry and rising prescription drug prices, a top voter concern and a priority of President Donald Trump’s administration.
Both the Democratic-led U.S. House of Representatives and the Senate, controlled by Republicans, have begun holding hearings this year on the rising costs of medicines. Sanders is an independent who usually votes with Democrats.
In the letter dated Feb. 4, Sanders asked Catalyst to lay out the financial and non-financial factors that led the company to set the list price at $375,000, and say how many patients would suffer or die as a result of the price and how much it was paying to purchase or produce the drug.
For years, patients have been able to get Firdapse for free from Jacobus Pharmaceuticals, a small New Jersey-based drug company, which offered it through a U.S. Food and Drug Administration (FDA) program called “compassionate use.”
The program allows patients with rare diseases and conditions access to experimental drugs outside of a clinical trial when there is no viable alternative.
Florida-based Catalyst received FDA approval of Firdapse in November, along with exclusive rights to market the medication for several years. The company, which bought rights to the drug from a company called BioMarin in 2012, develops and commercializes drugs for rare diseases.
In December, Catalyst announced it would price Firdapse at $375,000 a year.
“Catalyst’s decision to set the annual list price at $375,000 is not only a blatant fleecing of American taxpayers, but is also an immoral exploitation of patients who need this medication,” Sanders wrote in his letter.
Sanders joins other U.S. lawmakers in investigating the pricing practices of pharmaceutical companies this year.
Democratic Representative Elijah Cummings, chairman of the House Oversight Committee, in January, wrote to 12 pharmaceutical firms asking for detailed information on how they set drug prices.
Democratic Representatives Frank Pallone and Diana DeGette wrote to the heads of Eli Lilly, Novo Nordisk and Sanofi, the long-time leading manufacturers of insulin, requesting information on why the drug’s price has skyrocketed in recent years.
(Reporting by Yasmeen Abutaleb; Editing by Sonya Hepinstall)
By Yasmeen Abutaleb
WASHINGTON (Reuters) – Two powerful U.S. lawmakers sent letters to the three leading insulin manufacturers on Wednesday requesting information on why its cost has skyrocketed in recent years and how much the companies profit from the life-sustaining diabetes treatment.
Democratic Representatives Frank Pallone and Diana DeGette, the chairman and a top-ranking member of the House Energy and Commerce Committee, respectively, wrote to the heads of Eli Lilly and Co, Novo Nordisk and Sanofi, the long-time leading manufacturers of insulin. The drugmakers have all raised the price of insulin at similar rates over the last several years.
“Despite the fact that it has been available for decades, prices for insulin have skyrocketed in recent years, putting it out of reach for many patients,” the lawmakers wrote.
“As one of the few manufacturers of insulin in the United States, your company is well-suited to shed light on these issues and offer potential solutions,” the letter to the three companies said.
The committee has not set a date for a hearing, a spokesman for DeGette said. It has the power to subpoena the drugmakers if they do not answer the committee’s request.
The annual cost of insulin for treating a type 1 diabetes patient in the United States nearly doubled from 2012 to 2016 to $5,705 from $2,864, according to a recent study.
The lawmakers’ letters come amid intensifying scrutiny from Congress over the high cost of prescription drugs for U.S. consumers. Both the House Oversight Committee and Senate Finance Committee held hearings on prescription drug prices on Tuesday, with a focus on insulin.
Sanofi confirmed receipt of the letter and said it would work with the committee on its request. Neither Novo nor Lilly immediately responded to requests for comment.
High prescription drug costs have consistently polled as a top voter concern and have been a top priority of the administration of U.S. President Donald Trump, a Republican.
U.S. prescription drug prices are far higher than in other developed nations that either directly or indirectly control medicine costs.
Democratic Representative Elijah Cummings earlier this month wrote to 12 pharmaceutical companies asking for detailed information on their pricing practices, including the makers of insulin.
About 1.2 million Americans have type 1 diabetes, requiring daily insulin. Type 2 diabetes, which affects nearly 30 million Americans, according to the American Diabetes Association, is treated with a variety of other medicines. But those patients may also eventually become dependent on insulin.
(Reporting By Yasmeen Abutaleb; Editing by Bill Berkrot)
By Michael Erman
NEW YORK (Reuters) – Drugmakers kicked off 2019 with price increases in the United States on more than 250 prescription drugs, including the world’s top-selling medicine, Humira, although the pace of price hikes was slower than last year.
The industry has been under pressure by the U.S. President Donald Trump to hold their prices level as his administration works on plans aimed at lowering the costs of medications for consumers in the world’s most expensive pharmaceutical market.
During a White House meeting with members of his Cabinet, U.S. President Donald Trump on Wednesday said he expected to see a tremendous decrease in drug prices. Health and Human Services (HHS) Secretary Alex Azar was at the meeting.
The overall number of price increases was down by around a third from last year, when drugmakers raised prices on more than 400 medicines, according to data provided by Rx Savings Solutions, which helps health plans and employers seek lower cost prescription medicines.
Allergan Plc was particularly aggressive. It raised list prices on more than 50 drugs, and more than half of those by 9.5 percent, according to the Rx Savings data
AbbVie Inc increased by 6.2 percent the list price of its blockbuster rheumatoid arthritis treatment Humira, which is on pace to record about $20 billion in sales in 2018.
Allergan said in a statement that its average list price increase across its portfolio is around 3.8 percent this year. It said it does not expect to realize any net benefit from the increases this year because of higher rebates and discounts it expects to make to payers.
AbbVie did not immediately respond to request for comment.
More price increases are expected this month. Reuters reported late last year that nearly 30 drugmakers had notified California agencies they plan to raise list prices of their drugs. Not all of those increases have been announced yet.
The United States, which leaves drug pricing to market competition, has higher prices than in other countries where governments directly or indirectly control the costs, making it the world’s most lucrative market for manufacturers.
HHS has proposed policy changes aimed at lowering drug prices and passing more of the discounts negotiated by health insurers on to patients. Those measures are not expected to provide relief to consumers in the short-term, however, and fall short of giving government health agencies direct authority to negotiate or regulate drug prices.
“It’s business as usual” for drugmakers, said Rx Savings Solutions Chief Executive Michael Rea, who said he believes there has to be meaningful changes to the marketplace, rather than new regulations in order for drug prices to drop.
(Reporting by Michael Erman; additional reporting by Jeff Mason in Washington; Editing by Bill Berkrot)
WASHINGTON (Reuters) – A U.S. House of Representatives subcommittee will take up bipartisan legislation next week to foster generic drug development, the committee’s chairman, Representative Greg Walden, said on Thursday.
“President (Donald) Trump made it clear … he wants competition to lower drug prices, and that is precisely what this measure will help accomplish,” Walden, a Republican from Oregon, said at a health subcommittee hearing.
“Specifically the bill will require FDA (the Food and Drug Administration) to prioritize, expedite and review generic applications of drug products that are currently in shortage, or where there are few manufacturers on the market,” Walden said.
Trump this week met pharmaceutical executives and called on them to cut prices. He said the government was paying “astronomical” prices for medicines in its health programs for older, disabled and poor people.
Walden said recently there had been cases of “bad actors” who “jacked up the price of drugs because there was no competition,” but he did not name names. “We want to make sure that does not happen again,” the congressman said.
“For those in the industry who think it’s okay to corner a market, drive up prices and rip off consumers, know that your days are numbered,” Walden said.
He said the bill would also increase transparency around the backlog of generic drug applications at the FDA, saying there was an “unacceptably high” number.
The bill will be sponsored by Representative Gus Bilirakis, a Republican from Florida, and Representative Kurt Schrader, a Democrat from Oregon, Walden said. Republicans have the majority in both chambers of Congress.
(Reporting by Susan Cornwell; Editing by Chizu Nomiyama and James Dalgleish)
