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The provision, part of the Senate budget bill, was described as "a blatant giveaway to the pharmaceutical industry that would keep drug prices high for patients while draining $5 billion in taxpayer dollars."
The deep-pocketed and powerful pharmaceutical industry notched a significant victory on Monday when the Senate parliamentarian ruled that a bill described by critics as a handout to drug corporations can be included in the Republican reconciliation package, which could become law as soon as this week.
The legislation, titled the Optimizing Research Progress Hope and New (ORPHAN) Cures Act, would exempt drugs that treat more than one rare disease from Medicare's drug-price negotiation program, allowing pharmaceutical companies to charge exorbitant prices for life-saving medications in a purported effort to encourage innovation. (Medications developed to treat rare diseases are known as "orphan drugs.")
The consumer advocacy group Public Citizen observed that if the legislation were already in effect, Medicare "would have been barred from negotiating lower prices for important treatments like cancer drugs Imbruvica, Calquence, and Pomalyst."
Among the bill's leading supporters is Sen. Martin Heinrich (D-N.M.), whose spokesperson announced the parliamentarian's decision to allow the measure in the reconciliation package after previously advising that it be excluded. Heinrich is listed as the legislation's only co-sponsor in the Senate, alongside lead sponsor Sen. John Barrasso (R-Wyo.).
"Sen. Heinrich should be ashamed of prioritizing drug corporation profits over lower medicine prices for seniors and people with disabilities," Steve Knievel, access to medicines advocate at Public Citizen, said in a statement Monday. "Patients and consumers breathed a sigh of relief when the Senate parliamentarian stripped the proposal from Republicans' Big Ugly Betrayal, so it comes as a gut punch to hear that Sen. Heinrich welcomed the reversal and continued to champion a proposal that will transfer billions from taxpayers to Big Pharma."
"People across the country are demanding lower drug prices and for Medicare drug price negotiations to be expanded, not restricted," Knievel added. "Sen. Heinrich should apologize to his constituents and start listening to them instead of drug corporation lobbyists."
The Biotechnology Innovation Organization, a lobbying group whose members include pharmaceutical companies, has publicly endorsed and promoted the legislation, urging lawmakers to pass it "as soon as possible."
"This is a blatant giveaway to the pharmaceutical industry that would keep drug prices high for patients."
The nonpartisan Congressional Budget Office has estimated that the ORPHAN Cures Act would cost U.S. taxpayers around $5 billion over the next decade.
Merith Basey, executive director of Patients For Affordable Drugs Now, said that "patients are infuriated to see the Senate cave to Big Pharma by reviving the ORPHAN Cures Act at the eleventh hour."
"This is a blatant giveaway to the pharmaceutical industry that would keep drug prices high for patients while draining $5 billion in taxpayer dollars," said Basey. "We call on lawmakers to remove this unnecessary provision immediately and stand with an overwhelming majority of Americans who want the Medicare Negotiation program to go further. Medicare negotiation will deliver huge savings for seniors and taxpayers; this bill would undermine that progress."
"Elected officials who align themselves with this unpopular and greedy industry, against the will of voters, do so at their own political risk," said one patient advocate.
Republican lawmakers who support Big Pharma's efforts to block Medicare from negotiating for lower drug prices do so at their own peril, said an advocacy group Tuesday as it released polling data that shows the U.S. public overwhelmingly opposes drug companies' scheme.
Along with Hart Research Associates and GS Strategy Group, Patients for Affordable Drugs Now (P4ADNOW) polled 1,000 likely voters from August 23-27 and found that respondents opposed the numerous lawsuits the pharmaceutical industry has filed to block implementation of the Inflation Reduction Act's provision allowing Medicare to negotiate.
Seventy-two percent of voters said the law should be implemented, and 77% said they didn't believe the industry's claim that it's suing because of concerns about the provision's constitutionality—saying they think companies are only concerned it will reduce their profits, which reached a combined $110 billion last year for the eight largest pharma firms.
"The American people understand the lawsuits to block lower drug prices through Medicare negotiation are not about looking after the best interests of patients and consumers, but about the industry seeking to restore its unilateral power to dictate prices of brand name drugs without limits in the United States," said David Mitchell, founder of P4ADNOW. "The lawsuits are a naked assault against the will of the American people, and we stand with the people."
Ninety percent of respondents said lowering drug prices should be an important or a top priority for Congress, and 53% said they had an unfavorable view of drug companies after learning of the lawsuits they have filed against the Biden administration. Eighty-four percent supported allowing Medicare to negotiate directly with drug companies to lower costs for patients.
The poll was released less than a month after the Biden administration announced the first 10 prescriptions that will be subject to the negotiations, drawing applause from Democratic lawmakers and patient advocates.
Republicans such as Sens. Marsha Blackburn of Tennessee and Mike Crapo of Idaho—who received a combined $468,900 in campaign donations from pharma companies and their political action committees from 2017-22—have joined the industry in attacking the law, claiming it will "stunt the development of lifesaving treatments and cures," as Blackburn said last month.
Only 18% of voters included in the poll agreed that the law will harm research and development in the industry, while 67% believed drug companies will still be able to make huge profits and find new treatments and cures for diseases.
"Efforts in Congress to undermine implementation of the Inflation Reduction Act fly in the face of the wishes of the overwhelming majority of voters—84% of whom support the law, including 93% of Democrats, 78% of independents and 80% of Republicans," said Mitchell. "Elected officials who align themselves with this unpopular and greedy industry, against the will of voters, do so at their own political risk."
Merith Basey, executive director of P4ADNOW, noted that pharmaceutical companies draw huge profits in other high-income countries, despite the fact that they negotiate drug prices with federal agencies working on behalf of patients.
"Those nations have better health outcomes, longer life expectancy, and for lower cost," said Basey. "It's in the United States that the drug industry seeks to fleece patients with unlimited pricing power."
"It is vital that affordable insulin access is provided to everyone, including those who do not have insurance," wrote healthcare advocates.
More than three dozen healthcare and consumer advocacy groups on Monday applauded recently passed legislation to expand access to lifesaving insulin—but with more than a million people in the U.S. still forced to ration the diabetes treatment due to skyrocketing costs, the groups said U.S. Senate Majority Leader Chuck Schumer must take further action to ensure no more Americans risk their health, or even die, due to insulin prices.
With the Senate expected to advance a packages that will address high drug prices, groups including Public Citizen, Metro New York Health Care for All, and Patients for Affordable Drugs told the Democratic leader, who represents New York, that any legislation must pass "the Alec Smith test."
Alec Smith died at the age of 26, less than a month after he aged out of his parents' insurance plan. He made just enough money to not qualify for any insurance subsidies or patient assistance programs and so was forced to pay for insulin for his Type 1 diabetes out of pocket—$1,300 per month. Unable to afford the medication on top of housing costs, bills, and other essentials, Smith rationed his insulin supply and died of ketoacidosis in 2017.
"Any insulin legislation that would not have prevented this tragedy fails the Alec Smith test," wrote the groups. "It is vital that affordable insulin access is provided to everyone, including those who do not have insurance, in addition to those who are privately insured."
"Insulin legislation advanced through the Senate should put an end to perverse arrangements between drug corporations and middlemen that stifle potential savings from lower-priced insulins and put patients' lives at risk."
The groups said the legislation must include three key elements, including:
"Insulin legislation advanced through the Senate should put an end to perverse arrangements between drug corporations and middlemen that stifle potential savings from lower-priced insulins and put patients' lives at risk," they added.
The organizations credited the Democratic Party with passing medication price reforms in the Inflation Reduction Act and the American Rescue Plan, guaranteeing access to insulin for Medicare recipients for no more than $35 per month and lifting a cap on Medicaid rebates.
A recent study published in the Annals of Internal Medicine, however, showed that 1.3 million people in the U.S. are still forced to ration insulin, including 29.2% of people without insurance and nearly 20% of those with private insurance.
"Hopefully soon, some of these patients will feel improvements in access and pricing due the policies that have been enacted," wrote the groups, "but many require further relief—the Senate's work is far from complete."