Inflation Reduction Act Archives - Medical Design Sourcing

In latest move, Biden targets 48 medications that have outpaced inflation

[Image courtesy of Biden for President]

In the latest move targeting Big Pharma, the Biden Administration has signaled its intent to target the pricing of dozens of prescription drugs. In a recently announced Fact Sheet, the Administration announced a strategy under the Inflation Reduction Act to focus on 48 Medicare Part B drugs that have raised prices faster than inflation. This initiative requires pharma firms to pay rebates to Medicare, which could translate to savings of $1 to $2,786 per dose for beneficiaries. The administration notest that it estimates more than 750,000 seniors to use the medications the act covers.

The Inflation Reduction Act is the backbone of Biden’s drug pricing policy, mandating rebates from pharma firms if their prices increase outpace inflation. The legislation also gives Medicare the ability to negotiate the price of a number of drugs. The law also includes a significant cap on o…

Navigating the new regulatory terrain pharma companies face with IRA and 340B

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The ever-evolving landscape of pharmaceutical regulations has long been challenging to navigate, but now pharma companies face additional complexities with the introduction of the Inflation Reduction Act (IRA) and the ongoing implementation of the 340B drug pricing program. In recent years, the IRA has made waves for its impact on the pharmaceutical industry, including proposals to allow Medicare to negotiate drug prices for the first time and imposing rebates on drug price increases that outpace inflation. Additionally, the 340B Drug Pricing Program, which was created in 1992, is a U.S. federal government program that aims to allow healthcare organizations to offer affordable prescription drugs to underserved and low-income populations. In 2021, 340B backed entities purchased $43.9 billion worth of covered outpatient drugs under the program.

To get a clearer sense of how the indu…

BMS sees new drug sales surge as Revlimid dips in Q3

Bristol-Myers Squibb (BMS) reported a mixed bag of results for the third quarter, with new drug sales up even as its popular blood cancer drug Revlimid fell 41% to $1.43 billion owing to generic competition. The anticoagulant Eliquis is in a similar position, but was also selected to be one of the first 10 drugs eligible for the new Medicare negotiations under the Inflation Reduction Act.

In the third quarter, BMS’s new product portfolio raked in $928 million in the quarter — up 68% year-over-year. “Based on the performance year to date, we now expect the new product portfolio to deliver roughly $3.5 billion for the full year 2023,” said CFO David Elkins in an earnings call. The company expects its new drug portfolio to reach $10 billion in sales by 2026.

Still, the company delayed its projections that its new drugs would hit at least $10 billion to 2026 from its earlier projection of 2025. The delay comes as departing CEO Giovanni Caforio …

Prices of top 25 Medicare Part D drugs more than doubled since market entry; AARP offers new insights in drug pricing report

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Medicare Part D drug prices have seen a significant surge in recent years. The price of the arthritis drug Enbrel has soared 701% since its launch in 1998, and the diabetes drug Januvia has jumped 275% since its debut 2006. All in all, the average price increase for the 25 brand-name drugs with the highest Medicare Part D spending in 2021 was 226%, noted AARP in a recent drug pricing report.

Such attention-grabbing stats aren’t isolated cases, but part of a bigger picture. Almost 60% of the current list price for the top 25 drugs is a result of price increases post launch. “On average, the prices of the 25 top Medicare Part D drugs have more than tripled since they first entered the market,” said Leigh Purvis, director, health care costs and access at AARP, in a media briefing. “Some of the prices are more than eight times higher than they were when they launched.”

The economic…

Astellas latest to wage war against the Inflation Reduction Act

In a recent move, Astellas Pharma challenges IRA, a step that sees them join other pharmaceutical heavyweights in a lawsuit against the federal government. The bone of contention is the Inflation Reduction Act (IRA), a law primarily designed to drive down prescription drug prices, a proposition that no Republican supported.

Astellas, along with the other pharma companies, takes issue with the IRA’s plan to let Medicare negotiate prices on their top-selling drugs. They argue this will not only be financially burdensome but also stifle new drug development and breach their constitutional rights.

Constitutional violations: Astellas Pharma challenges IRA

Astellas Pharma, in its public statement last week, outlined three ways in which it believes the new Medicare Drug Price Negotiation Program is in violation of the Constitution. The key concern is that it’s essentially theft or a “taking of property” by forcing companies to offer lower price…

The economic impact of pharma giants’ fight with the U.S. government over drug pricing reform

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Big Pharma firms Merck and Bristol Myers Squibb are challenging President Biden’s Inflation Reduction Act, alleging the law’s plan to lower drug prices infringes on their rights. The U.S. Chamber of Commerce — whose members include drugmakers AbbVie and Eli Lilly — is also aiming to block Medicare from rolling out the program.

In 2022, President Biden signed the Inflation Reduction Act (IRA) into law to fund major healthcare and climate change initiatives. No Republican supported the bill. The IRA allows Medicare to negotiate the prices of certain high-cost drugs. The program would first focus on 10 drugs in 2026. From there, it is slated to expand to 15 drugs in 2027 and 2028, and 20 drugs per year from 2029 on. Only medications on the market for years without competition are eligible.

Assessing the impact of the Inflation Reduction Act on drug …

Exploring Merck’s key arguments in its constitutional challenge against the Inflation Reduction Act

In a strong move against the federal government, Merck & Co., based in Kenilworth, New Jersey, has launched a lawsuit against the Inflation Reduction Act (IRA). The firm has retained the services of prominent law firm Jones Day, at times known for its assertive litigation style. In recent years, the firm has also been involved in contentious cases, for instance, representing Volkswagen in its emissions scandal and Donald Trump during his presidential campaigns. In Merck’s opening salvo against the government’s prescription drug pricing program under the Inflation Reduction Act (IRA), the company has fired off a strongly-worded complaint. The suit was filed on June 6 in the U.S. District Court for the District of Columbia against senior federal healthcare officials and agencies including the Secretary of Health and Human Services Xavier Becerra, and the Centers for Medicare & Medicaid Services.

This legal challenge is the latest chapter in Merck’s…

A timeline of Merck’s legal battle over Medicare negotiation

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Marking the first legal challenge of its kind, pharma giant Merck & Co. took to the courts on Tuesday, directly contesting the U.S. government over the Medicare drug price negotiation program. The Big Pharma company’s lawsuit, filed in the U.S. District Court for the District of Columbia, contends the program’s basis — the Inflation Reduction Act (IRA) — infringes upon the Fifth and First Amendments of the U.S. Constitution.

The legislation has put pricing pressure on the industry and contributed to a wave of recent M&A deals.

Merck, and the wider pharmaceutical industry, are raising the alarm. They claim the law, in effect, coerces drugmakers into accepting below-market rates. The lobbying group PhRMA (Merck is a member) released a statement in April 2023 arguing that the Inflation Reduction Act threatens patient access and complicates R&D efforts.…