USA —In a dramatic legal move, pharmaceutical giant AstraZeneca has thrown down the gauntlet against the Biden administration’s attempt to rein in drug prices.
The company contends that the measures, while aimed at curbing costs, could inadvertently stifle groundbreaking research in critical areas like cancer and rare diseases.
AstraZeneca’s clash with the US government’s Inflation Reduction Act (IRA) adds it to a growing list of pharmaceutical heavyweights, including Merck & Co., Bristol Myers Squibb, and PhRMA, who are taking a stand against the potential repercussions of this contentious legislation.
Clash with the Orphan Drug Act
At the heart of AstraZeneca’s dispute lies a conflict with the Orphan Drug Act (ODA), a pivotal federal statute created to incentivize manufacturers to invest in innovative therapies for rare diseases.
AstraZeneca, which boasts a portfolio that could see some of its products affected by the new pricing regulations, contends that the IRA’s drug-price negotiation provisions are at odds with the ODA’s objectives.
Dave Fredrickson, head of AstraZeneca’s oncology business unit, remarked, “Rare disease and cancer patients depend upon high-risk, low-probability drug development that takes many years to develop and aims for cure.”
He pointed out that if the current version of the law stands, patients with rare conditions in the US could experience delayed access to groundbreaking treatments compared to their global counterparts.
AstraZeneca emphasized the remarkable impact of the Orphan Drug Act, which has catalyzed the creation of over 600 medicines addressing nearly 1000 rare conditions, including various cancers.
Despite these gains, the company highlighted that a staggering 7000 rare conditions still lack approved treatments.
Implications for lifesaving medicines
The focus on AstraZeneca’s cancer drug Lynparza (olaparib) illustrates the potential implications of the IRA for critical therapies.
The company underscored that numerous cancer treatments begin with orphan indications before expanding to broader populations over time.
AstraZeneca contended that if the IRA had been in effect earlier, pursuing late-line ovarian cancer approval for Lynparza might have been discouraged in the US.
Another illustrative example is the rare-disease therapy Soliris (eculizumab), obtained through AstraZeneca’s acquisition of Alexion.
Originally greenlit for paroxysmal nocturnal hemoglobinuria in 2007, this drug’s continued research investment led to expanded approvals, even more than a decade later.
AstraZeneca argued that the IRA’s implementation could have impeded the ongoing development of this transformative medicine for patients with rare diseases beyond its initial application.
According to AstraZeneca, “Addressing these concerns and safeguarding medications like Lynparza and Soliris from stringent price controls may wield limited impact on the overall expenses of the US healthcare system, but its effects on patients would be immeasurable.”
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