RESOURCES

“Had the IRA been in place decades ago, it’s likely that far fewer rare-disease medicines would have been developed for fewer diseases or indications.” Commentary: What impact the Inflation Reduction Act can have on Boston biotechs September 1, 2023

Alnylam announced it’s reconsidering developing RNA interference therapy for Stargardt disease, a rare genetic eye disease that can cause vision loss, because of the IRA and potential price negotiations. The company wanted to pause the Stargardt disease plans to “consider options for the best path forward.” As Amvuttra makes inroads in ATTR, Alnylam scraps heart disease trial interim analysis, rethinks another rare disease plan October 27, 2022

“I would venture to guess that none of the legislators who advocated for that legislation recognize what the long-term effect will be on oncology research in this country. "I think the nine-year window for small molecule drugs] is going to prove to be unrealistic. The net result will be exactly what you’d expect: When the returns of an industry go down, the investment in the industry follows. So, we will see a reallocation of capital, certainly away from those parts of our industry which the IRA most directly affects, like small molecule research. “It is unfortunate that there are some interesting, promising small molecules for cancer research that may not see the light of day." BIO 2024: Amgen CEO Robert A. Bradway on the impact of policy on the innovation ecosystem June 5, 2024

“I think in a post-IRA world, it would be very difficult to contemplate that type of study [nine-year EMBARK study] and that type of investment. The risk is you lose that innovation; you lose that benefit." On conference circuit, biotechs lobby for their identity as new IRA drug pricing reforms take hold June 28, 2023

“I surveyed 100 VCs and biotech executives and [asked] two questions: Are you seeing a decline in small molecule funding for the elderly? Are you planning a decline based on this IRA? 85% of them are pulling out of small molecule research for the elderly as a result.” Vital Health Podcast episode: "Cancer Drug Developer Dr. Steve Potts' Congressional Testimony on the IRA" September 27, 2023

“It makes no sense to take a medicine that is already priced based on the value it delivers and demand even greater concessions, especially given that there is no requirement that the insurance companies that administer Medicare benefits will pass any new savings to patients.” The High Cost of Price Controls on Eliquis and Other Drugs August 29, 2023 “I do expect that we will cancel some programs, whether that is, you know, a full-on indication for an existing medicine or a new medicine. We are undergoing a review of our portfolio now.” Bristol Myers Squibb warns US price reforms will dent drug development November 20, 2022

“So you raise the question of should I even try for government access for new innovation if it’s going to get caught up in potential downstream negotiation.” IRA side effect: Pharma companies will increasingly skip Medicare altogether, Lilly CEO says June 14, 2023

“These are not the sorts of dilemmas we like to have to make. We’d like to put the patient first. But now we’re trying to figure out how to make a return with a nine-year clock.” Gentech CEO Hardy warns of ‘unintended consequences’ from the Inflation Reduction Act July 6, 2023 “Although we could bring it [drug targeting tumors] to ovarian patients earlier,” Hardy said, “[Genentech will] wait and seek approval for the prostate cancer indication.” IRA forcing pharmas to leave cancer patients in the lurch, CEOs say June 2, 2023

"When the government sets the price for a drug it is essentially picking the winners and losers, and removing any incentive to invest in prescription drug research and development." Guest commentary: Government price setting could hurt patient access and economy November 7, 2023

“We’ve been really clear that we do think the IRA drug setting provisions are damaging to the healthcare innovative system. It is not something that is going to help reinforce the tremendous investments that we’re making in R&D to develop the next types of treatments and cures.” Johnson & Johnson (JNJ) Q1 2024 Earnings Call Transcript April 16, 2024

“Normally we would go as fast as we can in mesothelioma,” but now the company will wait until other studies in more common types of lung cancer catch up. Keytruda’s benefits, a breast cancer win, the ‘don-zim doublet’: Weekend wrap-up from ASCO June 5, 2023 The company has cut some early-stage cancer drug programs because “nine years is just too short a time period to fully develop a drug across all of the indications … and make a reasonable return.” Novartis CEO: Some Cancer Drugs Dropped From Pipeline Because of Medicare May 19, 2023

“Biologics represent a more durable revenue potential based on a number of factors, including differentiated access and affordability to the patient, IRA considerations and patent expiration timeline. … Biologics have that 13-year versus the 9-year [for small molecules] before you enter negotiation or price negotiations, so I think that all of that strengthens the case and that has driven us to be deliberate intentionally not just on our tumor types but on the modalities that you heard about today—the ADCs as well as the bispecifics.” IRA Drive Pfizer's Decision to Focus on Biologics, Not Small Molecules March 4, 2024