Post-approval R&D is critical for fighting cancer. The IRA makes it more difficult.

The Inflation Reduction Act (IRA) and its drug price setting policies will hurt patients, especially seniors, in many ways, such as higher costs at the pharmacy, less access to prescription medicines and fewer new innovative treatments. According to new research published in Health Affairs, the law also poses a significant threat to important R&D that may continue for medicines after they are approved by the FDA.

We’ve discussed the importance of post-approval R&D previously, especially in the fight against cancer, where post-approval research often opens the door to new ways of possibly treating cancer, including new uses of existing treatments.

Why it matters: Under the IRA, medicines can be selected for price setting early in their lifecycle. For small molecule medicines – which make up a majority of cancer medicines that receive FDA approval – selection can occur just seven years after FDA approval. And post-approval R&D decisions are impacted even before selection, as the Health Affairs study warns.

The study, which reviewed 155 oncology medicines first approved between 2000 and 2021, builds on a previous analysis that shed light on the importance of post-approval research in cancer medicine development. The new study’s key findings include:

• For nearly nine out of 10 (89%) approved cancer medicines, additional clinical trials were begun after the medicine’s initial approval, with the goal of developing new uses for the medicine.
• More than half (57%) of all uses of cancer medicines ultimately approved by FDA were approved after those medicines were first approved, and approximately two-thirds (68%) of industry-sponsored clinical trials for these medicines started post-approval.
• Half of all post-approval indications (51%) were in a new disease area for that medicine, typically a new type or subtype of cancer, such as a cancer with a different genetic biomarker or affecting a different part of the body.

The development of many cancer treatment options patients benefit from today would have been threatened if the IRA had already been in place.

• For small molecule cancer medicines approved between 2000 and 2004, 65% of post-approval clinical trials ended seven years or more after initial approval. For biologic cancer medicines, 45% of post-approval trials ended 11 years or more after approval. Given the makeup of when drug price selection occurs under the IRA, innovative biopharmaceutical companies’ business decisions would weigh heavily under such a timeline, threating new medical advances 

What does this mean for patients and the fight against cancer? As top R&D leaders at America’s biopharmaceutical research companies previously warned:

“The IRA empowers the federal government price setting to occur so soon after initial FDA approval, threatening the continued investment and R&D necessary to evaluate the full therapeutic value of the medicine, cutting off hope for patients facing this devastating disease.”

The Health Affairs study – along with a new study by the National Pharmaceutical Council – are the latest to highlight the critical role post-approval R&D plays in improving outcomes for patients and the unintended consequences of the IRA. We know what’s wrong with the law. Now lawmakers need to fix it.