One year later: IRA’s unintended consequences are becoming reality

It’s been one year since President Biden signed the Inflation Reduction Act (IRA) into law. And while the IRA’s price setting provisions are still being implemented, the law is already having negative consequences on the development of medicines. 

Here are just a few examples: 

• One manufacturer has made clear they are “not going to do certain [clinical] trials … because it is becoming financially not viable.” Others are reassessing portfolios to see if entire programs need to be shut down.  
  
  
• As a recent analysis shows, R&D investment is already shifting away from small molecule medicines as a result of the IRA’s “pill penalty” despite the significant benefit these types of medicines have for patients. These findings reaffirm concerns that other leading biopharmaceutical research companies have expressed regarding the law’s impacts on critical R&D decisions.  

As the government makes unilateral and arbitrary decisions about what innovation is valued and what is not, access to medicines will be restricted and seniors’ needs will be left unaddressed.  

• One manufacturer noted the IRA is “leading to companies…deprioritising pills for the elderly, which is not going to be the right thing in the long run for public health.” 
  
  
• And experts have predicted Part D plans will likely rely on more utilization management and move more medicines to more expensive non-preferred and specialty tiers in their formularies. The result is more barriers to medicines for seniors enrolled in Part D. 

As PhRMA CEO Steve Ubl recently highlighted, “Advances in cancer research are not accidents, nor are they inevitable.” Some may believe the unintended consequences of the IRA won’t be felt by patients, but the law is clearly having a chilling effect already.  

If lawmakers want to make medicines accessible and affordable for patients, they should advance policies that crack down on the primary drivers of what people are paying out of pocket: abusive practices of insurers and pharmacy benefit managers. Destroying the development of future cures and treatments and threatening access to medicines isn’t the answer.