top of page
Search

Perspective of a Korean Pharmaceutical Company on the Inflation Reduction Act

  • Writer: Jaemin Cho
    Jaemin Cho
  • Jul 20, 2023
  • 2 min read

In August 2022, the Inflation Reduction Act (IRA) was signed into law. For US pharmaceutical markets, there will be a limitation on drug price increases surpassing inflation. Congress projected that the IRA would save more than $287 billion over 10 years.


Under the IRA, starting in 2026, the Department of Health & Human Services will be authorized to negotiate prices for certain expensive prescription drugs in the Medicare program. The number of drugs subject to price negotiations is limited and will gradually increase from 10 in 2026 to 60 in 2029. The emphasis lies on FDA-approved drugs that are expensive and originate from a single source, lacking any competing alternatives.


Korean pharmaceutical companies are expected to experience relatively less impact from the IRA since it primarily pertains to the U.S. Medicare program. However, Korean pharmaceutical companies targeting the US market can still expect several impacts from the IRA.


The IRA is expected to reduce the revenue of all pharmaceutical companies, including Korean companies. Consequently, this could lead to lower investments in research and development, as well as potential job losses within the Korean pharmaceutical industry.


The IRA has the potential to offer a more advantageous position to businesses with a stronger emphasis on biologics rather than chemicals in their portfolios. The former will be less affected by the IRA since the legislation might be applied to them after an extended period of 11 years, whereas businesses primarily dealing with chemicals may face its effects after seven years.


The IRA will have a lesser effect on companies not receiving federal funding for research. As a result, drug makers may become less motivated to collaborate with the National Institute of Health and instead opt to develop their own technologies to avoid government support.


From the perspective of a Korean pharmaceutical company, the IRA is expected to have a stronger impact on pharma companies that deal with small molecule drugs, with a primary focus on the U.S. market, and those with considerable exposure to Medicare. To effectively adapt to the effects of the IRA, these companies should implement a repositioning strategy. This involves conducting a thorough reassessment of their revenue projections, revising their research and development (R&D) investments, and carefully reconsidering their long-term pipelines.

 
 
 

Recent Posts

See All
FDA 신약 승인을 위한 해외 임상 전략: IND 포함 vs. 비포함 (Under IND vs. Out of IND)

미국 시장 진출을 준비하는 바이오/제약 기업들에게 고민되는 질문 중 하나는 바로 이것입니다. "해외(미국 외 지역)에서 진행하는 임상시험을 미국 IND (임상시험 계획 승인) 하에 진행해야 할까, 아니면 현지 규정에 맞춰서만 진행해야 할까?" 이 결정은 향후 FDA 신약 승인 (NDA/BLA)의 성패를 가를 수 있는 중요한 전략적 선택입니다. 블로그 포스트

 
 
 
신약 개발 스타트업이 새겨야 할 조직

‘시작이 반이다’라는 속담이 있다. 어디에도 그 기원을 특정하기는 어렵지만, 오래전부터 우리 사회에서 사용되어 온 만큼, 농경 사회를 바탕으로 살아온 우리 조상들의 경험과 지혜를 담고 있다고 볼 수 있을 것이다. 농사는 씨앗을 뿌리는 것으로...

 
 
 
FDA 제출 문서 영문 번역

영문 문서는 국제적인 소통의 필수 도구다. 신약 개발 회사의 경우, 영문 논문 발표, 특허 출원, 임상 시험 보고서 작성 등 다양한 영역에서 영문 문서가 활용된다. 또한, 글로벌 규제 기관과의 소통을 위해서도 정확하고 명확한 영문 문서 작성 능력...

 
 
 

Comments


bottom of page