Summary
Adds 180 days to the special time a new drug for a rare disease can be sold without competition, helping makers affected by the COVID-19 pandemic.
What problem does this solve?
The COVID-19 pandemic caused delays in creating new medicines for rare diseases, which could discourage companies from making them. This law gives drug makers an extra 180 days of exclusive sales rights, making it more worthwhile to continue developing these important drugs.
Who does this affect?
- Patients with rare diseases
- Pharmaceutical companies
- Generic drug manufacturers
What does this bill do?
Extends market exclusivity by 180 days
Adds 180 days to several key periods where a new drug for a rare disease cannot face competition from generic or similar products. This applies to drugs that started the investigation process during the COVID-19 emergency.
Defines a 'covered orphan drug'
Specifies that the extension applies only to drugs for rare diseases that were submitted for investigation during the COVID-19 emergency period and have no approved uses for common conditions.
Specifies the COVID-19 emergency period
Defines the relevant time frame as starting on December 1, 2019, and ending 120 days before the official termination of the public health emergency.
Takes effect immediately
States the law becomes effective as soon as it is enacted, without waiting for the Secretary to issue any new rules or guidance.
What is the real world impact?
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Encourages development of drugs for rare diseases
Provides extra time for companies to sell their new drugs without competition, making up for delays caused by the COVID-19 pandemic and encouraging them to invest in these needed medicines.
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May delay cheaper generic drugs
By extending the exclusive sales period for brand-name drugs, this could delay when cheaper generic versions become available, potentially keeping costs high for patients and insurance providers for an additional six months.
When does this start?
The changes in this bill will take effect as soon as it is signed into law.