RE:RE:RE:RE:RE:RE:RE:Inflation Reduction Act (IRA) boosts biological drugs The IRA negotiations do not apply to drugs with generic or biosimilar competition or for orphan drugs, which are used to treat a single disease.
It also differentiates between small molecule drugs, like pills, which will be granted nine years of exclusivity before negotiations begin, and large molecule drugs, or complex biologics, which have 13 years of exclusivity.
Currently, many drugs are protected by patents for at least 20 years — but that clock begins once the drug is invented, and years of development can eat into the exclusivity time. Going forward, the IRA provides 13 years of market exclusivity from the date of the FDA's product approval.
"In some cases, the approval of a new drug is expedited. Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies. This approach allows for the approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit, or on a clinical endpoint that occurs earlier but may not be as robust as the standard endpoint used for approval. This approval pathway is especially useful when the drug is meant to treat a disease whose course is long, and an extended period of time is needed to measure its effect. After the drug enters the market, the drug maker is required to conduct post-marketing clinical trials to verify and describe the drug’s benefit. If further trials fail to verify the predicted clinical benefit, FDA may withdraw approval. A number of targeted cancer-fighting drugs have come onto the market through this pathway.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval