Faster Access to Affordable Medicines: Ending Approval Delays
This act aims to speed up the market entry of more affordable generic medicines. The changes will make it harder for pharmaceutical companies to block new drug approvals by filing unjustified petitions. This means citizens could gain quicker access to more affordable treatments.
Key points
Officials can deny petitions primarily intended to delay drug approvals, speeding up access to medicines.
Clear criteria are introduced to identify delaying petitions, such as late submission or repeated issues.
Companies filing delaying petitions will be reported to the Federal Trade Commission, potentially leading to further action.
Petitions must be submitted within 60 days of obtaining the information they are based on, preventing intentional delays.
Reporting to Congress will be required on petitions, their processing time, and their impact on drug approval delays.
Expired
Additional Information
Print number: 117_HR_2843
Sponsor: Rep. Levin, Andy [D-MI-9]
Process start date: 2021-04-26