By filing a petition shortly before a generic's expected approval, a manufacturer can force the FDA to spend time and resources reviewing the claim.
Allows the FDA to summarily deny petitions that are deemed to be submitted solely for the purpose of delay. 4. Current State of Play 06C1C8EE-6564-46FE-9989-DBF4FBF086FE_1531776 - ...
To curb potential abuse, the U.S. Congress passed of the Federal Food, Drug, and Cosmetic Act. This law: By filing a petition shortly before a generic's
Even if the petition is ultimately denied, the delay can preserve the brand's monopoly for months, translating into significant additional revenue. 3. Legislative Countermeasures 06C1C8EE-6564-46FE-9989-DBF4FBF086FE_1531776 - ...
The core issue discussed in the SSRN study (ID 1531776) is whether brand-name manufacturers use these filings strategically.