Prevents the FDA from delaying the approval of a generic drug unless a delay is necessary to protect public health.
Feature: The Strategy of Delay — Understanding FDA Citizen Petitions 06C1C8EE-6564-46FE-9989-DBF4FBF086FE_1531776 - ...
Sets strict timelines for FDA responses (currently 150 days). Prevents the FDA from delaying the approval of
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 3. Legislative Countermeasures Under FDA regulations
Under FDA regulations, any individual or entity can petition the agency to take (or refrain from taking) a specific administrative action. In the context of pharmaceuticals, these are often used to raise concerns about the safety or bioequivalence of a pending generic drug application (ANDA). 2. The "Sham" Petition Concern
The core issue discussed in the SSRN study (ID 1531776) is whether brand-name manufacturers use these filings strategically.
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.