House, Senate Re-Introduce Bill Targeting Generic Drug Suppression
House and Senate leaders re-introduced legislation to keep drugmakers from blocking generic competitors.
Sen. Patrick Leahy (D-Vt.) and Rep. Tom Marino (R-Pa.) reintroduced the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which would allow generic drugmakers to take brand-name manufacturers to court to obtain samples of branded products for research and testing.
The bill would also authorize judges to award damages to generic makers to deter future anti-competitive behavior.
The bill takes aim at the brand-name practice of refusing to allow generics makers to participate in a distribution safety protocol, limiting their ability to get FDA approval for generic versions. Under the bill, the FDA would have more leeway to approve alternative safety protocols rather than requiring generic and brand-name drugmakers to develop shared protocols.