House Committee Clears Bills To Prevent Pay-For-Delay Deals, Assure Generic Access To Samples
Legislation on patent settlement agreements will not be retroactive; CREATES Act amended to give brand companies affirmative defense to litigation.
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CREATES Act and 180-day exclusivity reforms also in legislation headed to US House floor, even as generic industry remains opposed to two of the three main provisions. The Rx pricing language is bundled with Obamacare language designed to force a tough vote by Republicans.
US committee will likely re-examine the language regarding the burden of proof in a bill prohibiting pay-for-delay settlements.
House Ways & Means Committee clears legislation requiring manufacturers to justify 10% WAC increase in one year and 25% increase over three years, and to report number of free product samples.