FDA’s Catch-22 Problem Although the generic drug approval process was intended to be streamlined and efficient, Abbreviated New Drug Applications (ANDAs) often run a gauntlet of unnecessary and senseless regulatory hazards during the review process.  One of the biggest is FDA’s “Catch-22” policy regarding qualitative and quantitative (Q1/Q2) sameness.  On the one hand, many generic drugs – particularly injectables and complex generics – cannot be approved unless they contain the same inactive ingredients in the same amounts as the reference listed drug (RLD).  This is what Q1/Q2 ..read more

It is very unusual for a Hatch-Waxman exclusivity issue to intersect with a Pixar movie. But a recent viewing of The Incredibles got me thinking about FDA’s 2016 final regulation regarding 180-day exclusivity, particularly its new rule that an ANDA applicant cannot submit a paragraph IV certification until the day after a new patent is published in the Orange Book. For those who don’t have kids (or, in my case, young nephews), the Incredibles lived in a world where being special – better, stronger, faster – was discouraged, where everybody got a “participation trophy” just for showing up. As t ..read more

On July 22, 2019, the United States District Court for the District of Columbia ruled against the Food and Drug Administration (“FDA”) in a lawsuit challenging FDA’s application of 3-year exclusivity in the context of a 505(b)(2) application. The court’s decision in Braeburn Inc. v. FDA (Civ. Action No. 19-982 (BAH)) took direct aim at what we have called “Submarine Exclusivity” in prior blog posts, faulting the Agency for making decisions about the scope of exclusivity without any “intelligible decisional principle.” The court thus vacated FDA’s exclusivity determination and remanded the issu ..read more

For many things in life, details matter. Take cooking, for instance: add the wrong ingredient or combine your ingredients in the wrong order, and you may have an unexpected disaster rather than a prize-winning pie. Trust me, you don’t want to eat a cake made with baking soda when the recipe calls for baking powder. NCE Exclusivity for Combination Drug Products For many years, the same rule applied to new chemical entity (NCE) exclusivity for fixed-combination drug products. Under FDA’s longstanding policy, if a company mixed the active ingredients together in the wrong order, NCE exclusivity w ..read more

In the world of exclusivity, there is one overarching rule: all good things must come to an end. New chemical entity (NCE) exclusivity expires after five years (sometimes four); orphan drug exclusivity ends after seven years; and even Reference Product exclusivity expires eventually – after a whopping 12 years. But there is one glaring exception to this general rule: Orphan Drug Designation (ODD). If exclusivity periods were candies, ODD would be an Everlasting Gobstopper. While ODD is not an exclusivity period in its own right, it is close enough. It comes with a multitude of benefits – such ..read more

Welcome to the new Exclusivity Rules blog, sponsored by Lassman Law+Policy.  As the name suggests, this blog will focus on the complex rules – both written and unwritten – that govern FDA’s exclusivity decisions for drugs and biologics. The blog will explore both recent developments and past precedents that may have been forgotten but are still relevant and important today.  And while Exclusivity Rules will be sharply focused on exclusivity issues, it will address all types of exclusivity, including NCE, 3-year, orphan, pediatric, 180-day, competitive generic therapy, reference produ ..read more