REMS Bill – Is It Really the Answer?

The Hill report (here) that “Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) on Wednesday reintroduced legislation intended to close a loophole that drug companies can exploit to block competition, including from lower-cost generic drugs.”  The bill would permit FDA to approve a drug product for a generic immediately if all other approval requirements are […]

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Skinny Label Reprieve, But Not Out of the Woods Yet!

The generic community sprung into action with amicus briefs filed by the Association of Accessible Medicines and letters written by various other organizations to challenge the attack on the skinny label.  Teva was able to convince the Court of Appeals for the Federal Circuit to rehear its skinny label case.  Clearly, Congressional intent and regulatory […]

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Kick, Fight, and Scream, but Most of All Hope the Full Appeals Court (and/or the Supreme Court) Reverses

Ever since November 24, 1984, the effective date of the Drug Price Competition and Patent Term Restoration Act (aka Hatch-Waxman) which created the unique and delicate balance between innovation and safe and effective high quality generic copies of brand name products, the use of the “skinny label” has been a touchstone of that balance.  Rather […]

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Tidbits from the Monday AAM Afternoon Sessions – and Pay Close Attention to Little viii Carve Out Issue

We all know you can’t be in two places at once (although it would certainly be handy at times).  That applies to the Association for Accessible Medicines (AAM) meeting as well.  While there are lots of good sessions, as a one-man band, some tough choices had to be made. Let’s tackle one of the most […]

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Extension Sought on Comments Regarding Patent Listing

On June 1, 2020, in Docket FDA-2020-N-1127 and published in the Federal Register, the Agency asked for public comment regarding updating and clarifying the types of patents that could be listed in the Orange Book (here).  The document sought comments on two specific issues of continued interest: should patents be submitted to the FDA and […]

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