By Kurt R. Karst – We were wondering how long it might be until a company went running to FDA to request that the Agency reset the date of approval of its NDA, as well as any unexpired marketing exclusivity, as the result of a proprietary …
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Orphan Drugs
- No Good Precedent Goes Overlooked: FDA is Asked to Reset FUSILEV Approval and Exclusivity Dates Because of Proprietary Name ReviewOctober 20th, 2014
- Invitation Accepted: PhRMA Sues HHS Over “Interpretive” 340B Orphan Drug RuleOctober 16th, 2014
By Jay W. Cormier & Alan M. Kirschenbaum – As we previously reported, in late August, the U.S. District Court for the District of Columbia denied PhRMA’s request that the Court vacate a recent HRSA interpretive rule on the orphan drug exception under the 340B drug …
- Court Upends FDA’s Clinical Superiority Requirement for Granting Orphan Drug Exclusivity; Decision Leaves a Lot of Questions to Be AnsweredSeptember 11th, 2014
By Michelle L. Butler & Kurt R. Karst – As we recently reported, the U.S. District Court for the District of Columbia granted Depomed Inc.’s ("Depomed’s") Motion for Summary Judgment and ordered FDA to recognize orphan drug exclusivity for Gralise (gabapentin) Tablets “without requiring any proof …
- District Court Orders FDA to Recognize Orphan Drug Exclusivity for GRALISE; Rejects FDA’s Requirement to Demonstrate Clinical Superiority of GRALISESeptember 8th, 2014
By Kurt R. Karst – Nearly two years after Depomed, Inc. (“Depomed”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s denial of orphan drug exclusivity for GRALISE (gabapentin) Tablets, the court (Judge Ketanji Brown Jackson) has finally ruled in …
- 340B Orphan Drug Exclusion Saga Continues; Court Says PhRMA Must Start OverAugust 27th, 2014
By Alan M. Kirschenbaum – We have reported previously (here and here) on PhRMA’s lawsuit challenging a HRSA regulation implementing the orphan drug exclusion that applies to certain types of covered entities under the 340B Drug Discount Program. To recap briefly, the rule had provided that …
- How Rare is the MC-to-PC Basis for Demonstrating that Two Drugs Are Not the Same Orphan Drug? Another Precedent SurfacesAugust 14th, 2014
By Kurt R. Karst – The Major Contribution to Patient Care (“MC-to-PC”) basis for demonstrating that an orphan drug is clinical superiority, and is therefore not the “same drug” as a previously approved orphan drug containing the same active moiety, is supposed to be a pretty …
- FDA Was For PROCYSBI Orphan Drug Designation Based on Clinical Superiority Before It Was Against It . . . And Then For It AgainAugust 3rd, 2014
By Kurt R. Karst – “Driveway moments” – most of us have had them. It’s that moment when we feel compelled to stay in the car and finish listening to something on the radio. This blogger recently had such a moment commuting home from work on …
- New Developments in the Ongoing PhRMA v. HHS/HRSA Saga Over the Interpretation of the Exclusion of Orphan Drugs Under the 340B ProgramJuly 23rd, 2014
By Michelle L. Butler – On July 21, 2014, the Department of Health and Human Services (“HHS”)/Health Resources and Services Administration (“HRSA”) announced the availability of an interpretive rule titled “Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program,” which …
- KV Lawsuit Involving MAKENA and Compounded 17p Concludes . . . . In Sopranos StyleJuly 7th, 2014
By Kurt R. Karst – The years-long, knock-down, drag-out fight between the K-V Pharmaceutical Company (“KV”) – now known as Lumara Health Inc. – and FDA (and the Department of Health and Human Services) involving KV’s pre-term birth orphan drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL, …
- As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List GrowsMay 29th, 2014
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
- U.S. District Court Agrees With PhRMA, Vacates HRSA 340B Orphan Drug RuleMay 28th, 2014
By Jay W. Cormier & Alan M. Kirschenbaum – Last summer, the Health Resources and Services Administration (“HRSA”) promulgated a final regulation to implement a statutory provision, added by the Affordable Care Act, that excludes orphan drugs from the ceiling price limitations of the 340B Program …
- OOPD Clarifies Orphan Drug Designation Policies for Scleroderma and Pulmonary HypertensionJanuary 15th, 2014
By Kurt R. Karst – FDA’s Office of Orphan Products Development (“OOPD”) recently revised its Standard Operating Procedures and Policies (“SOPP”) concerning review of orphan drug designation requests to provide the Office’s policies on designating products for two diseases: scleroderma and pulmonary hypertension. The second version …
- DC Circuit Reinstates KV Lawsuit Over MAKENA and Compounded 17p in Light of Cook Decision and DQSAJanuary 9th, 2014
By Kurt R. Karst – With primary briefing over (briefs here, here, and here), and a December 13, 2013 Oral Argument before Judges Griffith, Kavanaugh and Randolph concluded, we were waiting with bated breath for the U.S. Court of Appeals for the District of Columbia Circuit …
- The Shutdown: An Update on FDA ActivitiesOctober 7th, 2013
By Kurt R. Karst – We’re now entering the second week of the shutdown of the federal government (or “the lapse period” as some have called it), and there does not appear to be an end in sight. In fact, the environment in Washington, D.C. has …
- Non-Designated Uses of Orphan Drugs – To 340B or Not to 340B?October 2nd, 2013
By Jay Cormier & Alan Kirschenbaum – The Patient Protection and Affordable Care Act made extensive changes to the 340B drug discount program, which we have previously described. Among other things, the statute expanded the categories of covered entities entitled to purchase drugs at the …