By Kurt R. Karst – The Orphan Drug Tax Credit (“ODTC”) is not an incentive you hear about all too often, but it’s been around for quite some time – since the enactment of the Orphan Drug Act of 1983 – and is a strong incentive …
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Orphan Drugs
- BIO & NORD Report Explores a World With and Without the Orphan Drug Tax CreditJuly 7th, 2015
- Update to Seminal Report on Orphan Drugs Co-Authored By HP&M Attorneys Shows FDA’s Continued “Extraordinarily Reasonable Flexibility” in ApprovalMay 1st, 2015
On April 27, 2015 the Drug Information Association journal, Therapeutic Innovation and Regulatory Science, published the findings of a study conducted by HP&M Attorneys Frank J. Sasinowski and James E. Valentine*, along with co-author, Erika B. Panico, RAC, head of U.S. Regulatory Affairs for Chiesi …
- Otsuka Sues FDA Over “Corrected” ABILIFY Approval; Alleges Violation of the Most Fundamental Precept of FDA’s Statutory Drug Approval AuthorityMarch 25th, 2015
By Kurt R. Karst – Does FDA has the authority to approve a new indication for an approved drug when that new indication has not been shown to be safe and effective by adequate and well-controlled studies submitted by the sponsor of the application? And under …
- How Orphan Drugs Came to Be Called “Orphan”February 22nd, 2015
By Frank J. Sasinowski & Andrew J. Hull* – Even though we often blog on orphan drug developments (see two of our most recent posts here and here), many may be unaware of the origin of the term “orphan.” Today, we may think that the term …
- The 2014 Numbers Are In: FDA’s Orphan Drug Program Shatters RecordsFebruary 16th, 2015
By Kurt R. Karst – Earlier this month in a post concerning the Orange Book we mentioned our love of data and discussed how solid figures can reveal some interesting conclusions. After all, it’s rather difficult – and dangerous – to come to a conclusion without …
- House Energy & Commerce Committee Releases 21st Century Cures Act Discussion Draft; The Nearly 400-Page Bill Includes More Proposals Than You Can Shake a Stick At!January 28th, 2015
By Kurt R. Karst – For months we have been waiting with bated breath for the promised January 2015 release of a discussion draft of legislation to implement the 21st Century Cures Initiative, which was launched in April 2014 by now-Chairman of the House Energy and …
- FDA Issues Post-Depomed Policy Statement; Agency Doubles Down on Clinical Superiority RequirementDecember 22nd, 2014
By Kurt R. Karst & Michelle L. Butler – Ever since FDA withdrew a notice of appeal in Depomed Inc. v. U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592, to the U.S. Court of Appeals for the District of Columbia Circuit (see …
- HRSA’s 340B “Mega-Rule” Becomes Casualty of PhRMA Lawsuit Against Orphan Drug RuleNovember 18th, 2014
By Michelle L. Butler & Alan M. Kirschenbaum – On November 13, 2014, the Health Resources and Services Administration (“HRSA”) withdrew the 340B program “mega-rule” it had submitted for review to the Office of Management and Budget. In a previous blog post we reported on a …
- FDA Withdraws Appeal in the Depomed CaseNovember 11th, 2014
By Michelle L. Butler – We previously reported that FDA had filed a notice of appeal in Depomed Inc. v. U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592. In another turn of events, on November 6, 2014, FDA filed an unopposed motion to dismiss …
- FDA Appeals Depomed Orphan Drug CaseNovember 4th, 2014
By Michelle L. Butler & Kurt R. Karst – On November 3, 2014, just short of the 60-day deadline, FDA filed a notice appealing to the U.S. Court of Appeals for the District of Columbia Circuit the Final Judgment and Order entered on September 5, 2014 …
- No Good Precedent Goes Overlooked: FDA is Asked to Reset FUSILEV Approval and Exclusivity Dates Because of Proprietary Name ReviewOctober 20th, 2014
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 …
- 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 …