Posted: 09 May 2017 05:26 AM PDT By Kurt R. Karst – Earlier this week, the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee released a “Manager’s Amendment” to S. 934, the FDA Reauthorization Act of 2017 (“FDARA”). The 171-page Manager’s Amendment, which is slated for a HELP Committee vote later this week, includes several riders to the “clean” UFA (User Fee Act) package introduced last month. The package of riders includes provisions addressing drug importation and counterfeiting, device accessory classification, over-the-counter hearing aids, risk-based device inspections, generic drug product-specific bioequivalence guidance, real-world evidence, and pediatric drug development, among other things. But the rider that really caught our attention is Section 608 of the package. Titled “Technical Corrections,” Section 608 would amend provisions added to the FDC Act by the Orphan Drug Act and that are the topic of current litigation. Here’s what Section 608 of the Manager’s Amendment says: SEC. 608. TECHNICAL CORRECTIONS.And here’s how those proposed changes would appear in the statute if enacted (deletions shown in strikethrough typeface and additions in bolded and italicized red typeface): PROTECTION FOR DRUGS FOR RARE DISEASES OR CONDITIONSThe changes above would reflect FDA’s current and long-standing interpretation of the statute – that to obtain a period of orphan drug exclusivity for a drug that is otherwise the “same drug” as a previously approved drug (i.e., a drug containing the same active moiety and that is for the same orphan disease or condition), the sponsor must demonstrate that its product is clinically superior (by showing greater efficacy, greater safety, or by providing a major contribution to patient care) to the previously approved drug – but they would also legislatively undo a September 2014 court decision. As we previously posted, in a September 2014 Memorandum Opinion, Judge Ketanji Brown Jackson of the U.S. District Court for the District of Columbia ruled against FDA in a case brought by Depomed Inc. (“Depomed’s”) challenging the Agency’s refusal to grant Depomed a period of orphan drug exclusivity for the company’s orphan drug-designated GRALISE (gabapentin) Tablets (NDA 022544) because the company did not demonstrate the clinical superiority of GRALISE vis-à-vis NEURONTIN (gabapentin). Judge Jackson decided the case on Chevron Step 1 grounds, finding that “the plain language of the Orphan Drug Act requires the FDA to recognize exclusivity for Gralise.” FDA decided not to appeal Judge Jackson’s decision. Instead, FDA published in the December 23, 2014 Federal Register a “clarification of policy” notice in which the Agency addresses the effects of the Depomed court decision (see our previous post here). In that notice, FDA “double-downed” on the Agency’s pre-Depomed regulations. In short, FDA says that Judge Jackson’s decision is limited to GRALISE, and that the Agency will continue to apply its clinical superiority regulatory paradigm insofar as orphan drug exclusivity is concerned. But then another similar lawsuit was filed in April 2016 by Eagle Pharmaceuticals, Inc. (“Eagle”) alleging that FDA violated the Administrative Procedure Act when the Agency refused to grant periods of orphan drug exclusivity upon the December 7, 2015 approval of Eagle’s 505(b)(2) NDA 208194 for BENDEKA (bendamustine HCl) Injection, 100 mg/4 mL (25 mg/mL), for both the treatment of patients with Chronic Lymphocytic Leukemia and for the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen (see our previous post here). FDA previously approved TREANDA (bendamustine HCl) for Injection, for Intravenous Infusion (NDA 022249) for these same orpan diseases and determined that Eagle did not demonstrate the clinical superiority of BENDEKA vis-à-vis TREANDA. Eagle says in the company’s Complaint that “FDA denied Bendeka exclusivity . . . taking essentially the same position it took in Depomed,” and that “[h]ad FDA respected Judge Jackson’s [Depomed] ruling in 2014, this case would not be necessary. Unfortunately, FDA’s defiance of this Court’s prior order leaves Plaintiff no choice but to file this suit.” Both parties have filed Motions for Summary Judgment (here and here). A decision in Eagle’s case is still pending. |
martes, 9 de mayo de 2017
FDA Law Blog: FDA User Fee Package Includes “Technical Corrections” to Address Orphan Drug Clinical Superiority
FDA Law Blog: FDA User Fee Package Includes “Technical Corrections” to Address Orphan Drug Clinical Superiority
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