By Kurt R. Karst – Earlier this week, Public Citizen announced the release of a report, titled “House Orphan Drug Proposal: A Windfall for Pharma, False ‘Cure’ for Patients,” that takes aim at a particular provision in the 21st Century Cures Act (H.R. 6) that the …
By Jennifer M. Thomas & Michelle L. Butler – The U.S. District Court for the District of Columbia ruled decidedly in favor of PhRMA and against the government earlier this week in PhRMA v. HHS, No. 14-1685 (Oct. 14, 2015), potentially concluding a protracted fight between the Health …
By Kurt R. Karst – The legal world is chock-full of tests, doctrines, and processes named after a particular case or court decision. It’s kind of a legal short-hand; a lexicon of legal eponyms. There’s the “Winter Standard” for preliminary injunctions in federal courts; the “Lemon …
By Kurt R. Karst – In a September 10, 2015 Response to a September 2, 2011 Citizen Petition (Docket No. FDA-2011-P-0657) submitted by the National Organization for Rare Disorders (“NORD”), FDA refuses to add a statement to guidance documents concerning orphan drugs that the Agency’s official …
By Alexander J. Varond & James E. Valentine* – FDA recently released a draft guidance, titled “Rare Diseases: Common Issues in Drug Development.” The fourteen-page document amounts to more of a primer than a focused discussion of technical issues. It serves as a useful reminder of the …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
