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 …
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Orphan Drugs
- FDA Was For PROCYSBI Orphan Drug Designation Based on Clinical Superiority Before It Was Against It . . . And Then For It AgainAugust 3rd, 2014
- 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 …
- As Partial Government Shutdown Kicks In, FDA’s Foods Program Is Hardest HitOctober 1st, 2013
By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …
- FDA Announces Fiscal Year 2014 User Fee Rates; They’re Movin’ On Up!August 1st, 2013
By Kurt R. Karst – Now that we've put the theme from The Jeffersons in your head . . . . On August 2, 2013, FDA will officially announce in a series of Federal Register notices the Fiscal Year 2014 (“FY 2014”) user fee rates under …
- FDA SOS: New Bill Would Exempt FDA User Fees From the Ravages of SequestrationJuly 18th, 2013
By Kurt R. Karst – “… — …” – That’s the international Morse code distress signal commonly shown as SOS. SOS is also in the title of the acronymized “FDA SOS Act,” or the “FDA Safety Over Sequestration Act,” which a bipartisan group of members …
- Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75!June 25th, 2013
By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
- House Appropriations Committee Report Expresses Concerns About FDA; Would Require a Slew of New Action DeadlinesJune 13th, 2013
By Kurt R. Karst – A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …
- FDA Issues Final Orphan Drug RegulationsJune 12th, 2013
By Michelle L. Butler – On June 12th, the final rule to amend FDA’s 1992 orphan drug regulations was published in the Federal Register. 78 Fed. Reg. 35117 (June 12, 2013). This final rule, which largely finalizes the revisions as proposed in October 2011, will …