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 …
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 …
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 …
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 …
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, …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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, …
