Orphan Drugs

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, …

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 …

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 …

Earlier this week, the National Organization for Rare Disorders (“NORD”) held its annual gala here in Washington, D.C. recognizing achievements and advances in the area of rare (orphan) diseases.  Of course, this year is extra special; it’s the 30th anniversary of the enactment of the …

By Kurt R. Karst –       Briefing is underway in K-V Pharmaceutical Company’s (“KV’s”) appeal of a September 2012 decision from the U.S. District Court for the District of Columbia that stymied the company’s efforts to “restore” orphan drug exclusivity for the pre-term birth drug MAKENA …

By Kurt R. Karst & Frank J. Sasinowski – The Orphan Drug Act (“ODA”), which President Ronald Reagan signed into law on January 4, 1983, turned 30 years old in January.  The milestone came just days after the death of actor Jack Klugman, who has been …

By Frank Sasinowski & William Koustas – FDASIA/PDUFA V elevates the role of patients in developing orphan therapies.  It mandates that FDA implement ways to bring patients' views into drug development and FDA’s regulatory review.  This is appropriate as it is often these patients that …

Hyman, Phelps & McNamara, P.C. Director David B. Clissold will be speaking at an upcoming Management Forum conference on myriad topics, including orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products.  The conference, titled “EU and US Regulatory Issues for IP Professionals,” will take …

Hyman, Phelps & McNamara’s Robert A. Dormer will be speaking at the American Conference Institute’s upcoming conference, “Orphan Drugs and Rare Diseases – Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process.”  The conference will take place on November 28th and 29th …

Hyman, Phelps & McNamara, P.C. is pleased to announce that David B. Clissold will be speaking at an upcoming Management Forum conference on myriad topics, including orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products.  The conference, titled “EU and US Regulatory Issues for …