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, …
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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 …
Frank Sasinowki, Director at Hyman, Phelps & McNamara, P.C. and board member of the National Organization for Rare Disorders ("NORD"), is giving the keynote address for the Campaign Urging Research for Eosinophilic Disease’s ("CURED’s") first research symposium on eosinophilic gastrointestinal disorders ("EGID"). CURED is a …
By Kurt R. Karst – Public turmoil over FDA decisions involving orphan drug exclusivity has been relatively rare in recent years. That has changed over the past several months. First there was the lawsuit brough against FDA by K-V Pharmaceutical Company to “restore” …
By Kurt R. Karst – There’s a first time for everything! And on August 8th, 2012, FDA decided, for the first time since the enactment of the Orphan Drug Act, to rescind a period of 7-year orphan drug exclusivity. The decision came in the form of …
Earlier this week, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (“FDASIA”) (usually pronounced “fuh-day-zha”). In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, FDASIA establishes new user fee statutes for …
By Kurt R. Karst – In a rare lawsuit against FDA involving the Orphan Drug Act of 1983, as amended, K-V Pharmaceutical Company (“KV”) and its wholly-owned subsidiary, Ther-Rx Corporation (“Ther-Rx”), filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction in the …