In a Complaint filed in the U.S. District Court for the District of Columbia last week, United Therapeutics Corporation (“UTC”) alleges that FDA unlawfully denied granting the company a period of orphan drug exclusivity upon the Agency’s December 20, 2013 approval of NDA 203496 for …
Earlier this week, we discussed in a post how FDA, under the Agency’s decades-old regulations defining the term “same drug,” evaluates orphan drug “sameness” in the context of fusion proteins. At the end of that post we suggested that gene therapy “sameness” might be the …
FDA’s Orphan Drug Program, which traces its birth back to the January 4, 1983 enactment of the Orphan Drug Act (“ODA”) (see our previous post here), is probably one of the most successful FDA programs to date. The success of the ODA is most apparent …
Back in mid-May 2017, when FDA issued the fourth cumulative supplement to the 37th edition of the Orange Book, observant readers may have noticed a couple of interesting entries on page A-7 of the publication. There, in the “PATENT AND EXCLUSIVITY DRUG PRODUCT LIST,” FDA …
Earlier this week, the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee released a “Manager’s Amendment” to S. 934, the FDA Reauthorization Act of 2017 (“FDARA”). The 171-page Manager’s Amendment, which is slated for a HELP Committee vote later this week, includes several riders …
Periodically, legislators and others become concerned about reports citing the high price of some orphan drugs, including drugs that achieve blockbuster status (earning more than $1 billion a year). Several proposals have been introduced in response to such concerns. In 1990, Congress passed legislation that …
Every year, hundreds of rare disease patients and caregivers descend on Capitol Hill to participate in Rare Disease Week to learn about federal legislative issues, meet other advocates, and share their unique stories with legislators. As part of this, on March 2, 2017, Hyman, Phelps …
Hardly a day goes by that we don’t see a press release or announcement that a company has requested or received from FDA’s Office of Orphan Products Development (“OOPD”) designation of its drug or biological product as an “orphan drug.” There’s a reason for that: …
By Kurt R. Karst – We recently posted on an orphan drug clinical superiority precedent we came across: PURIXAN (mercaptopurine) Oral Suspension, 20 mg/mL, for the treatment of Acute Lymphoblastic Leukemia in pediatric patients. It’s the sixth “greater safety” orphan drug clincial superiority precedent we know …
By Kurt R. Karst – We like hunting down orphan drug clinical superiority precedents. And although it’s been said that “the thrill is in the chase, never in the capture” (by a Doctor Who character at least), we enjoy the capture just as much as the …
By Kurt R. Karst – Earlier this week, iPR Pharmaceuticals, Inc. (“iPR”), the owner of NDA 021366 for CRESTOR (rosuvastatin calcium) Tablets, 5 mg, 10 mg, 20 mg, and 40 mg, and AstraZeneca Pharmaceuticals LP (“AstraZeneca”), iPR’s agent, filed a Complaint in the U.S. District Court …
By Kurt R. Karst – It was just last week when one orphan drug exclusivity labeling carve-out case (presumptively) came to an end when the U.S. Court of Appeals for the District of Columbia Circuit ruled for FDA in the context of a generic version of …
By Kurt R. Karst – An FDA decision to revoke designation of a drug (or a biological product) as an orphan drug is a rare event. (Though it’s not as rare as revocation of orphan drug exclusivity, which has happened only once – see our previous …
By Kurt R. Karst – On April 27, 2016, Eagle Pharmaceuticals, Inc. (“Eagle”) filed a Complaint in the U.S. District Court for the District of Columbia alleging that FDA violated the Administrative Procedure Act (“APA”) when the Agency refused to grant periods of 7-year orphan drug …
By Kurt R. Karst – For several years now we have been following instances in which FDA designated, and later approved, a drug (including a biological product) as an “orphan drug” on the basis that it is not the “same drug” as a previously approved product …
