By Kurt R. Karst – Last week marked the 5th anniversary of the March 23, 2010 enactment of the Affordable Care Act (“ACA”). Title VII of the ACA, the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), amended the Public Health Service Act (“PHS Act”) …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a junior to mid-level associate with substantive experience in medical devices and other areas of food and drug law and regulation to assist with a growing practice. Strong verbal …
By James C. Shehan – Events keep on coming at a furious pace in the biosimilar world, with two new developments in the battle between Amgen and Sandoz over the latter’s hopes to launch its recently approved Zarxio, a biosimilar version of the former’s Neupogen (filgrastim). On March …
By Alexander J. Varond – On March 23, Representative G.K. Butterfield (D-NC) introduced H.R. 1537, the “Advancing Hope Act of 2015.” The Advancing Hope Act would reauthorize the rare pediatric disease priority review voucher (“Pediatric Voucher”) program, which is slated to sunset in March 2015. Rep. …
By Kurt R. Karst – Does FDA has the authority to approve a new indication for an approved drug when that new indication has not been shown to be safe and effective by adequate and well-controlled studies submitted by the sponsor of the application? And under …
By Riëtte van Laack & Ricardo Carvajal - The 9th Circuit Court of Appeals reversed a district court’s dismissal of a lawsuit targeting certain allegedly false and misleading nutrient and health-related claims for Benecol, a vegetable oil-based spread. As noted in our prior posting on this case, the district …
By Alexander J. Varond & Josephine M. Torrente – On March 17, 2015 FDA approved Cholbam (cholic acid) for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders. In approving Cholbam, FDA also issued the third …
By Allyson B. Mullen – On March 17, 2015, CDRH released the final guidance entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” The draft guidance was issued in May 2011 and is now being finalized on the heels of highly publicized outbreaks …
By Kurt R. Karst – Hopes for a victory were running high among folks in the blossoming biosimilars industry after Judge Richard Seeborg of the U.S. District Court for the Northern District of California indicated at a hearing last Friday (March 13th) that he wasn’t inclined …
By Ricardo Carvajal & JP Ellison - On March 9, the Supreme Court handed down a decision in Perez v. Mortgage Bankers Association that does away with what we’ll refer to in this posting as the Paralyzed Veterans doctrine, after an appellate court decision by that same name. The Paralyzed Veterans doctrine …
By John A. Gilbert – On March 16th, the U.S. House of Representatives passed by voice vote H.R. 639, the Improving Regulatory Transparency for New Medical Therapies Act, which would amend the Federal Food, Drug & Cosmetic Act (FD&C Act) and the Controlled Substances Act (CSA) …
By Kurt R. Karst – Nothing lasts forever in our mortal world, though some things try to come close: Wonka’s Everlasting Gobstoppers, The NeverEnding Story, Doctor Who, the Energizer Bunny . . . . and perhaps one day in the not too distant future, the Everlasting …
In a new Legal Backgrounder published by the Washington Legal Foundation, Hyman, Phelps & McNamara, P.C.’s James P. Ellison, Anne K. Walsh, and Andrew J. Hull* write a “Warning Letter” to FDA-regulated drug establishments regarding FDA’s inspection practices. We have written on FDA’s inspection authority …
By Jay W. Cormier & Alan M. Kirschenbaum – The stage is set for yet another court ruling in the battle between the Health Resources and Services Administration (HRSA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) over HRSA’s implementation of the 340B Orphan Drug Rule. …
By Alexander J. Varond – Evidence from recent approvals of breakthrough therapy-designated products suggests that, for some time now, FDA has been operating under accelerated review timelines for certain drugs with breakthrough therapy designation. Recently, FDA confirmed this and stated that it has been informally instituting …
