By Kurt R. Karst – A recent report from the National Institutes of Health (“NIH”) Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research leaves unanswered questions about the future utility of FDA’s so-called “Animal Efficacy Rule” for NIH-funded research intended …
By Alexander J. Varond – In response to FDA’s increasing reliance on Risk Evaluation and Mitigation Strategies (“REMS”) for the management of risks presented by certain drugs, the US Department of Health and Human Service’s Office of Inspector General (“OIG”) conducted an investigation into FDA’s …
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 Alexander J. Varond – FDA announced earlier this week that it will hold a public hearing to obtain input on a potential new pathway to expedite the development of drugs and biological products for serious or life-threatening conditions that would address an unmet medical …
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 …
By Alexander Varond – On December 14, FDA released a draft guidance document entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Enrichment Guidance”). The thirty-nine-page document was more than six years in the making and aims to provide …
By Kurt R. Karst – While Congress and The White House debate whether user fees paid pursuant to various UFAs – User Fee Acts – will be sequestered under the terms of the Budget Control Act (see here), FDA continues to move forward with planning …
By Alexander J. Varond – The Institute of Medicine (“IOM”) recently issued a paper titled “Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary.” The IOM paper summarizes the “Maximizing the Goals of the Cures Acceleration Network to …
By Kurt R. Karst – Just before Congress recessed for the month of August, and less than a month after the July 9th enactment of the FDA Safety and Innovation Act, several FDA-related bills were placed in the hoppers in the U.S. Senate and U.S. House …
By Kurt R. Karst – In two Federal Register notices (here and here) scheduled for publication on August 1st, FDA will announce the Fiscal Year (“FY”) 2013 user fee rates pursuant to the fifth iteration of the Prescription Drug User Fee Act (“PDUFA”) and pursuant to …
By Kurt R. Karst – Last week, Representative William Keating (D-MA) announced the introduction of new legislation – the Stop Tampering of Prescription Pills Act of 2012, or STOPP Act (H.R. 6160) – that is intended to direct companies “to invest in research and production to …
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 Anne Marie Murphy & Benjamin K. Wolf* – On June 12, 2012, FDA announced the availability of a draft guidance, titled “Considerations When Transferring Clinical Investigation Oversight to Another IRB” (“FDA Draft Guidance”). This is the first time FDA has provided through guidance specific direction …
By Kurt R. Karst – After a round of congratulatory speeches, the U.S. House of Representatives passed H.R. 5651, the FDA Reform Act of 2012, as amended, on May 30th by a vote of 387-5. Unlike the U.S. Senate, which passed its version of the bill …
By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
