By Kurt R. Karst – “Driveway moments” – most of us have had them. It’s that moment when we feel compelled to stay in the car and finish listening to something on the radio. This blogger recently had such a moment commuting home from work on …
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Drug Development
- FDA Was For PROCYSBI Orphan Drug Designation Based on Clinical Superiority Before It Was Against It . . . And Then For It AgainAugust 3rd, 2014
- FDA Releases Report on Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare DiseasesJuly 21st, 2014
By Alexander J. Varond — FDA recently released its report entitled “Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases Including Strategic Plan: Accelerating the Development of Therapies for Pediatric Rare Diseases.” The report fulfills the …
- Want to Unlock the 21st Century Cure? Hearing Witnesses Agree, Patient Input is KeyJuly 16th, 2014
By James E. Valentine* & Sara A. Khan** – On July 11, 2014, the House Energy and Commerce’s Subcommittee on Health held its fourth hearing, as part of its 21st Century Cures Initiative, to seek input regarding the incorporation of patient perspectives in drug development and …
- “I Didn’t Inhale” – But FDA’s Position on Medical Marijuana is Still CloudyJune 25th, 2014
By James C. Shehan & Karla L. Palmer – In a curious posting on Friday, June 20, 2014, FDA with little fanfare set forth its latest position on medical marijuana. Amounting to little more than a statement of general support of scientific research on medical marijuana …
- “Drug Lag” Redux? Speeding Access to Already Approved Pharmaceuticals Act Would Require FDA to Take Cues from EuropeJune 22nd, 2014
By Kurt R. Karst – The so-called “drug lag” – i.e., the difference (or perceived difference some might say) in drug availability between the United States and other countries – was one of myriad reasons some folks back in the early 1990s thought it was necessary …
- Sex Matters: Research for All Act Seeks to Facilitate the Research, Development, and Approval of Drugs With an Eye Towards Male and Female DifferencesJune 19th, 2014
By Kurt R. Karst – Interest in and efforts to address shortfalls in the inclusion of women in clinical trials and clinical research, and differences in the sexes in drug development are not new. There’s the National Institutes of Health (“NIH”) Revitalization Act of 1993, which …
- HP&M’s David Clissold to Present at 4th Annual CNS Diseases World SummitJune 18th, 2014
GTCbio recently announced that it will be holding the 4th Annual CNS Diseases World Summit from September 18-19, 2014 in San Francisco, California. The summit consists of two individual conferences that will run in parallel: (1) the 7th CNS Partnering & Deal-Making conference; and (2) …
- Will More Marketing Exclusivity be the 21st Century Cure? Hearing Witnesses Debate IncentivesJune 17th, 2014
By James E. Valentine – On June 11, 2014, a panel before the House Energy and Commerce Committee’s Subcommittee on Health hosted its second hearing on the 21st Century Cures Initiative. The Subcommittee sought input on whether current economic and regulatory incentives are sufficient to encourage …
- FDA Issues Expedited Programs Final Guidance, Refines Breakthrough Therapy Designations and Accelerated ApprovalJune 3rd, 2014
By Alexander J. Varond – On May 29, FDA issued its final guidance on “Expedited Programs for Serious Conditions – Drugs and Biologics.” We blogged previously on the draft guidance and each of FDA’s four expedited programs (fast track designation, accelerated approval, priority review, and breakthrough …
- Picking a Proprietary Name for a New Drug is No Simple Task – FDA Issues a Draft Guidance on Best Practices in Developing Proprietary NamesJune 1st, 2014
By James C. Shehan & David B. Clissold – Good brand names have been important to drug marketers as far back as Biblical times – the Book of Ecclesiastes tells us that “a good name is better than precious ointment.” In a new draft guidance applicable …
- As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List GrowsMay 29th, 2014
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
- 21st Century Cures Initiative: HP&M’s Frank Sasinowski Testifies at First Congressional HearingMay 21st, 2014
By Alexander J. Varond & James E. Valentine – On May 20, 2014, Hyman, Phelps & McNamara, P.C.’s Frank J. Sasinowski appeared on a panel before the House Energy and Commerce’s Subcommittee on Health to present testimony at the first hearing on the 21st Century Cures …
- FDA Denies 3 Petitions Seeking NCE Exclusivity for Combo Drugs, But Proposes to Reinterpret the Law for New NDAsFebruary 24th, 2014
By Kurt R. Karst – In moves that may displease both brand-name and generic drug manufacturers, and that could lead to litigation from both sides, FDA has with one hand proposed to giveth New Chemical Entity (“NCE”) exclusivity to certain Fixed-Dose Combination Drugs (“FDCs”) and has …
- Purdue Pharma Petitions FDA to Apply ER/LA Requirements to IR Opioid AnalgesicsFebruary 23rd, 2014
By Alexander J. Varond – Purdue Pharma recently submitted a citizen petition challenging FDA’s decision to require labeling revisions and postmarket study requirements for extended-release and long acting opioid analgesic products but not immediate-release products. We discussed these revisions here. Purdue’s citizen petition, dated February 11, 2014, …
- Maybe There Is Such a Thing As a Free Lunch – Vermont Considers Allowing Drug and Device Makers to Again Provide In-Office Meals to Healthcare ProfessionalsFebruary 20th, 2014
By James C. Shehan – Vermont law has banned manufacturers of prescription drug, device, and biologics products from providing most gifts to physicians and other healthcare professionals since 2009 and has required these manufacturers to report permitted gifts and payments to Vermont HCPs since 2002 (summarized …