By Kurt R. Karst – We’re now entering the second week of the shutdown of the federal government (or “the lapse period” as some have called it), and there does not appear to be an end in sight. In fact, the environment in Washington, D.C. has …
Menu
Prescription Drugs and Biologics
- The Shutdown: An Update on FDA ActivitiesOctober 7th, 2013
- As Partial Government Shutdown Kicks In, FDA’s Foods Program Is Hardest HitOctober 1st, 2013
By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …
- National Rx Track and Trace System Could Soon Be a Reality – House Passes HR 3204September 30th, 2013
By William T. Koustas & Jessica A. Ritsick – With California’s electronic pedigree requirement set to take effect in 2015, we have been following recent efforts by Congress to enact a national prescription drug track and trace system (see our previous posts here, here, here, …
- Center for Legal Policy Report Takes Aim at FDA’s Regulation of Autologous Stem Cell ProceduresSeptember 29th, 2013
By William T. Koustas – We have previously reported (here and here for example) on the litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA. Regenerative is a Colorado company that owns a medical procedure known as the Regenexx Procedure. It is a non-surgical procedure by …
- Money Has a Way of Changing People: The UFAization of FDA’s Office of Generic DrugsSeptember 26th, 2013
By Kurt R. Karst – Anyone from the United States who has visited a foreign city – like São Paulo, Brazil or Mumbai, India – knows immediately upon exiting the sealed environment of their aircraft that they are no longer in the United States. There’s …
- FDA’s Fifth Annual Report to Congress on 505(q) Citizen Petitions: Something Old, Something New, Something Borrowed, FDA is Still BlueSeptember 25th, 2013
By Kurt R. Karst – FDA’s latest Report to Congress, required by FDC Act § 505(q)(3), on the Agency’s experience with so-called “505(q) citizen petitions” during Fiscal Year 2012 (“FY2012”) is largely a rehash of the FY2011 Report to Congress (see our previous post here on …
- Act II, Scene II: A Rose By Any Other Name Would Smell as Sweet? “No!” Says GPhA in Citizen Petition to FDA on Biosimilar NamingSeptember 19th, 2013
By Kurt R. Karst – The titles – and sometimes even the content – of some of our posts are inspired by the things we experience (or have experienced) in our regular, non-attorney lives. For years now we’ve weaved together with food and drug law …
- FDA Grants PROP Petition (in Part), Proposes New Labeling and Requires Post-Marketing Studies for ER/LA Opioid AnalgesicsSeptember 16th, 2013
By Delia A. Stubbs – As previously reported, the Physicians for Responsible Opioid Prescribing (“PROP”) filed a Citizen Petition in March requesting that FDA limit the labeling of “controlled release” opioids to severe-only pain in non-cancer patients. The petition also requested that FDA impose certain …
- “You Can’t Handle the Truth!” Code Orange: Court Dismisses Lanham Act-Orange Book Therapeutic Equivalence Rating Complaint on Primary Jurisdiction GroundsSeptember 15th, 2013
By Kurt R. Karst – In the 1992 movie A Few Good Men, military lawyer Lt. Daniel Kaffee (played by Tom Cruise) handles the court martial of two U.S. Marines charged with the murder of a fellow Marine. The Marines contend they were acting under …
- Not In Our Backyard! Pharmacists and Trade Groups Sue to Block Implementation of Maine Drug Importation LawSeptember 12th, 2013
By Kurt R. Karst – Earlier this week, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), along with several other trade groups – the Maine Pharmacy Association, Maine Society of Health-System Pharmacists, and Retail Association of Maine – and two pharmacists, filed a Complaint and …
- The Biosimilars State Legislation ScorecardSeptember 4th, 2013
By Kurt R. Karst – We present to you the Biosimilars State Legislation Scorecard. Links are provided to each piece of legislation. We also give you a word or two on status. In most cases, a summary of each bill is provided at the linked-to website. …
- Alameda County Drug Take-Back and Disposal Ordinance Not Unconstitutional Says Federal JudgeSeptember 3rd, 2013
By Kurt R. Karst – Last week, Judge Richard Seeborg of the U.S. District Court for the Northern District of California issued an 11-page ruling in a lawsuit filed in December 2012 by the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and …
- Public Shaming: FDA Edges Closer to Citizen Petition Denial for Intent to Delay Generic Drug Approval, But Prefers to Pass the Buck on EnforcementAugust 28th, 2013
By Kurt R. Karst – Public shaming has been used as a type of punishment for centuries and has taken on many forms. In Colonial America, for example, physical forms of shaming and humiliation like stocks and pillory were common. And who could forget Nathaniel …
- Lifting the Veil on FDA Subpart H Surrogate Endpoint ApprovalsAugust 27th, 2013
By Kurt R. Karst – In June 2013, FDA announced the issuance of a draft guidance document, titled “Expedited Programs for Serious Conditions – Drugs and Biologics” (Docket No. FDA-2013-D-0575). As we previously reported, the draft guidance, as well as a related Manual of Policies …
- First Post-FDAAA “New Active Ingredient” Election and Grant of NCE Exclusivity Made With the Approval of FETZIMAAugust 25th, 2013
By Kurt R. Karst – If you wait around long enough, almost any scenario feasible under the FDC Act with respect to Hatch-Waxman exclusivity is bound to happen. Nearly six years after the September 2007 enactment of the FDA Amendments Act (“FDAAA”), one company’s drug …