Regulatory Focus™ > News Articles > Regulatory Reconnaissance (26 March 2013)

Regulatory Reconnaissance (26 March 2013)

Posted 26 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, all eyes yesterday were on the Supreme Court, which argued the legality of pay-for-delay settlements. Elsewhere, FDA said it is in the process of developing an electronic submission system for reporting supplement labeling, OMB signed off on a DTC advertising study, Lilly and Boehringer submit a new NDA for a diabetes drug, Abbott warns about problems with its MitraClip as US regulators review it, a new bill would restrict usage of dextromethorphan, and researchers work on making changes to the Common Rule.

Abroad, another company seeks a compulsory license in India, France updates stakeholders about the risk of VTE from contraceptives, a man jumps from a building to escape a clinical trial, EMA posts a video of its workshop on preventing medical errors, Bayer's Eylea was shot down by IQWiG on a technicality, and NICE shoots down Roche's Avastin for ovarian cancer.

Editor's Note: My computer decided to quit on me last night without first saving the work I had done on this edition; Apologies for a relatively sparse edition of Regulatory Reconnaissance.

Five in Focus:

  1. Supreme Court justices signal uncertainty on drug settlements (Reuters) (Transcript of Arguments) (SCOTUS Blog) (The Hill) (Med Page Today) (WSJ) (The Pink Sheet Daily) (Bloomberg) (GPhA) (Patent Docs)
  2. FDA in the process of developing electronic submission system for reporting dietary supplement labeling statement (FDA)
  3. OMB Signs off on FDA's Proposed Study of Corrective DTC TV Advertising (OMB)
  4. BDR Pharmaceuticals seeks Compulsory License for BMS cancer drug, offers 95% cheaper generic copy (Economic Times)
  5. Man Enrolls in Clinical Trial. Man Decides Trial is a Bad Idea. Clinical Trial Sponsor Disagrees. Man Jumps out Window. (Pharmalot)

US

Pharmaceuticals/Biotechnology
  • Supreme Court justices signal uncertainty on drug settlements (Reuters) (Transcript of Arguments) (SCOTUS Blog) (The Hill) (Med Page Today) (WSJ) (The Pink Sheet Daily) (Bloomberg) (GPhA) (Patent Docs)
  • FDA in the process of developing electronic submission system for reporting dietary supplement labeling statement (FDA)
  • Cook Pharmica OKed by US FDA Without Inspection (Outsourcing Pharma)
  • Propofol Lethal Injections Blocked as Teva and Hospira Re-Enter Market (Outsourcing Pharma)
  • Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness: QUESTRAN (Cholestyramine for Oral Suspension, USP) and QUESTRAN LIGHT (Cholestyramine for Oral Suspension, USP) (FDA)
  • Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment (Eli Lilly)
  • Idenix Pharma Drops After Faltering in Gilead Patent Dispute (Bloomberg)
  • FTC Drug Meddling Would Needlessly Push Pharmaceutical Costs Higher (CEI)
  • Eye Drops Seen as  Relatively Common Poisoning Threat (Wired)
  • FDA Provides Award to Company to Help Support "On-Going Genomic Research on Antimicrobial Resistance" (FDA)
  • The FDA's New Alzheimer's Guidance: Wonder or Blunder? (In the Pipeline)
Medical Devices
  • Abbott Vascular warns on MitraClip (Mass Device) (Fierce Medical Devices)
  • FDA is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR) (FDA) (FDA)
  • OMB Approves New FDA Estimates of Time it Takes to Register and List a Medical Device (OMB)
  • Washington Post Editorial: On health reform, a shortsighted vote on the medical device tax (Washington Post)
Assorted
  • OMB Signs off on FDA's Proposed Study of Corrective DTC TV Advertising (OMB)
  • Advertising in the Supplementary Information? (In the Pipeline)
  • Common Rule wrap-up at National Academies (Harvard Bill of Health)
  • CBO: Medicare Part D Spending Lower Than Anticipated Because of Off-Patent Drugs, Lower Rates of Enrollment (CBO)
  • Harvard's Wyss Institute awarded DARPA contract to further advance sepsis therapeutic device (EurekAlert)
  • A Bankrupt CRO Leaves Gift Coupons For Participants (Pharmalot) (Outsourcing Pharm)
  • Report: HIGH-CONTAINMENT LABORATORIES - Assessment of the Nation's Need Is Missing (GAO) (JAMA)
Government and Budget
  • S.644 - A bill to amend the Federal Food, Drug, and Cosmetic Act to prevent the abuse of dextromethorphan, and for other purposes. (Congress)
Meetings This Week
  • 25 March 2013: FDA Webinar on Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (FDA)
  • Webinar Draft GFI On Enrichment Strategies For Clinical Trials To Support Approval Of Human Drugs And Biological Products - March 25, 2013 (FDA)
  • 27-28 March 2013: Public Meeting on the Food Safety Modernization Act (FSMA) (FDA)

International

  • Initial appraisal of a European Commission Impact Assessment European Commission proposal on clinical trials (February 2013) (ENVI)
  • BDR Pharmaceuticals seeks Compulsory License for BMS cancer drug, offers 95% cheaper generic copy (Economic Times)
  • France's ANSM Provides Update on the Risk of VTE With Use of Contraceptives (ANSM)
  • EMA Posts Video of its Workshop of Medication Errors (EMA)
  • Man Jumps From Building To Escape A Clinical Trial (Pharmalot)
  • EUnetHTA Provides Update on its Activities (EUnetHTA)
  • EUnetHTA Guideline on Colorectal Cancer Screening to be Finalized by November 2013, Group Says (EUnetHTA)
  • Spain Approves Measure to Encourage use of Generic Drugs (Europa Press)
  • Bayer's Eylea Shot Down By IQWiG On A Technicality (The Pink Sheet Daily) ($)
  • Xeljanz (tofacitinib citrate) Approved in Japan for the Treatment of Adults with Rheumatoid Arthritis (RA) (Pfizer)
  • Phytopharm gives up after Parkinson's drug failure (Reuters)
  • Negative NICE Decision For Avastin® (Bevacizumab) Highlights Challenges Facing UK Access To Medicines (Medical News Today) (Pharma Times)
  • NHS patients in Wales to get access to angioedema drug (Pharma Times)

General Regulatory and Interesting Articles

  • Analysis: Roche stays a step ahead of copycat drugmakers (Reuters)
  • PatientsLikeMe goes global with trial matching tool (Pharma Times)
  • NextDocs, Microsoft mobilize clinical trials with Trial Exchange and Windows 8 (CenterWatch)
  • Same Nuclear Engine That Powers Mars Rover Was to Power Artificial Hearts (Med Gadget)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Did we miss a story? Send us a tweet at @RAPSorg or @AlecGaffney and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe