Regulatory Focus™ > News Articles > Regulatory Reconnaissance (7 March 2013)

Regulatory Reconnaissance (7 March 2013)

Posted 07 March 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance. The "snowquester" may have fizzled out, but at least one House legislator says the real sequester will likely delay the regulatory approval of one of Alexion Pharmaceuticals' drugs.

In the US, the House has passed a temporary budget bill that would fund FDA, a new method of finding unreported side effects looks promising, sleep aids are being tied to hip fractures, the SEC has released a Form 483 for Impax Labs, FDA tells Mylan it won't require a class-wide Fentanyl risk monitoring program, FDA releases reports regarding veterinary user fees and two new VICH guidances, FDA gives presentations on early feasibility studies for medical devices, a JAMA study finds significant study publication lag, and the USTR plans to meet in April regarding a joint US-EU regulatory compatibility plan.

Abroad, the UK plans to loosen reins on drug advertising, EMA will investigate the presence of drugs in horse meat, ABPI issues warnings regarding new API rules in the EU, a researcher calls out Roche over its transparency plans, GSK submits a dossier for albiglutide in the EU, and GSK's CEO gets a big payday despite record fines.

Five in Focus:

  1. Unreported Side Effects of Drugs Found Using Internet Data, Study Finds (NYTimes) (Study)
  2. FDA takes effort to curb antibiotics in livestock on the road (The Hill) (FDA) (Federal Register)
  3. US Trade Representative Seeking Comment on US-EU Joint Request for Plant to Promote Regulatory Compatibility, Will Hold April Meeting (The Center for Regulatory Effectiveness)
  4. FDA on progress, challenges with Early Feasibility Study (FDA/Cardiovascular Business)
  5. UK to Loosen Reins on Drug Advertising (Eye for Pharma)

US

Sequester & Budget
  • Rep. Cicilline (D-RI): Alexion Pharmaceutical's Regulatory Approval "Will Likely be Delayed Because of Sequestration" (GPO)
  • Seeking a budget deal, Obama reaches out to Republican rank and file (Washington Post)
  • Rep. Waxman (D-CA): Sequester Will Result in Delays in New Drug Approvals (GPO)
  • House advances 2013 spending bill over opposition from Dems and 16 Republicans (The Hill) (Federal Times)
Pharmaceuticals/Biotechnology
  • Unreported Side Effects of Drugs Found Using Internet Data, Study Finds (NYTimes) (Study)
  • Takeda execs scrambled after Actos cancer risks emerged, witness says (Fierce Pharma)
  • Sleep aids tied to hip fractures in the elderly (Reuters)
  • SEC Releases Impax Laboratories' Form FDA 483 (SEC)
  • Study: Prescription-only PSE legislation carries a significant cost burden (Drug Store News)
  • Kentucky: Up-schedule hydrocodone combination products to Schedule II (Citizen petition)
  • FDA to Mylan: We Won't Require a Class-Wide RMP for Fentanyl Products (Citizen Petition)
  • Osmotica Pharma: Revise Draft Bioequivalence Guidance for Mesalamine Delayed Release Tablets (Citizen petition)
  • FDA Responds to Petitioner Regarding Uses, Testing of Aspirin (Citizen Petition)
  • Teva Holds Its Breath During Third Phase 3 Trial for Multiple Sclerosis Drug Concerto (BioSpace)
  • Angry Parents Force J&J To Do Damage Control (Pharmalot)
  • Washington Legal Foundation Approves of Abbott's Citizen Petition on Biosimilars (Patent Docs)
  • AMAG Pharmaceuticals Announces FDA Acceptance of Supplemental New Drug Application for Feraheme Label Expansion to Include Iron Deficiency Anemia Patients Who Cannot Take Oral Iron (Business Wire)
  • ViiV Healthcare presents data from Phase III study of dolutegravir vs raltegravir in treatment-experienced adults with HIV-1 (GSK)
Veterinary Pharmaceuticals (Special)
  • FDA takes effort to curb antibiotics in livestock on the road (The Hill) (FDA) (Federal Register)
  • FY 2012 ADUFA Performance Report (FDA)
  • FY 2012 AGDUFA Performance Report (FDA)
  • VICH; Draft Revised Guidance for Industry on "Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing" (VICH GL23(R)); Availability (FDA)
  • VICH; Revised Guidance for Industry on "Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish a Microbiological Acceptable Daily Intake (ADI)" (VICH GL36(R)); Availability (FDA)
  • New Animal Drug Applications: Alfaprostol; Bicyclohexylammonium Fumagillin; N-Butyl Chloride; et al (FDA)
  • New Animal Drug Applications: Ag-Mark, Inc., et al.; Withdrawal (FDA)
  • FDA's Cumulative Adverse Drug Experience (ADE) Reports for Veterinary Products (FDA)
Medical Devices
  • FDA on progress, challenges with Early Feasibility Study (FDA/Cardiovascular Business)
  • Boston Scientific to Present Full Device Study at Meeting (Boston Scientific) (Bloomberg)
  • NIH Panel Says New Diagnostic Approach to Diabetes not Warranted at This Time Due to Lack of Evidence (NIH)
  • Safety and Efficacy in mHealth (Med City News)
  • Philips announces FDA clearance for its EchoNavigator live image-guidance tool (Philips)
  • Human brain treats prosthetic devices as part of the body (EurekAlert)
Assorted
  • JAMA Study Shows Time to Publication Among Completed Clinical Trials Nearly Two Years (JAMA) (Reuters)
  • US Trade Representative Seeking Comment on US-EU Joint Request for Plant to Promote Regulatory Compatibility, Will Hold April Meeting (The Center for Regulatory Effectiveness)
  • Report: Risk-based monitoring: Reduce clinical trial costs while protecting safety and quality (PWC)
  • Maine Considering Law to Make Changes to its Unused Pharmaceutical Disposal program (Maine)
  • Florida Bills to Require Physicians to Consult Prescription Drug Database, Add Hallucinigenic Substances to Schedule I List (Florida) (2)
  • Nevada Bill Would Make Manufacturer of Controlled Substance Liable if Patient Develops Addiction (Drug Wonks)
  • Mississippi Bill to Add Anabolic Steroids to Schedule II Substances List Dies in Committee (Mississippi) (Scout)
  • President Obama faces deadline to find gatekeeper for new regulations (The Hill)
  • CDISC Launches New Initiative to Support a Standards-Based learning Health System (CDISC)
  • Top 20 Best-Selling Drugs of 2012 (GEN)
  • HHS to push health information technology in 2013 (The Hill)
  • Narcotic painkiller prescriptions leveled off in 2012, new figures show (Journal Sentinel)
  • Solicitation of Nominations to the Presidential Advisory Council on HIV/AIDS (DHHS)

International

  • UK to Loosen Reins on Drug Advertising (Eye for Pharma)
  • GSK Chief Gets €4M Payout Despite Record Regulatory Settlements (The Guardian) (Pharma Times)
  • AstraZeneca Mulls Appeal Of Australian Court Crestor Patents Ruling (PharmAsia News) ($)
  • Researcher: Roche data transparency plans are "all talk and no action" (Pharma Times)
  • EU agencies to advise on risks from phenylbutazone in horsemeat (EMA)
  • GSK announces regulatory submission for albiglutide in Europe (GSK) (Reuters)
  • Irish app certified by CE as a medical device (Silicon Republic)
  • ABPI issues supply chain warning regarding new API rules (Pharmafile)
  • Nippon Kayaku has received the second G-CSF biosimilar approval in Japan (Biosimilar News)
  • Hospira Issues Safety Warning Regarding its Infusion Pump (ANSM)
  • Mylan Issues "Dear Doctor" Letter After Montelukast Drug Packaged With Wrong Prescribing Information (MHRA)
  • CDSCO Issues Updated List of Approved Fixed Dose Combinations (CDSCO)
  • India's Drugs Consultative Committee to Focus on Manufacturing Sales, Enforcement and Drug Test Labs (PharmaBiz)

Interesting

  • Special Report: Behind a cancer-treatment firm's rosy survival claims (Reuters)
  • Roche's Rituxan Cures Rare Skin-Blistering Disease in Study, No Plans for Further Regulatory Approval-Yet (Bloomberg)

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.


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