Regulatory Focus™ > News Articles > Regulatory Reconnaissance (12 March 2013)

Regulatory Reconnaissance (12 March 2013)

Posted 12 March 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, fallout over deficient pharmaceutical compounding operations continues, FDA could disclose clinical investigator final data when approving products, FDA's criminal investigator director says he plans to look more closely at GMPs, PhRMA says more than 900 biologics are in development, a new track and trace guidance is out via GS1, good news for Edward's heart valve system, J&J faces still more lawsuits over its hip implant devices, and ProPublica is out with a huge database of industry-doctor interactions.

Abroad, the EU is out with revised rules on the distribution of medicinal products in the EU, Ghana uncovers a massive fraud perpetrated by three companies, EU HTA Net is out with the final version of the HTA Core Model for pharmaceuticals, a report says just 45 trial deaths have been compensated in India since 2005, the head of Russia's Roszdravnadzor retires, EMA issues a draft guideline on flu vaccine development, India plans to look into unethical marketing practices in the country, and Interpol gets money to fight drug fakes.

Five in Focus:

  1. Compounding pharmacy trouble extends beyond NECC (CBS) (NCPA)
  2. FDA May Disclose Clinical Investigator Financial Data In Product Approvals (The Pink Sheet Daily) ($)
  3. Revised rules on the distribution of medicinal products in the EU (European Commission)
  4. Ghana FDA uncovers massive fraud by 3 giant pharmaceutical companies (Ghana Web)
  5. The final version of HTA Core Model and the Methodological Guidelines for Rapid Relative Effectiveness Assessment of Pharmaceuticals is now available (EU HTA net)

US

Sequester & Budget
  • Government Funding Bill Unveiled By Senate Democrats (AP)

Pharmaceuticals/Biotechnology
  • FDA investigative chief eyes manufacturing practices (Thompson Reuters)
  • Compounding pharmacy trouble extends beyond NECC (CBS) (NCPA)
  • Report: More Than 900 Biologic Medicines and Vaccines in Development (PhRMA) (Report)
  • Pharmacies push back on call for regulations after '60 Minutes' report (The Hill)
  • FDA demand helped push Biovest into bankruptcy (Tampa Bay Biz Journal)
  • Meetings: Cellular, Tissue and Gene Therapies Advisory Committee (FDA)
  • Judge rules out wider recall of generic Lipitor containing glass (Thompson Reuters)
  • Sales Reps As Soccer Balls: Warner Chilcott & Fraud (Pharmalot)
  • Cangrelor More Effective Than Plavix (Drug Discovery & Development)
  • Protein Sciences' Pitch: a "Pure" Flu Vaccine Alternative (Xconomy)
  • The New GS1 Healthcare US Track & Trace Guidance (RxTrace)
  • Aeterna Zentaris to stop late-stage cancer drug trial, shares fall (Reuters)
  • KV appealing dismissal of suit against FDA (BioCentury)
  • Merck Says it Will "Vigorously Defend" Itself Against Pending Fosamax Litigation (Merck)
  • Osmotica Pharma Submits Petition for FDA Approval of Mesalamine Delayed Release Tablets (Petition)
  • MedChi applauds Maryland State Senate action with regard to biosimilars (Biosimilar News)
  • Non-inferiority observed in phase 3 trial of seasonal flu vaccine (BioSpectrum) (2)
  • U.S. Law On 12-Year Biologics Data Exclusivity Remains Stumbling Block To Trans-Pacific Partnership Agreement (PharmAsia News) ($)

Medical Devices
  • Edwards heart valve system good as surgery at 3 years-trial (Reuters) (WSJ) (Bloomberg)
  • J&J Faces Second Trial Over Recalled Hip After Loss (Bloomberg)
  • Public Citizen Blasts FDA for Not Withdrawing Approval for Stryker Wingspan Stent (Petition)
  • Abbott winds up for March 20 FDA panel for mitral valve clip (Fierce Medical Devices)
  • InVivo updates bid for FDA OK of spinal trauma treatment (Mass Device)
  • Transcatheter mitral valves are going to the dogs-literally (Mass Device)
  • Boston Scientific's Stroke Device Shows Mixed Results (Bloomberg)
  • Microsoft Kinect Helps Bring Augmented Reality to Operating Rooms (Medgadget)
  • J&J Faces Potentially Disrupting Competition In Its Lucrative Glucose Monitoring Business From Tiny Diagnostics Outfit (Forbes)
  • New Data Reinforce Strong Long-Term Clinical Performance of Abbott's Absorb Bioresorbable Vascular Scaffold (Abbott)
  • Does Fitbit's WiFi-enabled Aria scale need FDA clearance? (Mobi Health News)
  • Editorial: mHealth is medtech's 'Wild West' for now (Medical Design)

Assorted
  • ProPublica's "Dollars for Docs" Database Updated (ProPublica)
  • FDA May Disclose Clinical Investigator Financial Data In Product Approvals (The Pink Sheet Daily) ($)
  • HHS OIG: Recent FCPA, False Claims and Anti Kickback Settlements (Policy and Medicine)
  • Overseas Tax Savings for U.S. Drugmakers Under Threat (Bloomberg)
  • How FDA strives to ensure the safety of OTC products (FDA)
  • When a drug costs 30 times what it once did (Los Angeles Times)
  • Walgreen sued over Vitamin E supplement claims (Reuters)
  • Attorneys General Call for Tamper-Resistant Versions of Generic Prescription Pain Relievers (NAAG) (FDA Law Blog)
  • How companies promote a product's off-label use using medical journals. (Trials Journal) (Pub. Aug 2012)
  • FDA Team Advances Women's Health (FDA)
  • Refuting, Once Again, the Medicare Part D Myth (Center on Budget and Policy Priorities)
  • Agencies struggle with cybersecurity despite increased spending (Federal Times)

International

  • Head of Russia's Roszdravnadzor retires (Emergo Group)
  • Revised rules on the distribution of medicinal products in the EU (European Commission)
  • The final version of HTA Core Model and the Methodological Guidelines for Rapid Relative Effectiveness Assessment of Pharmaceuticals is now available (EU HTA net)
  • 'Indian companies to shell out Rs 30 lakh for generic drug fee' (The Economic Times)
  • Report: Only 45 Indian trial deaths compensated since 2005 (Fierce CRO)
  • Ghana FDA uncovers massive fraud by 3 giant pharmaceutical companies (Ghana Web)
  • Draft guideline on influenza vaccines - quality module (EMA)
  • European Medicines Agency and European Commission renew confidentiality arrangement with Japan (EMA)
  • India's Union Health Ministry to take up unethical marketing practices of pharma cos with DoP (PharmaBiz)
  • Interpol gets a bit of cash from global drugmakers to fight fake medicine (Philadelphia Inquirer)
  • India Activists Press For Compulsory License of Roche's Herceptin Breast-Cancer Drug (PharmAsia News) ($)
  • Biomedical Catalyst's £47.2M funding for "valley of death" projects (Pharma Times)
  • Greek firms blame govt as drug access "reaches breaking point" (Pharma Times)
  • April Meeting of World Medical Association Could See Update of Declaration of Helsinki (WMA)

Interesting

  • Antibiotic resistance 'has the potential to undermine modern health systems' (EurekAlert)


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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