Regulatory Focus™ > News Articles > Regulatory Reconnaissance (4 March 2013)

Regulatory Reconnaissance (4 March 2013)

Posted 04 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. The sequester is now enacted, and the White House's final accounting shows FDA poised to lose $210 million over the rest of the coming year.

In the US, the Office of Management and Budget is getting a new director by way of Wal-Mart, FDA is getting ready to re-issue an IDE guidance, fewer generics were approved in 2012 than in 2011, FDA is cracking down on compounding pharmacies, the cancer risk from calcitonin salmon medicines may be too high, Zimmer says its SEC/DOJ probe is over, Teva wants to delay competition to its copper contraceptive, and a Bangladesh company wants to make generic facility fees a one-time payment.

Abroad, China is preparing to create a new single agency to regulate food and drug products modeled off of the US FDA,  Indian regulators are once again in hot water for approving dozens of drugs under unusual circumstances, Canada's device industry is out with its 2013 profile, Roche is hugely discounting the price of Herceptin in India, Ilaris gets EC approval, and a group says China's crackdown on counterfeit medicines is delivering results.

Five in Focus:

  1. FDA inspects specialty compounding pharmacies in targeted action (Washington Post) (FDA's 483s) (Rhode Island) (And more are planned, reports Bloomberg)
  2. Fewer generics approved in 2012 but still a banner year (Fierce Pharma)
  3. FDA To Re-Issue Draft Guidance On Investigational Device Exemption Standards (The Gray Sheet) ($)
  4. China to set up food and drug agency after safety scandals (South China Morning Post) (Food Quality News)
  5. Panel Says India Drug Agency Improperly Approved 38 Drugs Past Decade (DNA India) (PharmAsia)($)

US

Sequester & Budget

  • And So It Begins … (Alliance for a Stronger FDA) (More)
  • OMB Report on Cuts Shows FDA to Lose $210 Million, $82 Million in User Fees (Report)
  • Congress is Getting Ready to Take up a New Continuing Resolution for the Remainder of the Year (The Hill)
  • Sequestration puts speed bumps in drug review fast lane (Fierce Pharma)
  • As sequestration dawns, FDA supporters scramble to ease woes on drug reviews (Fierce Biotech)
  • Senate GOP pushes HHS for sequester details (The Hill)

Pharmaceuticals/Biotechnology

  • FDA inspects specialty compounding pharmacies in targeted action (Washington Post) (FDA's 483s) (Rhode Island)
  • More Compounding Investigations Planned, Says FDA's Jefferson (Bloomberg)
  • Fewer generics approved in 2012 but still a banner year (Fierce Pharma)
  • FDA staff say calcitonin salmon cancer risk appears plausible (Reuters)
  • Hamburg: FDA Joining with other organizations to encourage prescribers to seek training to safely prescribe opioid pain medicines (FDA) (FDA)
  • Pharma Spent Less $$ Last Year To Promote Drugs (Pharmalot) (Pharma Marketing Blog)
  • Celgene's apremilast succeeds in Phase III psoriasis trial (Pharma Times) (Reuters) (WSJ)
  • Determination That GEREF (Sermorelin Acetate) Injection and GEREF (Sermorelin Acetate) Injection, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
  • Compassionate Use Plea Rejected With Clinical Precision (Drug and Device Law)
  • Sun Sues FDA Over 180-Day Exclusivity for Generic ZOMETA (FDA Law Blog)
  • Teva Women's Health: Don't Approve Any ANDA That References its ParaGuard Intrauterine Copper Contraceptive Because Generics Could be Unsafe (FDA)
  • Square Pharmaceuticals Citizen Petition Calls on FDA to Amend GDUFA Annual Fees, Make Them a One-Time Fee Instead of Annual (Federal Register)
  • Clinipace to FDA: Sanofi's Plaquenil (hydroxychloroquine sulfate tablets) should be suitable for submission in an ANDA (FDA)
  • Law Firm (GSK/Reliant) to FDA: Amend the Strength of Lovaza (omega-3-acid ethyl esters) Capsules Because FDA's Orange Book Posting Describes Required Strength and Weight (FDA)
  • Quarterly Update of FDA's Medical Countermeasures Initiative (FDA)
  • Outdated Regulatory System Slows Technical Progress, Investigator Charges (The Pink Sheet) ($)
  • Sunshine Database Could Aid Pharma In Defense Against DOJ Suits (The Pink Sheet)
  • Cycle time metrics for multisite clinical trials in the United States (CTTI)
  • 'Shelf life' of blood? Shorter than we think (EurekAlert)

Medical Devices

  • Medtronic Suspends Trial at Specific Site After IRB Receives Warning Letter (Mass Device)
  • Zimmer: Justice Dept.-SEC probe is over (Mass Device)
  • Closing arguments in DePuy ASR lawsuit (Mass Device)
  • Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator (FDA)
  • Exemption From Premarket Notification; Class II Devices; Powered Patient Transport (FDA)
  • Princeton study: Bacteria clogs devices rapidly (Fierce Medical Devices) (Infection Control Today) (EurekAlert)
  • FDA To Re-Issue Draft Guidance On Investigational Device Exemption Standards (The Gray Sheet) ($)
  • CDRH's Division of Cardiovascular Devices Starts 30-Day Notice Reviews (The Gray Sheet) ($)
  • Philips MicroDose Mammography System Gets U.S. Clearance (MedGadget)
  • Tandem t:connect Software for t:slim Insulin Pumps FDA Approved (MedGadget)
  • Endocyte's Dx spots ovarian and lung cancer patients ripe for Merck drug (Fierce Medical Devices)
  • Class 1 Recall: AD-Tech's Macro Micro Subdural Electrode (FDA)

Assorted

  • White House Appointing a New Director of the Office of Management and Budget (Reuters) (Washington Post)
  • Warning and NOV Summary - 4th Quarter 2012 (Eye on FDA)
  • Former FDA Head: FDA Reform Can Lift U.S. Economy (Bloomberg)
  • Part D negotiation bill introduced (BioCentury)
  • This is what a smart pill bottle looks like (Med City News)

International

  • China to set up food and drug agency after safety scandals (South China Morning Post) (Food Quality News)
  • Panel Says India Drug Agency Improperly Approved 38 Drugs Past Decade (DNA India) (PharmAsia)($)
  • Industry Canada's Medical Device Industry Profile 2013 (Industry Canada)
  • Roche dropping Herceptin price in India by 30% (Fierce Pharma)
  • Recent Efforts By Chinese Government To Crackdown On Counterfeit Drugs Show Progress (Partnership for Safe Medicines)
  • EC approves Ilaris for gouty arthritis (BioCentury)
  • Zaltrap launched in UK (Pharmafile)
  • NICE recommends mirabegron for OAB subgroup (BioCentury)
  • IQWiG says Pixuvri provides 'no additional benefit' (BioCentury)
  • Q&A on 26 new EU research projects on rare diseases (European Commission)
  • Maharashtra FDA seizes 33 not-of standard drugs in Jan, 20 in December (PharmaBiz)
  • US Sanctions Preventing Export of Pharmaceuticals to Iran, Says Op-Ed (NYTimes)
  • International orphan drug marketplace is expected to grow some 30 percent by 2014 (BIO)

Interesting


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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