Regulatory Focus™ > News Articles > Regulatory Reconnaissance (11 December 2012)

Regulatory Reconnaissance (11 December 2012)

Posted 11 December 2012 | By Alexander Gaffney, RAC

Regulatory Reconnaissance is your daily news recap for the regulatory news and intelligence space. Top stories today include: The US Food and Drug Administration (FDA) estimates each medical device pre-submission package takes 137 hours to complete, congressional leaders are going after a compounding trade group, efforts to delay a medical device excise tax are ramping up, a researcher has called for batch-testing all medicines to be donated to humanitarian groups, a new EU single-patent system creeps closer to existence, the UK has unveiled a faster OTC switch paradigm, and new questions have been raised about the safety of an FDA-approved diet drug.

United States

(FDA) FDA has given expanded approval to Janssen Biotech's drug Zytiga (abiraterone acetate), now indicated to treat men with late-stage, metastatic, castration-resistant prostate cancer prior to receiving chemotherapy. The drug was first approved in April 2011 for a similar indication in prostate cancer.

(FDA) Regulators have debarred Susan Knott, a supervisory nurse who in 2009 pled guilty to ordering other nurses in her practice to dilute supplies of Botox injections. FDA said her guilty plea included charges that she had misbranded the drug.

(FDA) FDA estimates that it will take 137 hours to compile each pre-submission package for medical device products submitted to either the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Research and Evaluation (CBER). CDRH will receive an estimated 2,465 responses per year, while CBER will receive 79 submissions.

(Pharmalot) Congress is going after a compounding trade group, investigating allegations that the group may have instructed its members to purposefully impede regulators from conducting safety assessments on their products, reports Ed Silverman of Pharmalot.

(Fierce Medical Devices) Johnson and Johnson's Ethicon Biosurgery unit has announced the approval of its Evarrest Fibrin Sealant Patch by FDA. The device is used to stop otherwise uncontrollable bleeding during surgery, reports Fierce Medical Devices.

(Bloomberg) Drug maker Boehringer Ingelheim is being sued by hundreds of patients over allegedly suffering from strokes and other adverse events after taking the blood thinner Pradaxa.

(Fierce Medical Devices) Despite some strong opposition to a soon-to-be-implemented medical device excise tax, legislators thus far have been unable to dismantle it. Now, in a bid for more time, at least a dozen Democratic Senators have signed onto a letter saying the tax should be delayed. (CBPP lays out the case for the tax here)

(GAO) A US report concedes that reimbursement rates for drug intended to treat end-stage renal disease (ERSD) may be too low judging by a 23% decline in utilization between 2007 and 2011.

(AEI) "The US should also make pre-shipment batch testing and post-market surveillance a condition of all drug-related aid, especially for the Global Fund," writes the American Enterprise Institute's Roger Bate, a noted expert in drug quality.

(Drug Wonks) The regulatory acceleration group TransCelerate has named Dalvir Gill as its CEO, reports Peter Pitts of the Center for Medicine in the Public Interest.

(Alliance for a Stronger FDA) How's the negotiation over the fiscal cliff going? Check, then check again in an hour; you may well get an entirely different answer each time, writes Stephen Grossman of the FDA advocacy group Alliance for a Stronger FDA.


(Pharma Times) UK regulators are looking to halve the time it now takes to switch a drug from a prescription-only indication to an over-the-counter one. MHRA has already launched an initiative, complete with guidance, on how to switch products more quickly, reports Pharma Times.

(Court of Justice of the EU) The EU is inching toward a single patent system, and now-after 30 years of discussion-some stakeholders say the system could soon "see the light of day." The EU Court of Justice is now pressuring two holdouts, Spain and Italy, to join the other 25 members of the EU in the creation of such a system. (European Commission's take)

(PharmaBiz) India's Central Drugs Standard Control organization (CDSCO) is trying to better assess the quality of medicines across the country by directing state regulators to collect and send it samples from regulated facilities on a regular basis, reports PharmaBiz.

(TGA) Australian regulators are out with a host of new documents they hope will better allow sponsors to submit minor variations to prescription medicines.

(UK DOH) UK health officials have announced the preferred candidate for the post of the National Institute of Health and Clinical Excellence: Prof. David Haslam, currently an advisor to the Care Quality Commission and a member of NICE's Evidence Accreditation Advisory Board.

Interesting Reads

(EurekAlert) Could the weight loss drug orlistat, more commonly known as Alli and Xenical, create severe toxicity of internal organs when taken with other drug therapies? At least one researcher thinks so, according to his press release.

(Pharma Times) A semi-public repository for raw clinical trials data could be useful to both the industry and the public, says a group reported on by Pharma Times, but those benefits would largely be realized before marketing authorization.

(NIH) The National Institutes of Health have announced a potentially significant breakthrough for depression, saying a new antidepressant can start working within hours instead of weeks. The drug, similar to ketamine, "serves as a proof of concept," officials said.

[Editor's note: Your Regulatory Focus news editor is at a regulatory conference today. Regular coverage will resume on Wednesday, 11 December.]

Regulatory Focus newsletters

All the biggest regulatory news and happenings.