Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Morning News for 22 October

Regulatory Reconnaissance: Morning News for 22 October

Posted 22 October 2012 | By Alexander Gaffney, RAC

United States

(FDA) The US Food and Drug Administration (FDA) has granted an expanded approval for Edwards Lifesciences' Sapien Transcatheter Heart Valve (THV) to include patients with aoertic valve stenosis, a progressive and age-related disease in which the heart's aortic valves narrow as the result of a buildup of calcium. Edwards' THV does not require open-chest or open-heart surgery to implant, reducing the amount of risk normally assumed during the complex procedure.

(FDA) FDA approved a 90-minute infusion for Genentech's Rituzan (rituximab) for non-Hodgkin's lymphoma patients who did not experience certain adverse reactions during a first cycle of the drug.

(Inside Health Policy) FDA is preparing regulatory fall-back measures if its efforts to curtail the use of antibiotics in animal feed through voluntary measures fail, reports IHP. Those findings were revealed through a Freedom of Information Act (FOIA) request by an environmental group.

(NY Times) The incubation period for fungal meningitis-which 14,000 patients in the US may have been unwittingly exposed to through compounded injections-is so long and variable that many patients will not know if they are infected for months. Another problem: Medical professionals have little experience in treating this type of infection because of its rarity.

(NY Times) Another problem: The number of infected drugs may be much, much higher than originally estimated. FDA has passed along 131,000 shipping invoices from the New England Compounding Center (NECC) to state health officials in the hope of tracking down the facility's products for testing.

(AP) FDA may not approve compounded drug products, but Medicare still pays for them, reports the Associated Press. With the latest outbreak of meningitis, Medicare officials are scrambling to determine how many program participants may have become sick through the steroid injections and, more importantly, how to prevent such an oversight from happening again.

(Washington Post) Most compounding pharmacies aren't accredited-not by FDA, state officials or even third-party accreditors. The lack of proper oversight now has many asking whether it is time to transfer such authorities in their entirety to FDA.

(FDA) Sunscreen manufacturer Banana Boat is recalling 23 of its products after being made aware of the potential for users of its continuous spray products to have their skin ignite if they are exposed to a source of ignition before the product is completely dry. The company said it believed the problem is the size of the spray valve, which may be delivering too much product. Four patients have already experienced adverse events.

(Med City News) Pharmaceutical whistleblowing is increasingly being done not by industry insiders, but by analyzers of huge data sets fueled by insurance and reimbursement data.

(Alliance for a Stronger FDA) Because 80% of FDA's expenditures are spent on personnel costs, the effect of budget sequestration-an across-the-board budget cut with the potential to take 8.2% of FDA's budget-the agency could be in line for crippling employee reductions, which would come just as the agency is being asked to assume increasingly levels of responsibility. (Chart Estimating Effect of Budget Cuts)

(Mass Device) Planning to use an iPhone, iPad or mobile device to remotely monitor patients? Buckle in for patent infringement lawsuits. AirStrip Technologies, a mobile health company, this week filed a lawsuit against another company for allegedly infringing upon its patents for remote monitoring using mobile devices, which it won in August 2012.

(Reuters) After approving two diet drugs in the last three months, FDA said it could allow Orexigen to resubmit its application for its diet drug Contrave faster than it would normally allow. The drug was shot down by regulators in early 2011 after regulators flagged potential heart problems in clinical trial participants. The company has since enrolled thousands of patients into a new study, and is trying to present interim data to show safety.

(Reuters) GlaxoSmithKline announced positive results from five late-stage trials testing two of its quadrivalent influenza vaccines. Current generation influenza vaccines are trivalent. A quadrivalent would hypothetically offer broader protection for patients.


(Reuters) Novo Nordisk has won approval from the European Medicines Agency (EMA) for its new ultra long-lasting insulin injector, Tresiba (Degludec). The product could represent a huge benefit for type 2 diabetes patients, who would only need to take the product half as often.

(Health Canada) Canadian regulators are preparing to release more information about the country's planned launch of a clinical trials registry similar to the US'

(PharmaBiz) A recent order from the Drug Controller General of India to instruct local authorities not to approve branded generic medication is likely to be challenged in court, say experts consulted by PharmaBiz.

(PharmaBiz) Also in India: A highly anticipated report by the Central Drugs Standard Control Organization (CDSCO) is set to be released within the next two weeks. The report was ordered after a parliamentary inquiry into the CDSCO found the organization had been sorely deficient in its basic duties to test and approve drugs based on safety, efficacy and strong clinical evidence.

(PMLive) Novartis' Glivec (imatinib) is set to receive biosimilar competition from Israeli drug manufacturer Teva after EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the drug's use. The biosimilar would be required to be paired with a pharmacovigilance plan to receive approval.

(The Gray Sheet) China, which has historically conducted much of its purchasing at the hospital level, may soon transition to a provincial, centralized bidding system. The change could have a huge impact on medical device manufacturers, notes The Gray Sheet. (Subscription)

Essential Reading

(Medical News Today) A meta-analysis conducted by The Cochrane Library has determined that approximately half of all new treatments are superior to existing ones. The study's authors claim their finding proves trials are being conducted ethically by showing that researchers don't know whether the treatments will work or not.

(Scientific American) How should pediatricians cut down on the overprescribing of antibiotics to children? Educational programs are surprisingly effective, cutting down inappropriate prescriptions by half, claims a new study.

(Reuters) Do sponsors of clinical trials need to do a better job of educating patients-and in particular parents-about the role of Phase 1 clinical trials? That's quite likely, finds a new trial. Only a third of parents interviewed by the study's authors could accurately describe the role of the trial and its potential benefit for their child. An additional third showed little to no understanding regarding the trial, which tests the safety of a product-not efficacy.

(Drug Topics) Dosing guidelines for obese children should be developed for acetaminophen, argues a new study published in the European Journal of Hospital Pharmacy. The study looked at two factors-the age of a child and his or her weight-and asked prescribing physicians to evaluate which factor they were more likely to prescribe a specific dose based on. Roughly half of prescribers would do so based on weight, not age.

(Reuters) The biggest competition for branded biologics manufacturers is likely to be other branded biologics manufacturers, claimed the outgoing CEO of Swiss biotech Actavis.

(The Economic Times) A researcher has developed a computational model to predict liver toxicity, a development with the potential to reduce the cost of clinical trials and the danger to patients enrolled in studies.

(NY Times) Have you received an adverse event report regarding bloody stool, but no other symptoms? Make sure the patient isn't a fan of Flamin' Hot Cheetos, which can cause blood-red stool in fans of the snack food.

[Editor's note: More meetings to attend today. In lieu of our normal article coverage, please enjoy this selection of the morning's news. Normal coverage will resume shortly.]

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