Regulatory Reconnaissance: Morning News for 19 October

Posted 19 October 2012 | By Alexander Gaffney, RAC 

United States

(Technology Review) Many medical devices found in hospitals are riddled with malware and viruses, reports a panel of government experts. The findings could place pressure on regulators with the US Food and Drug Administration (FDA) to prioritize postmarket information security in light of the potential risks to patients.

(MDDI) Jeffery Shuren told a meeting of industry regulators that the Center for Devices and Radiological Health (CDRH), FDA's device oversight body, that submission review times have dropped across the agency-the first time such an event has happened since 2002.

(Pharma Times) An FDA advisory committee panel has backed Sanofi and Isis Pharmaceutical's Kynamro (mipomersen sodium)-a drug used to treat homozygous familial hypercholesterolaemia (HoHF), a disease which disrupts a patient's ability to process low-density lipoproteins (LDL).

(FDA) Regulators have approved ThromboGenics' symptomatic vitreomacular adhesion drug Jetrea (ocriplasmin).

(Reuters) The FDA review period for Biogen's multiple sclerosis drug BG-12 has been extended by regulators for three months. Analysts said regulators likely needed additional time due to the size and complexity of the company's regulatory filing.

(Fierce Biotech) An FDA advisory committee panel has recommended Aegerion's HoHF drug, saying the drug's safety concerns were outweighed by its likely benefits.

(AP) The Associated Press asks:  Just how did those steroid injection shots manufactured at the New England Compounding Center (NECC) come to be infected with fungal meningitis?

(FDA) FDA has confirmed that the outbreak of fungal meningitis came from contaminated vials manufactured by NECC.

(Wall Street Journal) The Wall Street Journal reports that some patients who received steroid injections to treat back pain-the same now linked to meningitis-continue to receive the shots despite the risks and the questionable benefits.

(RPM Report) Bloomberg recently reported FDA is interested in forming a "special medical use" pathway for socially beneficial drugs, such as obesity treatments. The RPM Report asks, what would this pathway look like, and what are some of its potential benefits and pitfalls? (Subscription)

(Scientific American) Scientific American notes US regulators-and in particular FDA-have remarkably little authority to stop unsafe cosmetic products from entering the market. The resulting regulatory vacuum can be devastating for people who regularly use or administer a particular product.

(NPR) National Public Radio reports that some old antibiotic drugs are getting a second look as newer-generation ones fail as drug-resistant bacteria become more common.

(FDA) FDA's Arthritis Advisory Committee will meet on 20 December to evaluate Hemisherx Biopharma's drug Ampligen (rinatolimod injection) for patients with chronic fatigue syndrome.


(Reuters) The European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) has recommendation against the approval of Vivus Inc's anti-obesity drug Qsiva. The drug recently won approval in the US under the name Qsymia, but CHMP officials said the drug is potentially unsafe when used for lengthy periods of time.

(EMA) EU regulators have approved the first radiopharmaceutical for PET imaging of beta-amyloid neuritic plaque density, used to evaluate patients for Alzheimer's disease.

(EMA) CHMP also recommended the approval of a higher-strength type of insulin. Current doses are 100 units/ml, but the new dosing will allow for up to 160ml.

(PM Live) The National Institute of Health and Clinical Excellence (NICE), the UK's rationing body, and the Association of the British Pharmaceutical Industry are clashing over a new report. ABPI claims it shows medicines are not being widely adopted despite their cost effectiveness, while NICE claims the adoption rate is higher than is to be expected.

(Pharma Times) After receiving pressure from Medicines Australia, the Australian government has launched a review of patent term extensions for pharmaceutical products. Industry has argued patents are not given for a sufficient amount of time to make their investment worthwhile.

(PharmaBiz) A recent order from India's Drug Controller General (DCGI) asking local health ministries to refrain from issuing licenses for branded generics could lead to weakened growth in the country's pharmaceutical sector, argues the pharmaceutical industry. (2) (Economic Times)

(Health Canada) Canada's Minister of Health, Leona Aglukkaq, announced plans on 18 October to create a Canadian version of the US's database. The database would just be for pharmaceutical products, she said.

(EMA) The European Medicines Agency (EMA) has said its investigation into the Pandemrix vaccine, which has been associated with safety concerns involving patients coming down with narcolepsy, has failed to substantiate the concerns and requires additional research. Pandemrix is manufactured by GlaxoSmithKline.

(EMA) EMA investigators also said the current risk paradigm for non-steroidal anti-inflammatory drugs (NSAIDs) is adequate following an investigation into the potential for the drugs to cause cardiovascular problems.

(Med Tech Insider) Additional details have come out regarding the ousting of EU Health Commissioner John Dalli. European Union officials said Dalli was aware of attempts to bribe European Commission officials but did not make efforts to disclose the wrongdoing.

(Biosimilar News) EMA received six biosimilar applications during the first half of 2012-a significant increase relative to 2011.

[Editor's note: I'm in meetings all morning. Rather than leave you with an article or two to read, please enjoy this summary of the morning's top news topics. Regular news coverage will resume this afternoon.]

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