Archive for category The Pharmaceutical Industry

National Health Amendment (Pharmaceutical Benefits) Bill 2014

Bills Digest No. 7, 2014-15 14 July 2014, Parliamentary Library, Parliament of Australia
Author: Leah Ferris
“The purpose of the National Health Amendment (Pharmaceutical Benefits) Bill 2014 (the Bill) is to amend the National Health Act 1953 (the Act)1 to increase the co-payment and Safety Net amounts for items listed under either the Pharmaceutical Benefits Scheme Schedule (PBS Schedule) or the Repatriation Schedule of Pharmaceutical Benefits (RPBS). In particular the Bill will: increase the co-payment for general patients by $5.00 (to $42.70) and the co-payment for concessional card holders by $0.80 (to $6.90) 2 and increase the safety net for general patients by ten per cent each year for four years and the safety net for concessional patients by two prescriptions each year for four years.3″
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When does medical confidentiality become unjustified secrecy?

Croakey, the Crikey Health Blog, online 10 July 2014
Authors: Marie McInerney/ Adam Stakevicius
“The Consumers Health Forum says Medicine Australia’s proposed new code of conduct has “failed to put in place transparency safeguards against the schmoozing of doctors to influence prescribing”.  In the post below, CEO Adam Stankevicius says this is the latest step in a “disturbing trend towards unjustified and unacceptable secrecy” where the “camouflage of confidentiality” is also blocking access to valuable data about the effectiveness of healthcare treatment and services.”
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Drug treatments in people with intellectual disability and challenging behaviour: Time to rethink?

BMJ 2014;349:g4323
Authors: Peter Tyrer, Sally-Ann Cooper, Angela Hassiotis
“Do we still need to be reminded that the drug treatment of people with intellectual disability is often prolonged and not without dangers? We probably do.”
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FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rules

Washington Post, 9 July 2014
Author: Brady Dennis

“Should a pharmaceutical sales rep be allowed to tell a doctor that Topamax, a drug approved to treat seizures and prevent migraine headaches, might also help combat alcohol dependence? Or suggest the epilepsy drug Neurontin could also help treat bipolar disorders or insomnia? Or offer data showing that any number of other drugs could have uses beyond those listed on their labels? For decades, the answer overwhelmingly has been no.

Prompted in part by recent federal court decisions, the FDA is reviewing its rules on what kind of data drug companies should be allowed to distribute to doctors regarding off-label uses, as well as how they should respond to unsolicited questions from physicians about those uses. Its goal is to issue new guidelines by the end of the year.”

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MSD Italy is criticised for threatening legal action over prescription advice to GPs

BMJ 2014;349:g4441
Author: Fabio Turone

“The Italian branch of the drug company Merck Sharp and Dohme (MSD) has stopped a leading public health doctor and administrator from circulating texts to GPs advising them about the use of one of the company’s drugs. In the texts, Alberto Donzelli—the head of education, appropriateness, and evidence based medicine at the public health authority of Milan (Milan Healthcare)—had analysed the published evidence on the cholesterol lowering drug ezetimibe and discouraged its prescription in addition to statins…”

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Proposed rule would end Sunshine Act’s CME exclusion

Modern Healthcare News
Authors: Joe Carlson and Jaimy Lee

“The CMS intends to eliminate the exclusion for continuing medical education in the Open Payments program, more commonly known as the Sunshine Act, which requires drug and device companies to disclose payments to physicians. The reversal was included in the proposed Physician Fee Schedule for 2015…”

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Indian Supreme Court demands clarity on clinical trial approvals

BMJ 2014;349:g4383
Author: Meera Kay
“The Supreme Court of India has told the government that applicants seeking approval to conduct clinical trials must be asked to provide a risk-benefit assessment of the drug being investigated, its potential benefit to patients, and the advantages it offers over existing treatments. The order was passed during the hearing of a petition1 filed by the non-governmental organisation Swasthya Adhikar Manch (Health Right Forum), which advocates issues related to health rights in India, seeking directions for the regulation of clinical trials involving new drugs and chemical entities.”
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India will make 50 essential drugs available free of charge

BMJ 2014;349:g4321
Author: Sanjeet Bagcchi

“Fifty essential drugs are to be made available to the entire population of India free of charge, the Indian government has announced. The government argues that the list of 50 drugs will be sufficient to deal with three quarters of most people’s medical needs and will enable it to negotiate pricing deals during procurement and provide more than a third more drugs for the same amount of money. The list includes analgesics, antibiotics, antihypertensives, and antidiabetes drugs.

The initiative will be implemented in selected Indian hospitals initially and then rolled out across the country. Eventually all 50 drugs will be available free on prescription at public hospitals and dispensaries…”

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Woolworths under fire for health check trial

Sydney Morning Herald, 1 July 2014
Author: Jessica Gardner

“Two lobby groups criticised a plan by Woolworths to offer health checks to customers, although the plan drew interest from consumer advocates.

The retailer confirmed on Tuesday it has had nurses checking blood pressure and cholesterol across nine stores in NSW and Queensland since October. This trial will be reviewed before any decision on a full store roll-out is taken.

The plan upset the Australian ­Medical Association and the Pharmacy Guild of Australia. The guild has long opposed any moves by supermarket retailers to encroach on its patch.In markets such as the United States and the United Kingdom, supermarkets are able to open pharmacies and sell prescription drugs, but in Australia that activity is restricted to registered pharmacists…”

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Indian generic drug manufacturers in the spotlight

The Lancet, Volume 383, Issue 9936, Page 2186, 28 June 2014
“Concerns have arisen about safety and quality issues in the manufacture of pharmaceuticals in India, a major exporter of generic drugs to the USA and elsewhere. These concerns came into sharp focus last week when the US Food and Drug Administration (FDA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued two recalls of commonly taken drugs.”
Find editorial here.