Australian-first with corporation fined $127,500 for unlawful advertising

AHPRA, 4 October 2017
“In an Australian-first, Wellness Enterprises Pty Limited, which traded as Australian Male Hormone Clinic, has been fined $127,500 plus costs after being found guilty and convicted of 17 charges related to unlawful advertising of regulated health services.”
Find article here.

 

The United Kingdom Sets Limits on Experimental Treatments: The Case of Charlie Gard

JAMA. 2017;318(11):1001-1002
Author: Robert D. Truog
“The case of Charlie Gard in London, England, has been the focus of international attention, generating polarized views about the use of experimental treatments. On one side are those who hold that patients should be able to purchase whatever treatments they desire and can afford; on the other are those who maintain that governments must play a regulatory role in protecting patients from harm and that unproven therapies must meet a threshold of scientific validity before they are offered, regardless of the ability of the patient to pay.”
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FDA plans new compounding pharmacy policy, agency head says

Reuters, 16 September 2017
Author: Nate Raymond
“The head of the U.S. Food and Drug Administration said on Friday the agency is working on a new policy that would encourage more compounding pharmacies to register under a law enacted in the wake of a deadly 2012 meningitis outbreak linked to one such company.”
Find article here.

France to prosecute its drug regulator and Servier in scandal over diabetes drug

BMJ 2017; 358: j4231
Author: Owen Dyer
“France’s drug regulator and one of its leading drug companies, Servier, will stand trial as legal persons over the marketing of the antidiabetes and weight loss drug benfluorex (marketed in France as Mediator), which is believed to have killed between 500 and 2300 people before being pulled from the market in 2009.”
Find article here.

Pharmaceutical Marketing for Rare Diseases: Regulating Drug Company Promotion in an Era of Unprecedented Advertisement

JAMA. 2017; 317(24): 2479-2480.
Authors: Sham Mailankody, Vinay Prasad
“This Viewpoint uses the recent instance of disease awareness promotion on a television soap opera to discuss questions about the role and regulation of novel forms of direct-to-consumer disease awareness marketing.”
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Undermining Genetic Privacy? Employee Wellness Programs and the Law

NEJM, 24 May 2017
Authors: Kathy L. Hudson, Karen Pollitz
“Genetic information is becoming ubiquitous in research and medicine. The cost of genetic analysis continues to fall, and its medical and personal value continues to grow. Anticipating this age of genetic medicine, policymakers passed laws and regulations years ago to protect Americans’ privacy and prevent misuse of their health-related information. But a bill moving through the House of Representatives, called the Preserving Employee Wellness Programs Act (H.R. 1313), would preempt key protections. Because the bill, which was sent to the full House by the Education and the Workforce Committee in March, would substantially change legal protections related to the collection and treatment of personal health and genetic information by workplace wellness programs, it should be on the radar screens of physicians, researchers, and the public.”
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State Sepsis Mandates — A New Era for Regulation of Hospital Quality

NEJM, 21 May 2017
Authors: Tina B. Hershey, Jeremy M. Kahn
“Sepsis is a major cause of illness and death in the United States, affecting more than 1.5 million Americans each year at an annual cost of over $20 billion. To improve outcomes of sepsis, policymakers are increasingly using regulatory mechanisms intended to provide incentives to clinicians and hospitals to improve the quality of sepsis care. One such initiative is an unprecedented set of New York State regulations implemented in 2013 and collectively known as “Rory’s Regulations.” Named after Rory Staunton, who died at 12 years of age from sepsis resulting from a soft-tissue infection, Rory’s Regulations mandate that all hospitals in the state use evidence-based protocols for sepsis identification and management and that they report to the state government data on their sepsis-protocol adherence and clinical outcomes.”
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Responsible advertising of health services: Practitioners reminded about their legal obligations on advertising

AHPRA, 21 April 2017
“The National Boards and the Australian Health Practitioner Regulation Agency (AHPRA) published a strategy for the National Scheme today to help keep health service consumers safe from misleading advertising. The Advertising compliance and enforcement strategy for the National Scheme explains how National Boards and AHPRA will manage advertising complaints and compliance, including the regulatory powers available to deal with breaches of the National Law.”
Find media release and strategy here.

California Has A Deadly Problem With Regulating Naturopathic Doctors

Forbes, 24 April 2017
Author: Britt Marie Hermes
“Since there is no “naturopathic standard of care,” a point that the committee acknowledged in 2009 and that critics of the regulation of naturopathy have noticed too, naturopathic expert reviewers must make ad hoc determinations that are likely to deviate from the medical consensus and fail to establish lasting precedent. For some influential naturopathic doctors, the standard of care includes anything taught in naturopathic school or done by two or more practitioners.”
Find article here.