NPA working on safe harbor list of pre-DSHEA dietary ingredients
WASHINGTON – The Natural Products Association announced Wednesday it is in the later stages of developing a comprehensive safe harbor list of pre-DSHEA dietary ingredients for the industry based largely on evidence from past media reports, advertising and other public sources.
“NPA has a treasure trove of useful labels and label information dating back to the 1940s from our retailing magazines, which will be used as evidence of dietary ingredients sold in interstate commerce before Oct. 15, 1994,” stated Daniel Fabricant, NPA CEO. “There are industry lists from the late 1990s and NPA’s own list from 1996. In short, we have the evidence FDA is seeking to make these determinations, and we look forward to engaging FDA on developing a safe harbor list," he said. “The most common question we get from our members is whether something is an old ingredient and therefore off-limits to FDA or a new dietary ingredient, which triggers the NDI notification process. While future dietary ingredients may be appropriately subjected to that process, we are developing a safe harbor list now for greater clarity as to exactly what ingredients fall safely into the approved category and can be used in products today.”
NPA hopes to complete the Safe Harbor database of dietary ingredients in the near future, and will engage FDA in the coming months on its methodology and evidence.
College of Pharmacists of BC remove all barriers to sale of naloxone
VANCOUVER, British Columbia – The College of Pharmacists of BC on Wednesday switched naloxone, the life-saving drug used to reverse the effects of an opioid overdose, from a Schedule II drug to one that is unscheduled and widely accessible.
As such, naloxone is now available outside of pharmacies.
"Given the current public health emergency and increasing numbers of fatal opioid overdoses, the College feels compelled to do whatever we can to make this life-saving antidote available to whomever needs it," stated Bob Nakagawa, registrar College of Pharmacists of BC. "This amendment to the BC Drug Schedules Regulation makes BC the first province in [Canada] to deregulate and unschedule emergency use naloxone. This will save lives."
Recent changes had already made emergency use naloxone available in BC without a prescription. On March 22, 2016, in response to the significant increase in opioid-related deaths, Health Canada made changes that allowed for emergency use naloxone to be available without a prescription. In BC, the College Board approved the change (to Schedule II) in hopes of increasing access to this life-saving drug. Having naloxone classified as Schedule II and behind the counter ensured pharmacists had the opportunity to provide purchasers with important training on how to administer the drug.
Since then, the number of opioid-related deaths has continued to rise. In April 2016, the BC Provincial Health Officer declared the crisis a public health emergency. After further consideration, on Sept. 16, 2016 the College Board removed emergency use naloxone from the Drug Schedules Regulation to ensure there are no regulatory barriers to access the drug.
"We are in the midst of an overdose crisis in BC and making naloxone easier for people to get will help to save lives," Canada Health Minister Terry Lake said. "The College made this decision after consultations with the Ministry of Health, BC Centre for Disease Control and patient advocacy groups, and this will go a long way to help people gain easier access to a potentially life-saving treatment."
The benefit of greater accessibility clearly outweighs any real or perceived risks associated with having naloxone available outside of pharmacies. In particular, removing emergency use naloxone from the Drug Schedules Regulation will make it easier for other public health organizations to help distribute the drug (often in take home kits) to friends and family of those who may find themselves in an emergency overdose situation.
The College would like to emphasize that training is still important. Anyone administering naloxone needs to know to call 911 right away and be aware that naloxone may bring on symptoms of withdrawal. It also wears off after 30-75 minutes which means an overdose can return.
The College provided educational sessions to pharmacists in April 2016 in order for them to provide information and training in the pharmacy, however other organizations such as the BC Centre for Disease Control are successfully providing information and training on how to use naloxone.
GSK Consumer Healthcare CEO in line to succeed GSK CEO Andrew Witty
LONDON — GSK on Tuesday named Emma Walmsley GSK CEO Designate and successor to Andrew Witty as GSK CEO when he retires on March 31, 2017. She will join the GSK board of directors on Jan. 1, 2017.
"Emma is an outstanding leader with highly valuable experience of building and running major global businesses and a strong track record of delivering growth and driving performance in healthcare," stated Philip Hampton, GSK chairman. "Under Andrew’s leadership, GSK has successfully developed into a company with market-leading positions in pharmaceuticals, vaccines and consumer healthcare. These provide excellent platforms for sustainable, long-term growth, and we are confident Emma will successfully build on these strengths.”
“I am delighted and honoured to be appointed GSK’s next CEO," Walmsley said. "GSK is a company that leads both in science and in the way it does business. We have momentum in the Group and as the demand for medical innovation and trusted healthcare products continues to rise, we have the opportunity and the potential to create meaningful benefits for patients, consumers and our shareholders. I’m looking forward to working with Andrew and other leaders over the next few months to ensure a smooth handover and to develop plans for 2017 and beyond.”
Walmsley is currently CEO of GSK's Consumer Healthcare division.
Prior to this, Emma was president of GSK Consumer Healthcare and has been a member of GSK’s corporate executive team since 2011. Emma joined GSK in 2010 from L’Oreal where, over the course of her 17-year career, she held a variety of marketing and general management roles in the U.K., Europe and U.S. From 2007 she was based in Shanghai as general manager, consumer products for L’Oreal China.