UK Regulatory Agency Considering Using Social Media for Adverse Events Reporting

Over two years ago at the beginning of the social media/pharma debate, I proposed that social media platforms like Twitter and Facebook would be great for adverse event reporting for drugs, biologics and medical devices. At the time, the suggestion was largely ignored and relegated to the category of “unlikely to happen anytime in my lifetime.” 

Imagine my delight after reading a post on today’s Pharmalot Blog which suggested that the Medicines and Healthcare products Regulatory Agency (MHRA)—the UK equivalent of the US Food and Drug Administration (FDA)—is considering whether to allow the public to use Twitter and Facebook to report side effects and adverse events.

According to the Pharmalot post:

"The MHRA is now “actively working on introducing other ways of reporting to make it easier and encourage more reporting,” Mick Foy, the MHRA group manager for vigilance and risk management of medicines, tells GP. “Applications for smartphones, improved web reporting forms and the use of social media such as Twitter and Facebook are being carefully considered as potential routes for reporting.”

While the MHRA is considering the use of social media, it is not clear that the agency will ultimately adopt Twitter, Facebook or other mobile applications for adverse event reporting. Like in the US, possible adverse reported in the UK must meet several criteria before they are verified and considered to be reportable adverse events. Despite potential problems and pitfalls, the fact that the MHRA is even considering social media as a means to improve adverse event reporting is laudable; considering the fact that FDA has yet to provide guidance on the use of social media in the US life sciences industry. Many companies, social media advocates and mobile app developers have been waiting for the said guidance for almost two years now.

Like it or not, social media is now part of the social fabric of today’s world. Rather than fighting its implementation, life sciences companies would use their considerable creative talent to figure out how to integrate and leverage social media (in non-promotional ways) to their benefit.

Until next time...

Good Luck and Good Tweeting and Following!!!!

 

Layoff Alert: GlaxoSmithKline Reveals Jobs Will Be Eliminated at UK Facility

After announcing that it would lay off about 4,000 workers two weeks and then refusing to disclose which facilities would be affected,  the British drug maker, GlaxoSmithKline (GSK) today revealed that several hundred workers at it Harlow, Essex  facility will lose their jobs. 

The Harlow facility, formerly the headquarters of SmithKlineBeecham which was taken over by Glaxo almost 10 years ago, is located 25 miles (40 km) northeast of London. Although not confirmed, as many as 380 of the 1,1150 employees at the facility may lose their jobs.

Stay tuned for more GSK layoff updates!

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!!

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More Downsizing on Both Sides of the Atlantic

Cambridge, MA-based Alkermes announced today that it is restructuring its operations following the termination by Eli Lilly and Company of its inhalable AIR Insulin program (Alkermes manufactured the inhaler delivery device). The company is reducing its workforce by approximately 150 employees and closing its AIR commercial manufacturing facility in Chelsea, MA. The company is taking these actions based on its current expectations of the financial impact of Lilly's termination of the AIR Insulin program.

The job cuts, effective this week, represent almost 18% of Alkermes’ total workforce. Employees affected by the restructuring will be eligible for a severance package that includes severance pay, continuation of benefits and outplacement services. The company expects cost savings from the restructuring in the range of $15 million to $20 million in fiscal 2009.

In other news from across the pond, the trade group, the Association of the British Pharmaceutical Industry (ABPI), reported today that the UK pharmaceutical industry lost about 8.000 pharmaceutical jobs or about 10% of its workforce over the past three years. The ABPI asserts that there is a direct link between job cuts and changes to the British government’s pricing mechanisms for medicines. A spokesperson for the group said “Every time a new PPRS (Pharmaceutical Price Regulation Scheme) comes into force there is a decline in the number of jobs”. Not surprisingly, the group is urging the government to not make any changes in the PPRS.

The UK pharmaceutical workforce has taken a number of big hits of late– Pfizer recently closed a manufacturing plant in Kent, while British drug makers AstraZeneca and GlaxoSmithKline both announced substantial global job cuts many of which were located in Britain.

Until next time….

Good Luck and Good Job Hunting!!!!