Politics
Members of the European Parliament have voted overwhelmingly to approve the European Council’s Brexit guidelines, which say that “arrangements should be found” to facilitate the transfer of EU agencies located in London, such as the EMA, to alternative locations. Reuters have reported that 21 of the 27 EU member states have expressed an interest in hosting the EMA. http://g8fip1kplyr33r3krz5b97d1.wpengine.netdna-cdn.com/wp-content/uploads/2017/03/FullText.pdf Deaths due to overdosing on prescription opioids are on the rise in the US and Senator Claire McCaskill is taking action by launching an investigation to find out how the country’s leading opioid manufacturers are marketing their drugs. She is asking for internal company documents that discuss the risk of misuse, abuse, addiction and overdose, as well as documents outlining business and marketing plans, and quotas for sales representatives. In 2015, more than 15,000 people in the US died from overdoses relating to prescription opioids. In December 2016, the US Department of Justice alleged that six former executives of opioid manufacturer Insys Therapeutics had engaged in a bribery scheme, leading doctors to unnecessarily prescribe opioids. http://edition.cnn.com/2017/03/28/health/senate-opioid-manufacturer-investigation/Regulation
The EMA Board has adopted a new policy on whistleblowing – aiming to “create an environment where individuals from outside the Agency feel confident to raise their concerns on improprieties in their area of work”. To this end, the EMA has created a dedicated email address, reporting@ema.europa.eu, where individuals can anonymously raise concerns. The agency has reportedly received “a total of 43 reports that relate, for example, to the manufacturing of medicines or the conduct of clinical trials,” since 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/03/WC500224494.pdf President Trump’s nominee to head the FDA, Scott Gottlieb, has pledged in his confirmation hearing to “remain faithful to the FDA’s gold standard” for establishing the safety and effectiveness of new drugs, and that he would not approve drugs based only on safety. Gottlieb also said that price rises à la Daraprim are enabled by the FDA’s approval process and that this is a “solvable problem”. http://healthaffairs.org/blog/2017/04/07/scott-gottliebs-fda-commissioner-confirmation-hearing-remarkably-unremarkable/Manufacturing
Mylan’s recall of faulty EpiPens has spread to the US, after an international recall of around 81,000 EpiPens in Australia, New Zealand, Europe and Japan took place in March. The recall has followed two reports of the life-saving allergy shot not working in emergencies – though in both situations patients were able to use an alternative EpiPen. http://fortune.com/2017/04/01/mylan-epipen-us-recall/ GSK is voluntarily recalling nearly 600,000 Ventolin inhalers in the US because of a defect that may cause the inhalers to deliver fewer doses than indicated. The recall affects three inhaler lots that were manufactured in Zebulon, North Carolina. http://www.reuters.com/article/us-gsk-recall-idUSKBN1762F3 A strike over pension plans at a Pfizer plant in Ringaskiddy, Ireland, has ended after the company agreed to let 35 new staff access the firm’s benefit pension scheme. The industrial action involved around 200 workers and lasted for more than eight weeks. http://www.in-pharmatechnologist.com/Ingredients/Strike-ends-at-Pfizer-plant-after-firm-lets-new-staff-join-pension-planNewsletters
Receive the latest analytical science news, personalities, education, and career development – weekly to your inbox.
