Regulation
- The management board of the EMA recently met to discuss their new premises in Amsterdam. A new, tailor-made facility will be built for the EMA in the business district Zuidas, but this will not be ready before the UK leaves the EU at the end of March 2019 (expected completion is November 2019). Temporary premises for the agency are being prepared in the Sloterdijk area of Amsterdam and will be ready by January 1, 2019.
- The UK and China have signed a memorandum of understanding on medicine and device regulation, and expanded on the previous memorandum, with new areas of cooperation outlined, including effective regulation of online trading.
- The European Commission has proposed mandatory future European cooperation on Health Technology Assessments. The legislation, currently being discussed by the European Parliament, covers joint clinical assessments for the innovative health technologies, joint scientific consultations whereby developers can seek advice from HTA authorities and identification of emerging health technologies to identify promising technologies early.
Controversies
- After paying US$2.5 billion to buy the PharMEDium sterile drug compounding pharmacy operation, AmerisourceBergen has run into regulatory problems with its PharMEDium lab in Memphis, USA. In January the company had to recall compounded sterile products due to lack of sterility assurance, and in February it received a Grand Jury subpoena for testing documents on a certain type of syringe.
- In an ongoing bribery probe, GlaxoSmithKline is facing new questions from the UK Serious Fraud Office. GSK has been asked to provide information regarding “third-party advisers engaged by the company in the course of the China Investigations”.
- Pharma companies sat out the Super Bowl for the second year in a row, despite it being the largest (albeit most expensive) US advertising opportunity of the year. The decision may have been influenced by the backlash three pharma companies faced two years ago for ads than ran during the Super Bowl, with some viewers questioning the timing of discussing fungus and diarrhea during a soccer game.
- GSK has rocketed from number five to number one in an online excellence ranking by Bowen Craggs & Co – the first pharma company to do so in almost ten years. The company’s strong homepage, headlines, career section and it’s transparency in its online presence all contributed to it moving up the rankings. “GSK turned what was a good site into an excellent one through relentless polish and refinement,” said Scott Payton, managing partner at Bowen Craggs.
- Rare Disease Day will take place on February 28, with the aim of raising awareness about rare diseases and the impact on patients’ lives. It is believed that 1 in 20 people will live with a rare disease at some point in their life.
- In his first State of the Union address, Donald Trump urged Congress to pass the “Right to Try” Bill, which aims to make it easier to give patients with terminal illnesses access to promising investigational therapies that have not yet been approved by the FDA. Some patients, particularly those suffering from rare diseases, say they would welcome the bill, but the National Organization for Rare Disorders is concerned that there may be “bad actors looking to profit off of false hope”.
- The National Institutes of Health is partnering with government, biopharmaceutical and non-profit organizations to help improve drug development successes for Parkinson’s disease. The collaboration will focus on identifying and validating disease biomarkers and new biological targets. More than $12 million has been invested as part of the initiative.
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