This week saw an unusually large amount of biotech deal activity in Canada, so you should check out the Monday Deal Review for all those details; but in between all the transactions, there were some interesting concepts to think about:
REMS: The FDA has, increasingly often, been imposing Risk Evaluation and Mitigation Strategies when it approves new drugs. REMS restrict the way new drugs can be distributed, administered and/or promoted. When the program was first introduced, common wisdom said that REMS were to be avoided at all costs, but lately some advantages have become apparent:
- Way back in June, we noted that REMS are expensive for drug companies, but that REMS make life expensive for generic copies as well, meaning that REMS provide a sort of price protection for pharmas even after patent and data exclusivity expire.
- This week, we saw that for some products that are mediocre performers, REMS requirements can keep the product viable by providing a perfect reason not to over-spend on product promotion; and we also saw BOTOX maker Allergan claim that REMS required them to make otherwise forbidden overtures to physicians using the drug off-label (outside of FDA-approved indications).
Comparative Effectiveness: CER is a hot topic, and it inspires controversy because of fears that a beneficial treatment will be denied because of cost considerations. Nevertheless, it has the potential to help patients avoid ineffective or harmful treatments by making head-to-head comparisons of competing treatment options. This week, we saw that sometimes the financial interests of a CER study sponsor can impact study design (cynics delight!), which to me emphasizes the importance of neutral government support for these types of studies.
Swine Flu! No matter how many other interesting ideas were floating around, a lot of people are focused on Influenza A-H1N1 (aka swine flu, aka grippe porcine) this week. At the Cross-Border Biotech Blog, we are your one stop swine flu shop™. This week, we gathered some recent Ontario data and since the summer we have been aggregating swine flu news in the widgets column on the right of the blog. Come for the flu, stay for the fun!