Webinar Tomorrow: New Requirements for Naming Drugs
This is outside our normal “online law” topic, but if your practice deals with pharmaceutical issues you may be interested. I’m helping promote an educational webinar for pharmaceutical lawyers to discuss new FDA and USPTO regulations for drug naming. Please take a look and, if you like, plan to join us.
The importance of drug labels is being underscored by the high profile case Wyeth v. Levine. Its decision is potentially worth tens of billions of dollars to the pharmaceutical industry.
The core question of the case is whether FDA approval of drug labeling should insulate drug makers from later claims that labels should have contained additional warnings. The arguement behind this is that federal law trumps state law, so if a federal agency approves such drug information, then state courts may be blocked from challenging such decisions.
Names are part of the label, and they’re highly regulated. Naming a drug can be as complicated as creating a rhythmic string of unpronounceable syllables and emphatic-sounding letters, such as C and P. Other naming strategies include letters that when strung together sound like something high-tech–think Zyprexa, Lexapro, and Xanax.
But whether it’s the sound of certain letters that manufacturers like, or the vision that a name conjures up, the FDA says that selection must take into account concerns for reducing errors and for avoiding trademark infringement. It’s a difficult task, complicated by an approval process that wends its way through both the FDA and the USPTO. And that’s where educational programs like this can make a difference.
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