Who Lost Opioids?

Google “opioid abuse deterrence” and you’ll find a lot of hits from lawyers and elected officials. What you won’t find is a lot of expert thinking from the FDA.

That needs to change. FDA Commissioner Hamburg’s March 13, 2014 testimony in front of the Senate HELP Committee) hopefully represent a more aggressive stance by the agency. That’s good. But there needs to be more. The FDA must be the leading voice on the issue of abuse deterrence and the safe use of opioids.

At present, politicians and pundits (not to mention trial lawyers) own the conversation. They’re the ones talking about it. They’re the ones the media goes to when they write about it. Have a look at a sampling of the press coverage surrounding Zohydro and see who’s quoted and what they’re saying.

The struggle over control of the opioid abuse deterrence story is, shall say, not going the right way for the FDA.

Staking an Advantage in an AIA World: Practical Patent Tips for Biotechnology Companies

With passage of the Leahy-Smith America Invents Act (AIA), new rules and procedures related to the application of prior art now apply to patenting under a “first-inventor-to-file” system. This article summarizes certain key prior art provisions that biotechnology companies should be aware of and details practical steps that can be implemented to help stake a competitive advantage under the new law including the use of patent liaisons, early provisional and patent application filings, and in certain circumstances, defensive publication of patentable subject matter.