3. Track and trace left on the backroom floor

The FDA has been advocating for a track and trace system for some time. Giving unique identifiers to each individual drug package not only makes them easier to retrieve in the case of adverse effects, but it provides another deterrent to counterfeiters. The FDA wants a nationwide program that includes and tracks identifiers on individual containers. The thinking goes something like this: If Netflix can deliver millions of movies to individual households in days, drugmakers should be able to keep track of the medications in their supply chains.

A plan put up by an industry coalition would put unique serial numbers on individual drug packages but require scanning drugs only in "lots" when they get to distributors. The coalition argues that to expect individual tracking from truck to warehouse, to distributor, to pharmacies is unworkable, at least for now.

It looked like some version of track and trace would make it into the FDA user fee reauthorization bill that Congress passed this summer, but in the final negotiations, the whole thing got left on the negotiating room floor.

While it may be some time before the FDA gets a legislative opening to reintroduce track and trace here, it is not entirely dead. California has passed its own law that should start in 2015, which could lead other states to follow, a situation the FDA and the industry have hoped to avoid. And Europe has a program slated to kick off in 2016.

3. Track and trace left on the backroom floor

Suggested Articles

How long can one infusion of CAR-T drug Yescarta continue helping patients with refractory large B-cell lymphoma? Pretty long, Gilead showed Saturday.

AbbVie and Roche have been fielding their fair share of questions about how well their fixed-duration regimen of Venclexta and Rituxan could keep chro

Saturday, AstraZeneca revealed more of the data that convinced the FDA to green-light Calquence in previously untreated chronic lymphocytic leukemia.