Obama deficit plan rolls back biotech marketing exclusivity to 7 years

The healthcare reform bill contained plenty of pain for the pharma world, which had to make some big concessions on drug costs for federal health programs. But it also contained some nuggets of pure gold for the biotech industry--chief of which was a provision for 12 years of marketing exclusivity for biologics. That was exactly the number of years BIO had sought. And the long commercial runway helped satisfy biotech investors that successful biologics would earn substantial returns.

Now, however, the Obama administration wants to undo a done deal. In his new budget proposal Obama is calling on Congress to squeeze the 12-year window down to 7 years, carving out $3.5 billion in projected savings over 10 years. That amounts to a tiny fraction of the $3 trillion deficit reduction plan.

Obama, of course, has signaled several times that he always wanted a 7-year market runway. But even as Rep. Henry Waxman (D-CA) unsuccessfully argued against the 12-year provision, Democrats on the committee he then chaired helped shove the longer period through Congress. BIO has kept its own keen eye on the topic and likely already has a set of Republicans as well as Democrats willing to champion the issue.

- read the New York Times story

Suggested Articles

Moderna’s shares shrunk by nearly 5% before the long holiday weekend Thursday after a report out by Stat said the biotech was delaying its trial.

Keep your post-pandemic trials on track: learn how the right clinical supply chain partner can help sponsors avoid trial disruption. Read now>>

Helsinn Group and MEI Pharma penned a near $500 million biobucks pact for experimental blood cancer drug pracinostat back in 2016.