I don’t think that Merck and BMS’s loss of breakthrough...

I don’t think that Merck and BMS’s loss of breakthrough designation for their Hep C drugs should be blamed on pharma lobbying/connections.

To qualify for breakthrough therapy designation a drug must demonstrate substantial improvement over existing therapies.

Previously, there were four companies with breakthrough therapy designations racing to get their Hep C drugs to be the first approved and to market. Gilead and AbbVie got there first. Their Hep C drugs have been proven to be very effective - wiping out all signs of the virus in over 90% of patients after 2 to 3 months.

Unfortunately for Merck and Bristol Myer Squibbs, their Hep C drugs simply aren’t better than that; hence they no longer meet the BTD criteria and designation has been rescinded. It was always clear that these were the rules for BTD; it’s just that some have been surprised that the FDA has actually followed through. They have, and I see that as a positive. It preserves the integrity of BTD imo.

The main fight is now between Gilead and AbbVie as they furiously try to outmanoeuvre each other to dominate in the Hep C market.

Lesson to be learned? It's vitally important to be first-in-class or best-in-class.