Senator Warren (D-MA) introduced a bill that would authorize the federal government to directly manufacture or contract for some high cost generic drugs including insulin. I don’t have a well formed opinion about this bill yet as I am still trying to think through the dynamic effects. But there is one very good point that Alexander Gaffney is making
I know i'm late to the party on this Warren drug manufacturing bill. Plenty of other comments aside for now — I seriously doubt the government could even *hire* a staff for this office within a year, let alone start manufacturing. https://t.co/VGeCRUNBu5
— Alexander Gaffney (@AlecGaffney) December 19, 2018
The bill has an aggressive schedule for success:
MANUFACTURING LEVELS.—Not later than 1 year after the date of enactment of this section, the Office shall manufacture, or enter into contracts with entities for the manufacture, of not less than 15 applicable drugs. Not later than 3 years after such date of enactment, the Office shall manufacture, or enter into contracts with entities for the manufacture, of not less than 25 applicable drugs.
This is a new program. The federal government does not do new programs quickly. For success to be achieved, especially first year success, the agency would need to find at least an interim director, recruit at least a core staff including several exceedingly hard to find and hire scientific, manufacturing and legal advisors, lease office space, find the coffee pot, get complex contracts negotiated and reviewed and then get things started. This is a complex undertaking even if we assume there are no significant legal challenges from any of the entities that are probably going to be losing money from this policy.
As we think about healthcare bills and changes, we need to think about implementation timelines. If there is anything other than shifting money flows, the federal government needs time especially if program success counts on private sector actors active and enthusiastic participation. They need to know what the rules are, they need to prepare their bids, they need to rework their internal processes.
This applies for any of the pharmacy bills. It will apply to ACA 3.1 or Medicare for All or Medicare Buy-in. I was recently having a beer with a fellow health policy nerd, and we were stuck debating whether or not the earliest major implementation of anything that re-opens Title 1 of the ACA (the coverage requirement section for guaranteed issue and community rating) would be a twenty four or a thirty six month slog. I’m leaning towards thirty six months. My friend thought that depending on the definition of “major”, twenty four months would be a plausible time frame. Medicare for X packages would need several years to ripen after a Presidential signature before implementation could proceed well for large parts of the population.
Implementation timelines are not sexy. They are not fun. The project managers who have to think about these things scare me. But these timelines partially define what is plausibly promised.