If a drug company decided today to move a simple oral drug from where it is now made, they would have to find a US source for the active ingredient, all the inactive ingredients and the container, and have an available US site to fabricate the pills. The FDA would have to approve the move, with data to support stability of products made …
If a drug company decided today to move a simple oral drug from where it is now made, they would have to find a US source for the active ingredient, all the inactive ingredients and the container, and have an available US site to fabricate the pills. The FDA would have to approve the move, with data to support stability of products made at the new site. Time required to locate a site and have data on the drug for submitting to FDA about a year and a half (if everything goes well) and FDA approval (with inspection of the sites involved) at best 6 months and probably longer. Meanwhile the drug (plus tariffs) would be imported in the interim. Also tariffs on imported raw materials that could not be replaced would raise the cost of drugs already made here. If there is no confidence that the tariffs would be in place all that time, why would companies make the investment? They would just pass tariffs on to the patient.
If a drug company decided today to move a simple oral drug from where it is now made, they would have to find a US source for the active ingredient, all the inactive ingredients and the container, and have an available US site to fabricate the pills. The FDA would have to approve the move, with data to support stability of products made at the new site. Time required to locate a site and have data on the drug for submitting to FDA about a year and a half (if everything goes well) and FDA approval (with inspection of the sites involved) at best 6 months and probably longer. Meanwhile the drug (plus tariffs) would be imported in the interim. Also tariffs on imported raw materials that could not be replaced would raise the cost of drugs already made here. If there is no confidence that the tariffs would be in place all that time, why would companies make the investment? They would just pass tariffs on to the patient.