President Trump signed an executive order Thursday directing the federal government to buy certain drugs solely from American factories.
The so-called “Buy American” order could represent a seismic shakeup of the drug industry: No one knows exactly how much of the American drug supply chain is produced abroad, but some experts insist up to 90% of critical generic drugs are made at least partially abroad.
It remains unclear, however, how broadly the order will be implemented — the executive order does not specify what drugs it covers. Instead, the order directs the Food and Drug Administration to decide which medicines will be subject to the new requirements. Certain drugs can also be exempted from the executive order if they’re too expensive to make in the U.S. or the U.S. isn’t already making them...
Direct manufacture of chemicals isn't a major driver of chemical employment, i.e. there are (I suspect) 3 or 4 research-oriented chemists for every one production-oriented chemist in industry. That being said, if this executive order (
language here) succeeds in moving more chemical manufacturing to the United States from China and India, that cannot help but impact employment. Developing...
GDUFA review time for major amendments 10 months
ReplyDeleteStability, different people take different approaches for PAS. I'd want at least 3 months (plus 1 month for data review, dropping the data in the filing and publishing)
Validation batches manufactured and released
Tech transfer in (process, QC, raw material sourcing, write batch records etc)
Build the plant (if you are Kodak or adding flow)
Hire the people who are up to date with current regulations and can tell you what to do (if you are Kodak)
I'm not sure I see this all done in the executive order reporting period :)
I think this needs a little more clarification. Are we talking about both drug substances and drug products? Most generic drug substances are purchased abroad. Can the drug substance be purchased from an international manufacturer and then be formulated here in the US?
ReplyDeleteI don't think so, but check the wording of the EO just to be sure: https://www.whitehouse.gov/presidential-actions/executive-order-ensuring-essential-medicines-medical-countermeasures-critical-inputs-made-united-states/
DeleteMy read was that this applied to both DS (critical inputs) an DP (Essential medicines). Happy to hear your interpretation!
DeleteI am interpreting it the same way. I just have questions about the sustainability, costs, and revenue. There is already a slim profit margin when manufacturing generic medications. What about the supply chain and RSM's? Can those be sourced abroad? If the intent is to bring manufacturing solely here in the US, than that would include RSM's.
DeleteHowever, as MCH pointed out, there are many activities that must take place within a given time period.
Oof. Requiring generic drug products to use api's made in the US would certainly raise generic prices. Also, it takes a lot of analytical chemists to get and keep a drug product on the market. Same for drug substances. FYI
ReplyDeleteRunaway out of control EO's! It had lost its meaning and no one pays attention or benefits anyone.
ReplyDelete