4 ms·
> Most drug companies actually view the US as the beta test country in a lot of ways. This is mostly wrong, except maybe for vaccines. The EMA, for example, ha
by centimeter 6y ago
> Most drug companies actually view the US as the beta test country in a lot of ways.
This is mostly wrong, except maybe for vaccines. The EMA, for example, has vastly lower regulatory requirements for most drugs than the FDA. Many sources actually estimate that, on net, the FDA has killed more people than it's saved simply by excessively delaying the availability of new drugs in the US.
Vaccines go through a different process in the US than most drugs, where the vaccine manufacturers self-certify the safety of their drugs and send a report to the FDA, who either signs off on the certification or doesn't. But the FDA doesn't manage any of the trials, unlike with other drugs. Vaccine manufacturers are also more protected from liability than other kinds of drug manufacturers, via the NVICP.
If a non-vaccine drug is approved first in the US, it's almost certainly because the drug is expensive to manufacture and the only country where the manufacturer can expect to break even (at least at first) is the US.