Drugs

U.S. Generally Fastest in New Drug Launches

A RAND study funded by HHS finds that nearly 85% of new drugs sold in the U.S. were sold here either first or in the same quarter in which they were introduced in other Organization for Economic Cooperation and Development countries. The study analyzed data on prescription drug availability and launch timing to compare countries’ performance.

It lists these additional key takeaways:

of 287 new drugs launched in the U.S. or comparison countries from 2018 to 2022, 57% were available in both the U.S. and comparison countries by the end of 2022;
the 57% of new drugs available in both the U.S. and other countries accounted for 90% of spending on all new drugs in the U.S. and 93% in the comparison countries, suggesting the most important new drugs are widely available in both the U.S. and comparison countries;
some 17% of drugs were available only in the U.S. and 26% were available in at least one of the comparison countries but not in the U.S.;
over half of new drugs are launched first in the U.S. before being launched in other countries, with an average lag of about one year between launch in the U.S. and launch in another country;
among comparison countries, Germany and Japan were the fastest to launch after the U.S., with average lags of about three quarters after the U.S. for Japan and four quarters for Germany;
some drugs launched in Germany and Japan first before launching in the U.S.; and
the U.S. spends a higher and growing share of total drug spending on new drugs compared with other countries — 12.8% in the U.S. and 6.9% in comparison countries in 2022.

The report says the availability of new drugs in individual countries and the timing of their launch can vary due to regulatory differences, business decisions, and other factors. It makes no direct references to FDA.

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