September 17, 2014
Sometimes a single chart can jumpstart a movement. This chart certainly qualifies:
Looking at this, you might conclude that the 1980s and early 1990s were the “glory years” for new antibiotic introductions.
But that would only be partially correct. Nineteen of the antibiotics on this chart were not commercially or clinically successful and were ultimately withdrawn or discontinued from the market. Since 1980, antibiotics have suffered market withdrawals at triple the rate of all other FDA-approved drugs. Six of these drugs were formally withdrawn for safety-related reasons, while for others, safety questions played a role in limiting clinical and commercial success. Approval of these drugs didn’t help patients much, nor were the companies rewarded because sales were low. In short, we should not celebrate antibiotic introductions from the 1980s and early 1990s in the way the chart above implies.
When discontinued and withdrawn drugs are backed out, the chart looks quite different:
Governments and think tanks are mooting many proposals to boost antibiotic innovation. We must focus on the quality of the new drug, not just the sheer quantity.
For details on each of the new systemic antibiotics that were approved by the FDA during 1980-2009 but were subsequently withdrawn or discontinued, please view this chart:
Kevin Outterson is Professor of Law & N. Neal Pike Scholar in Health and Disability Law at Boston University and Visiting Fellow at Chatham House.
Post image via Shutterstock.
