Federal drug officials Thursday claimed credit for an increase in the approval of new drugs and argued that the results demonstrated the need for legislation to continue financing the current drug approval system.
The Food and Drug Administration approved 35 new drugs in the year that ended in September, a number that was surpassed only once in the past decade.
The agency approved 24 of the drugs before they were approved in any other country. And many of them were important advances, including the first new drug for lupus in 50 years, the first new drug for Hodgkin lymphoma in 30 years, and the first drugs for late-stage melanoma that have been shown to prolong survival.
“I want to underscore that we approved a set of drugs that are truly medically important, and in fact did so in a way that made these drugs available to Americans before other places around the world,” Dr. Margaret Hamburg, commissioner of the FDA, said at a news conference.
The increase in drug approvals is good news for the pharmaceutical and biotechnology industries, which have failed to produce many new drugs in recent years. New drug approvals peaked in the mid-1990s and have generally declined since then despite increases in research spending. Major drugmakers have steadily cut their research spending since 2008 because of poor productivity, although increased spending by the biotechnology industry has generally made up for this shortfall.
For years, FDA officials said little about the declining number of new drug approvals. When some industry analysts blamed government rules for the slowdown, agency officials instead blamed a decline in high-quality industry applications and a general drought in industry labs.
Now that approvals are increasing, however, Hamburg is claiming some credit by saying that the agency has lowered some approval standards — particularly for cancer drugs — and speeded up many of its reviews.
Asked about this apparent contradiction, Hamburg responded, “I think the point we’re trying to make is that when high quality science, good applications come before us, we are able to act swiftly and surely.”
Part of the reason for the agency’s new message is that it wants to try to defuse growing calls in Congress — supported by biotechnology and medical device industry groups — to weaken its approval processes.