The process for approving new drugs in the U.S. takes a long time and costs a lot of money. But in trying to speed things up too much, Congress runs the risk of allowing drugs to reach the market that aren’t necessarily safe.
Some lawmakers – led by Reps. Fred Upton, R-Michigan, and Diana DeGette, D-Colorado – assert that drugs are slow in coming because the Food and Drug Administration has been failing to innovate quickly enough.
But last year the agency approved more new drugs than it had in almost 20 years. In 2013, the median approval time for a new drug was about a year, faster than that of the FDA’s counterparts in Europe or Japan. Most new drugs in the U.S. now qualify for some form of expedited review.
That said, it does take a long time – almost 13 years – for a new drug to arrive at the FDA’s doorstep. The discovery and development phase lasts an average of 6½ years, and clinical trials take six more.
To encourage faster drug discovery, the House proposal would fund more research. But how can clinical trials be made to move faster without increasing the risk that unsafe drugs might be approved?
Congress wants to make it easier for drugmakers to use changes in so-called biomarkers, like plaque concentrations in the brain, as proxies for more traditional health outcomes that take longer to measure. It also wants the FDA to give more weight to evidence from outside the trials and to testimony from patient groups.
Some of these ideas have promise. But lawmakers need to give the FDA more flexibility without pushing it to weaken specific aspects of the approval process, especially clinical trials, in ways that the agency considers unsafe.
Modest change is the only safe kind.
Send questions/comments to the editors.
