HIGH ideals have a way of seeming like high hurdles when time is running out. If someone you love has been told they have just months to live, and there is a drug that might offer them even a few months more, it suddenly matters less that the drug isn’t cost-effective, or that it was approved on the basis of a small trial and its risks and benefits remain unclear. What matters is that it might buy precious time right now.
Such dilemmas are why the US Food and Drug Administration (FDA) and similar agencies around the world aim to strike a balance between efficacy and expediency, speed and safety when it comes to approving new medications. In the 1970s, it took the FDA nearly three years to usher a new drug through its evaluation process. But in response to public demand after the , the agency began to introduce expedited approval processes to get new medicines to market much faster.
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Today, there are several methods used to speed things up, and more than half of medicines are now evaluated through some kind of expedited pathway. To pay for the staff to keep up the pace of approvals, however, the FDA has come to rely more heavily on pharmaceutical industry fees – and accepts those funds in exchange for keeping to set timelines.
“When your time is running out, it suddenly matters less that a drug was approved on the basis of a small trial”
The trouble is, the kind of research needed to ensure that drugs are safe and effective takes time. Faster approvals may be based on smaller studies or measure things that are proxies for the desired effect. Medication that is rushed to market in this way is more likely to be withdrawn later over safety concerns or to turn out not to work as intended.
There is a growing group of researchers raising the alarm over this trend. They don’t dispute the need for quicker access to new treatments or pretend that it is a straightforward problem to solve. And they don’t expect regulatory agencies to do it without help from companies. Fortunately, there is no shortage of ideas about how to strike a better balance.
That balance is critical, because if the drugs you take to get better could actually cause you harm, then the system meant to protect you just isn’t working.
