'Cures' bill, designed to speed drug approvals, could be too much of a good thing, dissenters say

For years, the FDA faced criticism that its one-size-fits-all approach to evaluating new drugs and devices was ill-conceived and failed to take into account a changing healthcare environment. The agency has since made strides in shortening review times and accelerating the path for breakthrough treatments, but a new bill designed to break down even more regulatory barriers has attracted a chorus of critics worried that it could go too far at the expense of patients.

The so-called 21st Century Cures Act, which passed the House of Representatives earlier this month, contains a bevy of provisions designed to bring medicines to the market more quickly. That includes allowing the FDA to approve new antibiotics based on preclinical results and data from small human trials, and encouraging a broader embrace of surrogate endpoints in drug evaluations, encouraging the agency to approve treatments based on what is effectively second-hand evidence.

The implications of such changes have alarmed many high-profile physicians and policy experts, who caution that the rush to find new treatments could backfire if vital checks and balances are lost in the process. Joining them this week is The New York Times editorial board, which, in a column tersely titled "How Not to Fix the FDA," demands the Senate take a knife to the bill and excise its most sweeping provisions before passing it.

High on the Times' list is the bill's move to loosen regulations on pharma's reporting of payments to physicians. Under 21st Century Cures, drug companies wouldn't have to disclose doctor payouts when they're tied to education, a nebulous distinction that the bill's detractors say is an invitation for abuse. The editorial board also took issue with new incentives for antibiotics that it fears could encourage overuse and contribute to the rise of superbugs.

The bill has thus far found bipartisan support in large part because it includes a nearly $9 billion check to the National Institutes of Health, which has dealt with years of budget stagnation. And while there's little opposition to such an investment in research, the Times and others wonder whether the act's broader goal of speeding up drug and device reviews is actually necessary.

The FDA's approval process is on average the fastest in the world, and, as The New England Journal of Medicine noted this month, about one-third of all new drugs are cleared on just one pivotal study. With new programs like priority review and breakthrough therapy designations, the FDA is consistently shortening its standard 10-month vetting process to as few as 6 months. Any faster, critics worry, and the agency risks letting patients take toxic medicines.

- read the editorial

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.