Real World Evidence Might Give Trump an Excuse To Kill the FDA

Consumer advocates worry that President-elect Donald Trump has it in for the FDA, and that new medications might be approved before being thoroughly tested in clinical trials, according to STAT. The other side has its argument, put forth most prominently by former House Speaker Newt Gingrich, one of Trump’s main advisors. Gingrich has long considered the agency a barrier to bringing innovative medications to the market at a fast enough pace. In 2013, Gingrich called the FDA a job-killer, and wrote in National Review: “Its standards for evaluating new treatments and therapies are completely unsuited for the age of regenerative medicine, and the cost of getting these treatments approved in the United States will be absurdly high even compared with the absurdly high cost of getting normal drugs approved.” (Gingrich, known for being a policy wonk, shared some of his ideas about health care with Managed Care over a decade ago.)

In the same National Review article, Gingrich seems to make an argument that real world evidence makes many of the FDA safeguards obsolete, writing that “the agency should begin to loosen its requirements in an age when we could track side effects and bad results in real time and make changes based on immediate data.”

This battle has been fought by lawmakers in the last few years in the form of debate about bills that would make drug and medical device approval faster. As STAT reports: “Regardless of whether that legislation advances, Trump’s presidency is likely to enable the industry to get much of what it wants in terms of deregulation.”

Not surprisingly the FDA’s current chief, Robert Califf, takes a different view. In a speech in May to the Food and Drug Law Institute, Califf complained that too many decisions about drugs and medical devices are made without enough evidence of efficacy and safety.

He told the group: “The current deficit in evidence has become particularly acute for the FDA, which in numerous areas lacks vital evidence needed to support definitive regulatory determinations of safety, efficacy, and appropriate indications for marketed medical products.”

Source: STAT