FDA/TRUMP AS PRESIDENT: “President Donald Trump, in his State of the Union address, gave a boost to so-called Right to Try legislation that would give terminally-ill patients greater access to experimental drugs.
Public-health advocates are pushing back, characterizing the Right to Try movement as a solution to a nonexistent problem.
Right to Try laws, having passed in 38 states, give access for such patients to as-yet-unproven drugs that are in clinical trials. Driving the adoption of these laws is the conservative Goldwater Institute think tank, which contends that there is too much red tape getting in the way of desperately ill people whose lives might be saved by medicines that lack Food and Drug Administration approval.
The president, in his Tuesday [1-30-18] address, suggested some patients are driven overseas to get access to experimental drugs… Public health advocates note the vast majority of terminally ill patients already have access to experimental drugs in the U.S. The FDA has a compassionate-use program in place for patients in dire circumstances. In testimony Oct. 3 before the House Energy and Commerce Committee, FDA commissioner Scott Gottlieb noted that ‘in recent years, FDA has received over 1,000 applications annually for expanded access to treat patients with investigational drugs and biologics. FDA authorizes 99% of these requests.’…
The FDA’s Dr. Gottlieb, in response to the contention that red tape slows down such requests at the agency, testified that ’emergency requests for individual patients are usually granted immediately over the phone.’
He recommended that the language in the Senate-passed bill be modified. Instead of limiting patients to those with terminal illness with a reasonable likelihood of imminent death, the Senate bill calls for experimental drugs to go to people who face a ‘life-threatening disease or condition.’ “
-Thomas M. Burton, “Trump Supports ‘Right to Try’ Law Expanding Access to Experimental Drugs for Terminally Ill,” The Wall Street Journal online, Jan. 31,2018 12:35pm