Senate Passes ‘Right-To-Try’ Legislation, But Critics Say Bill Is ‘Inherently Deceptive’
The legislation says terminally ill patients can ask drug companies for experimental treatments, but companies often are reluctant to provide unapproved products for a variety of reasons. And the FDA has a system to handle requests for such drugs.
The Washington Post:
Senate Passes ‘Right To Try’ Bill To Help Terminally Ill Patients Get Experimental Drugs
The “right-to-try” legislation has been championed by the libertarian Goldwater Institute, which has worked to pass similar legislation in 37 states. The federal version, now headed to the House, would bar the government from blocking patients from getting access to medications that have undergone only preliminary testing in humans. Patients first would have to try all other available treatments and be ineligible for clinical trials. The bill would provide drug companies some legal protection if a treatment results in harm. (McGinley, 8/3)
Politico:
Libertarians Score Big Victory In 'Right-To-Try' Drug Bill
The bill, S. 204 (115), passed swiftly and easily in a Senate bitterly divided over health care. The powerful pharmaceutical lobby, which had quietly opposed an earlier version, kept an unusually low profile. The industry has been focused on fighting off any efforts to go after drug pricing, which President Donald Trump has said he would tackle. (Karlin-Smith, 8/3)
The Wall Street Journal:
Senate Approves Bill To Allow Terminally Ill Patients Access To Unapproved Drugs
The bill’s language is actually somewhat broader than simply applying to the terminally ill. It says that a patient “with a life-threatening disease or condition…who has exhausted approved treatment options” generally can get experimental drugs if a doctor certifies it is necessary. (Burton, 8/3)
Stat:
Senate Approves 'Right To Try' Bill Barring Federal Intervention In State Laws
The new version emphasizes that drug companies wouldn’t be held liable for problems patients face using the drugs and that results from those patients couldn’t be used to undermine other clinical trials. It does, however, explicitly require the companies to report any problems to FDA — and adds exemptions that would let the agency use the results if it saw a public health risk or if the companies themselves request the consideration. The new version also makes it much more explicit that the bill doesn’t create any new “entitlements” for terminally ill patients, and that companies don’t have to provide the drugs. (Mershon, 8/3)