The US Food and Drug Administration is considering proposals that would expand patient access to experimental drugs, and could even allow drug companies to charge patients fees for some treatments, according to a report in the Wall Street Journal.
Most people who want access to drugs during the their development have to be enrolled into a trial, yet many patients do not meet qualification criteria.
The FDA does allow some instances of experimental drug access, but the regulations are "difficult to navigate," according to the WSJ.
The FDA is looking at two separate proposals that could expand access to experimental drugs. The first would allow drugmakers and doctors to provide the drugs in small groups or to individuals, where serious conditions exist and treatment options are limited. The second would allow drugmakers to charge for the supply of the medicines, provided there was no profit.
The proposals require approval by the White House Office of Management and Budget.
Rachel Berman, Deputy Director of the Office of Medical Policy at the FDA's Center for Drug Evaluation and Research, told the WSJ: "we are striking a balance to ensure patients have access to the drugs they need, when they need them, while at the same time safeguarding the integrity of the drug development process and safeguarding the individual."
Patient and physician groups have differing takes on the proposals, with some such as the American Society of Clinical Oncology suggesting that the measures go too far and could put vulnerable patients at risk of toxicities, while others, including the Washington Legal Foundation, want access to experimental medicines to be made even freer.