FDA Might Expand Access to Experimental Medications
FDA plans to consider two separate proposals that would expand access to experimental medications for certain patients and allow pharmaceutical companies to charge patients fees for such treatments in some cases, the Wall Street Journal reports. In most cases, patients who seek experimental medications currently must enroll in clinical trials, but patients might not meet requirements for participation.
In addition, FDA allows "treatment" access to experimental medications in some cases, but the "regulations can be difficult to navigate," according to the Journal. One of the proposals would clarify the process through which physicians and pharmaceutical companies provide certain experimental medication to small groups and individual patients with serious diseases and no other treatment options, according to individuals familiar with the situation.
The second proposal would clarify cases in which pharmaceutical companies and researchers could charge patients fees for experimental medications, although not for a profit, the individuals said. The proposals, which require approval by the White House Office of Management and Budget, might change prior to their release.
According to the Journal, the proposals, "which wouldn't represent a major revamping of the current system, don't go as far as the most aggressive patient activists wish," and "some doctors warn that the agency needs to make sure there is reason to believe a drug could work before patients start taking something that may not help."
Rachel Behrman, deputy director of the Office of Medical Policy in the Center for Drug Evaluation and Research at FDA, said, "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" (Wilde Mathews, Wall Street Journal, 11/9).