Plan Would Widen Access to Experimental Drugs
FDA on Monday released a proposal that would ease access to unapproved medications for certain patients and allow pharmaceutical companies to charge patients for the drugs in some cases, the Washington Post reports (Stein, Washington Post, 12/12).
Since the 1970s, FDA has made experimental drugs available to individuals or groups of patients under compassionate-use programs. The new guidelines offer additional details on the circumstances under which experimental drugs can be made available (USA Today, 12/12). Under the new guidelines, FDA would clarify that drugs could be available during all stages of drug development, including during Phase I testing (Bridges, AP/Seattle Post-Intelligencer, 12/11).
The proposal includes measures to allow patients to find out more easily how to access experimental drugs. The guidelines also would give scientists, small research organizations and drug companies a method for calculating how much they can charge patients for the experimental drugs, possibly allowing them to make the treatments available to more people (Washington Post, 12/12).
The rules would allow manufacturers to charge for the cost of making and providing an experimental drug, but they would not be permitted to make a profit (Corbett Dooren, Wall Street Journal, 12/12). The proposed guidelines will be subject to public comment for 90 days.
Janet Woodcock, FDA deputy commissioner for operations, said the FDA's guidelines attempt to find an acceptable balance between helping people with critical medical conditions and protecting patient safety and the drug development process.
Woodcock said, "FDA hopes this proposal will increase awareness in the health care community of the range of options available for obtaining experimental drugs for seriously ill patients" (Cohen, Newark Star-Ledger, 12/12).
Sidney Wolfe of Public Citizen's Health Research Group said, "It seems like it could be unleashing some floodgates that could do more harm than good for a number of people" (Washington Post, 12/12).
Frank Burroughs, president of the Abigail Alliance for Better Access to Developmental Drugs, said the proposal does not go far enough to ensure quick access to potentially lifesaving treatments (Manor, Chicago Tribune, 12/12).