by Playfuls Staff |
12th December 2006
Monday saw the release of the new proposed US government guidelines that could give a greater number of seriously ill patients access to experimental drugs.
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The amended guidelines announced by the Food and Drug Administration offer more details about the conditions in which unapproved drugs can become available to patients that have no alternative treatment to a life-threatening or critical disease or condition, according to the FDA. It appears the basic hypothesis will be that the potential benefit of the treatment justifies its potential risks. Both can be largely unknown at such a preliminary stage.
The revised guidelines will be available for public analysis and discussion over the following 90 days. If they are adopted, they will enforce the availability of drugs throughout their stages of development, including during initial, phase-one testing. At such an incipient level, experimental drugs are usually tested on as few as 20 people. Just 10 percent to 15 percent of phase-one drugs ultimately win FDA approval. The new regulations will provide specifications about all the circumstances in which access would be allowed, including to small groups of patients.
The proposed guidelines will also clarify when drug companies could charge for the medicines. Drug companies, research institutions and other drug developers are striving to compensate the great production costs they bear and will be able to charge patients. In some cases they will charge the patients for medication while under study.
The FDA said doing so would encourage drug developers to provide early access to drugs by allowing them to recuperate some of their costs. Drug companies can now charge for experimental drugs, but generally do not.
The FDA has made experimental drugs available to either individuals or large groups of patients under compassionate use programs since the 1970’s. Patients have had access to certain unapproved treatments, including those for HIV/AIDS, cancer and cardiovascular diseases but limited to emergency use for individuals and widespread treatment use access for large groups of patients.
“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,” said Dr. Janet Woodcock, FDA's deputy commissioner for operations. “By clarifying and streamlining the processes, FDA also hopes to encourage companies to make such drugs available, and reduce barriers for healthcare practitioners in obtaining them,” she said.
Some have expressed concern that the new guidelines would greatly diminish the rules, thus exposing the patients to health risks, due to medication being taken before its safety and effectiveness were proven.
Others are welcoming the change as real chance for people in a grave condition to see an improvement in their state.
