Proposed guidelines provide experimental drugs to critically ill

Christen Wiese

Contributor

0 CommentsPrint ArticleSubscribe

Revised federal guidelines have been proposed to the FDA regarding experimental drugs being given to the seriously ill. The revised guidelines will lay out the specifics regarding when the drugs will be given and also provide if and when the drug companies could charge for the experimental drug. Since the 1970's the FDA has made experimental drugs available to large groups of people or individuals.

The revised guidlines further specify the circumstances that the seriously ill could receive the drug, including use for small groups of people. The new guidelines could also provide that the experimental drugs could be given at an earlier stage of development, possibly even phase-one testing when only 10-15 percent of drugs make it to FDA approval. Another revised guild line proposed is the drug companies could charge for the use of the experimental drug to recover some of the cost of developing the drug.

Understanding that the people that participate in the studies are more than likely terminally ill and all other options have been exhausted BUT experimenting with a drug that is in the first level of study does not sound like a safe option especially when only 10-15 percent of those drugs make it to the next level. Also the fact that the revised guidelines gives the drug company the option to charge for the experimental drug seem unfair as these people are making themselves a part of the experiment that determines the safety of the drug.