 |
 |
On Apr 16, 9:02pm, lyn coles wrote: > Subject: Re: New drugs, FDA > This is true. Because of FDA's strict guidelines, thalidomide > had not been approved in the USA so parents were (spared) > the heartbreak of deformed babies. Unfortunately, in European > countries, England for one, I think, were not spared because the drug > was already in use there. >-- End of excerpt from lyn coles I'm very happy to wait as long as it (reasonably) takes for the FDA to determine whether or not a drug is safe. But I do not think that it is right for the FDA (i.e., the government) to refuse approval for a drug that has been proven to be safe, but has not yet been proven to be effective. Currently, the FDA requires both saftey and effectiveness to be proven before they will approve a drug. For example, look how long it took the FDA to approve Sinemet-CR, where safety was not an issue; and the same delays seem to be occurring for a levadopa skin-patch. The FDA could warn us about drugs whose effectiveness has not been proven--they could even require such warnings to be clearly sated on the drug's package. However, safety (not effectivesness) should be the only criterion for approval to market a drug. Bruce Anderson (b.43, dx.87, & care-giver for myself, unfortunately)