Laurie
If a person is willing to take the risk, KNOWING the risk I don’t see why they shouldn’t be able to do it.

Isn’t that the basis of medicine every day, and we seem to find lawsuits - A LOT. Listen to the radio or watch TV.

Now put out meds that we have no idea if it is worth the risk and you don’t see a recipe for disaster if something goes bad?

I think the public makes it hard enough for physicians and pharma, we don’t need 1 more way to get sued and look bad. Thanks anyway

There is no more a RIGHT to any investigational drug as there is to driving a car without a license. Of course, FDA can grant that privledged access - as they do under the IND process or even the personal importation rules. This all begs a larger question and is one of the great debates that has only been touched on in the margins and this is; is there a Constitutional Right to health care as a part of every American’s right to “life”, and thus by extension to all things that might protect life? Who knows that may be tested some day soon.

Those who believe that the societal needs of patients are not in concert with law or regulation or at least FDAs view of it in mid-2007 (as I do in this case) should take heart. There are remedies. I believe it is within the broad powers of FDA itself, through Congressional legislative action or regulatory agency oversight, to provide a remedy. FDA’s standards of proof of efficacy and safety are theirs to make. One of the issues that have been very difficult to move FDA on is flexibility of approval standards to apply certain types of reasonable standards to one condition vs. another. FDA has, under certain Commissioners and Administrations, moved a bit on creating approval standards that vary with the context of the product, the circumstance or the needs of the society that they serve. (I think that sometimes they forget that they serve the needs of society not the needs of the scientific community per se) but that is very rare. For example, the so-called Parallel Track approval process as it was fairly liberally applied to treatments for AIDS or the Compassionate Use provisions could all be pulled out, dusted off, reconfigured and applied – if regulators and sponsors cared to do that. Sometimes though it requires concerted effort by affected groups to make that happen.

The courts rightfully allow FDA in this case to do their job – so in that sense the ruling makes sense. What does not make sense, at least to this humble pharmacist, is FDAs inflexibility when reasonable, scientifically and legally viable options exist to try and save or extend life.