A few weeks ago, Representative Towns (D-NY) introduced an amendment, “ACCELERATED NEW THERAPY CONSIDERATION FOR TERMINALLY ILL PATIENTS” to the PDUFA (Prescription Drug User Fee Act).

The amendment would have required drug and biologic companies that develop new treatments for people with life threatening or terminal illness to also develop an expanded access program under the supervision of the FDA. It would have required that the FDA to be more flexible with its efficacy requirements. Additionally the FDA would have been forced to accelerate the approval of drugs and therapies for terminally ill patients, especially when a product may safely prolong the lives of the terminally ill.

Very sadly, this amendment did not make it out of the mark-up session and will not be included in the proposed legislation!

Does anyone want to explain to me why this was not included in the PDUFA re-authorization?

I know, terminally ill patients are probably not going to rise up out of their beds and march on Washington. Besides, I guess those of us who are dieing are not going to be here to vote in the future, so we can easily be ignored.

Joel T Nowak MA, MSW