The “right to try” bill of 2017 (S. 204) which was unanimously passed by the Senate last August will be voted on by the House of Representatives in the near future. If passed by the House, it will demonstrate that, despite this administration’s talk of “draining the swamp,” Congress continues to proceed as it has in the past — business as usual.
I say this as a supporter of President Trump and all the good he is doing for the citizens of this country.
{mosads}Rep. Greg Walden (R-Ore) who is the chair of the energy and commerce committee — along with others — attempted to improve upon S. 204 and put forth a House right to try bill (H.R. 5247).
In a previous op-ed I voiced my opposition to H.R. 5247 with numerous other patient advocates whose missions include advancing the cause for all patients, including those that are terminally ill.
Moreover, despite an impassioned plea on the House floor by Rep. Frank Pallone (D-N.J.) to not pass this bill, it was passed by majority vote.
There many reasons why the passage of right to try would be ill conceived and damaging to terminally ill patients. But I didn’t always think that way. I held the belief that, “What difference does it make, these people will die anyway.”
I thought that using investigational drugs to treat terminally ill children with cancer under the current Compassionate Use program with the Food and Drug Administration (FDA) would be a safety net. But we not come to see that the the FDA would be removed from that critical role under right to try.
When I made that same observation at a conference that I attended in 2014, a pediatric cancer physician from a well-known cancer center responded, “You would not say that if you had seen what I have witnessed, namely, terminally ill children with cancer ‘tortured’ after taking investigational drugs.”
It is not disputed that the FDA, when reviewing applications to give investigational drugs to terminally ill patients, makes suggested changes which improve safety for those patients in 11 percent of the cases.
FDA Commissioner Scott Gottlieb in his testimony before Congress when considering Right to Try, put the figure at 10 percent. It is also not disputed that for terminally ill patients, the FDA considers applications for investigational drugs within 24 to 48 hours.
After the House passed H.R. 5247, the Senate was then asked to consider it. There was widespread opposition from many patient advocacy groups, including myself on behalf of my organization,
It appears the Senate understood that H.R. 5247 shouldn’t be brought up for a vote, which resulted in the current effort to have the House approve S. 204. It is not disputed that S. 204 was passed by the Senate in response to Sen. Ron Johnson (R-Wisc.) putting a hold on Prescription Drug User Fee Act (PDUFA).
Because of this, there was no real opportunity for the Senate to consider S. 204 on the merits. In other words, S. 204 does not have the support of the Senate and was approved based on the unconscionable “wheeling and dealing” by Johnson.
The House had initially, as noted, rejected S. 204, attempting to improve upon it through H.R. 5247. The Senate, not surprisingly and rightly so, will not approve H.R. 5247. As a result,The House,=, is now being asked to approve S. 204 under what appears to me to be pressure from the administration to hold the Republican House members who do not vote for S. 204 accountable and in the future to work against those members’ efforts to help their constituents. If the House passes S. 204 in the face of the threats from the administration the swamp will definitely not be drained.
Richard L. Plotkin, Esq. is a retired lawyer. In 2008 he started The Max Cure Foundation, Inc., a non-profit charity whose mission is to advance the cause of pediatric cancers through research, family assistance and advocacy. Plotkin is an advocate for children with cancer and their families and has been consulted by Congress and by The Reagan-Udall Foundation in seeking his input on prospective changes to the existing federal laws with respect to expanded access/compassionate use when dealing with experimental drugs.