David, I can't see FDA going after the physicians, because FDA doesn't regulate the practice of medicine.
As far as I know, the only time FDA can pursue physicians for anything is when the physician has signed something (eg, 1572, financial disclosure) that opens the door for FDA to pursue them, and then only within the narrow constraints of what they have signed. I don't think any physician has ever signed anything that says they won't treat patients with products not approved by the FDA. The only time physicians are restricted in using an unapproved product is if they are an investigator in a trial of that product. The onus is on the manufacturer to control their unapproved product and keep it out of the hands of physicians who have not signed an Investigator's Agreement.
Nor can I see FDA going to war with the States over anything. If anyone takes this up with the States, I would expect it to be Congress, not FDA. If anyone were to go to war with the physicians, I would expect that to be DOJ, not FDA.
I would expect the FDA to focus its efforts where it always has...on manufacturers. I would expect FDA to take the position that it is a federal agency charged with various responsibilities under federal law (eg, the FD&C Act), and that it will continue to enforce applicable federal law until such time as Congress amends the law and tells it to do otherwise. Therefore, I expect that FDA would continue to take action against manufacturers shipping unapproved product without an IND/IDE. In other words, I would expect FDA to ignore the "right to try" laws, rather than go to war over them, and stick with business as usual.
This would leave it to the manufacturers to fight with FDA over this. I'm skeptical that manufacturers are likely to see this fight as being in their shareholders' interests.
The States do have jurisdiction over the practice of medicine. The "right to try" laws allow physicians licensed in a given State to treat terminally ill patients with therapies not approved by the FDA. Unless the manufacturer is in the same State as the physician, this would seem to be mostly theoretical, since physicians can't use drugs they can't get, and I don't think a State has any jurisdiction over manufacturers in another States.
I note that the model law says manufacturers may make an unapproved product "available." It does not say manufacturers may introduce them into interstate commerce. I would guess this wording was carefully chosen.
-------------------------------------------
Julie Omohundro RAC
Durham NC
United States
Original Message:
Sent: 03-24-2015 13:21
From: David Lim
Subject: State's "Right To Try" laws vs. Expanded Access
David,
Based on the supremacy clause, federal statutes/US code rule over the State laws. In this sense, FDA will/is likely to claim it is under our authority/jurisdiction over an expanded access IND/IDE, requiring FDA review/approval.
HOWEVER,
Based on the "Practice of Medicine" exercised by medical doctors, patient waivers to bring suits against the doctors, and "Right to Try" State law provisions, how is the FDA going to prosecute anyone if they want to?
If you look at the recent DOJ action (http://wp.me/P5vHi0-TR) indicting 14 people in connection with compounding pharmacy, we may get some idea on criminal charges.
If the matter goes on war between the States and the FDA, how is the FDA going to show/prove "intent" and potential crimes against the doctors who acted in accordance with the State's "Right to Try" beyond reasonable doubt? Who would the jury listen to and go with at the end?
I don't believe FDA will try to come after each State and the doctors against the State "Right to Try" provisions.
Accordingly, all things considered, I am convinced that the doctors and firms may/should work under the State's Right to Try provisions as the FDA will have to exercise "enforcement discretion" over the matter in lieu of going on war with all the States by trying to enforce the supremacy clause.
CAUTION: it should be noted that there may be some room for abusive use and practices over some drugs/devices for unjustifiable gains. Such abusive discretion/practices should be prevented.
Original Message:
Sent: 03-24-2015 11:10
From: David Vulcano
Subject: State's "Right To Try" laws vs. Expanded Access
I'm really interested to hear if anyone is convinced that they can ship without an expanded access IND/IDE. I am not but the advocates are convincing state legislators you can and the press is relaying this.
-------------------------------------------
David Vulcano RAC
Assistant Vice President, Clinical Research
Hospital Corporation of America (HCA)
Nashville TN
United States
-------------------------------------------