AG Watch

The FDA has answered Connecticut Attorney General Richard Blumenthal’s petition for a change in the warning for the prescription drug Thalomid. Alert the media! We think we like this…for the time being and with some qualifications, anyway.

Mr. Blumenthal thought that Thalomid’s off-label uses merited a modification in the label for thalomid. But he did not sue! Recogizing that the FDA is the authority on all things pharmaceutical, he wrote them a letter. Responding to Mr. Blumenthal’s specific requests, the FDA granted in part and denied in part. Just as importantly, they applied their particular expertise to each of Blumenthal’s requests and even to issues he had not addressed. For instance, the FDA wrote,

“While you have not requested that the boxed warning contain information about the use of prophylactic anticoagulation therapies, we believe that it should”

“While we have not implemented all of the changes that you identify in your petition, overall, we believe that the new labeling includes far greater detail about the risks of and prophlaxis for VTE than you propose (Petition at 12).”

However, the FDA did not adopt or extend Mr. Blumenthal’s suggestions wholesale. In answer to Mr. Blumenthal’s proposal of a new clinical study, the FDA declared,

“For these reasons, we are not comfortable recommending the randomized study of antithrombotic prophylaxis that you request.”

The fantastic dynamic at play in this situation may bring great benefits to both the FDA and the AGs, and, most importantly, to patients. The AGs have a different perspective on the applications and effects of medicine; they get the phone call—probably from very very concerned trial attorneys—when things go wrong. But they just don’t know enough about medicine to really get medically advantageous arrangements for their citizens—though they certainly know enough about the law to get economically advantageous arrangements for their citizens. The FDA, on the other hand, knows everything there is to know about medicine, but might happily welcome more input about on-the-ground applications and effects of previously approved drugs, especially from well-situated public officials. Of course, the FDA already monitors the post-approval landscape, but, at worst, the AG advice would be a state-funded redundancy with no external rents imposed on other states. At best, as in the case of Thalomin, the AG and FDA complement each other and the citizen-patient wins.

This dynamic is a good alternative to AG litigulation of the national drug scene, but only on three conditions:

1. The FDA’s word must be final. Mr. Blumenthal (and other AGs) must be satisfied with the FDA ruling, regardless of the particular outcome. If the FDA shoots down this recommendation or that suggestion, the AG must not go back to the old lawsuit approach.

2. The FDA’s silence must be final. If an AG shoots off a suggestion to the FDA and never hears back, that should not be a reason to turn to litigation. (Imagine the bombardment of AG suggestions when they find this new way to get their name in the paper.)

3. The arrangement must remain ad hoc. Some joint oversight commission of state lawyers and federal doctors might be the setup for a tremendous punchline, but would be a terrible prescription for national health. Nothing would get done for all the wrangling over wealth transfers. Litigulation is bad, but an institutionalized AG-FDA committee would be far worse.