After the Supreme Court in Mutual Pharmaceutical v. Bartlett (2013) deferred to the FDA's view in its amicus brief that generic drug makers were not free to change labeling without agency consent, Public Citizen petitioned the FDA to change the rule. The FDA responded favorably to Public Citizen's request that the FDA create "parity" among drug manufacturers: all should have the duty to respond to new health information and to warn patients and their doctors.
As Professor Alberto Bernabe observes much of the public debate on the FDA's new proposed rule (which would effectively overturn Mutual Pharmaceutical) centers on whether it will lead to more litigation. But as he notes - the FDA understands that the right question is will it lead to safer products? As the FDA observes in the proposed rule "the most critical safety-related label changes, boxed warnings and contraindications, occurred a median 10 and 13 years after drug approval (and the range spanned from 2 to 63 years after approval) underscoring the importance of persistent and vigilant postmarket drug safety surveillance."
The passive surveillance system which characterizes our quasi free-market regulatory approach has demonstrated its inadequacy. Unfortunately, in my view, court are unlikely to recognize a common law duty of manufacturers to active survey and report on the actual performance of their products in the market. Patients remain the subject of a vast, poorly controlled human experiment. As I argued in Punctuated Equilibrium courts should recognize a duty of "product stewardship".
- gwc
Torts Blog: FDA Proposes Rule To Allow Generic Drugmakers To Change Labeling:
by Prof. Alberto Bernabe
"Earlier this month, Pharmalot reported that the FDA has in fact proposed a new rule. The proposed rule will allow generic drugmakers to update labeling with new safety information before an FDA review of the change. The agency would then evaluate whether the proposed change is justified and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time.
As expected, the rule is controversial. Some agree that the new approach is a good idea (here, for example); others argue it is a bad idea (here and here, for example). For more comments see here." (go to original for other links)
'via Blog this'
As Professor Alberto Bernabe observes much of the public debate on the FDA's new proposed rule (which would effectively overturn Mutual Pharmaceutical) centers on whether it will lead to more litigation. But as he notes - the FDA understands that the right question is will it lead to safer products? As the FDA observes in the proposed rule "the most critical safety-related label changes, boxed warnings and contraindications, occurred a median 10 and 13 years after drug approval (and the range spanned from 2 to 63 years after approval) underscoring the importance of persistent and vigilant postmarket drug safety surveillance."
The passive surveillance system which characterizes our quasi free-market regulatory approach has demonstrated its inadequacy. Unfortunately, in my view, court are unlikely to recognize a common law duty of manufacturers to active survey and report on the actual performance of their products in the market. Patients remain the subject of a vast, poorly controlled human experiment. As I argued in Punctuated Equilibrium courts should recognize a duty of "product stewardship".
- gwc
Torts Blog: FDA Proposes Rule To Allow Generic Drugmakers To Change Labeling:
by Prof. Alberto Bernabe
"Earlier this month, Pharmalot reported that the FDA has in fact proposed a new rule. The proposed rule will allow generic drugmakers to update labeling with new safety information before an FDA review of the change. The agency would then evaluate whether the proposed change is justified and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time.
As expected, the rule is controversial. Some agree that the new approach is a good idea (here, for example); others argue it is a bad idea (here and here, for example). For more comments see here." (go to original for other links)
'via Blog this'
This settlement is only possible because J&J took advantage of the substantial equivalence loophole that enabled them to avoid full FDA pre-market review. If they had not been able to claim that their new metal-metal design was not substantially equivalent to pre-1976 devices they would have had to run extensive clinical rials, etc. That would have gained them immunity thanks to the Supreme Court pre-emption 8-1 ruling in 2008