Does Anybody Think This Makes Sense?
A few years before, the Court had ruled that brand-name drug manufacturers had a duty to update their labels as new safety information became available, even without formal approval from the Food and Drug Administration (FDA). However, in Pliva, the drug was a generic version, and the Court found that it was “impossible” to hold generics manufacturers liable in state court for not updating their labels to integrate new warning information. The Court’s rationale was that these requirements were preempted by legal requirements that generics manufacturers maintain labels identical to those of their brand-name counterparts.
Source: NEJM.
You would think that generics would be liable for anything they produce, and would have to update the labels accordingly… strange…
This is confusing. So — the court found that:
1. They are responsible for maintaining an identical label to their brand-name counterpart.
2. That this was also impossible?
I may have read this improperly, but I read over it a few times and this is still what I’m taking away from it. Someone have some clarification on this question?
That said, maybe the headline of the post is telling and it’s not supposed to make sense.
Cindy took the words right out of my brain.
If the brand-name is required to do something >> generic is required to follow.
Then how can the generic not be held to same standards, provided that brand-name has updated the information?
Does not compute.
(Not even going to touch the fact that chemically, molecularly it is the same product.)
The court was merely interpreting law passed by the legislature. After this both the house and senate tried to remedy the situation, but failed to pass anything.
However the situation stands, “It is unfair to patients injured by unanticipated adverse drug effects for their right to reparations to depend on whether they received a brand-name or generic version of the same medication, a choice that may have been entirely out of their control”
This doesn’t make sense. A generic drug maker could (theoretically) make small improvements to a generic drug (e.g. using Maalox to buffer a drug so it didn’t hurt the stomach) but then it wouldn’t be a generic drug — it would be a different drug. Of course, drug makers aren’t going to go to the expense to get a slightly improved generic drug approved as a different drug. The same is true of combining two generic drugs that have synergistic effects. These would be considered a different drug.
YES this makes sense based on the US Constitution.
In PLIVA, Inc. v. Mensing, J. Thomas writing for the majority relied on the [Supremacy] “Clause— which makes federal law ‘the supreme Law of the Land . . . anything in the Constitution or Laws of any State to the Contrary not-withstanding,’ U. S. Const., Art. VI, cl. 2”
The “Supremes” acknowledge SCOTUS interpretation of law is not predicated on fairness and they recognize that bad outcomes result from both SCOTUS decisions and SCOTUS denying petitions. The legislature, not the judiciary, is charged with revisiting bad outcomes and rewriting laws as is appropriate.
SCOTUS never said that the circumstances in this instant case made sense. . . quite the opposite.
J. Thomas continues for the majority:
“The Court finds impossibility here. If the Manufacturers had independently changed their labels to satisfy their state-law duty toattach a safer label to their generic metoclopramide, they would haveviolated the federal requirement that generic drug labels be the sameas the corresponding brand-name drug labels.”
It is unconstitutional to allow state law to trump federal law. So the majority upheld the federal law. . . allowing the representatives of the people in our democracy to make the necessary changes.
J. Thomas continues: “Here, state law imposed a duty on the Manufacturers to take a certain action, and federal law barred them from taking that action. The only action the Manufacturers could independently take—asking for the FDA’s help—is not a matter of state-law concern. Mensing and Demahy’s tort claims are pre-empted. . . Had Mensing and Demahy taken Reglan, the brand-name drug prescribed by their doctors, Wyeth would control and their lawsuits would not be pre-empted. . . it is not this Court’s task to decide whether the statutory scheme established by Congress is unusual or even bizarre.”
J. Sotomayor wrote in her dissent, joined by Justices Ginsburg, Breyer, & Kagan: that the Court “invents new principles of pre-emption law out of thin air to justify its dilution of the impossibility standard.”
Is it best for legislators to take responsibility to amend the relevant laws rather than judges?
Was the FDA’s role really as laudable as the majority opinion states?
What responsibility did the prescribing physician have?
What responsibility did the dispensing pharmacist have?
And the saddest question of all – did these patients really need to take the drug – irrespective of manufacturer?
There are many excellent lessons that can and will be learned from further discussion of these cases – but only one really mattered to the majority – that the CONSTITUTION must prevail.
Dorothy Calabrese M.D. San Clemente, CA
allergy-immunology.com
it makes sense to me- if the generic drug manufacturer had not updated its warning labels because the brand name drug manufacturer failed to do so, then the generic drug manufacturer is not held responsible for anything.