Certainly the piece will be fair and balanced -- as all pieces are in our national newspaper of record -- but whether or not adequate provision will be given to the facts remains to be seen.
To wit, a few pieces of information that may or may not make the final cut of the story.
When product manufacturers provide fraudulent information to FDA, or deliberately withhold information about safety problems associated with their products, preemption doesnâ€™t offer them protection and they can and should be held accountable.
The problem is that the current liability system doesnâ€™t reward lawyers who focus on these real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDAâ€™s best efforts to promote the safe and effective use of medications and medical technology. More and more often, these â€œmass tortâ€ firms specialize in taking a new product warning label or withdrawal decision by the FDA, and view it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets and result in a wounded American health care system.
As Dan Troy has written:
â€œJudgments concerning the need for and formulation of statements in drug labeling and advertising are squarely within FDAâ€™s statutory authority and expertise, and they deserve deference from courts and juries applying state tort law. The agency carefully considers the scientific evidence relating to a proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. FDA should not have to act to safeguard its control over the label each time a plaintiff brings a state law action challenging the absence of a particular warning in drug labeling. Where FDA repeatedly has reviewed particular drug labeling and advertising content, state courts and juries should not second-guess the agencyâ€™s scientific determinations.
FDAâ€™s legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agencyâ€™s decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.â€
It should also be noted that the FDA has consistently stood behind the concept of preemption through both Republican and Democratic administrations â€“ so any mention of â€œthe Bush FDA pushing preemptionâ€ is just bad reporting.
Recently, the 3rd U.S. Circuit Court of Appeals ruled that federal law bars a suit alleging false-advertising claims under state law because the U.S. Food and Drug Administration has "exclusive authority" to regulate prescription drug advertising.
"To allow generalized state consumer fraud laws to dictate the parameters of false and misleading advertising in the prescription drug context would pose an undue obstacle to both Congress' and the FDA's objectives in protecting the nation's prescription drug users," U.S. Circuit Judge D. Brooks Smith of the Western District of Pennsylvania, wrote in his 51-page opinion in Pennsylvania Employees Benefit Trust Fund, et al. v. Zeneca Inc.
Further, U.S. Solicitor General Paul Clement issues an opinion to the U.S. Supreme Court supporting federal preemption, saying that FDA-approved drug labeling preempts state law.
Specifically, Clement disagreed with the Vermont Supreme Courtâ€™s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug Phenergan (promethazine). In the case of Wyeth v. Diana Levine, Clement opined that the state court, â€œerroneously interpretedâ€ the law by saying the FDAâ€™s approval of a drug label is only a â€œfirst step.â€ He also noted that federal law prohibits a company from unilaterally changing the FDA-approved label.
Clement writes, â€œIf manufacturers were free to make unilateral changes to labeling the day after the FDAâ€™s approval, based on information that was previously available to the FDA, the approval process would be greatly undermined and the agencyâ€™s careful balance of risks and benefits thwarted.â€
I donâ€™t think itâ€™s a stretch to predict that the Berenson/Harris piece will not be a ringing endorsement for the principle of FDA preemption. And if the Gray Lady follows precedent, there will be a same-day editorial supporting the general view of the article -- that FDA preemption should be struck down as a general principle because of, among other things, the evil pharmaceutical industry and an agency that is â€œin the pocketâ€ of same.
Who does this help? Consumers? No. Trial lawyers? Yes. (And we all know that Alex Berenson has many of these folks on speed dial â€“ and visa-versa.)
So on Sunday, brew your coffee, toast your bagel â€“ and count how many times trials lawyers are quoted in the article.