Replies to post #67938 on Biotech Values

[zipjet]

>>[“Much of the argument for why we are proposing
to invoke pre-emption seems to be based on a false
assumption that the FDA approved labeling is fully
accurate and up-to-date…”]

That confuses the issues. {understand not DD doing that}

The public policy question is whether a drug company should be burdened with costs/liabilities for undesirable effects of a drug* whose utility/safety has met the standards of FDA and whose properties in detail have been described by FDA in the label.

Keep in mind that many of the cases brought are about the label - the theory being that the drug company "failed to warn" of the risks. Yet, the drug companies are prohibited from describing risks differently than the label - they can neither warn of greater nor lesser risks.

Preemption in this context says that since the drug company cannot vary the warning, it cannot be sued for risks that may be perceived to differ.

If Congress wants to widen or narrow the liability of drug companies for their products, then that is the appropriate forum for the balancing of interests to take place.

ij

* By "drug" here I mean the precise drug, should the company produce a compound that varies from the approved "drug" then liability would easily attach.

[genisi]

Wyeth Worries Over Supreme Court Pfizer Holdings

http://invivoblog.blogspot.com/2009/02/wyeth-worries-over-supreme-court-pfizer.html

By Ed Silverman February 06, 2009

Why should the drugmaker be anxious? And why should one of its attorneys write the US Supreme Court clerk about its deal with Pfizer?

As you know, Pfizer plans to acquire Wyeth, which has a closely watched case before the court involving preemption - the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. The case involves a Vermont musician, Diana Levine, who lost part of her arm after being administered a Wyeth drug, and the ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

Here's the rub: Chief Justice John Roberts sat out a case involving lawsuits against Pfizer because his May 2007 financial disclosure form indicated he held Pfizer stock between $10,000 and $50,000 (back story). The recusal yielded a 4-4 deadlock that upheld the rights of 27 Michigan residents to sue drugmakers for defrauding the FDA in winning product approvals.

As a result, the court left intact a lower-court ruling allowing the Michigan lawsuits to proceed. Had Roberts not recused himself, some observers believe he may have voted in favor of the pharmaceutical industry. Wyeth apparently fears a repeat in the Levine case, and so a Wyeth attorney wrote a letter on Wednesday to the clerk of the Supreme Court to argue that Roberts' Pfizer stock should not prevent him from voting.

Why? The acquisition won't close until at least July 31, after the court is expected to decide the case. "Wyeth does not believe the proposed acquisition warrants amendment of the corporate disclosure statement in its previously filed briefs," writes Seth Waxman, of Wilmer Hale, who represents Wyeth.