View Full Version : Just looking out for the downtroden isn't he?

Tyr-Ziu Saxnot
12-20-2013, 08:36 AM
http://www.forbes.com/sites/scottgottlieb/2013/12/19/obama-white-house-sides-with-trial-bar-at-costly-expense-of-generic-drug-makers/?partner=yahootix Obama White House Sides With Trial Bar At Costly Expense of Generic Drug Makers

The FDA has issued a new regulation that could open generic drug makers to the same sort of product liability suits that plague branded pharmaceutical companies.

It’s part of a political effort by the Obama team to find a regulatory end run around its failed bids to attain the same result in the courts and on Capitol Hill.

But the new rule will jeopardize the business model that has given the U.S. the world’s most vibrant, and low cost market for generic medicines.

At issue is whether generic drug makers can be sued for the “failure to warn” patients that a drug has certain risks that weren’t disclosed in its FDA mandated label. The question has been the subject of intense political lobbying by trial lawyers who argue that generic drug makers shouldn’t be immune to these suits.

The trial bar seems to have won the debate.

These “failure to warn” lawsuits are the backbone of modern drug torts and a booming legal industry. Lawyers troll for patients on TV commercials. In 2005 alone, 17,000 lawsuits were filed against the multi-national drug companies. This is more than the litigation filed against the next five most sued industries combined.

In a typical case, a branded drug company will be accused of failing to warn consumers of a risk that didn’t appear on the drug’s FDA-approved labeling.

Even though FDA maintains tight control over what can be included in the label, trial lawyers will typically argue that the branded drug makers have some latitude to unilaterally update labels without FDA’s prior permission, to reflect new warnings.

There are good legal and practical reasons why generics have been largely absolved from this same sort of litigation.

Under the 1984 law that created the modern generic drug approval process, named Hatch-Waxman after the bill’s principal sponsors, generic drugs have to largely reproduce the labels of the branded drugs that they’re copied from.

Because the generics aren’t free to insert their own safety warnings, they contend that they are pre-empted from state torts that seek to second-guess the contents of warnings.

The Supreme Court agreed in a landmark 2011 ruling. In a separate but related generic drug case decided last summer, the Supreme Court solidified this precedent.

In the 2011 Supreme Court ruling, Pliva v. Mensing, President Obama’s Solicitor General tried to argue that generic drug makers could be held liable in state torts, with the creative reasoning that generic labels only needed to conform to branded drugs at the time of approval, but generics were free to change their labels later. (Pliva is now a part of Teva NYSE:TEVA)

The Supreme Court disputed that reasoning. It held, among other things, that the generic drug laws clearly stated that the generic firms didn’t have freedom to adapt their labels at will. Moreover, the court argued that the law charged FDA with tightly controlling the warnings that got included in those generic labels.

The Obama Administration’s new effort is aimed at thwarting this precedent.

FDA’s draft regulation will obligate generic drug makers to update their labels without waiting first for FDA’s permission, or for a drug’s predicate drug label to get updated. This new rule may well conflict with not only the courts, but also the existing law. Anything to raise the costs , right Obama? Anything to make Americans suffer and die sooner ,right bamboy? Anything to get your way, right bastard? This lousy bastard never stops.. -Tyr