Supreme Court Asks Obama View On Generic Labels
13 CommentsBy Ed Silverman // May 25th, 2010 // 7:48 am
The preemption debate is not yet over. Several generic drugmakers want to preempt a product liability lawsuit brought by Gladys Mensing, a Minnesota woman who took a version of Wyeth’s Reglan heartburn med and developed a neurological disorder known as tardive dyskinesia, which causes involuntary muscle movements (the lawsuit). The drugmakers won a trial, but lost on appeal and want the US Supreme Court to decide the matter.
So the Supreme Court has asked the US Solicitor General for its views on whether generic drugmaker can be sued over allegations that they failed to provide adequate risk information in their product labeling (see this). The drugmakers, which include Teva Pharmaceutical and Mylan’s UDL Laboratories, claim federal law preempts the lawsuit because it would require them to write labels that are different from what appears on the label of the brand-name medication.
When it ruled against the generic drugmakers, the 8th U.S. Circuit Court of Appeals cited the closely watched 2009 Supreme Court decision against Wyeth, which is now owed by Pfizer, that ruled FDA regulations do not protect drugmakers from being sued under state law over labeling (here is some background on that case). The 8th Circuit said Congress could have crafted a provision to preempt such lawsuits against generic drugmakers but hasn’t (see the ruling).
JaT
Before you make your mind up on this or on generic user fees- keep in mind that big pharma is buying up generics companies.
JaT
And moving toward Branded Generics.
I’m not making a call on this yet, just saying.
JaT
On further thought, I think the bigger statement here is on bioequivalency requirements than a labeling issue. Tighten it up so the drugs fit the existing labeling or stop blowing smoke about the exchangability of products.
John
JaT, why would it matter who owned the generics companies?
http://www.jeffjacoby.com/5568/lady-justices-blindfold
The Rule of Law is actually a pretty good idea when you think about it.
JaT
It only matters because of the lobby and it’s influence on the decision making process. It seems reasonable to think that, if big companies own generics companies, they will lobby to support their interests. That’s all. Considering pharmas desire for preemtion…
Things get a little bit interesting when you have them saying, on one hand, that their branded products are superior. And on the other hand, they say that they want to provide different versions of the same product to cater to people of lower incomes (wish I could find that article now) or to fit other formularies. Then they reduce the quality of their branded products. The point is that they are playing both sides.
Thank you for the link.
“The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the innovator drug.”
(oh?)
“Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation.”
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm
JaT
preemption*
patrons99
Generally speaking, we need more rulings by the Supreme Court on the many pro-pharma laws presently on the books, many of which are unconstitutional, e.g. the PDUFA, e.g. DTCA and/or the off-label drug promotion “safe harbor”.
I’m a bit off-topic here, but I’ll state it anyway. Here’s a question from a non-attorney for you all. Why isn’t the federal Declaratory Judgment Act (DJA) employed more often to obtain high court rulings, when there’s at least a reasonable constitutional argument of prevailing?
Once federal jurisdiction has taken hold over a federal cause of action, that’s at least half the battle. Does that not then present a nearly PERFECT opportunity to move the court for judgments under the DJA?
JaT
This isn’t the article I was looking for- but it almost makes my point. It is about big drug companies backing generics and selling them for more money than other generics- because they feel people will trust the name-brand-generic more. Ridiculous when you consider that the approval process for those drugs is no more stringent than for any other generic.
http://www.nytimes.com/2010/02/16/business/16generic.html
patrons99
JaT - thanks for the link to the NYT article. Perhaps, with the advent of price controls in the U.S., the generics market, both prescription and OTC, will become a bigger market than the blockbuster branded market. That might actually be a blessing: Affordable generic drugs of reasonably high quality.
Many people will be willing to pay more for an assurance of higher quality. Or maybe, many people will pay more for something more than an illusion of higher quality. With respect to the public’s perception of quality versus the reality of quality, there will still be plenty of work for the FDA, e.g. assuring bioequivalence and comparable bioavailability.
JaT
Illusion is the word.
“Some companies are moving into branded generics as a short-term tactic to make up for revenue shortfalls and capture near-term growth in emerging markets, Mr. Gal said.”
Justice in MI
Getting in on this one late, despite my “favorite” topic.
I think the key issue is that, if you don’t enshrine a preemption shield, then all the permutations are in play. That is, there may well be cases in which independent generic companies could argue convincingly that they were not in a position (or at least it would have required “irrational-to-expect” initiative) to unilaterally strengthen a warning.
On the other hand, if a generic company is a branch of a branded company, that argument would be less compelling.
Preemption is an unnecessary imposition on judges and juries abilities to make such distinctions and weigh their relevance. It is, in effect, a way to short circuit (so to speak) that process.
JaT
Well stated, JiM. Some might wonder how you can hold some companies to a higher standard. But if those big pharma companies are willing to claim a higher level of quality based on their participation in the generics market (and to charge accordingly at times), they appear to have answered the question for us.
Justice in MI
I’m not sure it’s a question of different standards. As I understand, there is some legal uncertainty about whether generics companies have the same leeway to make a CBE change as a branded drug (which was the basis of the Levine case). So, to me, the relationship between a brand and generic company is potentially relevant.
Point is, preemption only blurs relevant distinctions (in the interest, of course, of reducing lawsuits across the board).