Preemption contention and more …
March 6, 2009 – 5:00 pmWell, we all know what the big news was this week: Wyeth was the loser in its preemption case before the Supreme Court . There was much weeping and gnashing of teeth from pharma and its supporters, and a lot of joy and exultation from pharma critics. There were even some measured, thoughtful responses on both sides. I’ll get to all I have found so far in a bit. There was other news as well: GlaxoSmithKline’s Tykerb was rejected by the U.K.’s NICE; Obama held his healthcare reform summit; four senators have introduced a drug reimportation bill; Pfizer drew the attention of Sen. Chuck Grassley, who was inquiring why one of the company’s employees was photographing a protest by medical students; KV Pharmaceutical reached an agreement with FDA that will allow the company to resume production; Genentech made its case that Roche should be paying more, Roche offered to pay more, and then Genentech advised its investors to take no action; Genzyme was cited by FDA for one of its production plants, but the company says the warning should not effect Aldurazyme sales; Sanjay Gupta won’t be Surgeon General after all; and get set for AstraZeneca going into court next week to defend Crestor from generic competition.
Surprising preemption ruling
Needless to say, supporters of pharma are very dismayed by the Supreme Court’s ruling. When asked for comment, John Kamp, executive director of the Coalition for Healthcare Communication, had this to say: “Plaintiff lawyers must be dancing in the streets. It allows juries to second guess FDA and industry labeling decisions in virtually every ‘failure to inform’ case. Since hindsight is 20-20 always, this decision destroys hopes for a uniform set of labeling and marketing rules. When rules are uncertain, inconsistent and shifting, it’s almost impossible to have coherent health care policy that uniformly and effectively protect patients.”
Incidentally, Mr. Kamp is an attorney at Wiley Rein, the firm that represented Wyeth in the case. Ed Silverman at the InVivo Blog, who had followed the preemption case at Pharmalot, talks about the ruling and provides a link to the official statement by Burt Rein, Wyeth’s attorney.
At Science-Based Medicine, Mr. Rein gets interviewed. He believes that the ruling will put a tremendous burden on the already taxed resources of pharma companies. “The Wyeth vs. Levine case is good for one industry - the lawsuit industry - and not really anyone else,” he says.
Joshua Slatko at the Med Ad News Insider blog also has a view from Will Sachse at Dechert LLP about the ruling. “This is a disappointing result, but it does not mean the end of preemption,” Mr. Sachse says. “The Court rejected the broad argument that mere approval of a drug necessarily gives rise to preemption, but left open the possibility that in some cases, the regulatory history with respect to a particular drug may demonstrate that the FDA’s actions preempt state law tort claims.”
Dr. Derek Lowe of In the Pipeline wound up blogging about this at The Atlantic. “So this decision might look like a whack at the drug industry, but it’s actually a case of a federal agency being told that its powers aren’t as broad as it occasionally seems to think … the verdict looks like a real endorsement of federalism,” he says. “And in the same way, you might not guess it, but the drug companies would probably like for the FDA to be that powerful, actually - that way, some of the responsibility could be offloaded, and there would be a single place to go for regulatory clarity. (Or a single place to go to exert influence, if you want to look at it that way). But that’s not going to happen.”
Peter Pitts at Drug Wonks mused at some length about the effect the ruling as well as other decisions would have on pharma innovation. He also agreed with the editorial in the Wall Street Journal from Thursday.
Merrill Goozner at GoozNews called the ruling a victory for consumers. He also disagrees with the opinion expressed by Peter H. Schuck at The New Republic’s Treatment blog. “It’s too bad Professor Schuck didn’t read the decision more closely, because the majority of justices directly addressed the issue of FDA competency in its reasoning for maintaining the state law backstop for failures of federal oversight,” Mr. Goozner says. “…When regulation fails, the states’ civil justice system – including the right to a jury trial – remains a vital backstop. Juries may start out without much knowledge, but at least they get to hear both sides of the story.”
At Eye on FDA, Mark Senak has his own take on the preemption ruling: “The notion that a label is somehow shielding from liability is kind of like saying - ‘Well, my state gave me a driver’s license, therefore, the state has endorsed my driving skills. You can’t sue me because the state has endorsed me.’ It isn’t that simple of course, but you get the idea.”
Now that the Supreme Court ruled out preemption for pharmaceuticals, Congressional Democrats are pushing to end preemption of medical device lawsuits as well, says Jonathon D. Rockoff at the Wall Street Journal Health Blog.
Healthcare reform 2.0?
Of course, the pharma industry is keeping close tabs on President Obama’s healthcare reform plans, and there was some blogger commentary about Thursday’s summit.
Mark Senak at Eye on FDA gives us the attendee list.
Over at the InVivo Blog, Michael McCaughan says although PhRMA and big pharma representatives had a seat at the table, BIO’s invitation seemed to have gotten lost in the mail.
Michelle Andrews of U.S. News & World Report’s On Health and Money blog says no one she talked with at the summit actually expected it to yield new insights. “Rather, this event was a chance for the president to showcase his commitment to healthcare reform and, not incidentally, demonstrate that his administration isn’t going to make the same mistakes that the Clintons did, when a small group of people negotiated a plan behind closed doors,” she says. “This process, we could clearly see, is open and inclusive.”
Around and about …
Genzyme’s recent difficulties with FDA show that it’s tough to reproduce biotech drugs, the Wall Street Journal Health Blog says.
Bob Ehrlich at DTC-In-Perspective says reimportation is closer now and pharma needs to act. “This bill is short-sighted,” he says. “We need a strong domestic drug industry. It is one of the few we have left. Our new government mantra seems to be to punish business. I would much rather see government and the drug industry agree on a program to expand utilization of price support programs for low and moderate income Americans. This would lower prices to perhaps less than European prices for the low income consumers while allowing higher prices for more affluent consumers.”
After Mr. Ehrlich sent out an e-mail offering to do consulting reviews of DTC advertising for pharma companies, John Mack at the Pharma Marketing Blog responded in his usual tongue-in-cheek manner. “John will use his snarky style to work with the team to determine if the DTC ads it proposes are too ridiculous and will be the brunt of his and other bloggers’ humor in the Pharma Blogosphere,” he says. “Remember, when John blasts your DTC ads on Pharma Marketing Blog, it spells death for your brand! This can easily be prevented by hiring John to preview your DTC ads! An extra-added benefit: you will be less likely to get a warning letter from the FDA! OK, maybe you’re looking forward to that letter as a trophy. But still, it’s bad press and who needs that?”‘
Mr. Mack also theorizes that Pfizer may be preparing Viagra for OTC status.
Rich Meyer at World of DTC Marketing says changes within pharma are needed now. “Big pharma is in trouble because they could not foresee the current health marketing environment and economic downturn,” he sys. “OK, not many companies knew the economy was going to head south in a big way but did strategic planners really believe that the pharma business model could continue as usual?”
Jim Edwards at Bnet says Gilead learned a lesson this week about the Internet. Expect to see a lot less posting of tapes from conferences because of this. Mr. Edwards also says Pfizer is not as close as previously believed to settling its Trovan cases in Nigeria, and interprets an Ad Age story to say DTC ads have almost no relationship to consumer demand for prescriptions.
In the “better late than never” category, Shwen Gwee over at Med 2.0 summarized his thoughts from the ePharma Summit in Philadelphia in February. (Our own Joshua Slatko was there until a migraine slew him mightily, but he did get in some blogging).
Good news! Ed Silverman now officially owns the name “Pharmalot.” Catch him microblogging at Twitter, as well as his regular stints with the InVivo Blog (such as his look at how a U.S. ruling in a Trovan case may nudge Pfizer into settling African cases).
And speaking of the In Vivo Blog, this week Roger Long looks at the horse race at Bristol-Myers Squibb; Wendy Diller says sticker shock may force pharma to open innovatation; and Melanie Senior looks at the delays in Takeda’s alogliptin.
Dr. Daniel Carlat at the Carlat Psychiatry Blog muses on the possibilities of physician speakers being arrested for kickbacks.
Mark Senak at Eye on FDA looks at the GAO’s report calling for more FDA control of dietary supplements. “These recommendations call for a lot of Guidance - which is relatively cheap,” he says. “But where will the money come from for the monitoring and enforcement? Could there be a VUFA (Vitamin User Fee Act) in our future?”
At Beaker’s Blog, the writer looks at why Congress thinks FDA is running around like a bunch of headless chickens.
Dr. Howard Brody at Hooked: Medicine, Ethics, and Pharma, has sticker shock over the price of a pharma sales and marketing conference. “What industry outsiders like me learn from this program, mostly, is the way that big fleas have little fleas to suck their blood and so forth,” he says. “Pharma wants to sell drugs to patients, meaning that physicians must write scripts, so they have to sell to physicians. In turn, marketing know-how companies (like eyeforpharma, and most of the companies that are putting on panels at the conference) want to sell their consulting services and technologies to the Pharma firms. It would all be laughable if all of this blood-sucking (including the exhorbitant conference registration costs) did not end up on the tab of the poor patient who has to pay for the drugs.”
Rob Fannon at Growthstockwire.com says wise investors should not miss out on the $500 billion generics trend.
Jack Friday at Pharmagossip so kindly passes on Pharma Giles’ take on the Pfizer photography of student protesters.
