The Fight Over Avastin

On June 29, 2011, a panel of the Food and Drug Administration rejected the drug Avastin for use in the treatment of end-stage breast cancer.  Manufactured by Genentech, a subsidiary of Roche, the drug has been approved for the treatment of other types of cancer, but as recently reported by NBC Nightly News, the panel believed that the drug is not effective, and the side effects too serious, for the treatment of breast cancer.  A final decision will come from the FDA in a few months.

As can be imagined, this action has brought a firestorm of criticism of the FDA.  Because the drug will still be on the market, it will be possible, perhaps, for doctors to prescribe the drug “off-label” for breast cancer, but of course, insurance companies won’t pay for it if it’s not approved for the specific disease for which it is prescribed.

But, as FiercePharma reports, it appears that Avastin will not be dropped from Medicare coverage, no matter what the FDA decides down the road, and the decision could have grave consequences for the FDA down the road:

Indeed, House Republicans are promising to make Avastin an issue during next week’s hearings on the reauthorization of FDA’s user-fee funding provisions. House Energy and Commerce Committee Chairman Fred Upton says he has “grave” concerns about FDA’s review of the data on Avastin, the Wall Street Journal reports, and aides are saying that either he or another member will raise those concerns at Thursday’s hearing.

Read the referenced Wall Street Journal article here.  Stay tuned.  If indeed the full FDA precludes usage of Avastin for the treatment of breast cancer, it will present many questions for the manufacturer, which will undoubtedly know that doctors may still be prescribing it for use as a treatment for the disease.  Of course, manufacturers of all sorts of drugs know that their medication is prescribed off-label, but this will be a much higher profile case than most.  Will that knowledge hurt the manufacturer if any defects are alleged?  We will have to wait and see.  Preemption is always a good argument in drug cases, but what preemption would there be if the FDA did not approve the drug for use for this particular disease?

Happy Fourth of July

What better way to celebrate the Fourth of July than the patriotic cover to Superman #53, depicted above and published way back in 1991? (It’s a good one, although it’s emotive impact is lessened a bit by Superman’s recent renunciation of his U.S. citizenship!) Whatever the case, we here at Abnormal Use and Gallivan, White & Boyd, P.A. wish you a fun and safe holiday. Let’s all pause a moment today and reflect upon those Founding Fathers – many of them lawyers themselves – who signed the Declaration of Independence way, way back in 1776.  Then we can grill out some burgers and have a beer.

And be certain to check out this far more substantive post on July 4th over at the Constitutional Law Prof Blog.

(Last but not least, click here to see last year’s Fourth of July post, complete with Greenville, South Carolina fireworks).

Friday Links

We’re not entirely certain why Captain America was on trial, or whether this was the same Captain America from the good old days of comics. Nevertheless, depicted above is the cover of Captain America #613, published only a few months ago in February of 2011.  The secret identity of the Captain America we all knew growing up was Steve Rogers.  Apparently, somewhere along the way, that Captain America’s sidekick, Bucky, replaced the original Captain America, but not before moonlighting as a Russian hitman during the Cold War when the original Captain America thought he was dead.  It’s his actions as a Soviet agent that caused him to be on trial.  That’s confusing (although we wonder if there was a motion in limine on whether he could wear his costume at trial).

We’ve received a number of responses regarding last week’s tribute to the late sax player Clarence Clemons of Bruce Springsteen’s famed E Street Band.  Friend of the blog Steve McConnell of the Drug & Device Law Blog emailed us: “You guys did a great post on the passing of Clarence Clemons. For a guy like me who grew up in Jersey in the ’70’s, the Big Man’s death is traumatic. It really feels like a body blow and is, of course, yet another grim reminder of mortality. I’m a neolithic fan of the Boss. For me, it never got better than Born to Run. That album reached operatic heights, and Clarence was a big reason why.”

The Ernie the Attorney blog has an interesting post about the mobile practice of law and the perils of simplicity and security. Says he: “I wouldn’t use free WiFi at a coffee shop to do anything related to client matters. Maybe I shouldn’t have back then, but in 2005 we didn’t have as many hacking incidents as we do now. When you see hackers attacking major companies like Sony and Sega, and even major governmental agencies like the Department of Defense, then you become aware that it’s a little dangerous to be cavalier about how you use the Internet. What’s a mobile simplicity-seeking lawyer to do?”

Congratulations to our own Stuart Mauney, who was recently designated the state chair of the Council on Litigation Management. You can see the news coverage here, and you can follow Stuart on Twitter at @stuartmauney.