Friday, March 18, 2011

Off-Label Uses Held "Medically Accepted" As A Matter Of Law

Could the FDA prosecute a drug manufacturer for sending a copy of a judicial opinion to its customers?  Maybe, if the decision described off-label use as favorably as Layzer v. Leavitt, 2011 WL 813822 (S.D.N.Y. Mar. 7, 2011).  Here's what happened.

The Medicare Act obligates the government to pay for "qualified" prescription drugs used by elligible persons.  Medicare covers all drugs prescribed for "medically accepted indications," not just drugs prescribed for uses the FDA has approved.  Id. at *1.

Plaintiff #1 had a rare disease, a "granulose cell tumor," that probably had no on-label treatment.  In any event, her oncologists prescribed a drug called Cetrotide, which they determined was the best possible treatment:

According to [the prescriber], Cetrotide retards the growth of [Plaintiff 1's] cancer and prevents her tumors from hemorrhaging.  He has warned that the medicine “is essential for my patient.  There is no substitute at this time.  Furthermore, if the medicine is stopped, even temporarily, it is likely that the remaining tumors will grow quickly and she will suffer grave consequences.  Other physicians have echoed the conclusion that Cetrotide is critical to [Plaintiff 1's]treatment.  Peer-reviewed medical literature has also recognized the unique and effective capacity of Cetrotide to treat ovarian cancer.
2011 WL 813822, at *1 (quotation marks and record citations omitted).  But Medicaid said no, to them it was a "fertility agent."  Id.

Plaintiff 2 was in the same boat, only he had muscular dystrophy rather than cancer.  He was prescribed a drug called Increlex, and her doctors likewise swore by it:

The drug Increlex proved significantly helpful in slowing or stopping the deterioration of [Plaintiff 2's] muscle; it also helped him regain strength and range of motion, and allowed him to function without a hand-arm tremor.  [His] physician . . . noted that Increlex has “helped to optimize [his] quality of life and maintain his present level of independence.
2011 WL 813822, at *2 (same omissions).  Medicare turned Patient 2 down, too, because the use was off-label.  Id.

After losing on several rounds of administrative appeals, both plaintiffs had had enough, and they took Medicare to court.  Medicare claimed that "medically accepted indications" meant either on-label uses or else a so-called "compendium requirement" - meaning that the particular use had to appear in one of three compendia:  (1) the American Hospital Formulary Service Drug Information; (2) the United States Pharmacopeia-Drug Information; and (3) the DRUGDEX Information System.   2011 WL 813822, at *1 n.2 (citing 42 U.S.C. §1396r-8(g)(l)(B)(i), and 42 C.F.R §423.100).

Neither Cetrotide for granulose cell tumor or Increlex for muscular dystrophy appeared in these compendia.  The government tried to argue that those compendia were exclusive, and further that the court should defer to its interpretation - because it's the government.  2011 WL 813822, at *2-3.

The court essentially told the government that its interpretation would make a good suppository.  The statute stated that the "medically accepted indication" "includes" the compendia, not that it was limited solely to those three sources.  Id. at *4 ("the term 'includes' as used in the Definition does not introduce an exhaustive category").  Had Congress intended "include" to mean "is limited to," well, "it would have said so."  Id.

There follows a bunch of mumbo-jumbo about statutory interpretation - until the court gets to off-label use.  Congress intended for medically beneficial off-label uses to be covered by Medicare.  "Congress subsequently expanded the definition of “medically accepted indication” at issue here to allow for certain off-label uses."   2011 WL 813822, at *5.

Under [an act improving Medicare], effective January 1, 2009, the relevant definition of “medically accepted indication” was expanded to include drugs utilized in an anticancer chemotherapeutic regimen even if supported solely by peer-reviewed medical literature.
Id. at *5 n.5.  So in Plaintiff 1's case, the government was resisting an off-label use that Congress later directed it to cover.  Gotta love those bureaucrats.  Ironically, it  seems clear that the so-called "death panels" existed back when Bush was president.

Because Medicare is a "remedial" statute, it "should be interpreted to avoid untenable distinctions and unreasonable results whenever possible."  Id. at *5.  Denying coverage for medically effective and necessary treatments just because they're off-label and not common enough to find their way into compendia was such an "unreasonable result":
[T]he Compendia Requirement precludes coverage of effective yet newly discovered prescription drug treatments - particularly for rare diseases - because FDA-approved uses often lag behind knowledge about actual effective treatment. . . .  [T]he lack of the required compendium listing is likely due to the rarity of [Plaintiff 1's] cancer.”  The more rare the disease, the more difficult it is for researchers to (1) determine which drugs provide effective treatment and (2) secure FDA approval to use the drugs for that particular treatment.
2011 WL 813822, at *5 (same omissions) (emphasis added).

Thus the court in Layser granted "judgment on the pleadings" to the plaintiffs, id. at *1, which means that it held that these two off-label uses were "medically accepted" as a matter of law, regardless of their appearance in the government's holy writ compendia.  The record, as quoted by the court contains ample evidence that these two off-label uses are effective treatments, and indeed may be the only effective treatments under the circumstances.

Several years ago we commented on what we thought was a weird case in which a plaintiff (a lawyer) alleged that it could be libelous to circulate a judicial opinion criticizing his conduct.  Wolk v. Teledyne Industries, Inc., 475 F.Supp.2d 471 (E.D. Pa. 2007).  The court held that the transmission of an unaltered judicial opinion to a lawyer's clients was "absolutely privileged" under the law, and thus could not be the subject of a libel action.  Id. at 510.

Interesting.  The equivalent of a lawyer's clients are a drug company's customers.

The Layser contains physician testimonials, under oath, in a formal proceding that these two particular off-label uses are not only safe and effective, but essential in treating these particular conditions.  What better way to spotlight the absurdity of the FDA's prohibition on manufacturers' truthful "promotion" (which means saying just about anything about it) of off-label use, but for these drug's manufacturers to post this opinion - which we're happy to make available, here (we'll also see if we can get it published in F. Supp.) - on their websites.  After all, it's a judicial finding of medical acceptance as a matter of law.

No comments: