We love it when our readers share good ideas with us. For one thing, it saves us the trouble of having to think up ideas ourselves. Today we’re sharing a couple of those with you.
Ted Heise, who’s at Cook Medical, was reading our post on methods of proving up FDA-related evidence. He took the time to let us know that, if the fact of FDA pre-market approval is what’s at issue, there’s another avenue of judicial notice that we hadn’t considered. He tells us that the FDA issues quarterly lists of its premarket approvals, and that these lists are published in the Federal Register.
That’s interesting, because anything published in the Federal Register is subject to mandatory judicial notice by statute. See 44 U.S.C. §1507 (“[t]he contents of the Federal Register shall be judicially noticed”).
Ted even sent us a link to one of these quarterly reports through the Government Printing Office – but us Luddites couldn’t get it to work. Maybe it’s necessary to have a GPO account or something.
Anyway…. We do have a Westlaw account, and Westlaw includes everything that appears in the Federal Register (since 1981, for stuff that’s searchable, and even further back for non-searchable PDFs). So we ran a simple search: “pre-market approval” and “quarterly.”
Sure enough, Ted is right on the money. The second document (of 3070) is “Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,” 74 Fed. Reg. 53270 (FDA Oct. 16, 2009). It’s a list of every medical device approval that the FDA granted for the third quarter of 2009. There were six of them.
As Ted pointed out when he tipped us off, these lists don’t include supplements – only the initial PMA for the device.
We could have left it at that, but we’re pretty compulsive about evidentiary matters.
That quarterly report mentions that “[t]he regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals.” 74 Fed. Reg. at 53270. So we went looking for the relevant regulation. We found this:
Upon issuance of an order approving. . .any PMA, FDA will make available to the public the fact of the existence of the PMA and a detailed summary of information submitted to FDA respecting the safety and effectiveness of the device that is the subject of the PMA and that is the basis for the order.
21 C.F.R. §814.9(e). It doesn’t say anything about “quarterly” reporting, though, so we kept looking. Then we found 21 C.F.R. §814.44(d)(1), and there it was:
The notice of approval will be placed on FDA’s home page on the Internet (http://www.fda.gov/), and it will state that a detailed summary of information respecting the safety and effectiveness of the device, which was the basis for the order approving the PMA, including information about any adverse effects of the device on health, is available on the Internet and has been placed on public display, and that copies are available upon request. FDA will publish in the Federal Register after each quarter a list of the approvals announced in that quarter. When a notice of approval is published, data and information in the PMA file will be available for public disclosure in accordance with §814.9.
(Emphasis added). So, for anybody who needs to authenticate an initial PMA, that’s the complete regulatory paper trail for doing it.
But we didn’t stop there, either. At the very end of the document was the statement: “Persons with access to the Internet may obtain the documents at http:// www.fda.gov/cdrh/pmapage.html.” Since the regs also mention the FDA’s website, we took a peek there, too.
If you’ve never been to the FDA’s website, you really should give it a shot – there’s a wealth of information on all sorts of things, and the courts generally (as we discussed in our prior post) seem inclined to judicially notice it.
We weren’t disappointed this time, either. The FDA’s website does better than just quarterly. It lists all PMA approvals by month, under the relevant year. The online PMA information goes back to 1994.
Not only that, the on-line information includes supplemental PMA approvals, too. We clicked on “January 2009,” and in addition to one PMA, there was information about the approval of 54 PMA supplements.
So if you know the month and year that a relevant PMA supplement was approved, you can look it up that way, without having to go through all of the rigmarole that we went through earlier about creating permanent FDA device history links. That’s not to say that the link creation technique isn’t valuable – it’s the only way to gather the entire device history in one place.
One last cautionary note: the monthly PMA supplement material starts with 1995. The 1994 link has only initial PMAs.
So that’s one helpful tip. Thanks, Ted.
We got a second one, in response to the off-label use part of our “This and That” post, from a reader who wishes to remain nameless, letting us know that Medicare in some cases knowingly and willingly pays for unapproved uses. This tip included a link to this recent New York Times article, R. Abelson & A. Pollock, “Medicare Widens Drugs It Accepts for Cancer,” (N.Y.T. Jan. 26, 2009), discussing Medicare’s decision to broaden the range of off-label cancer treatments it will reimburse.
The Times article notes “a 1993 federal law gave Medicare specific authorization to cover some unapproved uses of cancer drugs,” and states:
The new rules expand the number of reference guides — or compendiums — that Medicare relies on for determining which off-label uses of cancer drugs to cover. The writers and editors of these compendiums, who work completely outside the federal government, scan the medical literature and evaluate the evidence in making their recommendations.
In 1993, Congress had authorized three compendiums for Medicare, all published by not-for-profit organizations. But by 2007 two had stopped publishing, leaving Medicare with a single compendium. Having selected three additional guides last year, the agency plans to review its choice of guides every year.
We’d known a little bit about this before. The amicus brief that Bexis filed for the WLF in the Caputo case looked into Medicare reimbursement of off-label uses as one example of the government’s Dr. Jekyll/Mr. Hyde approach to off-label uses:
Medicare pays for many off-label uses, 42 U.S.C. §1396r-8(k)(6) (criteria for off-label use as a “medically accepted indication”), and sometimes mandates payment. Id. at §1395x(t)(2)(B)(ii) (cancer treatment).
WLF Caputo br. at 8. But plainly there’s more here than we’ve thought about before.
The Times article, being for non-lawyers, doesn’t cite any of the material it mentions, so we went looking. First we dug up the relevant Medicare document. It’s called “Process for Amending the List of Compendia for Determination of Medically-Accepted Indications for Off-Label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen,” and it was first listed as an available Medicare document in 73 Fed. Reg. 36596, 36599 (HHS, Ctrs Med. & Med. Svcs. June 27, 2008). This “process” document is available on-line from numerous sources, including this one.
The “process” document explains the history of medical compendia as a recognized basis for Medicare off-label use reimbursement. Congress designated the original compendia, here §42 U.S.C.A. §1395x(t)(2)(B)(ii)(I). It also provided that this list could supplemented with “other authoritative compendia as identified by the Secretary.” Id. So that’s exactly how the government came to pay for a large number of off-label uses.
We dug a little further, and found the Medicare Notice that actually added the new compendia to the prior list of resources for off-label compensation.
Next, we went looking for the four compendia themselves. We found them – sort of. The fly in the ointment is that each of these are commercial sources, and you’ll have to pay to look at them. In any event, here’s where the four current Medicare-accepted, off-label use compendia can be found, if you’re ready to shell out the cash:
- National Comprehensive Cancer Network, Clinical recommendations, accessible on-line, here (paid subscription only).
- American Hospital Formulary Service-Drug Information (AHFS-DI), accessible on-line here (paid subscription only).
- Thomson Micromedex DrugDex, accessible here (paid subscription only).
- Clinical Pharmacology, accessible on-line here (paid subscription only).
Finally, for sake of thoroughness, we’ll include a link to the FDA’s most recent authoritative statement on off-label use generally. This is the “Good Reprint Practices” guidance, that we discussed in greater detail here, shortly after it issued.
Once again, thanks to our readers for their useful tips. Keep them coming. We appreciate suggestions for topics like these that you think would be of interest to you.