“FDA Seeks to Broaden Range of Use for Drugs” read a headline in this past weekend’s New York Times. You’d be forgiven if you thought the article was about FDA trying to broaden the use of drugsâ€”but in fact it was about something quite different: a new FDA draft guidance that would change the rules on the distribution of medical journal articles on unapproved uses of drugs.
Pharma has long distributed reprints on off-label uses of drugs, but the rules in recent years were onerous, and, of course, the HHS Office of the Inspector General (OIG) has been diligently pursuing off-label promotion as a particularly pernicious form of Medicare fraud. So the real questions for pharma, which weren’t addressed in any of the news articles I read are:
- Just how new is the new guidance, and
- How much protection from OIG will the guidance offer if it is ever finalized (more about that in a moment).
The answers: Not very (but a bit) and not much. For pharma, the significant differences between the rules embodied in section 401 of the Food and Drug Modernization Act (FDAMA) of 1997 boil down to two major points:
- Companies will no longer have to submit their materials to FDA for approval before distributing them, and
- Companies need not apply for a new indication before distributing materials that discuss it.
Companies still need to be selective about what sorts of articles they distribute. (Expert peer review required, and no advertorials, letters to the editor, or Phase I reports allowed.) They have to package the reprint properly (with a warning that the usage described is not approved, full labeling information, a comprehensive bibliography, and conflict-of-interest disclosure, among other things). FDA also leaves itself the option of deciding that a particular reprint in a particular context is unfair or misleading.
Follow the rules, though, and your distribution of off-label materials is officially not promotion of off-label use:
FDA recognizes that the public health can be served when health care professionals receive truthful and non-misleading scientific and medical information on unapproved uses of approved or cleared medical products. Accordingly, if a manufacturer follows the recommendations described in Section IV of this draft guidance and there is no unlawful promotion of the product, FDA does not intend to use the distribution of such medical and scientific information as evidence of an intent by the manufacturer that the product be used for an unapproved use.
That’s generally good news for pharma. But does OIG have to go along, or can it continue to define the act of providing off-label information as Medicare fraud? Well, OIG, as a matter of policy, doesn’t comment on draft guidances, so we turned to a couple of lawyers with experience in the arena.
“If the FDA proposal becomes finalâ€”and thatâ€™s an ifâ€”then with respect to current marketing activities, the OIG would be bound to apply the new regulatory standards,” explains Howard Young, a partner in the healthcare practice of Sonnenschein and an OIG vet. “But many of the off-label investigations are looking back in time, theyâ€™re historical. Companies’ actions are going to be measured against the laws and standards at the time when claims were submitted [to Medicare].”
As for cases involving actions before the rule change, Young says, “What defendants may argue is there was a good policy and public-health reason for providing appropriate scientific articles that discuss off-label use, and it wasnâ€™t abusive from the get-go, even if the articles or other materials were provided by sales reps. These government investigations should focus on improper off-label marketing, not the mere exchange of infomration. It is not uncommon for regulatory agencies to change or clarify rules. FDA, exercising its regulatory authority, shouldn’t be limited in changing its rules just because there may be ongoing investigations involving off-label promotion.”
But there’s a lot more to the typical off-label case than just distributing reprints, says Areta Kupchyk, a partner at Reed Smith and former associate chief counsel at FDA. “Thereâ€™s always the debate over where you draw the line between what is true information and why canâ€™t that be discussed or disseminated,” she says. “At what point do you draw the line and say, ‘Youâ€™re not sharingâ€”youâ€™re promoting.’ FDA is recognizing that there is a right to share true information. This really is putting in writing what everyone has been doing. Merely the distribution of a document has not been the source of any OIG action.”
Which raises the key thing to remember about the proposed guidance: It’s just about what FDA is calling “Good Reprint Practices.” As for all the activities surrounding reprint distributionâ€”what the rep says, how the rep acts, the presence or absence of fair balance, and so forth, the guidance provides a few nos, but no safe harbors.
All of this may be moot, however. The draft guidance started attracting unfavorable notice even before it was issued. Late in January, Senator Chuck Grassley of the Senate Finance Committee was sending out letters demanding to know what had happened during meetings at which industry leaders discussed the issue of reprint distribution with FDA. There’s reason to wonder whether FDA has the clout to make the draft guidance a reality, given its current battered reputation.