Walking the regulatory line

Federal rules give mixed messages on prescribing drugs off-label. (Photo: Michelle Tribe)

Friday (1/30), drugmaker Eli Lilly is expected to appear in a Philadelphia court and plead guilty. The company’s crime? It illegally marketed an anti-psychotic for uses never approved by the Food and Drug Administration. Such marketing is a no-no. But nothing in the rules blocks doctors from prescribing a drug for what are called “off-label” uses. Kerry Grens, of WHYY’s health and science desk, reports on recent federal rulings that could muddy the situation even further. (Photo: Michelle Tribe)

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Eli Lilly’s drug Zyprexa is one of the drugs most often prescribed for off-label uses. While the FDA okayed Zyprexa specifically for schizophrenia and bipolar disorder, doctors frequently prescribe it for depression, dementia, and anxiety. Peter Swanljung, a doctor at Friends Hospital, says such flexibility is important in psychiatric medicine.

Swanljung: It’s not clear whether a patient may have a bipolar disorder, whether they have schizophrenia, and that becomes more clear over the time of their hospitalization. And we often start them on medication while we’re still clarifying that diagnosis.

That approach is perfectly legal. And common. In cancer treatment, off-label uses of a given drug can account for as many as 50 percent of prescriptions, says Robert Field, a professor at the University of the Sciences in Philadelphia.

Field: They’re approved for one kind of cancer and doctors use them for another kind. They’re approved for adults, doctors use them in children. If we didn’t have that a lot of patients would be cut out from a lot of important care.

The feds are sending some very mixed signals about off-label uses. Recently, even as Lilly was being prosecuted, Medicare agreed to pay for off-label cancer prescription. And the FDA just added to the confusion, with a new policy that encourages doctors to access research on off-label uses.

Field: The job of the FDA is to walk that very fine line between what’s legitimate promotion that’s going to help patients and what’s going over the top in terms of pushing uses that really aren’t known to be safe yet.

What will remain illegal is this: using marketing to promote off-label uses. That’s where Ely Lilly stepped out of bounds with Zyprexa — promoting the drug in nursing homes. Penn professor and doctor, Garret Fitzgerald, says the advertising was outrageous.

Fitzgerald: Made all the more so by the fact that this drug was associated with very serious adverse effects, particularly ballooning obesity and everything that goes with it.

For Lilly, those proved to be some costly ads. Its fine: $1.4 billion. So, ads are bad. But under the new FDA rule, drug companies can send doctors articles with research about off-label uses.

Fitzgerald: This recent guideline, or guidance, from the FDA moves things in a completely different direction.

Drug companies say the rules will help physicians in making prescribing decisions. Alan Bennett is a lobbyist representing pharmaceutical companies.

Bennett: I think that what the companies are essentially doing is making it a little bit easier for doctors to access information that’s already widely available. Just saving them some time.

Surrey Walton, an economist at the University of Illinois in Chicago, says that, given how widespread off-label prescribing has become, it is far too little studied.

Walton: When a doctor prescribes a medicine there should be a greater effort to collect information in terms of the indication for which that medicine is being prescribed.

But companies have little financial incentive to pay for expensive, off-label studies, says Field at the University of the Sciences.

Field: I think we need a much better system for encouraging the drug companies to do these tests.

Field expects the Obama administration to reverse the FDA’s recent ruling about disseminating research on off-label uses. In his view, this entire aspect of modern medicine needs an overhaul. But that, he said, could take years to achieve.