Medical Foods, Generics And Patient Safety

For those who enjoy sifting through regulatory issues, consider the sometimes confusing world of prescription medical foods. A heated dispute over alleged generic versions of pills that are sold by a little-known company in Louisiana to treat diabetic peripheral neuropathy and depression, among other afflictions, has been transformed from a backwater business dispute into a public health issue.

Until now, the battle has largely remained in the shadows, a spat that has preoccupied a few companies and their lawyers, who are grappling with an oversight vacuum that involves pharmacies, third-party payers, drug compendia and, of course, patients. But the issue has recently attracted the attention of state officials in Louisiana due to public health concerns. How so? Here's the story...

A company called PamLab, which sells several prescription medical foods, got upset when other companies began marketing what were being touted as allegedly similar products but without having to prove bioequivalency. Why? There is no system in place for evaluating equivalency. In FDA lingo, there is a lack of an Orange Book rating system and, as a practical matter, this means there is no way to verify label claims or scientific validity for products that are marketed as generic substitutes for prescription medical foods.

As a result, this allows compendia such First DataBank and MediSpan to list whatever comes their way, which is what PamLab says has been happening repeatedly. Products sold by allegedly unscrupulous rivals were being listed, effectively endorsing payment and usage. And so PamLab filed lawsuits charging false advertising and unfair competition. At least one dispute appears close to resolution, but in the process, PamLab managed to elevate its beef beyond a mere fight over money into a matter that raised a public health question.

This was accomplished by citing problems with label disclaimers and, in at least one case, instability due to an allegedly non-approved ingredient from China (look here). In doing so, PamLab caught the ear of the Louisiana Attorney General, who earlier this year filed a motion intervening on its behalf in federal court in New Orleans (read this). "Consumers don't know what they're getting with a substitution and the product isn’t held to the same standard of equivalency," Susan Crawford, an assistant Attorney General in Louisiana, tells us. "Patient safety is an issue."

One case involves PamLab's Metanx, which is used to treat diabetic peripheral neuropathy and contains L-methylfolate, a naturally occurring form of folate. In its lawsuit, PamLab claims a company called Brookstone Pharmaceuticals, which does business as Acella Pharmaceuticals, sells what a different version containing an isomer and has essentially marketed the pill as a generic without having to prove equivalency. Pamlab, by the way, uses an active ingredient supplied by Merck KGga.

Last year, PamLab revenue totaled Metanx generated $119 million in revenue, a level that PamLab fears will not recur as long as a generic is listed by compendia. "Once listed (in compendia), the false generics have progressed as any normal generic would gaining distribution, coverage and sales," says PamLab spokesman Jim Currie. "This is an obvious error in the system as wholesalers and pharmacists use the listing services as the proof that generic substitution is appropriate."

For its part, Brookstone argues that PamLab got it all wrong and its labeling arguments are, in fact, regulated by the Food, Drug and Cosmetic Act (see the motion) by maintaining its own products are actually dietary supplements that would be subject to misbranding violations. While this case plays out, PamLab appears close to resolving another, similar dispute involving its Deplin pill for depression. In this instance, PamLab again points to a lack of bioequivalency and has similarly circulated info about rival labeing (see this).

Last week, a federal judge backed PamLab and delayed ordering a temporary restraining order against Seton Pharmaceuticals after the company agreed to change the labeling on its rival DuLeek pills and inform compendia and customers of the revisions (see the order). In doing so, Seton agreed to make clear its products do not contain the same ingredient as the PamLab pills. And the move underscores the point that the Louisiana Attorney General has been making.

"Unfortunately, medical foods are not held to the same standards as drugs by the FDA," says Crawford. "And the information given to database companies can be misleading and that, in turn, is misleading to pharmacies. If products are being misrepresented, people are being duped into thinking their taking a product at the same level with the same ingredients as other products. And it’s a growing aspect of the maket. Medical foods is a growing business and the problem is, reasonably, anticipated to increase."