Oh No You Didn’t: OSU Suplexes FDA and Pharma in Publication

Bottle of pillsCo-authored by OSU College of Pharmacy professor Daniel Hartung and published in April’s Neurology, this is not your normal paper. After conducting the study informing his “Cost of Multiple Sclerosis Drugs in the US and the Pharmaceutical Industry,” Hartung concluded, “The marketplace for pharmaceuticals and health care in general is just totally dysfunctional.”

For instance, sophisticated drugs bought to treat the one percent of Medicare patients suffering from multiple sclerosis and various cancers may account for a quarter of Medicare’s annual prescription payments.

Not until last month did the FDA allow generic production of the multiple sclerosis drug Copaxone. No other generic versions of MS medicines have yet been approved. Hartung criticized corporate pharmaceutical patent holders, saying, “Drug companies can patent all sorts of different aspects of their drug, and the more things they patent, the more things they can potentially challenge other manufacturers for infringement on those patents.”

Hartung dismisses the notion that higher development costs of precision biogenic specialty drugs play a large role in higher prices for those drugs, compared to older compounds. With emotion uncharacteristic of a scientist, Hartung slams the current system, saying, “A lot of what’s been done, in the past decade, has had to go through the political process, and because of that, a lot of [regulation] that’s been passed has been very ‘pro-pharmaceutical’ and ‘pro-industrial-medical complex.’”

Specifically, Hartung pointed to the Medicare Modernization Act’s prescription drug plan, passed in 2003 and implemented in 2006, which forbade Medicare from negotiating with pharmaceutical companies on drug prices.

Hartung envisions an affordability watchdog group being formed, preferably outside the FDA.

By Paul Henry