Well, the actual title of the conference is "Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products". But the core issue of the conference is whether the generic version of extended release drugs -- used widely to treat pain, mental illness, Parkinson's, and bacterial infections -- deliver the medicine to the right place at the right time in the right amount. Too much can be painful, even deadly. Too little can cause setbacks. The drug might be cheaper but the outcome is costly.
To date no one has kept track of the total impact on patients. In part that's because until 2007 generic companies were not require by the FDA to monitor the effect of their products in the marketplace and only then it was limited to opioid based painkillers. The increased use of generic lamotrigine is strongly associated with increased physician visits and hospitalizations. The same goes for switching patients to a generic version of other anti-convulsants, anti-depressants, etc.
The key question of the conference is what can companies do to assure that all medicines affect us in more or less the same way. As I have written before, one step in the right direction is to hold drugs that are supposed to have the same benefit and same risks to the same standards of post market evaluation. Another approach, to be discussed by Gerard Sanderink of Sanofi will be how to use biomarkers to more precisely predict dose response and absorption of products in the earliest stages of development and periodically in the post market.
The conference may seem mundane. However the fact that Bob Temple is showing up indicates just how serious the FDA is about this issue. And more generally, it underscores the fact that the public at large is unaware of the importance of how a drug is delivered. Discovering a medicine is half the battle. Making sure it is delivered safely and effectively is as important.
Accordingly, CMPI will be covering the AAPS conference "live" with bloggers and a video crew in a effort to "deliver" the modified release message in a way that it interesting and timely.
To date no one has kept track of the total impact on patients. In part that's because until 2007 generic companies were not require by the FDA to monitor the effect of their products in the marketplace and only then it was limited to opioid based painkillers. The increased use of generic lamotrigine is strongly associated with increased physician visits and hospitalizations. The same goes for switching patients to a generic version of other anti-convulsants, anti-depressants, etc.
The key question of the conference is what can companies do to assure that all medicines affect us in more or less the same way. As I have written before, one step in the right direction is to hold drugs that are supposed to have the same benefit and same risks to the same standards of post market evaluation. Another approach, to be discussed by Gerard Sanderink of Sanofi will be how to use biomarkers to more precisely predict dose response and absorption of products in the earliest stages of development and periodically in the post market.
The conference may seem mundane. However the fact that Bob Temple is showing up indicates just how serious the FDA is about this issue. And more generally, it underscores the fact that the public at large is unaware of the importance of how a drug is delivered. Discovering a medicine is half the battle. Making sure it is delivered safely and effectively is as important.
Accordingly, CMPI will be covering the AAPS conference "live" with bloggers and a video crew in a effort to "deliver" the modified release message in a way that it interesting and timely.
