The pharmaceutical industry has become a favorite “bad guy” among the public, media, and legislators. There is a perception that the many risks of medications is proof that the industry does not care about the safety of patients. Nonsense. (more…)
Posts Tagged ‘Jeff Fetterman’
No Free Lunch: An Intuitive Approach to Benefit-Risk Management
Tuesday, November 16th, 2010REMS Coordination Office
Monday, April 26th, 2010The REMS Coordination Office (RCO) is the organizing hub among a Sponsor’s cross-functional team. The RCO is responsible for coordinating and tracking various aspects of REMS and the activities of outside service providers. The RCO features a core team of individuals tasked with managing REMS activities and processes.
This was the topic of a recent webinar hosted by ParagonRx. Jeff Fetterman, ParagonRx President, opened the webinar by borrowing two examples from the nuclear industry to illustrate how two different principles for organizing operational processes and systems have the potential for two different outcomes – flawless or disastrous. (more…)
REMS Programs for Opioid Drugs?
Thursday, February 19th, 2009REMS programs for opioid drugs? A worthy approach but many questions remain to be answered.
Developing an effective REMS program – one designed to preserve access for every person who would benefit from a medication while avoiding exposure in situations and individuals with excessive risk factors – is a challenge. The difficulty increases when the risks expand beyond inadvertent misuse to also include intentional abuse.
Recently the FDA signaled its intent to tackle risks involving opioids that have both significant benefits for certain segments of patients and also the potential for misuse and abuse. On March 3, the FDA will sit down with 15 manufacturers of 24 opioid medications to begin the process of outfitting them with REMS.
(more…)
REMS Planning – Not Just For Safety
Friday, February 6th, 2009REMS planning is not only good for safety, it can also help increase product adoption.
If you’re interested in REMS because you’re in the Regulatory, Legal, Medical or R&D departments of a pharmaceutical, device or biotech manufacturing company, you might want to forward this post to your colleagues in Marketing, especially if they are working on product launches. Many Marketing people intuitively suspect any attempt to guide appropriate use of their fledgling product – such as a REMS or other risk management program – is going to negatively affect sales and reputation.
And that does make sense, doesn’t it? But the facts don’t support the belief.
(more…)
