Archive for the ‘Pharmaceuticals’ Category
Thursday, September 24th, 2009
Description of RxFMEA™
RxFMEA™ is a proprietary modification and extension of the basic FMEA methodology and that of Healthcare FMEA (HFMEA™), an adaptation of FMEA that was developed by the U.S. Veteran’s Administration. My review of the process suggests that the objective of RxFMEA™ is the comprehensive management of risks in the pharmaceutical industry. Because of the active involvement of trained personnel and untrained consumers in the distribution and use of pharmaceuticals, RxFMEA™ extends the basic FMEA and HFMEA™ processes in the following ways (more…)
Tags: EASU, FMEA, medication, NDA, ParagonRx, regulatory, REMS, RxFMEA, safety
Posted in Pharmaceuticals, REMS | Comments Off
Thursday, September 3rd, 2009
Airplanes and medications seem like items that don’t mix well. In fact, the discussion of a recent webinar suggests otherwise, at least as it relates to risk management. Captain Ben Berman shared experiences from his role as former Chief of Major Investigations of the U.S. National Transportation Board in which he served as a member of the major accident go-team responsible for safety studies about flight crew human factors. (more…)
Tags: FDA Guidance, FMEA, medication, medications, NDA, ParagonRx, regulatory, REMS, REMS effectiveness, risk assessment, risk management, risk mitigation, safety
Posted in Pharmaceuticals, REMS | Comments Off
Wednesday, September 2nd, 2009
In a constantly changing regulatory environment, having a well planned contingency strategy is vital for successful Food and Drug Administration (FDA) negotiations. Today, this is more important than ever. The FDA is asking companies to prepare Risk Evaluation and Mitigation Strategies (REMS) to help ensure patient safety, and has issued a documentation template, but has yet to provide further guidance to the industry on how such REMS should be developed. (more…)
Tags: approval, communication plan, contingency plan, EASU, Elements to Assure Safe Use, FDA Guidance, guidance, medication, medication guide, patient safety, regulatory, REMS, REMS design, REMS program, risk evaluation, safety
Posted in Pharmaceuticals, REMS | Comments Off
Wednesday, August 19th, 2009
Guest Blog by Dr. Michael Benjamin
Dr. Jenkins–
I have seen your recent comments on providing REMS programs for opioids. Since you are the director of OND, I was hoping to give you some feedback on these programs, and to alert you to the adverse effect on patient care that they can have.
I am a clinical hematologist and oncologist. I have to contend with many drugs under these programs, including Promacta, Nplate, Thalomid, Tysabri, and Revlimid. Looks like opioids are next on the list. (more…)
Tags: FDA Guidance, NDA, REMS, REMS program
Posted in Pharmaceuticals, REMS | No Comments »
Wednesday, August 12th, 2009
Your company wouldn’t launch a new product and wait for the end-of-year results before assessing whether the launch strategy was effective, correct? In fact, the process most pharmaceutical product managers employ includes weekly measurement of prescription volume, tracking product inventory, assessing distribution patterns of promotional materials, measuring knowledge/attitude/practices of prescribers, and adjusting marketing activities to achieve success.
So why would tracking and adjusting risk management activities be any different? FDA requires an assessment of REMS performance at intervals no less frequently than 18 months, 3 years, and 7 years post launch. What are you doing before and between formal assessments to actively manage and maximize the effectiveness of the REMS? (more…)
Tags: benefit-risk, EASU, FDA Guidance, patient safety, REMS, REMS document, REMS effectiveness, REMS elements, REMS program, risk management, safety
Posted in Pharmaceuticals, REMS | No Comments »
Thursday, July 30th, 2009
One of the more challenging aspects of the new FDA world of REMS is the tension it can create among various functional groups such as Marketing, Risk Management, Safety and Medical within a Pharma or Biotech company. Rules are unclear. Territories are vaguely defined. New objectives seem similar to the old but may not be in reality. And it involves many players, across most internal disciplines. Maybe it’s time that we all think of this as a cross-disciplinary sport that no one really knows how to play well, yet.
The urgency of the new regulatory environment is simply demanding some quick innovative thinking and action.
Some of our clients and others are addressing this new “X-Disciplinary Sport” to good advantage. There are a number of principles that, if kept at the forefront of thinking, can help you re-organize and align your teams around this new REMS-driven world. (more…)
Tags: approval, FDA Guidance, medication, medications, NDA, patient safety, regulatory, REMS, REMS design, risk management, safety
Posted in Appropriate Use, Pharmaceuticals, REMS | No Comments »
Monday, July 20th, 2009
Today we want to focus on key lessons learned from our clients’ experiences. We are very grateful to these clients for allowing us to share their experiences with you so that you can do a better job in your REMS process.
Let’s begin with something that happened recently as we were working with a client during the tight 90-day period before they presented their PDUFA.
Expect the Unexpected
As we work with our clients on their REMS process, we are learning a lot about the uncertainties of interfacing with an internal FDA process that is itself a work in process. One thing that has become very apparent is that no matter how much advanced preparation you believe you have done, the FDA might just surprise you. (more…)
Tags: approval, contingency plan, FDA Guidance, PDUFA, REMS, REMS document, REMS elements, REMS program
Posted in Pharmaceuticals, REMS | No Comments »
Wednesday, April 8th, 2009
What a difference a year makes…
In early 2008, the topic of risk management was greeted with aversion by most pharmaceutical managers responsible for commercial activities. “If I encounter a drug with genuine safety concerns, I’ll call you” was a frequent response.
Today, everyone is talking about risk management… and for good reason. The FDA Amendment Act (FDAAA) of 2007 granted FDA sweeping new authority to require Risk Evaluation and Mitigation Strategies (REMS) of any product at any stage of lifecycle. In response to FDAAA, industry had three immediate questions:
- What determines if REMS will be necessary?
- How actively will FDA implement the REMS provisions?
- Who should be thinking about risk management?
(more…)
Tags: benefit-risk, contingency plan, evidence-based, FDA Guidance, FDAAA, FMEA, medication, ParagonRx, patient safety, pharmaceutical safety, REMS, REMS elements, REMS program, risk assessment, risk evaluation, risk management, safety
Posted in Pharmaceuticals, REMS | No Comments »
Thursday, February 19th, 2009
REMS 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…)
Tags: appropriate use, FDA Guidance, guidance, Jeff Fetterman, medication, medications, NDA, ParagonRx, pharmaceutical risk management, REMS, REMS program, risk management, risk mitigation, safety
Posted in Pharmaceuticals, REMS | No Comments »
Friday, February 6th, 2009
REMS 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…)
Tags: appropriate use, approval, FDA Guidance, Jeff Fetterman, medication, medications, ParagonRx, regulatory, REMS, REMS program, risk management, safety
Posted in Pharmaceuticals, REMS | No Comments »
