Posts Tagged ‘safety’
Monday, February 15th, 2010
- Guest blog by Wendy Kaplan Nickel -
Perhaps one of the greatest downfalls in drug history was the steep tumble of VIOXX after it was voluntarily pulled from the market in 2004. VIOXX was approved by the FDA in 1999 and quickly became “the” drug for arthritis. It gained widespread acceptance among physicians and over 20 million people were prescribed VIOXX at some point in its 5-year tenure. In fact, in the year prior to VIOXX’s withdrawal from the market, its manufacturer, Merck, experienced sales revenue of $2.5 billion from VIOXX alone. It is assumed Merck certainly had no intention of harming patients with its product, and in fact, celebrated in the fact that so many patients benefitted from the medication. However, it is worth exploring what might have happened if VIOXX’s safety issues had been discovered during the post-FDAAA era.
(more…)
Tags: cardiovascular risk, communication plan, EASU, FDA Guidance, FDAAA, heart attack, medication, medication guide, merck, NDA, REMS, risk management, safety, safety issues, vioxx, wendy kaplan nickel
Posted in REMS | 2 Comments »
Friday, January 8th, 2010
Since 2003, ParagonRx has helped design, document, or negotiate dozens of risk management programs and REMS for pharmaceutical products. Clients who choose to work with us have done so because of three operating principles:
- We believe in a balanced approach to REMS design in which safety objectives are achieved while preserving commercial viability.
- We employ science-based methods to reliably design and measure rational, defendable programs.
- We strive to inspire confidence in clients facing uncertain situations by providing specialized thinking, expert analysis and remarkable responsiveness by our experienced staff.
Those potential clients who did not choose to work with us often cited the need for a firm with broader capabilities to implement communication plans and elements to assure safe use.
At the start of this year, ParagonRx fulfilled its vision of being able to provide end-to-end REMS and risk management services by joining inVentiv Health. (more…)
Tags: communication plan, EASU, Elements to Assure Safe Use, NDA, ParagonRx, REMS, REMS design, risk management, safety
Posted in REMS | No Comments »
Wednesday, October 7th, 2009
On September 30th, FDA issued its long awaited draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”. While much of this draft guidance is a codification of what’s already been happening in practice over the past 2 years, there are a few interesting surprises (depicted in bold below) for those working in the REMS space to contemplate. This is the third in an ongoing series of blog articles about this important document.
Our first two articles covered the background of FDAAA and REMS relative to RiskMAPs and those RiskMAPs deemed to be REMS, an overview of a REMS submission, and greater detail about the more concise “proposed REMS” component of the REMS document submission. This article details the content of the more comprehensive “REMS Supporting Document”, which explains the rationale for, and supporting information about, the proposed REMS. A template for the REMS Supporting Document can be found on the www.fda.gov website. (more…)
Tags: approval, EASU, Elements to Assure Safe Use, FDA Guidance, FDAAA, guidance, medication, medication guide, Proposed REMS, regulatory, REMS, REMS approval, REMS assessment, REMS document, REMS elements, REMS supporting document, risk evaluation, Risk Evaluation and Mitigation Strategy, risk management, RiskMAP, safety, submission
Posted in FDA Guidance, Pharmaceuticals, REMS | No Comments »
Monday, October 5th, 2009
On September 30th, FDA issued its long awaited draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”. While much of this draft guidance is a codification of what’s already been happening in practice over the past two years, there are a few interesting surprises (depicted in bold below) for those working in the REMS space to contemplate. This is the second in an ongoing series of blog articles about this important document.
Our first article covered the background of FDAAA and REMS relative to RiskMAPs and those RiskMAPs deemed to be REMS, as well as an overview of a REMS submission. This second article addresses, in greater detail, the more concise “proposed REMS” component of the REMS document submission. The more expanded “REMS supporting document”, explaining the rationale for, and supporting information about, the proposed REMS being addressed in the next article. (more…)
Tags: communication plan, EASU, Elements to Assure Safe Use, FDA Guidance, FDAAA, guidance, medication, medication guide, NDA, Proposed REMS, REMS, REMS assessment, REMS document, REMS elements, REMS supporting document, risk evaluation, Risk Evaluation and Mitigation Strategy, RiskMAP, safety, submission
Posted in FDA Guidance, Pharmaceuticals, REMS | No Comments »
Wednesday, September 30th, 2009
FDA issued its long awaited draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”, on September 30. While much of the guidance is codification of what’s already been happening in practice over the past two years, there are a few surprises (indicated here in bold) for all of us working in the REMS space to contemplate. This is the first in a series of blog posts about this important document. (more…)
Tags: approved REMS, communication plan, deemed REMS, EASU, Elements to Assure Safe Use, FDA Guidance, FDAAA, guidance, medication, medication guide, NDA, Proposed REMS, regulatory, REMS, REMS assessment, REMS document, REMS guidance, REMS supporting document, risk evaluation, Risk Evaluation and Mitigation Strategy, risk management, RiskMAP, safety, submission
Posted in FDA Guidance, Pharmaceuticals, REMS | No Comments »
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 | No Comments »
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 | No Comments »
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 | 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 »
