Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Posted 11 November 2013 | By Alexander Gaffney, RAC,
The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has sent a Warning Letter to the CEO of Aegerion Pharmaceuticals, saying comments the executive made while on a television show constituted promotional speech and therefore resulted in the company's product being misbranded.
The OPDP Warning Letter-itself a rarity, as the office usually sends so-called "Untitled Letters" indicating its displeasure-is unusual in that it pertains to a television appearance. The overwhelming majority of deficient materials observed by OPDP relate to print materials.
According to the Warning Letter, Aegerion CEO Marc Beer appeared on the CNBC show Fast Money on 5 June 2013 to discuss his company's drug Juxtapid (lomitapide). Juxtapid is approved by FDA to lower various forms of cholesterol in patients with homozygous familial hypercholesterolemia (HoFH), a rare inherited disease in which the body is unable to remove low-density lipoprotein (LDL) cholesterol from the body. Importantly, the drug is approved as an adjunct-not for use on its own (monotherapy).
Juxtapid has two important limitations: It is not yet approved for patients with non-familial hypercholesterolemia, and has not yet been evaluated with respect to its cardiovascular morbidity and mortality rates. In addition, the drug has a number of serious safety risks, which resulted in FDA giving the drug a boxed warning and restricted access program as part of a Risk Evaluation and Mitigation Strategy (REMS).
But when FDA watched Beer's Fast Money appearance, it said his statements on the appropriate use of the drug did not reflect these risks or limitations, creating the "misleading [suggestion] that Juxtapid is safe and effective for use in decreasing the occurrence of cardiovascular events including heart attacks and strokes, and increasing the lifespan of patients with HoFH."
Similar remarks were made by Beer in a 31 October 2013 appearance on the show, FDA said.
Regulators contend that Beer's remarks had the effect of implying that Juxtapid could be used on its own, when it is only approved by FDA for use in combination with other therapies. "Use as a monotherapy is an unapproved use," FDA wrote.
FDA also explained that Beer had a duty to promote fair balance in his oral remarks as in the company's written materials. "While the statements cited [in the Warning letter] include substantial and repeated efficacy claims for Juxtapid, the presentation fails to communicate any [emphasis original] of the risk associated with these new intended uses or its approved use," OPDP wrote.
OPDP demanded that Beer immediately stop misbranding Juxtapid in the manner he has been doing, saying the violations thus far were "serious."
So serious, in fact, that FDA said it merits corrective advertising, which will need to be sent to FDA in the form of a "comprehensive plan of action to disseminate truthful, non-misleading and complete corrective messages about the issues discussed in this [Warning Letter] to correct any misimpressions about the approved use of Juxtapid.
In a statement, Aegerion said it planned to take "quick action" to address FDA's concerns and took them "very seriously."
OPDP Warning Letter to Aegerion
Tags: OPDP, warning letter
Regulatory Focus newsletters
All the biggest regulatory news and happenings.