Fwd: FDA, Compliance, 2011 guidelines, PEG unapproved for pediatric use and illegal marketing

[Guest guest]

Good Morning everyone...I am on the mailing list for the "FDA news".I have forwarded a couple of other highlights previously.Mention of pediatric testing overseen by the gentleman speaking/teaching on this webinar is made. An attorney and BIg Pharma lobbyist, among other things and now paid employee of the FDA, Kurt Karst is now a regulatory expert. A couple of statements found in the body of this message that caught my immediate attention: (of course always thinking about poly-ethylene glycol and the HOW and WHY it was ever allowed on the market to begin with, THEN allowed to become an OTC drug...bringing in $62 million a year now...something like that, surpassing Metamucil, the natural, safe fiber alternative, the very first year...why, because our trusty doctors became loyal 'pushers'. (angry, just a little bit...I never did like people who could so easily be ' bought' and in my entire nursing career, I have never had respect for pharmaceutical companies and their questionable practices, that rightfully have come under extreme scrutiny in the last several years. Laws have been implemented to curb the insanity when it has come to 'buying the doctors, but many, many practices are still alive and well. The constant stream of Big Pharma reps continues into Doctor's offices every day. And every day another child is given an 'illegal' dosing of a drug not recommended for children, because of articles published in pediatric journals by doctors espousing the wonderful benefits of poly-ethylene glycol, best known as Miralax, the 'miracle' drug. Read and digest America being taken: The FDA is providing industry the classic carrot and the stick; if firms marketing unapproved drugs are willing to come forward, they can get FDA's help in getting into compliance. If you try and fly under the radar — or reformulate and hope to not get caught — be prepared to face immediate penalties.(reformulate-not sure what this means in terms of the companies who know their product poly-ethylene should not be used on children, or adults for that matter, but turn a blind eye and hope to see surreptitious proponents continue their marketing of this dangerous product)New insights on how the FDA will prioritize enforcement actions and the real-world impact the 2006 and 2011 guidances are likely to have on both manufacturers and distributorsAre You Marketing Drugs FDA Hasn't Actually Approved?Begin forwarded message:Date: October 26, 2011 4:07:08 AM PDTAs of September 19, 2011, all unapproved drugs introduced onto the market are subject to immediate enforcement action.FDA's new guidance on Marketed Unapproved Drugs is stronger than the 2006 crackdown that resulted in dozens of warning letters and consent decrees.This time, there are six specific priorities for stepped-up enforcement — and enforcement action can occur at any time without prior notice and without regard to prior enforcement policies.Could the FDA target you? Here's how to get ready. Fast.Marketed Unapproved Drugs FDA to Take Immediate Enforcement Action at Any Time, Without Prior Notice An FDAnews Webinar with Regulatory Expert Kurt KarstThursday, October 27, 2011 · 1:30 p.m. – 3:00 p.m. EDTJust ONE day left to Register!The FDA is providing industry the classic carrot and the stick; if firms marketing unapproved drugs are willing to come forward, they can get FDA's help in getting into compliance. If you try and fly under the radar — or reformulate and hope to not get caught — be prepared to face immediate penalties.Bonus Resource for AttendeesAttorney and regulatory expert Kurt Karst will provide all registrants with a marked-up copy of the Marketed Unapproved Drugs Compliance Policy Guide. In the document, he has highlighted sections that demand your attention and provided real-world tips on how to comply with the various requirements in these sections.Register nowThe FDA's six priorities for stepped-up enforcement of rules against the marketing of unapproved drugs include:Drugs with potential safety risksDrugs that lack evidence about effectivenessHealth fraud drugsDrugs that present direct challenges to the new drug approval and OTC drug monograph systemsUnapproved new drugs that in any way violate the Federal Food, Drug and Cosmetic ActDrugs that have been reformulated to evade an FDA enforcement actionDon't risk severe new enforcement actions! Rely on this FDAnews webinar to get you and your entire team up to speed with what the FDA's new guidance says, who it targets, and what steps you need to be taking now to troubleshoot your marketing and shore up compliance.Register now, so when you hear from the FDA, you'll already be at work with best practices and the know-how to align compliance with the new priorities, including:New categories of marketed unapproved drugs created by amendments to the Federal Food, Drug and Cosmetic ActNew enforcement priorities set forth in the September 2011 guidanceNew strategies for how best to apply the Special Circumstances – Newly Approved Product section included with the new guidanceNew insights on how the FDA will prioritize enforcement actions and the real-world impact the 2006 and 2011 guidances are likely to have on both manufacturers and distributorsNew perspective on the FDA's enforcement methods and actions since the 2006 Compliance Policy Guide and how those Federal Register notices, warning letters, consent decrees and permanent injunctions will shape upcoming enforcementNew early-warning intelligence on what recent statements and activities reveal about what future enforcement initiatives the FDAmight be planningAnd moreA flexible fit for your busy scheduleThis webinar is convenient to attend. All that's required is that you be in front of a screen at the appointed time, whether you're at the office or telecommuting from your office-in-home.Of course, Kurt Karst will be on hand to answer all of your questions. Simply submit your questions via email, and you'll have answers by the time the session ends.Executives, regulatory affairs and compliance officers, sales and marketing personnel, R & D staff, auditors, corporate counsel, risk management specialists and QA/QC personnel will all benefit from taking part in this event. Best of all, everyone can do so at a cost that won't break the budget.You pay one single low registration fee per facility, regardless of how many participate. And every participant gets the FREE bonus: the highlighted version of the FDA's September 2011 guidance annotated with practical tips for complying with each section. So spread the word to your team!Register nowMeet Your InstructorKurt Karst, a director and attorney at Hyman, Phelps & McNamara, P.C., provides regulatory counseling to a wide variety of clients, including pharmaceutical and medical device manufacturers. He specializes in Hatch-Waxman patent and exclusivity, myriad drug development issues, pediatric testing, and orphan drugs. He previously worked as a lobbyist for F. Hoffmann-La Roche Inc. He has been published in numerous legal and industry journals, and is a primary author of the popular FDA Law Blog. Kurt earned his J.D. from American University Washington College of Law.Who Will BenefitThis webinar offers hands-on guidance of value to executives and personnel in drug and biologics companies as well as distributors, including:Compliance officersConsultants/service providersExecutive managementGeneral/corporate counselManagersManufacturing directors and supervisorsPersonnel new to the industryPharmaceutical and cGMP auditorsQA/QC personnelR & D staffRegulatory/legislative affairs professionalsRisk management specialistsSales/marketing personnelStrategic planning and business development staffWebinar DetailsDate:Thursday, October 27, 2011Location:Your laptop, office or conference room (No need to travel!)Time:1:30 p.m. – 3:00 p.m. EDT12:30 p.m. – 2:00 p.m. CDT11:30 a.m. – 1:00 p.m. MDT10:30 a.m. – 12:00 p.m. PDT6:30 p.m. – 8:00 p.m. BSTPrice:Webinar PLUS Audio CD and Transcript: $527 – Best Value!You'll have access to one log-in and dial-in for the live 90-minute webinar for unlimited participants. You also receive all presentation materials and the opportunity to ask questions by phone and email, plus an audio CD and transcript for the entire session.Webinar Only: $327You get one log-in and dial-in for the live 90-minute webinar for unlimited participants, presentation materials and the opportunity to ask questions by phone and email.Invite your entire team for maximum benefit!Register TODAY for one dial-in and log-in —and bring as many participants as you wish.Interested in registering multiple sites?Call in the U.S. or +1 globallyto learn about our special multisite discount.Three Easy Ways to RegisterPlease mention priority code 11O26 when registering.Enroll online.Call +1 or toll free (inside the U.S.) Use your American Express, Visa or MasterCard.Mail your check to: FDAnews, 300 N. Washington St., Suite 200Falls Church, VA 22046-3431.Can't Attend?Choose between the Audio CD and transcript or listening in on the Encore presentation:Audio CD and Transcript Only: $327 (plus shipping and handling)You'll receive an audio CD and written transcript of the entire 90-minute webinar, including the Q & A period, and all presentation materials. Delivery is approximately four weeks after the session.24/7 ENCORETM Audio Presentation: $327 You'll have access to one dial-in for an archived recording of the entire 90-minute webinar, including the Q & A period, for unlimited participants. You can dial in any time of day or night for three weeks, from Oct. 31 – Nov. 18, 2011. You'll also receive all presentation materials.Stay Current and Compliant on Today's Top Issues with FDAnewsFDAnews offers a variety of webinars and audioconferences to keep you and your staff current on today's most important regulatory, legislative and business issues. 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