http://pharmexec.findpharma.com/pharmexec/Regulatory/Article/list/43767 New developments and strategies for success in dealing with FDA, OIG, SEC, EMEA, and more. 2009-11-21T10:41:04Z http://pharmexec.findpharma.com/pharmexec/Marketing/Applying-FDA-Regulations-to-Online-Marketing/ArticleStandard/Article/detail/640297?contextCategoryId=43767&ref=25 This guide aims to provide pharma marketers with an overview of the key challenges surrounding Direct-to-Consumer (DTC) online marketing and some potential solutions for effectively leveraging this channel within the complex regulatory environment. 2009-11-09T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/462009/640297null REMOTE http://pharmexec.findpharma.com/pharmexec/News+Analysis/GAO-Accuses-FDA-of-Tardy-Trial-Data/ArticleStandard/Article/detail/637272?contextCategoryId=43767&ref=25 The US oversight arm scripted a hefty report complaining that FDA is not moving fast enough when it comes to screening clinical trials data for drugs green lit through its expedited approval program. 2009-10-28T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/442009/637272null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/New-NIH-Leader-Backs-Personalized-Medicine/ArticleStandard/Article/detail/613034?contextCategoryId=43767&ref=25 Collins seeks to parlay genomic discoveries into new biomedical therapies. Comparative effectiveness research, he says, should identify subpopulation responses to treatment and support personalized medicine. 2009-07-22T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/302009/613034null REMOTE http://pharmexec.findpharma.com/pharmexec/News+Analysis/FDA-Boosts-Warnings-on-Propoxyphene-Pain-Meds/ArticleStandard/Article/detail/609623?contextCategoryId=43767&ref=25 Pain medications containing propoxyphene could lead to overdose and death, according to new labeling mandated by FDA. However, public requests to take these drugs (including Darvon and Darvocet) off the market have been denied. 2009-07-08T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/282009/609623null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/Are-we-moving-towards-global-patenting/ArticleStandard/Article/detail/606930?contextCategoryId=43767&ref=25 Patents are an important tool for protecting innovative products, uses or processes intended for commercialization. A granted patent provides a limited monopoly, normally for up to 20 years from the filing date of a patent application, giving a patent owner the right to prevent other parties from making, stocking, selling, using or importing the patented invention without the patent owner's permission. A theoretical ideal for an innovator would be to obtain a patent in all countries of the world. However, patents must be sought and enforced in each territory where protection is desired because a global patent does not (yet) exist. For cost reasons, a decision is usually made as to where to file and process patent applications. 2009-07-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/262009/606930null XML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Sudden-Deaths-and-ADHD-Meds-Not-Necessarily-Relate/ArticleStandard/Article/detail/604388?contextCategoryId=43767&ref=25 Feds claim results of study comparing car crash deaths and children on ADHD drugs were not paramount to pulling kids off of ADHD treatments. 2009-06-17T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/252009/604388null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/WHO-Pushes-H1N1-Flu-to-Pandemic-State/ArticleStandard/Article/detail/603039?contextCategoryId=43767&ref=25 The Word Health Organization just bumped the H1N1 influenza to pandemic alert phase 6 (the highest alert level), making it the first worldwide pandemic in 41 years. 2009-06-11T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/242009/603039null REMOTE http://pharmexec.findpharma.com/pharmexec/News+Analysis/FDA-Launches-Transparency-Task-Force/ArticleStandard/Article/detail/601468?contextCategoryId=43767&ref=25 The feds green lit a task force charged with easing the flow of communication between FDA, pharma companies, and the general public. While the team is being billed as a task force for transparency, it?s still unclear what is being revealed. 2009-06-03T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/232009/601468null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/FDA-Releases-Guidance-on-Risk-in-Ads/ArticleStandard/Article/detail/600089?contextCategoryId=43767&ref=25 You know those loud soundtracks and distracting visuals during the safety information in your TV ads? Critics have been complaining about them, and new draft guidance from FDA is calling them a "no-no." 2009-05-27T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/222009/600089null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Pharma-Companies-Hit-With-Warnings-for-Search-Mark/ArticleStandard/Article/detail/592363?contextCategoryId=43767&ref=25 FDA is cracking down on content in search engine advertisements. The argument is that there is a serious deficiency of risk information in the tiny link ads that appear on search ads. With pharma already wary of marketing online, will FDA’s tactic hurt future Web campaigns? 2009-04-08T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/152009/592363null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/FDA-Demands-Pharma-Firms-Pull-Unapproved-Drugs/ArticleStandard/Article/detail/590830?contextCategoryId=43767&ref=25 The Feds are on the warpath, cracking down on pharmaceutical companies that manufacture and market unapproved prescription narcotics. 2009-04-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/142009/590830null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/Comparative-Effectiveness-Research-Coming-Soon/ArticleStandard/Article/detail/589172?contextCategoryId=43767&ref=25 Only time will reveal CER's true definition, and determine the full effects of a CER-based system 2009-03-24T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/132009/589172null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Massachusetts-Passes-New-Sales-and-Marketing-Rules/ArticleStandard/Article/detail/587894?contextCategoryId=43767&ref=25 The latest state-level attempt to regulate pharma marketing is also the most stringent, requiring both drug and device manufacturers to track and disclose marketing spend. And the state's very important biotech industry is crying foul. 2009-03-18T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/122009/587894null HTML http://pharmexec.findpharma.com/pharmexec/Marketing/GSK-Garners-FDA-Warning-Letter-for-Extraterrestria/ArticleStandard/Article/detail/584711?contextCategoryId=43767&ref=25 GlaxoSmithKline received a warning letter for use of misleading imagery in its television ad for Avodart. The Feds felt that comparing prostate size to planets might not be a good idea. 2009-03-04T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/102009/584711null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/Wyeth-Loses-Preemption-Battle/ArticleStandard/Article/detail/584710?contextCategoryId=43767&ref=25 The Supreme Court ruled in favor of the plaintiff in a case that has had the pharmaceutical industry on pins and needles. The verdict hammered home the fact that even though FDA approves a drug, pharmaceutical companies are responsible for making labels as clear as possible. 2009-03-04T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/102009/584710null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/EMEACanada-Health-Suspend-Raptiva-Sales/ArticleStandard/Article/detail/583392?contextCategoryId=43767&ref=25 After more reports surface that link Raptiva to a deadly brain infection, world drug regulation agencies decide the risks outweigh benefits. 2009-02-25T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/092009/583392null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Lilly-Gets-Green-Light-to-Sell-Prasugrel-in-Europe/ArticleStandard/Article/detail/583390?contextCategoryId=43767&ref=25 Lilly's blood thinner earns approval in Europe and challenges Plavix's status as king of the ACS market. 2009-02-25T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/092009/583390null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Bayer-to-Run-Corrective-Ad-for-Birth-Control-Pill/ArticleStandard/Article/detail/582362?contextCategoryId=43767&ref=25 FDA reprimanded Bayer for running misleading advertising touting unproven benefits of the contraceptive Yaz. Now the drug company will shell out $20 million for new ads setting the record straight. 2009-02-18T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/082009/582362null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/FDA-Wants-More-Gardasil-Data/ArticleStandard/Article/detail/575381?contextCategoryId=43767&ref=25 One week after submitting data to get Gardasil approved for men, Merck gets a total response letter from FDA requesting additional data before it makes a decision on authorizing the drug for older women. 2009-01-14T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/032009/575381null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/EU-Probes-Pharma/ArticleStandard/Article/detail/569071?contextCategoryId=43767&ref=25 Last January, the EU raided pharma companies searching for evidence of anti-trust violations. The newly issued report on the incident comes down hard on industry for what look like normal patent-protection activities. Could the same thing happen in the US? 2008-12-03T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/492008/569071null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/OTC-Viagra-Not-Ready-For-Prime-Time/ArticleStandard/Article/detail/568239?contextCategoryId=43767&ref=25 Pfizer decided to pull back its application for an over-the-counter version of its blockbuster ED drug after the release of a report stating that the ease of availability could lead to misuse of the drug. 2008-11-26T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/482008/568239null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Feds-in-Hot-Water-for-No-Bid-PR-Contract/ArticleStandard/Article/detail/566823?contextCategoryId=43767&ref=25 Things heat up in Washington as FDA is called to task for a controversial contracts deal with a local public relations firm. Both the Senate and the House are looking for answers, and the feds no longer have a PR firm to run damage control. 2008-11-19T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/472008/566823null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/FDA-Pulls-Amgen-Brochure-for-Misleading-Language/ArticleStandard/Article/detail/563054?contextCategoryId=43767&ref=25 Colorful and cheerful aren’t always a good thing; an illustrated brochure for Amgen’s Sensipar gets canned by FDA for too thin a listing of side effects and adverse reaction data. 2008-11-05T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/452008/563054null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory+News/iWyeth-v-Levinei-Takes-Center-Stage/ArticleStandard/Article/detail/563064?contextCategoryId=43767&ref=25 Wyeth v. Levine was argued before the US Supreme Court on Monday. With the justices asking aggressive questions of both sides, the verdict remains very much in doubt. All eyes are on Washington. 2008-11-05T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/452008/563064null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/Chantix-Heparin-Top-List-of-Adverse-Events/ArticleStandard/Article/detail/561584?contextCategoryId=43767&ref=25 A new study finds that side-effect reports are on the rise, with Chantix and heparin topping the list. Are popular drugs getting a bad rap because they're in the headlines? Or are people just reporting more side effects? 2008-10-29T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/442008/561584null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Shire-Receives-Warning-For-YouTube-Video/ArticleStandard/Article/detail/556971?contextCategoryId=43767&ref=25 Shire received a warning letter from FDA citing failure to provide warnings in non-traditional consumer ads. Is it time to look at better regulations for new media? Worse yet, is FDA watching YouTube? 2008-10-08T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/412008/556971null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Purepac-Preemption-Defense-Denied/ArticleStandard/Article/detail/555310?contextCategoryId=43767&ref=25 Just a few weeks from the start of the mammoth Wyeth v. Levine Supreme Court hearing, a small state case hammered home the fact that generic drug manufacturers can't expect preemption to save them just because FDA approved the label. 2008-10-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/402008/555310null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Prasugrel-Decision-Delayed-No-Reason-Why/ArticleStandard/Article/detail/555314?contextCategoryId=43767&ref=25 Lilly's coronary drug still hasn't been approved. FDA is mum on what?s taking so long, and analysts are left pondering the status of the medication. 2008-10-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/402008/555314null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/FDA-Approves-Additional-Gardasil-Indications/ArticleStandard/Article/detail/550564?contextCategoryId=43767&ref=25 Merck got good news on Monday, as its HPV vaccine Gardasil was given the green light to be used as a preventive for vaginal and vulvar cancer. 2008-09-17T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/382008/550564null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Feds-to-Post-Potential-Safety-Issues/ArticleStandard/Article/detail/548639?contextCategoryId=43767&ref=25 FDA launches new quarterly posting of drugs being assessed for possible safety problems. Oh, yes, and the agency recommends that patients keep taking drugs that make the list. 2008-09-10T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/372008/548639null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/New-FDA-Rules-Say-When-Pharma-Can-Act-Alone/ArticleStandard/Article/detail/544920?contextCategoryId=43767&ref=25 A controversial new rule allows pharma companies to upgrade drug warnings without FDA permission in narrow circumstances. Critics are not pleased. 2008-08-27T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/352008/544920null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/Feds-Release-Guidance-Against-Conflict-of-Interest/ArticleStandard/Article/detail/534036?contextCategoryId=43767&ref=25 FDA committee members will have to take a pass if they own more than $50K of a pharma, and investing less doesn?t secure a spot as an expert either. 2008-08-06T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/322008/534036null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/State-Bill-Nixes-Gifts-But-Still-Restricts/ArticleStandard/Article/detail/531197?contextCategoryId=43767&ref=25 The Massachusetts House of Representatives cuts a proposal to ban gifts and adds a revision that would cease the sale of prescription data. 2008-07-23T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/302008/531197null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/Feds-Propose-to-Black-Box-Epilepsy-Drugs/ArticleStandard/Article/detail/528643?contextCategoryId=43767&ref=25 After reviewing trials of 11 antiepileptic drugs, FDA is considering tacking black box warnings for suicidality on many of the drugs in the category. 2008-07-10T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/282008/528643null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/New-Act-to-Protect-Patients-Could-Cripple-Preempti/ArticleStandard/Article/detail/527134?contextCategoryId=43767&ref=25 Congressman Waxman and Pallone introduced a new legislation that could reverse the recent Riegel v. Medtronic decision. How will the ramifications of this act effect the upcoming pharma preemption case? 2008-07-02T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/272008/527134null HTML http://pharmexec.findpharma.com/pharmexec/Online+Only/FDAAA-Spelled-Out-at-DIA/ArticleStandard/Article/detail/525750?contextCategoryId=43767&ref=25 Feds walk the industry through the implementation of new drug safety legislation. Not surprisingly, money and staffing are the biggest issues. 2008-06-25T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/262008/525750null HTML http://pharmexec.findpharma.com/pharmexec/Online+Only/FDA-Takes-War-Against-Fake-Meds-Online/ArticleStandard/Article/detail/524473?contextCategoryId=43767&ref=25 FDA announced on Tuesday that it will go on the offensive against online pharmaceutical dealers selling fraudulent cancer products. The agency told reporters that it has sent 25 warning letters to companies actively marketing and selling drugs that have not been approved for treatment. A spokesperson said that the drugs in question could interfere with medication a patient is already taking, or could be used to forgo medically accepted treatment plans. 2008-06-18T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/252008/524473null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/Regranex-Foot-Gel-Gets-Stiffer-Warnings/ArticleStandard/Article/detail/522920?contextCategoryId=43767&ref=25 J&J topical formulation receives black box warning after a study revealed that the drug increases the mortality rate from cancer in a subset of patients. 2008-06-11T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/242008/522920null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Preemption-Watch-Two-Wins-for-Pharma/ArticleStandard/Article/detail/510237?contextCategoryId=43767&ref=25 Third Circuit finds for pharma in two much-watched liability cases, ruling that FDA trumps state-level litigation when the agency has specifically rejected a drug warning. 2008-04-16T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/162008/510237null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/DTC-Ads-to-Solicit-Side-Effects-Data/ArticleStandard/Article/detail/508505?contextCategoryId=43767&ref=25 Spurred by a Consumer Reports poll, lawmakers are pushing FDA to place its phone number on every pharma ad to encourage consumers to report adverse drug reactions. 2008-04-09T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/152008/508505null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Handling-Heparin/ArticleStandard/Article/detail/503826?contextCategoryId=43767&ref=25 FDA's cryptic plan for protecting patients from an unknown killer 2008-03-19T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/122008/503826null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory+News/ESA-Restrictions-Leave-Many-Questions-Unanswered/ArticleStandard/Article/detail/503822?contextCategoryId=43767&ref=25 Safety recommendations for erythropoiesis-stimulating agents have been released, but a lack of data and a narrow list of indication restrictions have left patient advocacy groups worried about unknown adverse effects. 2008-03-19T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/122008/503822null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Supreme-Court-Splits-on-Warner-Lambert-Preemption-/ArticleStandard/Article/detail/500187?contextCategoryId=43767&ref=25 Gadflies and rubberneckers hoping to gauge the Supreme Court?s view of preemption and pharma were left empty-handed as a 4-4 split in Warner-Lambert v. Kent provided little indication. 2008-03-05T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/102008/500187null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Baxter-Recalls-More-Heparin-Products/ArticleStandard/Article/detail/500189?contextCategoryId=43767&ref=25 Baxter has now pulled all Heparin blood thinner products—multi-dose, single-dose, and HEP-LOCK—off the market. 2008-03-05T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/102008/500189null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory+News/New-DTC-User-Fees-Whats-Your-Ad-Worth-to-You/ArticleStandard/Article/detail/480055?contextCategoryId=43767&ref=25 New DTC user fees will set companies back more than $40 grand per ad. But will these voluntary fees overhaul the review process? Some feel it's just another moneymaking scheme for FDA 2007-12-18T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/512007/480055null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Chantix-Concerns-Prompt-FDA-Investigation/ArticleStandard/Article/detail/475931?contextCategoryId=43767&ref=25 Side effects associated with Pfizer?s smoking-cessation drug have caused a stir in the blogosphere, prompting FDA to seek further information about incidents of depression and suicidal thoughts. 2007-11-29T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/482007/475931null HTML http://pharmexec.findpharma.com/pharmexec/PharmExec+Direct+Marketing+Edition/GSK-Told-to-Update-Avandia-Warnings/ArticleStandard/Article/detail/474124?contextCategoryId=43767&ref=25 Faced with contradictory data about the safety of the diabetes treatment, FDA asks for a black-box warning and additional trials. But how much damage will the black box do? 2007-11-21T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/472007/474124null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/JampJ-vs-Red-Cross-The-Battle-Continues/ArticleStandard/Article/detail/472527?contextCategoryId=43767&ref=25 Court rejects one of J&J's eight claims, but trademark dispute case will proceed. 2007-11-14T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/462007/472527null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Is-Mercks-Long-Vioxx-Nightmare-Really-Over/ArticleStandard/Article/detail/472514?contextCategoryId=43767&ref=25 A prominent pharma litigator argues that Merck's settlement was predictable from the start. And it has a chance of success—provided that it survives a key legal challenge and can meet its mark with plaintiff sign-on. 2007-11-14T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/462007/472514null HTML http://pharmexec.findpharma.com/pharmexec/Rotating+Feature+Article/FDAs-Approvable-Problem/ArticleStandard/Article/detail/469652?contextCategoryId=43767&ref=25 Approvable letters delay NDAs, cost pharma plenty, and are at an all-time high. Industry says FDA is gun-shy; the agency says it's business as usual. Who's right? 2007-11-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/442007/469652/fda_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/442007/469652/FDA_flash.gif XML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Eli-Lilly-Sends-Two-Warning-Lettersmdashand-Gets-O/ArticleStandard/Article/detail/464037?contextCategoryId=43767&ref=25 Drug company releases two Dear Doctor Letters notifying physicians of updated warning labels for Zyprexa and Symbyax, and receives a letter from FDA for false advertising in a Cymbalta campaign. 2007-10-10T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/412007/464037null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Big-Pharma-Forms-Consortium-for-Drug-Safety/ArticleStandard/Article/detail/461949?contextCategoryId=43767&ref=25 Introducing the International Serious Adverse Events Consortium, a new industry group that wants to identify the molecular roots of serious drug reactions. SAEC's first targets: liver failure and serious skin rashes. 2007-10-03T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/402007/461949null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/FDA-Switches-Up-Senior-Staff/ArticleStandard/Article/detail/461950?contextCategoryId=43767&ref=25 Galson and Woodcock were named acting surgeon general and director of CDER, respectively. Industry vets weigh in on the appointments. 2007-10-03T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/402007/461950null HTML http://pharmexec.findpharma.com/pharmexec/Medical+Education/Practical-Tips-for-Mitigating-Risk/ArticleStandard/Article/detail/463109?contextCategoryId=43767&ref=25 Want to keep your medical education program on the straight and narrow? Consider peer review. 2007-10-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/402007/463109null XML http://pharmexec.findpharma.com/pharmexec/Current+Issue/Some-Alzheimers-Patients-Left-Behind/ArticleStandard/Article/detail/463116?contextCategoryId=43767&ref=25 A landmark court case in the United Kingdom has left Alzheimer's patients with mild to moderate disease unable to receive any of the three drugs that might help them—Aricept (donepezil), Reminyl (galantamine), and Exelon (rivastigmine). Eisai and Pfizer, which make and market Aricept, had challenged the ruling made last year by the National Institute for Clinical Excellence that the drugs should be prescribed only to patients in the later stages of the disease. They were granted a judicial review—the first time one of NICE's decisions had been challenged in this way—and while the judge upheld one part of the challenge, the other two parts were dismissed and NICE's guidance stands. 2007-10-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/402007/463116null XML http://pharmexec.findpharma.com/pharmexec/News+Analysis/PDUFA-Passed-with-Refined-DTC-Component/ArticleStandard/Article/detail/460045?contextCategoryId=43767&ref=25 FDA gains power to review ads and levy fines for misleading material 2007-09-26T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/392007/460045null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/New-York-Sues-Merck-Over-False-Advertising-Claims/ArticleStandard/Article/detail/460057?contextCategoryId=43767&ref=25 New York State wants restitution for Vioxx 2007-09-26T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/392007/460057null HTML http://pharmexec.findpharma.com/pharmexec/PharmExec+Direct/House-Passes-Patent-Reform-Legislation/ArticleStandard/Article/detail/458136?contextCategoryId=43767&ref=25 Patent overhaul could cramp pharma industry?s style 2007-09-19T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/382007/458136null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Feds-Preempt-State-in-Pharma-Ad-Fraud-Case/ArticleStandard/Article/detail/456308?contextCategoryId=43767&ref=25 Pharm ads green-lit by FDA can?t be sued for fraud in Delaware 2007-09-12T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/372007/456308null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/Data-Clamp-Down/ArticleStandard/Article/detail/454637?contextCategoryId=43767&ref=25 Data-collection companies sue for freedom to gather information 2007-09-06T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/362007/454637null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/New-Rules-for-Asthma-Med-Makers/ArticleStandard/Article/detail/454640?contextCategoryId=43767&ref=25 NHLBI releases updated regulations for asthma treatment 2007-09-06T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/362007/454640null HTML http://pharmexec.findpharma.com/pharmexec/Articles/The-Complete-Pharm-Exec-Guide-to-PDUFA/ArticleStandard/Article/detail/455800?contextCategoryId=43767&ref=25 The history of prescription drug laws is a complex mix of evolution and politics—in particular, the politics following real or perceived public health crises. The bipartisan PDUFA IV legislation currently pending in Congress is no exception: The bills—the Senate FDA Revitalization Act (S. 1082) and the House FDA Amendments Act (H.R. 2900)—would both continue existing programs and create new regulatory burdens. 2007-09-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/372007/455800null XML http://pharmexec.findpharma.com/pharmexec/Current+Issue/For-Compliances-Sake/ArticleStandard/Article/detail/455796?contextCategoryId=43767&ref=25 Much has been said about the need and imperative for life science companies to comply with the various laws and regulations that govern our industry. More recently, state-level marketing laws have proliferated, adding new rules of the road and resulting in thousands of hours and millions of dollars for training, tracking, reporting, consulting, analysis, and support systems. 2007-09-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/372007/455796null XML http://pharmexec.findpharma.com/pharmexec/Regulatory+News/Feds-to-Eyeball-Distracting-Ads/ArticleStandard/Article/detail/452589?contextCategoryId=43767&ref=25 FDA to conduct market research on fair balance in television ads 2007-08-29T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/352007/452589null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory+News/08222007/ArticleStandard/Article/detail/451057?contextCategoryId=43767&ref=25 Lipitor Rejected for Reissued Patent 2007-08-22T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/342007/451057null HTML http://pharmexec.findpharma.com/pharmexec/News+Analysis/JampJ-Sues-Red-Cross/ArticleStandard/Article/detail/449697?contextCategoryId=43767&ref=25 If that's all you read, you don't know the half of it 2007-08-15T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/332007/449697null HTML http://pharmexec.findpharma.com/pharmexec/Washington+Report/Exclusivity-vs-Patents/ArticleStandard/Article/detail/446934?contextCategoryId=43767&ref=25 Twelve years is probably "the best deal the industry is going to get," comments former FDA official Scott Gottlieb. "This is a genuine compromise." 2007-07-30T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/312007/446934null XML http://pharmexec.findpharma.com/pharmexec/Regulatory+News/Fed-Up/ArticleStandard/Article/detail/441766?contextCategoryId=43767&ref=25 How a $65,000 dinner tab led to new reporting rules for Australian pharma 2007-07-18T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/292007/441766null HTML http://pharmexec.findpharma.com/pharmexec/Thought+Leader/Connected-Markets-Rob-Dhoble/ArticleStandard/Article/detail/442274?contextCategoryId=43767&ref=25 We'll see a more coordinated, worldwide platform not just for marketing, but for R&D and regulatory because of the harmonization that is slowly coming, primarily between Japan, Europe, and the United States 2007-07-03T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/292007/442274null XML http://pharmexec.findpharma.com/pharmexec/Technology/In-Sync-with-California/ArticleStandard/Article/detail/442282?contextCategoryId=43767&ref=25 Although pricey, serialization with RFID is expected to reduce logistical errors and address some aspects of supply chain security 2007-07-03T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/292007/442282/california_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/292007/442282/main_main.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/292007/442282null XML http://pharmexec.findpharma.com/pharmexec/Regulatory/The-View-From-Inside/ArticleStandard/Article/detail/429155?contextCategoryId=43767&ref=25 There's tremendous opportunity for us to understand how drugs can be used even better to get the right outcome, not only how to contain them in order to avoid complications or adverse events 2007-06-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/212007/429155/view_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/212007/429155null XML http://pharmexec.findpharma.com/pharmexec/Regulatory+News/Granite-States-Rx-Info-Law-Bites-Dust/ArticleStandard/Article/detail/425151?contextCategoryId=43767&ref=25 Judge strikes down New Hampshire law restricting sale of prescribing data. 2007-05-09T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/192007/425151null HTML http://pharmexec.findpharma.com/pharmexec/Regulatory/Kid-Tested-Government-Approved/ArticleStandard/Article/detail/423216?contextCategoryId=43767&ref=25 As the industry focuses its attention on the upcoming renewal of the Prescription Drug User Fee Act (PDUFA), there is a tendency to overlook two other significant pharmaceutical programs coming up for renewal and a related piece of legislation that has been introduced: 2007-05-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/182007/423216/kid_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/182007/423216null XML http://pharmexec.findpharma.com/pharmexec/Regulatory+Articles/Critical-Mass-for-Critical-Path/ArticleStandard/Article/detail/423202?contextCategoryId=43767&ref=25 Innovation in science is no quick trick, and neither is collaboration. Back in March 2004, FDA sounded a now-famous alarm: Despite the drug industry's 250 percent jump in spending on R&D, drug-development productivity had plunged by 50 percent over the previous decade. The report, which became known as the Critical Path Initiative (CPI), last year yielded an industry-wide call to arms regarding 76 action items (aka, the "Opportunities List") in six key areas: biomarker development, the streamlining of trials, the harnessing of informatics, improving drug manufacturing, public health initiatives against infections and bioterrorism, and special programs for adolescents, children, and other at-risk populations. 2007-05-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/182007/423202/critical_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/182007/423202null XML http://pharmexec.findpharma.com/pharmexec/Regulatory+News/Full-Court-Press-on-Medicare-Pricing-Bill/ArticleStandard/Article/detail/417749?contextCategoryId=43767&ref=25 Advocacy efforts rev up to fight or defend government negotiating power. 2007-04-11T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/152007/417749null HTML http://pharmexec.findpharma.com/pharmexec/Sales/Get-a-Grip-on-the-Supply-Chain/ArticleStandard/Article/detail/418779?contextCategoryId=43767&ref=25 The Sarbanes-Oxley Act—or SOX, as it is dubbed (not always so affectionately)—requires companies to provide greater control and quality assurance across a vast spectrum of business processes. In practice, SOX plays out differently industry by industry and even company by company. But for pharma, one of the most pressing consequences is the need to improve the accuracy of revenue recognition. 2007-04-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/152007/418779/getagrip_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/152007/418779null XML http://pharmexec.findpharma.com/pharmexec/Washington+Report/Washington-Report-Bundled-Together/ArticleStandard/Article/detail/401661?contextCategoryId=43767&ref=25 Democrats want more transparency from pharma, and Republicans also are making noise about pricing. But government drug reimbursement is hard to get right and often creates perverse patient care incentives. 2007-02-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/052007/401661null XML http://pharmexec.findpharma.com/pharmexec/Global+Report/Global-Report-Under-One-Roof/ArticleStandard/Article/detail/401663?contextCategoryId=43767&ref=25 The UK's 'unsystematic' healthcare structure is getting a makeover. It includes a new single body to oversee drug development, and potential incentives for pharma—if it plays nice. 2007-02-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/052007/401663null XML http://pharmexec.findpharma.com/pharmexec/Global+Report/Global-Report-No-Satisfaction/ArticleStandard/Article/detail/395592?contextCategoryId=43767&ref=25 In Germany, the eight million richest citizens contribute nothing to the system that pays for the remaining 70 million insured people. 2007-01-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/012007/395592null XML http://pharmexec.findpharma.com/pharmexec/Articles/Back-Page-Of-Movies-and-Drugs/ArticleStandard/Article/detail/395601?contextCategoryId=43767&ref=25 A free flow of cheap counterfeits eclipses the ability of local manufacturers to create new products. 2007-01-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/012007/395601null XML http://pharmexec.findpharma.com/pharmexec/Thought+Leader/Thoughtleader-Peter-Pitts-DrugWonkscom/ArticleStandard/Article/detail/395590?contextCategoryId=43767&ref=25 There are lots of politicians, Senators Grassley and Waxman to name just two, who often say FDA is in the pharmaceutical industry's pocket. But anybody that has ever worked with FDA realizes not only is that not right, it's comically wrong. 2007-01-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/012007/395590null XML http://pharmexec.findpharma.com/pharmexec/From+the+Editor/From-the-Editor-Left-Out/ArticleStandard/Article/detail/395589?contextCategoryId=43767&ref=25 A new GAO report sets out to explain why drug development is so expensive and what to do about it. What the report says is important, but what it leaves out is a sense of how the world of pharma actually works. 2007-01-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/012007/395589/TN_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/012007/395589null XML http://pharmexec.findpharma.com/pharmexec/Global+Report/Global-Report-Not-So-NICE/ArticleStandard/Article/detail/389282?contextCategoryId=43767&ref=25 Even when NICE has said that drugs should be available to anyone who needs them, patients still have to convince their Primary Care Trusts. 2006-12-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/482006/389282null XML http://pharmexec.findpharma.com/pharmexec/Articles/FDA-vs-the-Individual/ArticleStandard/Article/detail/389277?contextCategoryId=43767&ref=25 Who should make decisions about drug safety—FDA or patients and doctors? In this excerpt from his important new book Overdose, the renowned (and ever controversial) legal scholar Richard A. Epstein argues that the current system overvalues risk, ignores individual differences, and needlessly deprives patients of valuable treatments. 2006-12-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/482006/389277/TN_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/482006/389277null XML http://pharmexec.findpharma.com/pharmexec/From+the+Editor/From-the-Editor-Taken-Away/ArticleStandard/Article/detail/389271?contextCategoryId=43767&ref=25 To one major legal scholar, drug safety regulation isn't just about meeting standards, it's about what you take away from one group of patients in order to benefit the rest. 2006-12-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/482006/389271/TN_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/482006/389271null XML http://pharmexec.findpharma.com/pharmexec/Legal/Legal-E-headache/ArticleStandard/Article/detail/389281?contextCategoryId=43767&ref=25 Documents from R&D, clinical affairs, regulatory, and sales and marketing can be in the millions. Throw electronic information into the mix, and the number of documents required for litigation increases exponentially. 2006-12-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/482006/389281null XML http://pharmexec.findpharma.com/pharmexec/Articles/Confessions-of-a-Serial-Whistleblower/ArticleStandard/Article/detail/389276?contextCategoryId=43767&ref=25 Peter Rost, former Pfizer executive turned whistleblower, isn't just at war with his old employer. He's crusading against all of pharma, an industry he likens to the mob. 2006-12-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/482006/389276/TN_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/482006/389276null XML http://pharmexec.findpharma.com/pharmexec/Articles/Roundtable-Deficit-Reduction-Act/ArticleStandard/Article/detail/382538?contextCategoryId=43767&ref=25 The Deficit Reduction Act was designed to save the government money on Medicaid. But it also has the potential to change the very way pharma companies conduct business—if they can just figure it out. 2006-11-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/442006/382538/TN_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/442006/382538/main_main.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/442006/382538null XML http://pharmexec.findpharma.com/pharmexec/Global+Report/Global-Report-Bout-Time/ArticleStandard/Article/detail/382535?contextCategoryId=43767&ref=25 Pfizer says it is trying to stamp out counterfeiting by consolidating under one drug distributor. Critics think otherwise. 2006-11-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/442006/382535null XML http://pharmexec.findpharma.com/pharmexec/Legal/Legal-Keyword-Infringement/ArticleStandard/Article/detail/382533?contextCategoryId=43767&ref=25 When one company purchases another's branded trademarks as keyword search terms, the goal is to lure consumers to the buyer's site. 2006-11-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/442006/382533null XML http://pharmexec.findpharma.com/pharmexec/Washington+Report/Washington-Report-Waiting-for-Advice/ArticleStandard/Article/detail/382534?contextCategoryId=43767&ref=25 Long turnaround on ad reviews adds new complications to the process of developing marketing plans. 2006-11-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/442006/382534null XML http://pharmexec.findpharma.com/pharmexec/From+the+Editor/From-the-Editor-Under-Revision/ArticleStandard/Article/detail/382530?contextCategoryId=43767&ref=25 The US Department of Justice thinks that "Average Wholesale Price" should mean just what the words say—no more, no less. Why? It's never meant that before. 2006-11-01T05:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/442006/382530/TN_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/442006/382530null XML http://pharmexec.findpharma.com/pharmexec/Legal/Legal-Going-to-Court/ArticleStandard/Article/detail/378058?contextCategoryId=43767&ref=25 In cases that reached a verdict between 2002 and 2006, the branded pharma industry won six of six cases by verdict in Delaware, but lost six of eight in New Jersey, all by summary judgement. Despite what judges say, it's no coincidence. 2006-10-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/412006/378058null XML http://pharmexec.findpharma.com/pharmexec/Articles/A-Survey-of-Medical-Science-Liaisons/ArticleStandard/Article/detail/378063?contextCategoryId=43767&ref=25 MSLs tend to stay put. Just three in 10 left a job after less than a year. Half held their current position for more than three years. 2006-10-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/412006/378063null XML http://pharmexec.findpharma.com/pharmexec/Articles/Pharm-Exec-QampA-Inside-View/ArticleStandard/Article/detail/378066?contextCategoryId=43767&ref=25 Scientists are worried about what they can and cannot say. Senior scientists feel that if they voice the disagreements that are important to scientific discussion, they might have to leave FDA. 2006-10-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/412006/378066null XML http://pharmexec.findpharma.com/pharmexec/Legal/Legal-Authorized-Generics-Still-Legalmdashand-Hold/ArticleStandard/Article/detail/369267?contextCategoryId=43767&ref=25 Indeed, at this time, we are aware of no evidence that the practice of authorized generics has actually deterred any Paragraph IV certification or post-180 day generic entry, let alone a challenge to an invalid patent. 2006-09-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/362006/369267null XML http://pharmexec.findpharma.com/pharmexec/Global+Report/Global-Report-Break-with-Tradition/ArticleStandard/Article/detail/369269?contextCategoryId=43767&ref=25 Public revulsion at animal-rights extremists is damaging their cause. The majority of people deem the worst offenders to be terrorists. 2006-09-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/362006/369269null XML http://pharmexec.findpharma.com/pharmexec/Articles/Freedom-of-Information/ArticleStandard/Article/detail/369271?contextCategoryId=43767&ref=25 The suit draws a comparison to the newspaper industry: Even though papers profit from disseminating information, the information in question isn't commercial. 2006-09-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/362006/369271null XML http://pharmexec.findpharma.com/pharmexec/From+the+Editor/From-the-Editor-Undecided/ArticleStandard/Article/detail/369264?contextCategoryId=43767&ref=25 The world according to New Hampshire: Doctors prescribe expensive drugs because pharma reps sell them. Interfere with the selling, and you'll cut down on the prescribing. It's a plan. But for what? 2006-09-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/362006/369264/TN_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/362006/369264null XML http://pharmexec.findpharma.com/pharmexec/Articles/Pharm-Exec-QampA-A-Soft-Spot-for-Whistleblowers/ArticleStandard/Article/detail/369274?contextCategoryId=43767&ref=25 If I ran the FDA, I'd have a Rose Garden ceremony for all the histleblowers in my agency. No one can know where all the skeletons are buried. We ought to honor every one of those patriots. 2006-09-01T04:00:00Z http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/362006/369274/TN_thumbnail.jpg http://pharmexec.findpharma.com/pharmexec/data/articlestandard/pharmexec/362006/369274null XML