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Turn up the volume Each month, our team looks forward to what’s inside the next issue of PharmaVoice. It’s fresh, uncanny in its timeliness, and always relevant. (Like us.) Evenhanded panels of industry experts help us weigh the issues that are going to matter, and the statistics are so fresh that we can actually use them. Because you’ve successfully created a forum for constructive conversation, we need to tell you that something is missing. As the leading developer of branded Patient Experience programs, it’s our mission to give voice to millions of patientconsumers regard ing their medication use. By documenting and reporting on patients’ experiences with medications, we routinely see a powerful impact on physicians’ prescribing decisions and pharma ceutical marketing strategy. The patient expe rience — what’s happening with medications in the real world — is what’s missing. What more powerful voice is there to differentiate a brand in the marketplace. And what more credible voice is there to speak to physicians and regulatory bodies. The patient perspective must become part of the collective “pharma voice” if that voice is going to drive progress, and we challenge the magazine to turn up the volume on the way the patient is experiencing it all. Gina Ashe VP, MARKETING INFOMEDICS INC. The Value of Innovation I thoroughly enjoyed your article in the September issue of PharmaVoice, “The Value of Innovation.” It is a shame that our politicians are gaining votes by misinforming the public of the costs associated with prescription drugs. Although we certainly need to keep our per spective on the harm caused by allowing drugs onto the market that have been recalled, we also need to realize the incredible benefits to society from the innovation of NCEs. Joel R. Lirot DIRECTOR, BUSINESS DEVELOPMENT IRIX PHARMA SERVICES LLC Association disconnection I just read your wonderful article, Industry Heal Thyself. At about the same time I had just finished a conversation with some associa tion executives who read it too. Their thoughts were “what a waste of selfpromot ing energy these guidelines are.” I was happy to see a perspective from the medical commu nity as it was the only area that took into con sideration what they had to say. It was interest ing to find out that not one of the executives even mentioned this community outside of how easy it was to buy their opinion. There was a major disconnect between the two players. I got the feeling, however, that it’s not the physician (their target audience) that the pharmaceutical company is trying to protect, but themselves. They have leveled the playing field, which is good. As one physi cian put it “the race is on as to how many PDRs and books I now start to receive” and “now pharmaceutical review teams will be determining what we deem medically relevant.” Gene Casalvo EXECUTIVE VP, DIRECTOR, MEDICAL EDUCATION MARKETING WISHBONE I was happy to see a perspective from the medical community as it was the only area that took into consideration what the guidelines had to say. — Gene Casalvo WISHBONE INFORMATION STANDARDS, MORE FDA REGULATIONS The FDA’s regulation of information about offlabel uses, its blanket prohibition against the dissemination of educa tional material by drug makers, and its standards for the release of information about drug approvals may be illegal, according to the PhRMA.Commenting on the FDA’s regulation of speech, PhRMA said there should be no uniform prohibition against the dissem ination of information about offlabel uses found in medical or reference texts. The FDA also should consider relaxing its standards for press releases about drug approvals, which currently are almost always considered a promotion. The FDA issued the call for public comment May 16 after the Supreme Court said FDA restrictions on advertising of compounded drugs violated the First Amendment in Thompson v. Western States Medical Center. PharmaVOICE wants to know if the FDA standards should be relaxed in terms of offlabel promotion? WHAT’SYOUR OPINION? Please email your comments to firstname.lastname@example.org. What’s Your Opinion? LETTERS The community speaks out PharmaVOICE