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01-04-2009, 11:21 AM
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In Remembrance
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from Carolyn: Eye on FDA Welcome 2009 - What's in Store for the Pharmaceutical Industry in the New Year Posted: 31 Dec 2008 05:37 AM PST ......... In our little world of the pharmaceutical market, the world has been rather quiet, relatively speaking, and perhaps little has changed to the naked eye. For example, the number of new NMEs approved by the FDA is about the same as it was last year. There were no game-changing breakthroughs in new treatments. ..... But scratch the surface, and one can see immense possibilities for change. It is the events of the bigger world that stand to shape the future of the pharmaceutical market. There are four key changes that occurred during 2008 that stand to have profound impact on shaping the pharmaceutical market of 2009: 1.Public Policy. The overwhelming majority in Congress of the Democratic party substantially increases the ability and likelihood of success of those long-poised to initiate some sweeping reforms. Those market reform proposals are going to be aimed at Direct-to-Consumer advertising and are likely to include moratoria that will be in the form of years, not months ....- the game has changed........more ................. Importation will be passed and signed into law, as will the ability of the government to negotiate pricing under Medicare Part D. Other DTC marketing reforms will be aimed at the relationships companies have with physician organizations, payments, gifts and practices of expensive staffs of pharmaceutical sales representatives. These will be at the national and state levels. But it is important to note that the momentum is with change, not the status quo. ...more 2.Money. The meltdown of the financial markets has set the stage for remarkable change in virtually every aspect of American life - including spending money on drug treatments............. One effect is that employers will continue to shift the burden of cost of virtually everything to the employee - from ceasing contributions to 401(k)s to increasing the employee's share of cost for healthcare, including prescriptions while the employee's income is flat or worse. ....more 3.Communications. ...... There are two things of note in the newspaper industry - virtually every major newspaper has moved to blogs and even Twitter and nearly all newspapers have suffered crippling losses this year with some even cutting back daily publication. Digital communications is the place where people turn for information generally and for healthcare information specifically. People with chronic illnesses in particular are inclined to get information on treatment options from the Internet. Physician on-line communities have sprung up on WebMD and Sermo that include tens of thousands of docs. This demands of companies more than a Web site - it demands an integrated digital marketing strategy that takes into account all of the change that is occurring and moves to compensate. If you can't reach physicians through sponsored CME programs, reach them on-line.....more 4.Risk. The environment continues, as it has since 2002, to be focused on risk over benefit. That is not going to change anytime soon. In fact, risk will continue to be a driver of reform as well as pricing issues. Congress is going to demand that companies be more proactive in getting adverse event information and new products have to offer very specific benefits when compared to existing treatments. ...more http://www.eyeonfda.com/eye_on_fda/
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paula "Time is not neutral for those who have pd or for those who will get it." |
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Eye on FDA in 2009
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