Pharmaceutical Executive Digest Europe - January 21, 2009 - (Page 9) IT Matters Second, we should evaluate how Obama is likely to behave: • He is moderate: Although he won the election as a populist who supports the powerless, he is not really a liberal or a leftist. His academic and thoughtful approach to issues indicates that he will act in moderation. • He is realistic: The current economic mess should lead him to conclude that doing anything that would weaken any industry that is still doing well (e.g. biopharm) needs to be protected rather than chastised. • He is pragmatic: His appointments to date (although not yet at the FDA) show that inexperienced and/or idealistic people may be right but are not the ones needed to get the job done. Washington is a tough place to do business and insiders are the ones that can make things happen. • He knows how to lead: Given a difficult set of issues, he knows that it would be impossible to micro-manage anything. He has said that it’s his job to set goals and priorities and for others to do the heavy lifting. This is a key reason why something will happen on the healthcare IT front. Third, we must rank the issues where IT is a significant part of the solution: 1. Covering the uninsured: Without question, this is the number one healthcare issue in the US. To make it a reality, it will be necessary to reduce the cost of almost every other part of healthcare which now consumes 16% of GDP. The mantra of “doing more with less” is very much in evidence here and it can’t get done without a healthy dose of information technology. Electronic health records (EHR) will only be one of many solutions needed to improve both the medical and administrative parts of healthcare. 2. Managing patient data: EHR is widely perceived to be a requirement for reducing the cost of healthcare while improving patient care. After years of experimentation there is still no consensus on how the USA can get this right. Indeed, it is certain that in a free-market economy (see above) there won’t be a single solution. The implementation problems experienced in the UK will pale in comparison. Yet, it will happen because the desire, if not the means, is there. 3. Electronic prescribing: It is hard to imagine why the majority of prescriptions are still scribbled on pieces of paper by physicians. Determination on Obama’s part, backed by popular support, may finally force doctors to get on board. Expect this initiative to ride in on the coat tails of EHR. jerk reaction points to the inability of the FDA to come up with realistic strategies and plans or understand how IT can best be leveraged to enable the solution. Fourth, consider the FDA mystery. The words “much aligned” is now a recurring phrase in news reports about the FDA. One could argue, for example, that the FDA is not “in bed” with the biopharmaceutical industry that it supposedly regulates. It could also be argued that inspecting every raw material manufacturer or finding every shipment of counterfeit drugs are impossible tasks. History, however, has shown that the FDA is barely getting the job done. Its leaders, with the possible exception of Mark McClellan, had trouble aligning their political mandates with the public good. Its use of user fees to beef up its staff and systems looked promising at the start but ultimately proved disappointing. Those paying the fees are not getting the service levels they were expecting while critics use the fees as yet another example of the ‘incestuous’ relationship between the agency and the drug sellers. Without proper leadership, the worker bees do their best to get Obama is moderate: Although he won the election as a populist, he is not really a liberal or a leftist. His academic and thoughtful approach to issues indicates that he will act in moderation. 4. Curbing counterfeit and adulterated drugs: Widely reported deaths and injury caused by counterfeit and adulterated drugs have put tremendous pressure on the FDA to solve this problem. Bending to political pressure, the FDA’s response has been to step up inspections of foreign raw material manufacturers and ask for more money to hire more staff and improve its IT infrastructure (e.g. build a better database of foreign manufacturers). Such a knee- 11 BioFutures Forging a true industry– academia partnership 13 CALENDAR Next month’s pharma events 3 NEWS Pharma’s next ten years 4 FROM THE EDITOR Obama and Pharma!
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