Posts Tagged ‘FDA’

Power vs priorities in global pharma

Thursday, November 10th, 2011

Recent IMS data show that emerging markets are expected to see the quickest growth within the pharmaceutical market over the next five years. The increase, which is estimated to show a rise from 18% in 2010 to 28% by 2015, is likely to be driven by greater access to prescription medicines through reforms, blockbuster patent expiries and economic growth in countries such as Brazil, China and Russia. In contrast, European and US spending on pharmaceutical products is set to decline during the same period from 24 per cent to 19 per cent and from 36 per cent to 31 per cent respectively. So, how are the more established markets responding to this impending and seemingly inevitable shift in power?

In the US last week, the FDA announced that it had approved 35 new drugs during the 2011 financial year, which ended on 30 September. The announcement also highlights that the US was the first country to approve 24 of the 35 new drugs and that for all but one of these, an approval decision was issued within the timeframe agreed with the pharmaceutical manufacturer. Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, has suggested that the approvals reflect the agency’s flexibility in working with stakeholders and the introduction of the Prescription Drug User Fee Act (PDUFA). Whatever the reason, the upturn is good news for the industry, which has failed to produce many new drugs in recent years despite increases in research spending. However, whether this constitutes a blip or a real turning point obviously remains to be seen.

Across the pond this week, results from the annual Life Sciences Leaders’ Survey show that the industry is concerned about the UK’s position as a centre for global research and development. Since last year’s survey was conducted, the general consensus is that UK competitiveness has deteriorated and the Government could be doing more to help life sciences flourish with key issues cited including the cost of doing business in the UK, NHS reorganisation, future medicines’ pricing systems and the regulatory burden in Europe, as well as the UK. The findings have prompted Stephen Whitehead, chief executive of the ABPI, to say that: “More needs to be done to support pharmaceutical companies and the NHS in creating an environment where innovation thrives…” and “…unnecessary bureaucracy needs to be eliminated so that new treatments can reach patients as quickly as possible.” Significantly, at least half of those surveyed that answered the question on value-based pricing (the system of setting drug prices according to the value medicines provide) said they believed it would reduce market access and lead to the UK falling behind as an early launch market.

Similarly, while a recent report commissioned by the Department of Business, Innovation and Skills has revealed that health and medical sciences are two areas of research where the UK excels (based largely on the number of times the country’s researchers have their work cited in academic journals), it has also highlighted that the UK’s ability to sustain its leadership position is far from inevitable. Those working within the pharmaceutical industry feel that if the UK is to remain at the forefront, investment must continue to be encouraged. In response to this, the ABPI and the NHS are currently collaborating on a new policy paper on innovation and research, which is anticipated before Christmas.

Evidently, interested parties on both sides of the Atlantic are well aware of the predicament they face and have taken steps to try to address this, albeit in differing directions. While it might not be possible to turn back the tide, there is the potential to at least stem it. In the meantime, healthcare communications will need to continue to monitor the evolving situation and adapt its approach accordingly. In the very least, it seems likely that the same or more will be expected for less and ever smarter ways of working will need to be identified, combined with a healthy dose of realism! Despite these challenges, we remain adamant that patient interests should be considered first and foremost, wherever they live!

Pharma online: Are we wanted?

Friday, November 20th, 2009

Providing valuable, reliable online communications should be seen as one way to improve the reputation of and build trust in big pharma. Movements in the US offer some useful learnings for us, not least the stats quoted in Jon Richman’s FDA hearings presentation. Apparently, the survey by the ‘health activists’ at wegohealth showed 62% of people thought pharma “adds valuable professional expertise to the conversation” and 73% of people thought pharma “brings accurate information into conversations about drugs or devices”. Under the right circumstances, could pharma online be similarly welcomed in the UK?

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FDA hearings highlight need for improved EU social media regulation

Friday, November 13th, 2009

Over the pond, the FDA has just proposed the introduction of a safety logo on drug information pages validated by the agency. The move comes after recognising that although nearly two thirds (61%) of US adults look for medicines information online, a worrying amount of the drug information is unreliable and untruthful. While this does not affect us in Europe directly, the knock-on effect is already starting some very interesting discussions, not least within the EFPIA itself.

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Tweeting medics in trouble: But where is policy for online conduct?

Monday, September 28th, 2009

Lack of clear guidance on how professionals should conduct themselves on social networking sites has caused big problems for a lot of people, with the latest being US doctors. Research in the Journal of the American Medical Association published last week found one in ten reports of unprofessional content posted by student doctors contained violations of patient confidentiality. Many examples contained enough clinical detail that patients could potentially be identified. The problem is, few medical schools have policies on social networking. While this is no excuse, it only serves to show how important it is to be clear about what can and cannot be discussed online – otherwise this sort of thing is inevitable.

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