Last week, departing EMA chief Thomas Lonngren took the opportunity to question Big Pharma's R&D spending - saying, in effect, that $60 B of $85 B spent annually was being wasted. He reasoned that only 7-9 drugs were making it to market that were worth maybe $20 B and where did the rest of the $85 B in value go? He also took Big Pharma to task in relation to which therapeutic areas it chose to pursue - sopecifically he criticized cutbacks in CNS therapies and in antibiotic research. He finished his mini-rant with conviction that drug regulators around the world would unite to cooperate more in the coming years, saying "The evolutionary momentum of this is unstoppable." See Fierce Biotech report.
Yesterday, I read this article in the WSJ regarding Big Pharma's (and its investors) fears of how regulatory scrutiny is rising in unpredictable ways -- from Big Pharma's viewpoint. The poster child in this particular case was AstraZeneca's Brilinta receiving a delay in regulatory approval from the FDA - despite having already been approved by EMA earlier this month. AstraZeneca feels it can negotiate the regulatory hurdle but at what cost? Investors reacted by causing a significant drop in AZ's share price - reflecting a possible worst case scenario that the drug will never be approved in the US. Are drug developers and regulators working at odds here?
The fact is that success rates for new chemical compounds have fallen from about 12% a decade ago to less than 8% today and the trend is still going down. Clinical trials must be up to twice as large and costs of development are rising. Is this anyway to run an industry? It is high time that both developers and regulators work on changing the model to better optimize use of precious R&D and regulatory resources to get more successful launches of needed drugs to the market. This would seem to be more productive than hand wringing by either side.
Posted by Bruce Lehr December 21st 2010.
Here's a related article from Fierce Biotech on perceived increasing safety regulation at the FDA
http://www.fiercebiotech.com/story/2010-fda-gets-tougher-safety/2010-12-23?utm_medium=rss&utm_source=rss
Posted by: bigredbruce | 12/30/2010 at 10:57 AM