I have had the chance to read both Kenzi 2.0 and the FDA's response to the scientifically illiterate IOM report. It reads like a Nobel Prize winner grading a high school essay....
http://www.fda.gov/oc/reports/iom013007.pdf
Kenzi 2.0 is an improvement, but not by much. It would be a better product if it was rewritten to fund and support Critical Path and what the FDA suggests in its IOM response.
It does less harm than 2.0 but it a lot of it has to do with wiggle words that contradict each other. For instance, claiming that Risk Aversion Managment Systems should not place a burden on patient's getting new meds and then on the next page goes on to detail how companies should set up a system to restrict access that includes " health providers, pharmacists, patients, and other parties in the health care system who are responsible for implementing the restriction as well as those responsible for stopping the distribution of the drug..."
And by the way folks, Risk Aversion also applies to every new indication and supplemental approval. What if a doctor want's to use a drug in an off-label way based on his or her clinical judgement to help a dying or sick patient. Is that doctor a criminal under Kenzi? Is the company now responsible for any off-label use. Is this tort situation? Will purchase of this drug for off-label use be racketeering...?
As the ban of exchange of information about new drugs. Drugwonks wants to know if that extends to the internet. Does it mean that doctors who prescribe off-label outside the daisy-chain also violates the ban on commercial speech.
The Critical Path Institute proposal is still the strongest component. But it has weakened by the recommendation that it be kept within or the near the Beltway. The closer it is to DC the sooner it will become a captive of the political establishment.
It would be better to a non-profit organization that is already doing critical path work set up the Institute (I think that was in the original bill) like the C-Path Institute.
The 'limitation' on conflict of interests in advisory committees is guaranteed to attract more people who have other conflicts, interests and prejudices, particularly those that go largely unreported. Those include, prejudice about research methods, views about drug companies, the desire to conduct research and serve on boards for tenure or job advancement or to promote one own's agenda (Curt Furberg comes to mind). Since knowledge is power in academia, it is likely that investigators who come to the fore will use their position on advcomms to suppress or undermine results or views that refute findings or opinions they have. Thus, whatever credibility expert opinion has will become even less reliable.
Finally, Kenzi requires user fees to go to Risk Aversion. Another source of funding for critical path gone. And there is no sign of increasing funding for Critical Path or FDA to take on these new product life cycle responsibilities.
Finally, I still don't believe that we have a big crisis in drug safety.
We have a confidence problem that could be handled if companies took some steps I will describe in my next post. But with respect to the public health, the real crisis is that we have too few new medicines and too many sick people.
http://www.fda.gov/oc/reports/iom013007.pdf
Kenzi 2.0 is an improvement, but not by much. It would be a better product if it was rewritten to fund and support Critical Path and what the FDA suggests in its IOM response.
It does less harm than 2.0 but it a lot of it has to do with wiggle words that contradict each other. For instance, claiming that Risk Aversion Managment Systems should not place a burden on patient's getting new meds and then on the next page goes on to detail how companies should set up a system to restrict access that includes " health providers, pharmacists, patients, and other parties in the health care system who are responsible for implementing the restriction as well as those responsible for stopping the distribution of the drug..."
And by the way folks, Risk Aversion also applies to every new indication and supplemental approval. What if a doctor want's to use a drug in an off-label way based on his or her clinical judgement to help a dying or sick patient. Is that doctor a criminal under Kenzi? Is the company now responsible for any off-label use. Is this tort situation? Will purchase of this drug for off-label use be racketeering...?
As the ban of exchange of information about new drugs. Drugwonks wants to know if that extends to the internet. Does it mean that doctors who prescribe off-label outside the daisy-chain also violates the ban on commercial speech.
The Critical Path Institute proposal is still the strongest component. But it has weakened by the recommendation that it be kept within or the near the Beltway. The closer it is to DC the sooner it will become a captive of the political establishment.
It would be better to a non-profit organization that is already doing critical path work set up the Institute (I think that was in the original bill) like the C-Path Institute.
The 'limitation' on conflict of interests in advisory committees is guaranteed to attract more people who have other conflicts, interests and prejudices, particularly those that go largely unreported. Those include, prejudice about research methods, views about drug companies, the desire to conduct research and serve on boards for tenure or job advancement or to promote one own's agenda (Curt Furberg comes to mind). Since knowledge is power in academia, it is likely that investigators who come to the fore will use their position on advcomms to suppress or undermine results or views that refute findings or opinions they have. Thus, whatever credibility expert opinion has will become even less reliable.
Finally, Kenzi requires user fees to go to Risk Aversion. Another source of funding for critical path gone. And there is no sign of increasing funding for Critical Path or FDA to take on these new product life cycle responsibilities.
Finally, I still don't believe that we have a big crisis in drug safety.
We have a confidence problem that could be handled if companies took some steps I will describe in my next post. But with respect to the public health, the real crisis is that we have too few new medicines and too many sick people.
