Is a 21 on the act good trial#
A third of new drugs are currently approved on the basis of a single pivotal trial the median size for all pivotal trials is just 760 patients. These changes would be welcome.īut Avorn and Kesselheim feel that the Act goes too far in pushing the FDA to speed the drug approval process:Īn underlying premise of the bill is the need to accelerate approval for new products, but this process is already quite efficient. The bill also dictates that the FDA consider non-traditional clinical trial study designs to speed the approval of new drugs. It also calls for the creation of an “Innovation Fund” for the NIH to the tune of $2 billion per year for 5 years to stimulate further growth. For one thing, it provides for an annual 3% increases in the NIH budget, which has been stagnant for the past few years and which desperately needs more funding to capitalize on emerging scientific insights. The purpose of this Act, recently introduced into Congress, is to promote the development and hasten the approval of new drugs and devices. Aaron Kesselheim in the New England Journal of Medicine entitled “ The 21st Century Cures Act – Will It Take Us Back In Time?” raises a number of valid concerns.
However, the recent perspective that he co-authored with Harvard colleague Dr. For example, we are on opposite sides of the spectrum when it comes to the importance of the interaction of physicians with drug representatives as well as on the pricing of new medicines. Jerry Avorn on healthcare issues, particularly when it comes to his views on the pharmaceutical industry. Ordinarily, I differ with Harvard Medical School’s Dr.
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