Amid the hoopla over President Obama's $215 million precision medicine plan, how will new drugs and diagnostics resulting from the initiative be regulated? That's the question Henry Miller poses in Forbes.
The initiative, announced last month, plans to leverage genomics, bioinformatics, and healthcare technology to improve medical outcomes, but missing is how to carry out the initiative from a regulatory standpoint, according to Miller, currently a scholar at the Hoover Institution, and formerly a drug regulator at the US Food and Drug Administration, according to his Forbes biography.
Specifically, Miller says "the risk-averse posture and policies of his administration's FDA create significant obstacles to the ultimate success of personalized medicine." While improving treatment efficacy may be great for patients, doctors, and insurers, "the long-term benefits to drug companies are less certain," he says.
Already, the average cost of bringing a new drug to market is $2.6 billion, and currently only one in five approved drugs recoups its development costs, he argues. In a personalized medicine approach to healthcare, the number of patients who may benefit from a drug in development could be dramatically reduced, translating to lower revenue potential. As a result, there may not be an incentive for a drug maker to pursue such a drug as the return on investment could be too unattractive.
Miller suggests that for personalized medicine to really take off, coordination between drug and diagnostic device regulators will need to improve. Additionally, he says there needs to be increased accelerated approvals of new drugs that target especially life-threatening diseases with an unmet need.
On the latter point, he notes that more accelerated approvals could reduce the number of Phase III clinical trials as well as the size of such trials, which he says are "the most costly and time-consuming stage of drug development."
Miller adds that "[b]ecause the dual burdens of large, expensive clinical trials and diminished revenue potential could become unsustainable in the long term, the attitude of regulators will be critical to the success of personalized medicine."