The Personalized Medicine Coalition has defended recent actions taken by the US Food and Drug Administration to shorten the regulatory review process for personalized therapeutics.
This comes in response to an editorial that appeared in the New York Times last weekend that criticized the FDA, which has been working to speed its review of drugs and medical devices. It has allowed smaller and fewer clinical trials and the use of surrogate endpoints, particularly for personalized medicines, the Times notes. In its editorial, the Times argued while the agency's approach "seems practical," it could "do more harm than good."
PMC defends FDA's regulatory changes and says the rationale behind them is that personalized therapies rely on diagnostic tests to uncover patients who are the most likely to benefit from them. "By putting in place smarter policies to encourage the efficient development of personalized drugs whose safety and efficacy profiles are often higher than one-size-fits-all, trial-and-error treatments, FDA serves the interests not only of patients, but also the health system," PMC President Edward Abrahams says.
The Times also argued that patients are being sold on a promise of personalized medicine that may not match reality, as it may only help a small portion of patients and come with a high price tag. Only about 10 percent of respondents to a recent joint GenomeWeb/PMC survey said their doctors had ever mentioned or recommended a genetic test to diagnose a disease or guide treatment. Additionally, most respondents said they'd be unwilling to pay more than $100 out-of-pocket for whole-genome sequencing, a key step for personalizing treatment.