Re:”” June 14 Perspective essay.
The 21st Century Cures proposal does something that is sorely needed. In bipartisan fashion, it boldly exclaims there is a problem with the Food and Drug Administration, an institution whose mandate is to “to promote health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely fashion.” (The emphasis is mine.)
The FDA has a daunting mandate, and equally broad authority to fulfill its duties. So why was 21st Century Cures even needed when the FDA is repeatedly instructed to exercise its mandate, for example, with every re-authorization of the Prescription Drug User Fee Act?
Clearly, the FDA is not listening.
Why would the agency need to be told to do better with respect to its compassionate-use program, which allows for experimental drugs to be made available to terminal stage patients when Right to Try Laws have now been passed in 20 states, including Colorado, and there has been intense discussion of the issue with the FDA? FDA approval times are over the statute-defined period of 10 months for half of all new drug applications, and patients have mobilized and are being heard — by the states, but not by the FDA.
Why would the FDA need to be told to issue new guidance documents for the use of development tools like biomarkers and surrogate endpoints, which can speed the development and approval of potentially life-saving drugs, when the FDA has issued three guidance documents over the past two years on the use of biomarkers?
Why give the FDA another $550 million for 21st Century Cures to do that which it has been instructed to do on numerous other occasions even after it repeatedly flouts congressional authority?
Congress keeps throwing money at the problem rather than fixing the FDA. Particularly bothersome is that even more money is on the way in 2017 with PDUFA re-authorization. The FDA continually cites underfunding as the reason approval times are in violation of the law — and Congress keeps falling for it.
Joseph Gulfo is executive dir- ector of the Rothman Institute of Innovation and Entrepre- neurship at Fairleigh Dickinson University.
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