Fda and Entremed

THE FOOD AND DRUG ADMINISTRATION: A SAVIOR OR A STONEWALL?

I. INTRODUCTION

The Food, Drug and Cosmetic Act’s provisions regulating the approval of new drugs is the most ineffective and onerous statutory framework for the approval of medicine in the entire world and renders the United States uncompetitive as a market for innovative treatments while ultimately inhibiting patients with the most deadly cancers access to treatments that could extend their lives. While attempting to include provisions for the fast approval of medicine designed and proven effective against life-threatening diseases, the Food and Drug Administration (FDA) completely fails to expedite the availability of innovative treatments to patients who need them most. While the FDA responds to the complete lack of efficiency with safety justifications, many patients die before ever being able to take medicine that could very well extend their lives simply because the treatment has not been approved by the FDA.

Nothing the FDA does with respect to treatment for patients with the most deadly cancers protects lives. In fact, it is only the FDA standing in the way of extended life for many of these patients. This atrocity is shown by Entremed, Inc. and their novel agent ENMD-2076, an orally active kinase inhibitor showing promising results in many of the most difficult and deadly cancers, but is yet to receive approval for treatment in the United States. While hundreds of thousands of patients die before ever being allowed access to ENMD-2076, the FDA claims to be protecting lives. By stopping treatment from reaching cancer patients with deadly and difficult to treat cancers, the FDA allows more deaths to occur than it could have ever saved with the current statutory blunder under the auspices of perceived safety. This paper will outline the current new drug application regulations including fast track procedures for so-called breakthrough therapies, include a comparison to the Chinese drug...