505b

Understanding the 505(b)(2) approval process

INTRODUCTION

The number of prescriptions dispensed annually, along with the cost of pre s c r i ptions, continues to rise. In 2001, retail prescription drug expenditures exceeded $175 billion, an incre a s e of nearly $30 billion from the pre v i o u s year.1 The National Center for Health Statistics reported that 10 percent of health care costs in 2002 went to prescription costs.i For the last decade, prescription medication spending has remained the fastest-growing segment of the healthcare industry. Indicators predict the cost of prescriptions will continue to rise. in a small number of humans related to the medication’s effectiveness, side effects and risks in patients suffering from the disease or condition being evaluated. In Phase III trials, several hundred or thousands of participants are required in order to yield sufficient information pertaining to safety, efficacy and the overall risk-benefit ratio for use of this product in the population as a whole. When all three phases are complete, the manufacturer submits an NDA containing results from these studies to the FDA. The NDA is reviewed by FDA scientists to assess whether the trials demonstrate the product’s benefit, compared with its risks. Information submitted may include not only the results of the various clinical trials, but also the raw data that was used to generate the conclusions. The drug company is able to do this because it either conducted the studies itself or paid for the studies. This is called the “right of reference.” By the time an NDA is approved, the manufacturer has invested numerous years and many millions of dollars for development, clinical trials and regulatory approval. As compensation, the FDA grants the company the exclusive right to manufacture the p roduct for a period of time under patent p rotection. Manufacturers are granted patent protection for 20 years from the date of the first filing of the patent application. Being...