The FDA New Drug Approval Conundrum Revealed
FDA approvals of biopharmaceutical products have decreased in recent years. This includes recombinant proteins and monoclonal antibodies and cancer therapeutics. In the decade from 1996-2005, an average of 16.6 new drugs were approved each year. In marked contrast, there were only 11 and 12 new medications approved in 2006 and 2007, respectively.
Last year was an unusually unproductive year for the pharmaceutical and biotechnology industry. The combined sales for products approved in 2007 are projected to be less than $1.0 billion dollars–the benchmark for drugs that receives blockbuster status. Further, most or the approved drugs were similar to ones that were previously approved (so called “me too” drugs) and none will significantly improve healthcare for large numbers of patients. Finally, only two recombinant protein drugs were approved in 2007–a level more representative of the 1980s.
Most analysts agree that it is unclear why FDA approval of new drugs has decreased over the past few years and who, if anybody (FDA and/or industry), deserves the blame for the approval drop-off. Regulatory filings for a number of new products are either expected or currently pending. To that end, it is likely that there will be more new approvals in 2008 and 2009 as compared with previous years. To learn more about the drug approval conundrum please read this article recently written by Ronald A Radar.
The rate of new approvals must increase in order for the biopharmaceutical and pharmaceutical industries to remain economically healthy and viable. Industry and the FDA must work more closely with one another to continue to insure that the American public has ready access to innovative, safe and efficacious, new biopharmaceutical and pharmaceutical products.
