The act has to be reauthorized by Congress every five years. The current program expires in September. In its proposal, the FDA asked Congress for permission to increase fees by $87.4 million, to $392.8 million.
Overwhelmed with requests
The request for increased fees was expected. The Pharmaceutical Manufacturers Association of America adopted new guidelines for the industry's DTC communications last year, one of which was to submit TV ads to the FDA prior to hitting the market. Drug makers have overwhelmed the FDA with the number of ads needing approval.
However, the request for a program to collect a new, separate fee from pharma companies was something of a surprise.
Considering the huge amounts pharmaceutical companies spend on marketing, the cost to the drug industry for the proposed new program is relatively tiny. It would cost all drug makers a combined $6.2 million in the first year -- drug makers would have to pay a one-time fee for TV ads and additional charges for each ad submitted.
Big bucks for FDA
But for the FDA, the $6.2 million is significant: It would allow for the hiring of 27 additional staffers to help review new ads, which the FDA said would be reviewed within 45 days.
An FDA official said that "drug review has grown more than we can account for. And the method doesn't even account for the number of consultation meetings during the development of their new product. That has grown far more than we anticipated."
The FDA official said the agency held more than 1,800 meetings with drug sponsors in 2005. That averages out to about seven meetings per day.
And the drug industry seems to be supporting the measure. "The PDUFA proposals from America's pharmaceutical research companies and the Food and Drug Administration call for comprehensive improvements in all areas that are essential to timely, safe and effective use of new medicines by millions of American patients," Billy Tauzin, president-chief executive of the Pharmaceutical Research and Manufacturers of America, said in a statement.
Still, the request for increased fees didn't sit well with some.
"The FDA's crucial drug-regulatory functions are too important to be tainted and compromised by direct funding from the very companies whose drugs the agency reviews for safety," Dr. Sidney M. Wolfe, director of Washington-based advocacy group Public Citizen, said in a statement. "The agency should request these additional funds through the same process that funded the agency from 1906 through 1992 -- that is, the money should come from the federal Treasury, not the pharmaceutical industry."
An FDA official said the agency was "agnostic" with regard to where its funding comes from.
The FDA said the request for an increase in PDUFA fees would also help the agency's drug-safety activities and including hiring of 82 additional employees to perform post-market safety work.