FDA leader discusses improvement plans

Source of Article:  http://chronicle.augusta.com/stories/2009/08/05/met_543287.shtml

By Walter C. Jones | Morris News Service

Wednesday, August 05, 2009

ATLANTA --- More money, staff and regulatory authority will help the U.S. Food and Drug Administration streamline approval of new drugs and safeguard against food-borne diseases, FDA Commissioner Margaret Hamburg said Tuesday.

Ms. Hamburg met with reporters after touring the agency's regional office, where she described morale as high. Faces particularly brightened, according to her deputy Dr. Joshua Sharfstein, when she announced her decisions would be based on science.

Critics have charged that the Bush administration included political considerations in its decisions rather than strictly following the advice of scientists. Ms. Hamburg, without mentioning her predecessors, said things would be done differently.

For instance, she said the agency would require more of food processors to conduct the tests and guarantee the quality of their ingredients -- even imported ones. She said legislation that passed the House last week would give the agency authority to order recalls of tainted products and increase the frequency of inspections of food processors to prevent a repeat of the Sylvester, Ga., peanut-butter plant whose salmonella contamination led to eight deaths and made 575 people ill.

In the area of approvals for new drugs and medical devices, she is looking at employing new tests early in the process and more sophisticated data analysis that could avoid some of the lengthy and expensive drug trials that contribute to medical inflation.

"We are now starting to understand that there are certain markers that you can use to move the process more quickly, both on the (laboratory) side and on the clinical trials side," she said.

The vaccine for swine flu could be the first notable example. She is considering allowing an additive used in other countries to stretch the vaccine so more people could benefit from the limited quantity that can be produced by flu season.



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