FDA Unveils Plan To Modernize And Speed Up Regulatory Science
On Wednesday, the Food and Drug Administration (FDA) announced its plan to modernize and speed up agency to promote the "normative science" to ensure that new products, medicines and medical devices are effective and do not cause harm to people, and that products are safe, to eat.
Federal agency proposes to do this by developing new tools, standards and approaches, including working more closely with partners and creating "centers of excellence" for research in universities, private companies and other government agencies.
In a 20-page document titled White "Regulatory Development of science in public health," the agency said that "no discovery - not a magic wand" that will help the U.S. address the unique regulatory challenges of 21 st century, and the only way acquainted with them will have several new tools, approaches and methods of working with other researchers and developers.
Some of the projects outlined in the paper include new approaches to drug testing, looking for bacteria in food, and the search for new antibiotics.
At the dinner meeting is timed to release a white paper, FDA Commissioner Margaret Hamburg told the audience at the National Press Club that the regulatory science has been "under appreciated and under funded, and that funding will increase in the budget this year.
Hamburg, who is a former Commissioner of Health of New York, described the normative science as a bridge between science and consumers, and it was "not as robust as it should be." She said that too big a gap between scientific advances and patient care and regulatory science can bridge that gap.
Break the financial one: Billions of dollars are spent on medical research must be translated into treatment, "said Hamburg.
She said she hopes people will see as a report showing how regulatory science "really matters" and that "time to act is now."
FDA defines a normative science as "the science of developing new tools, standards and approaches for assessing the safety, efficacy, quality and effectiveness of FDA regulated products."
The FDA regulates between 20 and 25 percent of the products that consumers buy, from medicine to food to toothpaste.
One area that could be improved is the labeling of drugs according to individual needs of the patient. As an example of Hamburg said the study could improve the labeling of coagulants because they explain the optimal dose, depending on the patient's age, diet, current medications and genetics.
Another area would be to develop genetic tests that help doctors decide the optimal dose. And she also described a project in which FDA and the National Institutes of Health scientists are working on an artificial pancreas for help type 1 diabetes patients.
There is also a need to attract more outside talent in the FDA, and scientists to lure to join the agency he would offer them challenging work and attractive career. To this end, the agency has already developed a scheme of scholarships.
Independent advisory group said in 2007 that the FDA was in jeopardy, his job because he did not have enough scientific knowledge.
Hamburg also said, FDA will increase its attention to the problem of antibiotic resistance, which grew as a result of decades of widespread among humans and animals grown for food.
Antibiotics have been used to treat colds and minor infections, and because they are often added to animal feed, for example, for infection control in intensively farmed poultry and livestock, they entered the human food chain through meat, eggs, milk and cheese, and other animal products that people consume.
The result is that we now have a new generation of bacteria and life-threatening diseases that are highly resistant to even the new antibiotics.
Hamburg said that there should be more reasonable, how we use antibiotics, as we no longer have effective ways to treat serious infectious diseases. " She said she is concerned about the "disappointingly low" level of research and development into new drugs, particularly new antibiotics.
Costs of implementing the plan set out in the white paper will be made on the $ 25 million proposed new budget for FDA, that the Obama administration has put before Congress for fiscal year 2011, which began Oct. 1.
However, it is not clear whether the agency will be able to fulfill their wishes: the president asked the FDA budget should be increased by 23 percent to a total of $ 4 billion, but Congress has to pass it.
"Promotion of regulatory science in the field of public health" FDA, October 6, 2010.