FDA Vows to Bring Its "Regulatory Science" Into 21st Century

October 07, 2010

October 7, 2010 — The US Food and Drug Administration (FDA) yesterday released a roadmap for modernizing how it scientifically assesses the drugs, biologics, and medical devices that it regulates, and for speeding the good ones to market.

The plan accompanies a $25 million budget request by President Barack Obama for fiscal 2011 to upgrade what the agency calls "regulatory science." Although the term might smack of bureaucratic tedium, regulatory science has life and death implications, suggested FDA Commissioner Margaret Hamburg, MD, in a speech yesterday at the National Press Club in Washington, DC.

Right now, said Dr. Hamburg, burgeoning discoveries in biomedical research are slow to find their way into patient care because the agency relies on 20th-century methods to evaluate 21st-century science. Case in point, she said, is a shortage of new antibiotics during a time of increased antibiotic resistance.

"We need new and better drugs, and we need them now, yet the research and development pipeline is distressingly low," said Dr. Hamburg. "And the range of new antibiotics is disturbingly limited in terms of the type and class...available, and the diseases they treat."

It was this kind of public health threat that a subcommittee of the FDA's Science Board, an outside advisory group, had in mind when it issued a report in 2007 stating that the agency "suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities." The subcommittee noted that "while the world of drug discovery and development [has] undergone revolutionary change — shifting from cellular to molecular and gene-based approaches — FDA's evaluation methods have remained largely unchanged over the last half century."

Improvement Hinges on Better FDA Scientists, Information Technology

The game plan for regulatory science released by the FDA on Wednesday looks at how cutting-edge methodologies could help the agency protect the nation's food supply, regulate tobacco, improve children's health, respond to emerging infectious disease and bioterrorism, and accelerate the approval of new treatments for patients.

One challenge, the FDA report states, is increasing the availability of low-cost generic drugs. There are no generic equivalents of some off-patent medications such as metered-dose inhalers and certain topical creams because it is hard to ascertain their bioequivalence. More research is needed to develop validated methods of determining bioequivalence for these tricky products to open the door to generic versions.

A subset of regulatory science is bioinformatics, and here, too, the FDA has room to improve, the report states. The FDA possesses the largest known repository of clinical data about drugs, biologics, and medical devices, both before and after approval. However, the agency lacks the infrastructure and tools for making sense of it.

The agency wants to transform this welter of information into a common database that can be queried by topic and analyzed to answer questions about a medical product's safety or efficacy. Such a unified approach would allow the agency to look at 15 studies of HIV drugs simultaneously, for example, to determine which ones work best for which patients. Reaching this goal will require investments in informatics hardware and software, according to the report.

Another necessary investment is in FDA staff, said Dr. Hamburg on Wednesday.

"We're accelerating efforts to recruit, train, and retain outstanding scientists and build the science base within the agency," she said. "After all, the agency charged with evaluating the safety and efficacy of a central product must possess a scientific capacity equal to, if not greater than, the task."

The 2007 report by the Science Board subcommittee faulted the FDA for a shorthanded, subpar workforce as well as an "obsolete" information technology infrastructure.

Throughout its new plan for modernizing regulatory science, the FDA notes that it has already been addressing the concerns raised in the 2007 report.


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