More regulatory science: FDA chief

The US must bolster study on how to best craft regulations that bring drugs, medical devices and vaccines to market, the commissioner of the US Food and Drug Administration stressed in a speech delivered yesterday (September 16th) in Philadelphia. linkurl:Margaret Hamburg,; the former New York City health commissioner who was named FDA commissioner earlier this year, was speaking at the annual Regulatory Affairs Professional Society confe

By | September 17, 2009

The US must bolster study on how to best craft regulations that bring drugs, medical devices and vaccines to market, the commissioner of the US Food and Drug Administration stressed in a speech delivered yesterday (September 16th) in Philadelphia. linkurl:Margaret Hamburg,; the former New York City health commissioner who was named FDA commissioner earlier this year, was speaking at the annual Regulatory Affairs Professional Society conference to approximately 850 representatives from pharmaceutical companies, biotechs, and medical device manufacturers.
Margaret Hamburg speaking at the
RAPS 2009 Conference
"Just as biomedical research has evolved in the past decades, regulatory science -- the science and tools we use to assess and evaluate product safety, efficacy, potency, quality and performance -- must also evolve," she said. Hamburg added that too little attention and resources are paid to regulatory science as a discipline that can help the FDA protect and benefit American citizens. "Our efforts will be seriously compromised if we don't significantly increase the sophistication of our regulatory science soon," she said. "A strong and robust field of regulatory science is essential to the work of FDA, and I believe it represents an important driver of our nation's health." As Hamburg was addressing an audience of regulatory professionals, she gave only a cursory definition for regulatory science. This left me wondering: What the heck is regulatory science? For the answer, I turned to Alan Moghissi, the president of the linkurl:Institute for Regulatory Science,; a non-profit that advises universities, Congress, and state and local governments on matters of regulatory science. "Regulatory science is a unique application of science, at all levels, to the societal decision process," Moghissi told __The Scientist__. He explained that regulatory science involves taking existing information or data and using it to hone and develop effective regulations, laws and judicial systems. When these social or industrial parameters are set using ideals or emotions rather than scientific inputs, Moghissi added, the public often winds up misled. "The moment you bring in societal objectives, as good as they may be, they mess [the regulatory or legal process] up." Moghissi noted that the problem extends beyond FDA and into other agencies tasked with developing meaningful and effective regulations. "I believe there's a lack of recognition of the significance of regulatory science," he said. Indeed, there seems to be only a select few academic programs that specialize in turning out regulatory scientists. One such program, at the University of Southern California's School of Pharmacy, bemoans the lack of regulatory science practitioners and uses the need as a recruitment device. "Industry and government cannot find sufficient numbers of skilled personnel to meet demands," the program's linkurl:website; reads. "Our program can help you get to the forefront, to become a leader in this emerging profession." linkurl:Frances Richmond,; director of the USC program, said that beyond being under-appreciated in terms of its importance to policy and regulation making, regulatory science is not a career "that people even recognize." Richmond told __The Scientist__ that improving the practice of regulatory science hinges on improving how we train its practitioners. "The investment should be more on the education side," she added. During her speech, Hamburg also pointed to the essential role that regulatory science plays in translating biomedical research discoveries to the clinic. "The goal is to place the emerging, very promising areas in science and technology, such as genomics and personalized medicine, the development of stem cell therapies and therapies that harness the power of nanotechnology fully at the service of public health," she said. Both Moghissi and Hamburg indicated that increased investment in the field of regulatory science is crucial to boosting sound rule-making in the drug and medical device industry. "Our nation has invested billions of dollars in biomedical research, an effort that's indispensible for medical progress. But this research will not result in new therapies and cures unless it's married to a robust investment in regulatory science," Hamburg said. "We cannot afford to have a muscular investment in fundamental research and discovery with only a scrawny counterpart in regulatory capacity." "Some of the money that is being spent on R&D ought to be redirected with emphasis on regulatory science," Moghissi concurred. "Maybe more resources would attract more people to attend to it."
**__Related stories:__***linkurl:FDA head chosen, NIH names swirling;
[12th March 2009]*linkurl:Biosafety rules need scientists;
[15th July 2004]


Avatar of: JOHN DUNNE


Posts: 6

September 17, 2009

Delighted at the news, and wondering about implementation. The educators want more education, the Agency wants better metrics for their own efficiency; as an assay development scientist, I want investment in better analytical platforms that yield better data. Like most federal statements of intent, a natural reaction includes, "how can I get some of that?" The luckiest among us work on things that we believe could have big societal impact, and perhaps all of us would do more if investment grew, so we needn't be ashamed of asking the question. Those of us outside the beltway might share a common concern about how this investment gets prioritized?\n\nTackling the problem of cost and risk in novel therapeutic clinical development is a noble intent, with perhaps the biggest near term economic impact I can think of for the developed world. Regulatory Science sounds like a great technology platform that I hope has room for lots of ideas.
Avatar of: Denis Demarais

Denis Demarais

Posts: 3

September 18, 2009

Regulatory science has an essential role to play and is a very import team member in the partnership of various institutions joining hands in meeting the healthcare needs of the public. \n\nUniversities educate the next generation of scientists alongside providing the structure and facilities for faculty members to innovate and advance their field. Research institutions regroup senior scientists with common interest thereby enhancing dialogue and cost saving by sharing core facilities and services alongside providing a more research focus training to the university graduates. Industry provides manufacturing in large-scale facilities and advanced technologies so as to meet market demands alongside having the funds to conduct clinical trials and funding for profit revenue-generating R&D. Regulatory institutions ensures that a define standard of safety is met before the patient receives a medical treatment.\n\nIn the above segment of the division of human resources, science is the foundation that interlinks them all. While it is clear that universities and research institutions have a very close interactions whereby some senior scientists also spend time in teaching at universities in the function of adjunct or assistant professor and that industry is very close with some scientists at universities and research institutions, regulatory bodies are often perceived as the deal breaker by industry. What portrays this perception can easily be seen in the number of potential lead drugs submitted by the industry and the actual approval to market being granted by the regulatory institutions.\n\nThe lack of regulatory scientist training at universities is the outcome of a poor relationship between universities and regulatory institutions. Universities are bestowed the societal responsibility to impart skills in the education they provide such that young individuals go on the labor market with the necessary starting skill that the employment requires. Graduates are better serve when the employment demands are from a varied source. University itself alongside, research institutions and industry require young skillful individual merely to keep their staff from ageing. Thus teaching programs are amended so as to factor in the reality of the labor market demands.\n\nA crucial role that regulatory institutions ought to play is a tighter partnership with industry in the form of an advisor. It is in the profit interest of the industry that they know ahead of starting clinical trials if not R&D, what pitfalls to avoid such that they streamline their operation to achieve a minimum cost wastage. Research institutions know the major pitfalls which lead to drug candidates being turn-down but purely communicate that to the industry. Advisor training is largely imparting soft skills that this profession requires. Every graduate wants to have this little plus that make them stand out of the labor search crown. Therefore by providing soft skills modules in regulatory science advising alongside their core teaching, these universities will provide that little plus which would latter come to foster better interaction between regulatory institutions and their other team players.\n\nUlm, Germany\
Avatar of: Denis Demarais

Denis Demarais

Posts: 3

September 18, 2009

Research institutions know the major pitfalls, which lead to drug candidates being turndown but ...poorly... communicate that to the industry. \n.........\nEvery graduate wants to have this little plus that make them stand out of the labor search ...crowd...\n\n
Avatar of: Annan Amos

Annan Amos

Posts: 1

September 25, 2009

I suppose it makes me some sort of nut, but I don't think that MORE regulation is exactly the answer to very much. For one, more regulation means more money would be devoted to the FDA, which of course makes the FDA head very happy. Secondly, the FDAs track record isn't...good. They stink.\nInstead, I'd propose something entirely different. Reduce the scope of the FDA to the following - handling complaints. If someone falls ill due to medicinal side effects, or eats tainted food, instead of the FDA handing out fines and advocating for more reform, hand it over to the Justice Department. \nIn essence, an instance of a defective product would be treated as Criminal Negligence. Somebody dies because of a product, in a case where it wasn't intended use? That could be treated as a negligible homicide. Treat the actions as such, you'll see a drop off.\nI justify it thus - if you recall the melamine milk scandal about a year ago, three executives from the Chinese company were put on trial for the actions which resulted in so many deaths. One went to prison, and the other two were SHOT. I don't advocate fascistic executions in that manner at all, but I DO advocate that idea. If harm is done, the retribution is full out. That's justifiable. \nMore FDA regulation, which is already, for one, almost completely bought off by Big Pharma, and for two, already a huge expense. You can't justify putting even more taxpayer payday loans into an agency that fails to do it's job.

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