Originally published July 15.
By Turna Ray
As part of a reorganization at the US Food and Drug Administration, Commissioner Margaret Hamburg has placed a personalized medicine expert in charge of coordinating the agency's efforts around drugs, biologics, medical devices, and tobacco products.
Hamburg this week announced that she would make significant management changes to keep the agency in step with evolving science and technology and to make the best use of the agency's resources during tough economic times. These changes will not impact the daily work of the agency and its employees, though Hamburg noted that there will be changes in the agency's management hierarchy.
"The most obvious change you will see is that the agency’s programs, in terms of a reporting chain to me, will be divided into 'directorates' that reflect the core functions and responsibilities of the agency," Hamburg said in a memo announcing the restructuring. "This new management structure will enable the Office of the Commissioner to better support the agency’s core scientific and regulatory functions, and help tie together programs that share regulatory and scientific foundations."
One of the four "directorates" will be led by Steven Spielberg, former dean of Dartmouth Medical School and director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City. Spielberg will serve in the newly created position of Deputy Commissioner for Medical Products and Tobacco. The other directorates will be the Deputy Commissioner for Global Regulatory Operations and Policy and the Office of Operations, both new positions, and the previously created Office of Foods.
In his post, Spielberg will provide "high-level coordination and leadership across the FDA's centers for drug, biologics, medical devices, and tobacco products," Hamburg wrote in the memo.
Spielberg's hire comes during a time when the agency has been working to align the efforts of its various centers to coordinate regulatory oversight of drugs and devices that ideally need to be reviewed, approved, and marketed together in order to deliver personalized care.
Earlier this week, the agency released a draft guidance laying out the regulatory procedures that sponsors should follow in order to gain regulatory approval for companion in vitro diagnostics, which are meant to help doctors figure out which patients will likely respond to a drug or identify patients at higher risk for experiencing an adverse event to treatments (PGx Reporter 07/13/2011).
"To facilitate the development and approval of therapeutic products that are intended for use with IVD companion diagnostic devices, as well as the development of the IVD companion diagnostic devices themselves, FDA is clarifying relevant policies related to these devices and products," the agency said in the draft document. "FDA is also developing appropriate internal policies and procedures to ensure effective communication among the relevant centers and to promote consistent and efficient product review."
Spielberg's appointment will likely be viewed by personalized medicine advocates as a boost to their cause. Although the FDA has said that advancing personalized medicine is one of its main priorities, the agency has also admitted that it will be difficult to transition from old regulatory silos toward a model that enables the drug, biologics, and device agencies to collaboratively review Rx/Dx products. In fact, the FDA intends to release another draft guidance on drug/diagnostic codevelopment but because that guidance requires the input and approval of multiple agency centers, agency officials have noted that it may be a few years before that document is released (PGx Reporter 12/8/2010).
Some personalized medicine advocates have already embraced the new appointment. Edward Abrahams, president of the personalized medicine coalition, told PGx Reporter that Spielberg has "deep experience as an advocate for personalized medicine in the clinic, in research, and in policy development" and as such is "well-positioned to contribute to FDA's continued facilitation of personalized medicine."
Abrahams added that PMC "strongly endorses" the FDA's selection of Spielberg for the new post "and looks forward to working with him."
Likewise, Janet Trunzo, executive VP of AdvaMed's technology and regulatory affairs, said that the medical device trade association is "pleased that FDA is taking steps to improve coordination and oversight of its various centers.
"Speilberg will bring a unique perspective to the new deputy commissioner post," Trunzo said. "His extensive and varied background – including time spent in industry, academia and clinical practice – provides him insight on the challenges innovators face getting new products to market and the importance of ensuring timely patient access to new treatment options."
With more than 130 publications in the area of pharmacogenomics, personalized medicine, adverse drug reactions, and pediatric clinical pharmacology, Spielberg has the academic background to provide FDA with scientific leadership in this area. However, after a 15-year academic career, Spielberg also spent time with industry, as Merck's executive director of exploratory biochemical toxicology and clinical and regulatory development, and Johnson & Johnson's VP of pediatric drug development. As such, Spielberg has an insider's understanding of pharma's drug development process.
Moreover, his role on the FDA Pediatric ICH Initiative (ICH E-11), where he helped align pediatric drug development regulations across Europe, Japan, and the US, will fit well with FDA's efforts to expand its presence on a global scale. "We have seen the dramatic transformation of globalization – more products, more countries, more access by consumers and companies to global supplies – and this presents an enormous challenge to FDA in ensuring the safety and quality of the products we regulate," Hamburg wrote in the memo.
In addition to Spielberg's role in aligning the work of FDA's four centers, he will also oversee the agency's "special medical programs." FDA's Office of Special Medical Programs handles initiatives that are "cross-cutting and clinical, scientific, and/or regulatory in nature." Additionally, according to the FDA's website, the OSM coordinates internal and external review of pediatric science, safety, and ethical issues; oversees implementation of orphan products provisions under the Federal Food Drug and Cosmetic Act, and oversees the functions of the Office of Combination Products; among other functions.
Although Spielberg's experience suggests that he could exert a strong influence on personalized medicine matters at the agency, the FDA could not provide additional details about his specific role. However, an agency spokesperson said that more details about the restructuring will be available in the near future.
"We are interested in learning more about Spielberg’s specific responsibilities in his new post and in working with him on ways to improve the efficiency and predictability of the medical device review process," AdvaMed's Trunzo said.
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