Societies react to Scott Gottlieb’s confirmation as FDA head

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On May 9, Scott Gottlieb, MD, was confirmed as the new commissioner of the FDA by a 57 to 42 Senate vote. A resident fellow at the conservative American Enterprise Institute, Gottlieb was a controversial pick at the time of his nomination because of his long history of work with the pharmaceutical industry.

Despite concerns from some professional organizations, ASCO President Daniel F. Hayes, MD, FACP, FASCO, congratulated Gottlieb on his confirmation, saying in a press release that “as a physician and cancer survivor, Dr. Gottlieb knows firsthand that safe and effective cancer treatments must move from the lab to the patient as quickly as possible.

“We are hopeful that Dr. Gottlieb will serve as a passionate advocate for the public’s health,” Hayes continued. “We look to Dr. Gottlieb’s leadership in implementing key provisions of the 21st Century Cures Act that will increase patient access to information about the availability of investigational drugs and allow the FDA to decide how best to use real-world data from clinical practice to support new approvals for drugs already on the market.”

Shelly Fuld Nasso, CEO of The National Coalition for Cancer Survivorship, said the organization was “pleased” at Gottlieb's confirmation.

“The wealth of experience he brings as a physician, former FDA official, and cancer survivor will be important in this new role," Nasso said. "We look forward to working with him and the FDA as they work to approve safe and effective therapies that will help cancer patients live longer and better lives.”

Health and Human Services Secretary Tom Price, MD, also spoke out in response to Gottlieb’s appointment with a statement praising his experience.

“We are excited to partner with Dr. Gottlieb to protect and promote the health of the American people. Dr. Gottlieb brings considerable experience to the FDA,” Price said in remarks published on the department’s website. “His background will be crucial for keeping the FDA as the gold standard for safe treatments while advancing new, innovative solutions to the many public health challenges our nation faces. I am confident Dr. Gottlieb will make decisions that reduce regulatory burdens while protecting public health. Congratulations to Dr. Gottlieb and his family.”

Michael Carome, MD, director of the health research group at Citizen’s Health, said at the time of the nomination that Gottlieb “is entangled in an unprecedented web of Big Pharma ties.”

Gottlieb has collected speaking and consulting fees from numerous companies, including AstraZeneca PLC, Baxter International Inc., Bristol-Myers Squibb, Daiichi Sankyo Inc., GlaxoSmithKline, Insys Therapeutics, Novo Nordisk, Pfizer Inc., SI-Bone Inc., Takeda Pharmaceutical Co., Valeant Pharmaceuticals International Inc., and Vertex Pharmaceuticals, according to MarketWatch.

However, Bassil I. Dahiyat, PhD, president and chief executive of Xencor Inc., pointed to Gottlieb’s time working for the FDA under the George W. Bush administration, saying “we dodged a bullet [by getting a] professional, FDA insider with experience” when Gottlieb was first nominated. – by Andy Polhamus

Test.docx

On May 9, Scott Gottlieb, MD, was confirmed as the new commissioner of the FDA by a 57 to 42 Senate vote. A resident fellow at the conservative American Enterprise Institute, Gottlieb was a controversial pick at the time of his nomination because of his long history of work with the pharmaceutical industry.

Despite concerns from some professional organizations, ASCO President Daniel F. Hayes, MD, FACP, FASCO, congratulated Gottlieb on his confirmation, saying in a press release that “as a physician and cancer survivor, Dr. Gottlieb knows firsthand that safe and effective cancer treatments must move from the lab to the patient as quickly as possible.

“We are hopeful that Dr. Gottlieb will serve as a passionate advocate for the public’s health,” Hayes continued. “We look to Dr. Gottlieb’s leadership in implementing key provisions of the 21st Century Cures Act that will increase patient access to information about the availability of investigational drugs and allow the FDA to decide how best to use real-world data from clinical practice to support new approvals for drugs already on the market.”

Shelly Fuld Nasso, CEO of The National Coalition for Cancer Survivorship, said the organization was “pleased” at Gottlieb's confirmation.

“The wealth of experience he brings as a physician, former FDA official, and cancer survivor will be important in this new role," Nasso said. "We look forward to working with him and the FDA as they work to approve safe and effective therapies that will help cancer patients live longer and better lives.”

Health and Human Services Secretary Tom Price, MD, also spoke out in response to Gottlieb’s appointment with a statement praising his experience.

“We are excited to partner with Dr. Gottlieb to protect and promote the health of the American people. Dr. Gottlieb brings considerable experience to the FDA,” Price said in remarks published on the department’s website. “His background will be crucial for keeping the FDA as the gold standard for safe treatments while advancing new, innovative solutions to the many public health challenges our nation faces. I am confident Dr. Gottlieb will make decisions that reduce regulatory burdens while protecting public health. Congratulations to Dr. Gottlieb and his family.”

Michael Carome, MD, director of the health research group at Citizen’s Health, said at the time of the nomination that Gottlieb “is entangled in an unprecedented web of Big Pharma ties.”

Gottlieb has collected speaking and consulting fees from numerous companies, including AstraZeneca PLC, Baxter International Inc., Bristol-Myers Squibb, Daiichi Sankyo Inc., GlaxoSmithKline, Insys Therapeutics, Novo Nordisk, Pfizer Inc., SI-Bone Inc., Takeda Pharmaceutical Co., Valeant Pharmaceuticals International Inc., and Vertex Pharmaceuticals, according to MarketWatch.

However, Bassil I. Dahiyat, PhD, president and chief executive of Xencor Inc., pointed to Gottlieb’s time working for the FDA under the George W. Bush administration, saying “we dodged a bullet [by getting a] professional, FDA insider with experience” when Gottlieb was first nominated. – by Andy Polhamus

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