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WASHINGTON – Drug pricing was front and center as a Senate panel convened to review the nomination of Dr. Robert M. Califf as commissioner of the Food and Drug Administration.
During a Nov. 17 hearing of the Senate Health, Education, Labor, and Pensions (HELP) Committee, many members keyed in on the role of the FDA in trying to bring down drug prices.
When asked about the price of prescription drugs, Dr. Califf was clear in stating that the agency’s role was not to set prices, but suggested that the FDA could have an impact on pricing by making the approval process for both brand and generic products more efficient, including revamping the clinical trials needed for approval to make them cheaper and more inclusive, while improving the quality of the data produced.
“We think that we can do trials that are actually bigger and include more patients that are more representative for a much lower cost,” Dr. Califf said, responding to Sen. Orrin Hatch’s (R-Utah) concerns about length of time of data exclusivity and fears that calls for shortening it might lead to higher drug prices as companies try to recoup development costs.
He also pointed to the use of electronic health records as a way to broaden clinical trials at a lower cost.
“The key here is using electronic health records that we already have,” Dr. Califf said, adding that once interoperability issues are addressed, EHRs will enable manufacturers to develop therapies “at a much lower cost with better information about safety and efficacy.”
In looking at rising generic prices, Committee Chairman Lamar Alexander (R-Tenn) focused on generic approval times, noting that generic manufacturers estimated that it took on average 48 months for a generic to get approval in 2014, up from 30 months in 2011.
A more rapid approval, “if safe and effective, might have some effect on lowering drug prices,” Sen. Alexander said.
Dr. Califf responded that FDA is already ahead of the generic user fee goals that have been set and the agency has been clearing the more simple applications from its backlog.
“But we have this backlog of applications that are requiring a back-and-forth because we want generic drugs to be just as safe and effective as the innovative drugs and when the applications [are not complete and there are questions] those get held up,” he responded, adding that he was “confident” that once the backlog is cleared over the next several years, generic applications will be processed quickly.
However, his answers were not convincing to at least one member. Presidential hopeful Sen. Bernie Sanders (I-Vt.) was not convinced Dr. Califf will do enough in this area.
“At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices. Unfortunately, I have come to the conclusion that Dr. Califf is not that person,” Sanders said in an Oct. 9 statement.
Sen. Sanders reaffirmed his objection, saying that nothing he heard during the hearing has changed his opinions.
And while he openly objected to the nomination, both the chairman and ranking member of the committee both openly endorsed the White House nominee.
In his prepared remarks, Mr. Alexander noted that his staff “has spent 2 months carefully reviewing everything you submitted and has not found anything that would call into doubt your ability to lead the FDA fairly and impartially.”
Likewise, Ranking Member Patty Murray (D-Wash.) said during the hearing that after “careful consideration and review, I am confident that Dr. Califf would contribute leadership and expertise as we work to find new ways to advance medical innovation for patients and families, and improve the health and well-being across this country. He is a strong nominee for the role of FDA commissioner.”
In his opening statement, Dr. Califf outlined his priorities if confirmed as commissioner, including strengthening and better supporting FDA’s workforce, finishing work in an number of areas – including improving the nation’s food supply, tobacco regulation, better combating antibiotic resistant bacteria, medical countermeasure development, and the White House’s Precision Medicine Initiative – and “further develop the science base that informs FDA’s decision making.”
During his testimony, he also said there is “a need to work on postmarket surveillance of devices,” suggesting that a similar program, the FDA’s Sentinel Initiative drug surveillance program, be developed. Dr. Califf also said a new pathway is needed for approving drug/device combination products.
In the area of medical apps, Dr. Califf said there needs to be more clarity as to where the line for regulation should be. As an example, he said that an app that monitors heart rate does not need much oversight, but if that app were connected to an implantable defibrillator, that would require more regulatory oversight.
Sen. Sanders cited Dr. Califf’s ties to the pharmaceutical industry as the prime reason for opposing the nomination.
Dr. Califf noted that for any of the research he had conducted, even when primarily funded from industry, he was clear that manufacturers, while being able to make suggestions for analysis and publication of results, did not have final say, and he said that numerous studies were rejected because companies would not agree to full access to databases or independence with the final publication of results.
One area that was not raised during the hearing, but was raised by the Project on Government Oversight regarding the ROCKET AF trial of rivaroxaban (Xarelto), for which he was co-primary investigator (N Engl J Med. 2011 Sep 8;365:883-91).
“Dr. Califf’s handling of the Xarelto trial raises concerns about his judgment in overseeing the pharmaceutical industry.” POGO Executive Director Danielle Brian said in a statement. “As senators consider Dr. Califf’s confirmation to run the FDA, they should ask tough questions about the Xarelto clinical trial.”
FDA primary reviewers recommended against approval based on a number of issues with the trial, but FDA ultimately decided in favor of bringing the drug to market.
A cardiologist by training, Dr. Califf has received support from the American College of Cardiology.
In an Oct. 21, 2015, letter to the Senate HELP Committee, ACC called Dr. Califf “the right person to lead the FDA as commissioner based on his impressive medical knowledge, clinical research experience, and visionary leadership abilities.”
Dr. Califf joined the FDA in February as deputy commissioner of medical products and currently provides executive leadership to FDA’s Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products.
He also oversees FDA’s Office of Special Medical Programs and plays a critical role in providing high-level advice and policy direction on the agency’s medical product and tobacco priorities.
Prior to coming to FDA, he was vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University in Durham, N.C. He has held multiple positions at the university, including director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute.
He also served as a member of FDA’s Cardiovascular and Renal Drugs Advisory Committee and the agency’s Science Board Subcommittee on Science and Technology.
“We believe that with Dr. Califf’s diverse background, and his exemplary knowledge of clinical and translational medicine, he will continue to improve the FDA’s drug approval process while ensuring that patients are receiving the safest and most effective treatments as quickly as possible. We urge his immediate confirmation,” a coalitions of 50 medical and advocacy groups, including the American Academy of Pediatrics, American Society of Clinical Oncology, American Association of Cancer Research, National Organization for Rare Disorders, and the Personalized Medicine Coalition, said in an Oct. 29, 2015, letter to the Senate HELP Committee.
WASHINGTON – Drug pricing was front and center as a Senate panel convened to review the nomination of Dr. Robert M. Califf as commissioner of the Food and Drug Administration.
During a Nov. 17 hearing of the Senate Health, Education, Labor, and Pensions (HELP) Committee, many members keyed in on the role of the FDA in trying to bring down drug prices.
When asked about the price of prescription drugs, Dr. Califf was clear in stating that the agency’s role was not to set prices, but suggested that the FDA could have an impact on pricing by making the approval process for both brand and generic products more efficient, including revamping the clinical trials needed for approval to make them cheaper and more inclusive, while improving the quality of the data produced.
“We think that we can do trials that are actually bigger and include more patients that are more representative for a much lower cost,” Dr. Califf said, responding to Sen. Orrin Hatch’s (R-Utah) concerns about length of time of data exclusivity and fears that calls for shortening it might lead to higher drug prices as companies try to recoup development costs.
He also pointed to the use of electronic health records as a way to broaden clinical trials at a lower cost.
“The key here is using electronic health records that we already have,” Dr. Califf said, adding that once interoperability issues are addressed, EHRs will enable manufacturers to develop therapies “at a much lower cost with better information about safety and efficacy.”
In looking at rising generic prices, Committee Chairman Lamar Alexander (R-Tenn) focused on generic approval times, noting that generic manufacturers estimated that it took on average 48 months for a generic to get approval in 2014, up from 30 months in 2011.
A more rapid approval, “if safe and effective, might have some effect on lowering drug prices,” Sen. Alexander said.
Dr. Califf responded that FDA is already ahead of the generic user fee goals that have been set and the agency has been clearing the more simple applications from its backlog.
“But we have this backlog of applications that are requiring a back-and-forth because we want generic drugs to be just as safe and effective as the innovative drugs and when the applications [are not complete and there are questions] those get held up,” he responded, adding that he was “confident” that once the backlog is cleared over the next several years, generic applications will be processed quickly.
However, his answers were not convincing to at least one member. Presidential hopeful Sen. Bernie Sanders (I-Vt.) was not convinced Dr. Califf will do enough in this area.
“At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices. Unfortunately, I have come to the conclusion that Dr. Califf is not that person,” Sanders said in an Oct. 9 statement.
Sen. Sanders reaffirmed his objection, saying that nothing he heard during the hearing has changed his opinions.
And while he openly objected to the nomination, both the chairman and ranking member of the committee both openly endorsed the White House nominee.
In his prepared remarks, Mr. Alexander noted that his staff “has spent 2 months carefully reviewing everything you submitted and has not found anything that would call into doubt your ability to lead the FDA fairly and impartially.”
Likewise, Ranking Member Patty Murray (D-Wash.) said during the hearing that after “careful consideration and review, I am confident that Dr. Califf would contribute leadership and expertise as we work to find new ways to advance medical innovation for patients and families, and improve the health and well-being across this country. He is a strong nominee for the role of FDA commissioner.”
In his opening statement, Dr. Califf outlined his priorities if confirmed as commissioner, including strengthening and better supporting FDA’s workforce, finishing work in an number of areas – including improving the nation’s food supply, tobacco regulation, better combating antibiotic resistant bacteria, medical countermeasure development, and the White House’s Precision Medicine Initiative – and “further develop the science base that informs FDA’s decision making.”
During his testimony, he also said there is “a need to work on postmarket surveillance of devices,” suggesting that a similar program, the FDA’s Sentinel Initiative drug surveillance program, be developed. Dr. Califf also said a new pathway is needed for approving drug/device combination products.
In the area of medical apps, Dr. Califf said there needs to be more clarity as to where the line for regulation should be. As an example, he said that an app that monitors heart rate does not need much oversight, but if that app were connected to an implantable defibrillator, that would require more regulatory oversight.
Sen. Sanders cited Dr. Califf’s ties to the pharmaceutical industry as the prime reason for opposing the nomination.
Dr. Califf noted that for any of the research he had conducted, even when primarily funded from industry, he was clear that manufacturers, while being able to make suggestions for analysis and publication of results, did not have final say, and he said that numerous studies were rejected because companies would not agree to full access to databases or independence with the final publication of results.
One area that was not raised during the hearing, but was raised by the Project on Government Oversight regarding the ROCKET AF trial of rivaroxaban (Xarelto), for which he was co-primary investigator (N Engl J Med. 2011 Sep 8;365:883-91).
“Dr. Califf’s handling of the Xarelto trial raises concerns about his judgment in overseeing the pharmaceutical industry.” POGO Executive Director Danielle Brian said in a statement. “As senators consider Dr. Califf’s confirmation to run the FDA, they should ask tough questions about the Xarelto clinical trial.”
FDA primary reviewers recommended against approval based on a number of issues with the trial, but FDA ultimately decided in favor of bringing the drug to market.
A cardiologist by training, Dr. Califf has received support from the American College of Cardiology.
In an Oct. 21, 2015, letter to the Senate HELP Committee, ACC called Dr. Califf “the right person to lead the FDA as commissioner based on his impressive medical knowledge, clinical research experience, and visionary leadership abilities.”
Dr. Califf joined the FDA in February as deputy commissioner of medical products and currently provides executive leadership to FDA’s Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products.
He also oversees FDA’s Office of Special Medical Programs and plays a critical role in providing high-level advice and policy direction on the agency’s medical product and tobacco priorities.
Prior to coming to FDA, he was vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University in Durham, N.C. He has held multiple positions at the university, including director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute.
He also served as a member of FDA’s Cardiovascular and Renal Drugs Advisory Committee and the agency’s Science Board Subcommittee on Science and Technology.
“We believe that with Dr. Califf’s diverse background, and his exemplary knowledge of clinical and translational medicine, he will continue to improve the FDA’s drug approval process while ensuring that patients are receiving the safest and most effective treatments as quickly as possible. We urge his immediate confirmation,” a coalitions of 50 medical and advocacy groups, including the American Academy of Pediatrics, American Society of Clinical Oncology, American Association of Cancer Research, National Organization for Rare Disorders, and the Personalized Medicine Coalition, said in an Oct. 29, 2015, letter to the Senate HELP Committee.
WASHINGTON – Drug pricing was front and center as a Senate panel convened to review the nomination of Dr. Robert M. Califf as commissioner of the Food and Drug Administration.
During a Nov. 17 hearing of the Senate Health, Education, Labor, and Pensions (HELP) Committee, many members keyed in on the role of the FDA in trying to bring down drug prices.
When asked about the price of prescription drugs, Dr. Califf was clear in stating that the agency’s role was not to set prices, but suggested that the FDA could have an impact on pricing by making the approval process for both brand and generic products more efficient, including revamping the clinical trials needed for approval to make them cheaper and more inclusive, while improving the quality of the data produced.
“We think that we can do trials that are actually bigger and include more patients that are more representative for a much lower cost,” Dr. Califf said, responding to Sen. Orrin Hatch’s (R-Utah) concerns about length of time of data exclusivity and fears that calls for shortening it might lead to higher drug prices as companies try to recoup development costs.
He also pointed to the use of electronic health records as a way to broaden clinical trials at a lower cost.
“The key here is using electronic health records that we already have,” Dr. Califf said, adding that once interoperability issues are addressed, EHRs will enable manufacturers to develop therapies “at a much lower cost with better information about safety and efficacy.”
In looking at rising generic prices, Committee Chairman Lamar Alexander (R-Tenn) focused on generic approval times, noting that generic manufacturers estimated that it took on average 48 months for a generic to get approval in 2014, up from 30 months in 2011.
A more rapid approval, “if safe and effective, might have some effect on lowering drug prices,” Sen. Alexander said.
Dr. Califf responded that FDA is already ahead of the generic user fee goals that have been set and the agency has been clearing the more simple applications from its backlog.
“But we have this backlog of applications that are requiring a back-and-forth because we want generic drugs to be just as safe and effective as the innovative drugs and when the applications [are not complete and there are questions] those get held up,” he responded, adding that he was “confident” that once the backlog is cleared over the next several years, generic applications will be processed quickly.
However, his answers were not convincing to at least one member. Presidential hopeful Sen. Bernie Sanders (I-Vt.) was not convinced Dr. Califf will do enough in this area.
“At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices. Unfortunately, I have come to the conclusion that Dr. Califf is not that person,” Sanders said in an Oct. 9 statement.
Sen. Sanders reaffirmed his objection, saying that nothing he heard during the hearing has changed his opinions.
And while he openly objected to the nomination, both the chairman and ranking member of the committee both openly endorsed the White House nominee.
In his prepared remarks, Mr. Alexander noted that his staff “has spent 2 months carefully reviewing everything you submitted and has not found anything that would call into doubt your ability to lead the FDA fairly and impartially.”
Likewise, Ranking Member Patty Murray (D-Wash.) said during the hearing that after “careful consideration and review, I am confident that Dr. Califf would contribute leadership and expertise as we work to find new ways to advance medical innovation for patients and families, and improve the health and well-being across this country. He is a strong nominee for the role of FDA commissioner.”
In his opening statement, Dr. Califf outlined his priorities if confirmed as commissioner, including strengthening and better supporting FDA’s workforce, finishing work in an number of areas – including improving the nation’s food supply, tobacco regulation, better combating antibiotic resistant bacteria, medical countermeasure development, and the White House’s Precision Medicine Initiative – and “further develop the science base that informs FDA’s decision making.”
During his testimony, he also said there is “a need to work on postmarket surveillance of devices,” suggesting that a similar program, the FDA’s Sentinel Initiative drug surveillance program, be developed. Dr. Califf also said a new pathway is needed for approving drug/device combination products.
In the area of medical apps, Dr. Califf said there needs to be more clarity as to where the line for regulation should be. As an example, he said that an app that monitors heart rate does not need much oversight, but if that app were connected to an implantable defibrillator, that would require more regulatory oversight.
Sen. Sanders cited Dr. Califf’s ties to the pharmaceutical industry as the prime reason for opposing the nomination.
Dr. Califf noted that for any of the research he had conducted, even when primarily funded from industry, he was clear that manufacturers, while being able to make suggestions for analysis and publication of results, did not have final say, and he said that numerous studies were rejected because companies would not agree to full access to databases or independence with the final publication of results.
One area that was not raised during the hearing, but was raised by the Project on Government Oversight regarding the ROCKET AF trial of rivaroxaban (Xarelto), for which he was co-primary investigator (N Engl J Med. 2011 Sep 8;365:883-91).
“Dr. Califf’s handling of the Xarelto trial raises concerns about his judgment in overseeing the pharmaceutical industry.” POGO Executive Director Danielle Brian said in a statement. “As senators consider Dr. Califf’s confirmation to run the FDA, they should ask tough questions about the Xarelto clinical trial.”
FDA primary reviewers recommended against approval based on a number of issues with the trial, but FDA ultimately decided in favor of bringing the drug to market.
A cardiologist by training, Dr. Califf has received support from the American College of Cardiology.
In an Oct. 21, 2015, letter to the Senate HELP Committee, ACC called Dr. Califf “the right person to lead the FDA as commissioner based on his impressive medical knowledge, clinical research experience, and visionary leadership abilities.”
Dr. Califf joined the FDA in February as deputy commissioner of medical products and currently provides executive leadership to FDA’s Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products.
He also oversees FDA’s Office of Special Medical Programs and plays a critical role in providing high-level advice and policy direction on the agency’s medical product and tobacco priorities.
Prior to coming to FDA, he was vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University in Durham, N.C. He has held multiple positions at the university, including director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute.
He also served as a member of FDA’s Cardiovascular and Renal Drugs Advisory Committee and the agency’s Science Board Subcommittee on Science and Technology.
“We believe that with Dr. Califf’s diverse background, and his exemplary knowledge of clinical and translational medicine, he will continue to improve the FDA’s drug approval process while ensuring that patients are receiving the safest and most effective treatments as quickly as possible. We urge his immediate confirmation,” a coalitions of 50 medical and advocacy groups, including the American Academy of Pediatrics, American Society of Clinical Oncology, American Association of Cancer Research, National Organization for Rare Disorders, and the Personalized Medicine Coalition, said in an Oct. 29, 2015, letter to the Senate HELP Committee.
AT THE SENATE HELP COMMITTEE HEARING
