War on Cancer Redux
Publicado por NiuKevin en
WASHINGTON -- President Obama taps the vice president to lead a "moonshot" mission to cure cancer, and a Senate committee backed Robert Califf, MD, to be FDA commissioner.
President Obama Pledges to Fight Cancer in Final SOTU
In his final State of the Union address Tuesday night, President Obama launched a national campaign to eliminate cancer, the leading cause of death worldwide.
"For the loved ones we've all lost, for the family we can still save, let's make America the country that cures cancer once and for all," Obama said.
The president appointed Vice President Joe Biden to lead the "moonshot" mission. He highlighted the vice president's role in lobbying Congress to grant more funding to the National Institutes of Health (NIH) than the agency had seen in a decade.
In December, Congress passed a $1.15 trillion spending bill which included a $2 billion increase to the agency.
FDA: Califf Wins Unanimous Support of Senate Committee
The Senate Health, Education, Labor, and Pensions Committee voted unanimously Tuesday in a voice vote to approve the nomination of Robert Califf, MD, as FDA commissioner.
Several committee members spoke briefly in praise of Califf, a cardiologist who is serving as the FDA's deputy commissioner for medical products and tobacco.
"I said [at his confirmation hearing] on Nov. 17 that I have seen nothing that calls into question his ability to lead the agency fairly and impartially," said committee chair Lamar Alexander (R-Tenn.). "I believe that today ... I plan to support him for commissioner and I encourage my colleagues to do the same."
Probuphine Gets Advisory Committee Thumbs-Up
An FDA advisory committee voted 12 to 5 to recommend approval of a buprenorphine implant (Probuphine) to treat patients who are already stable on low doses of the sublingual version of the drug on Tuesday.
The favorable vote followed a substantial reanalysis of clinical trial data by FDA reviewers, who raised concerns about missing data and the company's definition of a responder.
Ultimately, those reanalyses quashed drugmaker Braeburn Pharmaceuticals' suggestions that Probuphine was superior to sublingual buprenorphine, showing in conservative estimates that the company could only prove non-inferiority.
Meaningful Use Program is Ending, CMS Chief Says
The Centers for Medicare and Medicaid Services (CMS) is planning to end the Meaningful Use program, CMS acting administrator Andy Slavitt, MBA said at a healthcare investors conference in San Francisco.
"The meaningful use program as it has existed will now effectively be over and be replaced with something better," Slavitt said Monday at the J.P. Morgan Healthcare Conference. The specifics of the new program will be revealed in the next few months, he added.
"Now that we effectively have technology in virtually every place care is provided, we are now in the process of ending Meaningful Use and moving to a new regime culminating with the MACRA implementation," Slavitt explained, referring to the Medicare Access and CHIP Reauthorization Act, the law that repealed the Sustainable Growth Rate reimbursement formula. Most of MACRA's provisions take effect in 2019.
MedPAC Recommends Changes to 340B Drug Program
An advisory body to Congress voted 14-3 in favor of a draft recommendation that would cut Part B drug payments rates for hospitals in the 340B Drug Pricing Program by 10%.
In 2015, Congress tasked The Medicare Payment Advisory Commission (MedPAC) with reviewing the 340B drug program, which mandates that pharmaceutical companies must discount outpatient drugs to certain eligible healthcare organizations, such as Medicare/Medicaid Disproportionate Share Hospitals (DSH) and other safety-net providers.
In its review, the commission noted that Medicare pays the same rate to hospitals in the 340B drug program as non-340B hospitals. Yet 340B hospitals by definition receive Part B drugs at a much lower rate than Medicare pays them. Moreover, the 340B drug program bases eligibility criteria for the program on hospitals with the greatest share of Medicaid patients.
GAO Urges FDA to Improve Oversight and Monitoring of Expedited Approvals
A quarter of drug applications received by FDA's Center for Drug Evaluation and Research (CDER) between 2006 and 2014 used one or more of the FDA's expedited pathways, according to a report from the Government Accountability Office released on Thursday.
While the GAO was not directly critical of the surge of expedited approvals, the office, in its report, warned the FDA to keep a closer eye on the post-marketing safety of these products -- new drugs and biologics, and old agents approved for new uses.
The FDA has four unique expedited programs and many applications use two or more of these channels. Two of these programs, the "fast track" and "breakthrough therapy" designations, require sponsors to submit formal requests.
About two-thirds of the 770 requests for fast track designation received since 2007 have been approved, but less than half of the approximately 22o requests for breakthrough therapy designations were approved since the pathway was developed in 2012.
The GAO's review of the FDA's own data found the agency lacked "reliable, readily accessible data on tracked safety issues" of these products. The report also noted that the agency shirked certain postmarket safety reporting responsibilities.
A summary of the GAO's report emphasized that "evaluations conducted by CDER of data in its database revealed problems with the completeness, timeliness, and accuracy of the data." It also underscored that the methods for recording data limited access to the information.
The office recommends that the Secretary of HHS direct the FDA Commissioner to "develop comprehensive plans, with goals and time frames, to help ensure that identified problems with the completeness, timeliness, and accuracy of information in its database on tracked safety issues and postmarket studies are corrected."
A summary of the GAO's report emphasized that "evaluations conducted by CDER of data in its database revealed problems with the completeness, timeliness, and accuracy of the data." It also underscored that the methods for recording data limited access to the information.
The office recommends that the Secretary of HHS direct the FDA Commissioner to "develop comprehensive plans, with goals and time frames, to help ensure that identified problems with the completeness, timeliness, and accuracy of information in its database on tracked safety issues and postmarket studies are corrected."
President Obama Pledges to Fight Cancer in Final SOTU
In his final State of the Union address Tuesday night, President Obama launched a national campaign to eliminate cancer, the leading cause of death worldwide.
"For the loved ones we've all lost, for the family we can still save, let's make America the country that cures cancer once and for all," Obama said.
The president appointed Vice President Joe Biden to lead the "moonshot" mission. He highlighted the vice president's role in lobbying Congress to grant more funding to the National Institutes of Health (NIH) than the agency had seen in a decade.
In December, Congress passed a $1.15 trillion spending bill which included a $2 billion increase to the agency.
FDA: Califf Wins Unanimous Support of Senate Committee
The Senate Health, Education, Labor, and Pensions Committee voted unanimously Tuesday in a voice vote to approve the nomination of Robert Califf, MD, as FDA commissioner.
Several committee members spoke briefly in praise of Califf, a cardiologist who is serving as the FDA's deputy commissioner for medical products and tobacco.
"I said [at his confirmation hearing] on Nov. 17 that I have seen nothing that calls into question his ability to lead the agency fairly and impartially," said committee chair Lamar Alexander (R-Tenn.). "I believe that today ... I plan to support him for commissioner and I encourage my colleagues to do the same."
Probuphine Gets Advisory Committee Thumbs-Up
An FDA advisory committee voted 12 to 5 to recommend approval of a buprenorphine implant (Probuphine) to treat patients who are already stable on low doses of the sublingual version of the drug on Tuesday.
The favorable vote followed a substantial reanalysis of clinical trial data by FDA reviewers, who raised concerns about missing data and the company's definition of a responder.
Ultimately, those reanalyses quashed drugmaker Braeburn Pharmaceuticals' suggestions that Probuphine was superior to sublingual buprenorphine, showing in conservative estimates that the company could only prove non-inferiority.
Meaningful Use Program is Ending, CMS Chief Says
The Centers for Medicare and Medicaid Services (CMS) is planning to end the Meaningful Use program, CMS acting administrator Andy Slavitt, MBA said at a healthcare investors conference in San Francisco.
"The meaningful use program as it has existed will now effectively be over and be replaced with something better," Slavitt said Monday at the J.P. Morgan Healthcare Conference. The specifics of the new program will be revealed in the next few months, he added.
"Now that we effectively have technology in virtually every place care is provided, we are now in the process of ending Meaningful Use and moving to a new regime culminating with the MACRA implementation," Slavitt explained, referring to the Medicare Access and CHIP Reauthorization Act, the law that repealed the Sustainable Growth Rate reimbursement formula. Most of MACRA's provisions take effect in 2019.
MedPAC Recommends Changes to 340B Drug Program
An advisory body to Congress voted 14-3 in favor of a draft recommendation that would cut Part B drug payments rates for hospitals in the 340B Drug Pricing Program by 10%.
In 2015, Congress tasked The Medicare Payment Advisory Commission (MedPAC) with reviewing the 340B drug program, which mandates that pharmaceutical companies must discount outpatient drugs to certain eligible healthcare organizations, such as Medicare/Medicaid Disproportionate Share Hospitals (DSH) and other safety-net providers.
In its review, the commission noted that Medicare pays the same rate to hospitals in the 340B drug program as non-340B hospitals. Yet 340B hospitals by definition receive Part B drugs at a much lower rate than Medicare pays them. Moreover, the 340B drug program bases eligibility criteria for the program on hospitals with the greatest share of Medicaid patients.
GAO Urges FDA to Improve Oversight and Monitoring of Expedited Approvals
A quarter of drug applications received by FDA's Center for Drug Evaluation and Research (CDER) between 2006 and 2014 used one or more of the FDA's expedited pathways, according to a report from the Government Accountability Office released on Thursday.
While the GAO was not directly critical of the surge of expedited approvals, the office, in its report, warned the FDA to keep a closer eye on the post-marketing safety of these products -- new drugs and biologics, and old agents approved for new uses.
The FDA has four unique expedited programs and many applications use two or more of these channels. Two of these programs, the "fast track" and "breakthrough therapy" designations, require sponsors to submit formal requests.
About two-thirds of the 770 requests for fast track designation received since 2007 have been approved, but less than half of the approximately 22o requests for breakthrough therapy designations were approved since the pathway was developed in 2012.
The GAO's review of the FDA's own data found the agency lacked "reliable, readily accessible data on tracked safety issues" of these products. The report also noted that the agency shirked certain postmarket safety reporting responsibilities.
A summary of the GAO's report emphasized that "evaluations conducted by CDER of data in its database revealed problems with the completeness, timeliness, and accuracy of the data." It also underscored that the methods for recording data limited access to the information.
The office recommends that the Secretary of HHS direct the FDA Commissioner to "develop comprehensive plans, with goals and time frames, to help ensure that identified problems with the completeness, timeliness, and accuracy of information in its database on tracked safety issues and postmarket studies are corrected."
A summary of the GAO's report emphasized that "evaluations conducted by CDER of data in its database revealed problems with the completeness, timeliness, and accuracy of the data." It also underscored that the methods for recording data limited access to the information.
The office recommends that the Secretary of HHS direct the FDA Commissioner to "develop comprehensive plans, with goals and time frames, to help ensure that identified problems with the completeness, timeliness, and accuracy of information in its database on tracked safety issues and postmarket studies are corrected."