May 23, 2020–The Food and Drug Administration’s (FDA’s) use of and reliance on advisory committees has declined sharply over the past decade, according to an analysis in the May 2020 issue of the journal Health Affairs. How – and how often – the FDA relies on input from advisory committees were among the issues raised […]
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May 17, 2022 – Considering that the Food and Drug Administration (FDA) receives nearly half of its funding from medical product user fees, the timely reauthorization of user fees before the current iteration expires Sept. 30 is paramount to ensuring smooth product review operations. But this “must-pass” legislation opens the door to additional priorities and […]
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May 9, 2022 – New analyses of clinical trials conducted in the United States and in Europe on potential new drugs found that not only were study populations not as diverse as the general population, but that frequently no race or ethnicity data was included in the trial reports, and sometimes not even gender data. […]
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May 2, 2022 – Although Medicare Advantage (MA) plans often are touted for delivering more benefits at a lower cost than traditional Medicare, some critics argue that MA organizations (MAOs) deny beneficiaries coverage that they would receive under Medicare rules – including MRIs and post-acute care – in order to increase profits. As MA plan […]
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April 25, 2022 – With drug pricing a hot-button issue as the midterm elections draw near, a recent report from the IQVIA Institute for Human Data Science shines a spotlight on some of the nuances that often are missed when discussing the nuts and bolts of drug spending in the United States. One of the […]
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April 12, 2022 – Despite roughly 10,000 public comments and intense lobbying regarding a draft national coverage determination for the controversial Alzheimer’s drug Aduhelm, last week the Centers for Medicare and Medicaid Services (CMS) announced it will retain the proposal’s coverage plan: Medicare will only fund prescriptions of Aduhelm for patients enrolled in randomized, controlled […]
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April 4, 2022 – The fiscal year (FY) 2023 budget proposed by President Joe Biden last week emphasizes fiscal restraint more than new, big spending programs, but it does ask for increased funding for pandemic preparedness, the Food and Drug Administration (FDA), and projects such as the Cancer Moonshot and the Advanced Research Projects Agency […]
Read more March 21, 2022 – Pros and cons of the FDA’s accelerated approval pathway took center stage at a House Energy and Commerce Committee meeting held last week. While a slate of health-related bills for possible inclusion in the Prescription Drug User Fee Act (PDUFA VII) reauthorization package were discussed, the hearing led off with arguments […]
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Feb. 7, 2022 – Although the nomination of Dr. Robert Califf to return as FDA Commissioner was advanced by the Senate House, Education, Labor, and Pensions (HELP) Committee just weeks ago and it appeared Califf was poised to be confirmed by the full Senate, new opposition to his nomination reportedly has switched at least some […]
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Jan. 4, 2022 – 2021 was a year of many healthcare challenges, but against this backdrop the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) approved 50 novel drugs and its Center for Biologics Evaluation and Research (CBER) approved 10 biological license applications (BLAs) (plus three source plasma products). CDER nearly […]
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