Less than 1% of the U.S. population uses cannabis for medical purposes on a regular basis. A key obstacle to mainstream acceptance of cannabis as medical treatment is the lack of clinical trials that demonstrate safety and efficacy of treatment outcomes. The FDA will not allow medical or health claims on cannabis products that have not been proven in clinical trials, which currently cannot be conducted on cannabis as it is considered a dangerous Schedule 1 substance. (The Jerusalem Post)
Adverse Events are underreported in targeted therapy trials
In a recent study, many trials leading to the approval of a targeted therapy were not fully transparent about the risk for adverse events (AEs), and most were deficient in reporting recurrent and late toxicities. Underreporting of AEs might be more frequent with targeted treatments than conventional chemotherapies. AEs associated with targeted agents persist longer may not be not fully captured by physicians. (Clinical Oncology)
Former FDA commissioner: 5 takeaways on drug approval standards and safety
Dr. Robert Califf, the former commissioner of the Food and Drug Administration (FDA), shared his thoughts about keeping Americans safe- and making sure drugs actually work- after a year of overseeing the federal agency. Califf is concerned about plans to speed up drug approvals and dramatically reduce regulations at the agency, as advocated by President Donald Trump. (Modern Healthcare)
Should approval for 18 cancer drugs be withdrawn?
The U.S. Food and Drug Administration (FDA) has increasingly used the accelerated pathway to bring potentially lifesaving drugs to market faster. Once granted, accelerated drug approvals are subject to withdrawal if a postmarketing study fails to confirm clinical benefit. The authors examined 18 cancer drugs that received accelerated FDA approval, but were found in postmarketing confirmatory trials to have no overall survival (OS) benefit. The FDA should withdraw approval for cancer drugs that are proven to have no clinical benefit. (The JAMA Network)
Trump to pharma CEOs: 75% to 80% of FDA regulations will be eliminated
In a sign of what’s to come for the U.S. Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs that his administration will be cutting regulations at a level no one has ever seen before. He said the comments in terms of the drug approval process. Between 75% and 80% of all FDA regulations will be eliminated he added, before commenting on a lack of foreign relations without any specifics. (Regulatory Affairs Professionals Society)
San Diego VP is elected President of the European CRO Federation
In December, Martine Dehlinger-Kremer, VP of global medical and regulatory affairs at the Carlsbad CRO SynteractHCR, was elected president of the European CRO Federation, which represents 300 CROs across 18 countries.
The Current 21st Century Cures Legislation Is Still A Bad Deal For Patients
In July 2015, the House of Representatives passed the 21st Century Cures Act, which contained public science funding and numerous provisions aimed at adjusting how the Food and Drug Administration (FDA) evaluates new medical products and new indications for existing prescription drugs and devices.
Whereas the original bill was lauded for providing National Institutes of Health (NIH) funding for the discovery of new medical advances, the current bill provides significantly less certainty in its support for prevention, research, and regulatory science.
Easier Pathways, Greater Risk
Is It Worth It? (health affairs.org)
New clinical trials registry regulations go into effect in January 2017: top points in one chart
New HHS clinical trials registry regulations set to go into effect in January 2017: top points in one chart
28 NOV 2016
By: Gail Hannah Javitt | Jae Kim
Nearly a decade after Congress directed significant expansion of the national clinical trials database, www.ClinicalTrials.gov, the US Department of Health and Human Services (HHS) has issued final implementing regulations (the Final Rule). Weighing in at 177 pages, and informed by nearly 900 comments, the Final Rule, issued in late September, aims to improve public access to information about specified clinical trials involving FDA-regulated products.
Final Rule’s top points
The Final Rule codifies and expands on the requirements specified in the Food and Drug Administration Modernization Act of 1997 FDAAA. The table in the linked report highlights key clarifications and changes. (DLA Piper)
Juno and the FDA screwed up. People died. What now?
Let’s say it plain and simple: Juno Therapeutics $JUNO and the FDA screwed up and patients died.
The day ahead of Thanksgiving, Juno managed to once again stun its investors with the news that its lead CAR-T, JCAR015, killed two people. They died from cerebral edemas triggered by neurotoxicity. And the death toll from brain swelling triggered by its toxic combo has now reached six, including a death in a separate study. (John Carroll, Endpoints News)
House lawmakers passed the biggest health reform bill since the Affordable Care Act
After three years of wrangling, the House on Wednesday passed a $6.3 billion bill that would dramatically overhaul the way drugs are approved in the United States.
The 21st Century Cures Act is a bipartisan effort that’s been in the works since April 2014. The idea behind the bill is that the Food and Drug Administration’s current approval process is clunky and out of date, delaying potentially lifesaving drugs and devices from reaching the patients who need them. The bill aims to modernize the process, accelerate drug and device innovation by boosting funding for research, and get cures onto the market faster.
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