In the second of two hearings before the U.S. Senate Health, Education, Labor and Pensions Committee on the next iteration of the FDA drug and device user fee agreements, the focus was supposed to be on advancing regulation and innovation. But Ranking Member Richard Burr (R-N.C.) shifted the spotlight April 26 to accountability in his opening remarks and subsequent questioning.
There may be no COVID-19 vaccines authorized yet in the U.S. for the youngest children, but there’s now an approved treatment for some children who are already sick with an infection.
Links to electronic information may become a more common feature in Canadian prescription drug labeling, but electronic labeling is not expected to replace paper labels anytime soon.
Recognizing that patient views about the tradeoffs of using one drug over another may differ from those of doctors, the U.S. FDA’s Office of Prescription Drug Promotion is proposing to examine those tradeoffs in an analysis involving fictitious prescription drugs for type 2 diabetes and psoriasis.
The U.S. FDA wants feedback on its latest idea to reduce the number of unused prescription opioids shelved in American homes: requiring prepaid mail-back envelopes to be dispensed with the painkillers.
Sponsors developing PI3K inhibitors to treat hematologic malignancies in the U.S. may have to up their game if they want to get FDA approval. The Oncologic Drugs Advisory Committee voted 16-0, with one abstention, that future approvals of the drugs should be supported by randomized data. Given the FDA’s briefing document ahead of the April 21 meeting and its presentations to the committee, the agency is likely to follow that recommendation.
Citing the flexibilities implemented during the COVID-19 pandemic, the Bloomberg New Economy International Cancer Coalition is pushing to convert those improvements to a permanent paradigm shift in the way cancer patients are diagnosed, treated and cared for across the globe.
After several delays due to COVID-19, Canada is on track to implement, within a few months, its first major changes to its Patented Medicines Regulations in more than 30 years. One change coming July 1 is a new basket of comparator countries that will be used to determine whether a drug’s Canadian price is excessive.
The U.S. COVID-19 vaccine program is at risk of “booster fatigue,” which will undermine public confidence in the vaccines, several members of the CDC’s Advisory Committee on Immunization Practices (ACIP) said April 20 as they met to discuss the future of the vaccines. Rather than relying on boosters, “we need to use our expertise to advocate for something that’s better,” something that resolves the ill effects of COVID-19, whether it’s mild or severe, said Lynn Bahta, an immunization program clinical consultant for the Minnesota Department of Health.
With renewed focus on the U.S. Cancer Moonshot, the price of oncology drugs is more than a satellite issue, especially as new drugs launch with ever-increasing prices and other cancer drugs continue to see price hikes.
