FDA Holds Meeting the Review Merits of Approved Cancer Drugs
For the first time in a decade, the U.S. Food and Drug Administration will hold a meeting to consider revoking approvals of several cancer drugs that have not been shown to extend or improve life.
Drugs from Merck, Roche and Bristol-Myers Squibb will be the focus of the three-day meeting this week as part of industrywide review prompted by what FDA officials call an “unprecedented level of drug development” in recent years, the Associated Press reported.
Only three such meetings have been held in the agency’s history, with the last one held in 2011.
The FDA says it’s used an innovative approach to make medicines available more quickly for seriously ill patients. But many experts say the agency hasn’t taken action against medicines that fail to live up to their early promise, resulting in a number of costly, unproven drugs on the market, the AP reported.
“Doctors are using these drugs and patients are receiving them with all their toxicities and without knowing whether [they’re] actually doing anything,” Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania, told the AP. “We should not be in a situation where we’re endlessly uncertain.”
At this week’s meeting, the FDA will hear from the makers of the drugs and seek advice from a panel of cancer experts. The final decision on whether to revoke the cancer drugs’ approvals will be made by the FDA, the AP reported.
The U.S. spends more per person on prescription drugs than any other nation, and spending on cancer drugs has more than doubled since 2013 to over $60 billion annually, according to the data firm IQVIA, the AP reported. Many new medications typically cost $90,000 to $300,000 a year. And those prices have risen far faster than patient survival.
The FDA is prohibited from considering cost, but it is supposed to keep ineffective drugs off the market, the AP said.
“This is finally a referendum, a small court, where we can ask whether we are we better off for spending all this money,” Dr. Vinay Prasad, a cancer specialist at University of California, San Francisco. “And for many of these drugs, the answer looks like ‘no.'”
U.S. Will Help India in Fight Against Coronavirus: Biden
The United States will help India as it struggles with a massive wave of coronavirus cases, President Joe Biden said Sunday.
“Just as India sent assistance to the United States as our hospitals were strained early in the pandemic, we are determined to help India in its time of need,” Biden said in a tweet, the Associated Press reported.
He didn’t provide any specifics.
Earlier Sunday, the White House said the United States is “working around the clock” to immediately send drug treatments and rapid diagnostic COVID-19 testing kits to India. The United States also plans to send ventilators, personal protective equipment and oxygen supplies, the AP reported.
Other measures include providing raw material needed for India’s manufacture of the Covishield vaccine, and paying for an expansion of production capacity for the Indian vaccine manufacturer, BioE, so that it can make at least 1 billion doses of COVID-19 vaccines by the end of 2022, the AP reported.
CDC Issues Summer Camp Guidelines
Children at summer camps must wear masks at all times, except when swimming, napping, eating or drinking, the U.S. Centers for Disease Control and Prevention said in updated guidance released Sunday for summer camp operators.
The agency said children should be seated at least six feet apart for meals, snacks and water breaks, kept far apart when swimming, and positioned head to toe for naps, The New York Times reported.
As many activities as possible should be conducted outdoors. When activities must be indoors, spaces should be well-ventilated and windows should be kept open. Windows should also be open on camp buses and vans, the CDC said.
Children shouldn’t share toys, books or games, each camper should have a labeled cubby for their belongings, and each child should have a personal nap mat that’s sanitized before and after use, the Times reported.
Close contact, indoor sports, large gatherings and assemblies should be avoided, and singing, chanting or playing instruments should be done outdoors, the CDC advised.
Many camps are set to resume operations in mid-May, the Times reported.
Federal health officials also issued rules for overnight camps, saying eligible staff, volunteers, campers and family members should be fully vaccinated two weeks before traveling to camps, while those who are not vaccinated should self-quarantine for two weeks before arriving at camp, the Times reported. Those who are not fully vaccinated should also provide proof of a negative test for the virus, taken one to three days before arriving at the camp.
Campers and staff members should be screened for COVID symptoms upon arrival at camps, and screening tests should be conducted if there is substantial community transmission in the area. Daily symptom checks should also be carried out to monitor for possible illness, the advice said.
Anyone working at a camp who is 16 or older is “strongly encouraged” to get vaccinated “as soon as the opportunity is available,” the guidance added.
But immunized individuals must still wear masks around children, who are not eligible for vaccination yet, and stay 6 feet away from them. Children should also stay 6 feet away from children in other groups, the AP reported.
EU Will Allow Fully Vaccinated U.S. Tourists
American tourists who are fully vaccinated against COVID-19 will be allowed to visit the European Union over the summer, a top official said Monday.
“The Americans, as far as I can see, use European Medicines Agency [EMA]-approved vaccines,” Ursula von der Leyen, president of the European Commission, told The New York Times. “This will enable free movement and the travel to the European Union. Because one thing is clear: All 27 member states will accept, unconditionally, all those who are vaccinated with vaccines that are approved by EMA,” she added.
Von der Leyen did not offer a timeline on when exactly tourist travel might open up or details on how it would occur. But her comments are a top-level statement that the current travel restrictions are set to change on the basis of vaccination certificates.
She noted that the United States was making “huge progress” with its campaign to reach so-called herd immunity, or the vaccination of 70 percent of adults, by mid-June. She added that resumption of travel would depend “on the epidemiological situation, but the situation is improving in the United States, as it is, hopefully, also improving in the European Union.”
The EMA is the bloc’s drugs regulator and has approved all three vaccines (Moderna, Pfizer/BioNTech and Johnson & Johnson) being used in the United States, the Times reported.