Moderna, Pharma Stocks Fall as FDA Names Industry Critic as Top Vaccine Regulator
Biotech and pharmaceutical stocks were sliding Tuesday afternoon as the U.S. Food and Drug Administration (FDA) named Dr. Vinay Prasad, a critic of FDA policy and the U.S. COVID-19 response, as its top vaccine regulator. Prasad has been harshly critical of the drug industry, and condemned his predecessor, Dr. Peter Marks, as too friendly with drugmakers.
Prasad’s appointment seemed to snap a brief run of gains for the biotech sector. Biotech stocks were up 20% from their April 8 low as of the end of the day on Friday. By Tuesday afternoon, the sector had returned to its customary doldrums. Shares of biotech companies began to fall after various outlets reported Prasad’s selection around 12:30 p.m. Eastern.
Prasad, a hematologist-oncologist and a professor at the University of California San Francisco, has been a vocal, combative voice in hot-button medical debates. He will replace Marks as director of the Center for Biologics Evaluation and Research, the FDA division responsible for vaccine approvals, among other things. Marks’s forced departure in March led to a biotech selloff, and a small revolt in some corners of the sector.
Physicians Committee Praises NIH for Closing Its Last Beagle Lab
Physician’s Committee for Responsible Medicine reported:
The National Institutes of Health (NIH) has closed its last beagle laboratory, according to National Institutes of Health Director Jay Bhattacharya, M.D., Ph.D., a move the nonprofit Physicians Committee for Responsible Medicine (PCRM), which advocates for ending animal research and utilizing human-based research, is praising. “We got rid of all the beagle experiments on the NIH campus,” Dr. Bhattacharya said in an interview this weekend on FOX & Friends.
“The NIH’s closure of its last beagle lab is a huge step forward in its efforts to move away from animal research. Cutting funding for animal experiments and bolstering human-based research will save animals and lead to better understanding and treatments of human disease,” says Catharine E. Krebs, Ph.D., medical research program manager for the PCRM. “We look forward to more animal lab closures, both at the NIH and at institutions it funds, as innovative research using tissue chips, computational methods, and other human-based approaches becomes the norm rather than the exception.”
Last month, the Physicians Committee and 324 scientists, physicians, and other health professionals sent a letter to Director Bhattacharya, asking him to cut funding for animal experiments, and to lead the agency in the important shift away from the use of animals in medical research in favor of human-based science. The organization has long engaged with the NIH, encouraging it to move in this direction.
N.I.H. Bars New Funding From U.S. Scientists to Partners Abroad
The National Institutes of Health (NIH) will no longer allow American scientists to direct its funding to research partners overseas, casting doubt on the future of studies on subjects including malaria and childhood cancer.
Dr. Jay Bhattacharya, the new director of the NIH, announced the policy on Thursday, the same day Dr. Matthew J. Memoli, the principal deputy director, blasted these so-called subawards in an email obtained by The New York Times. “If you can’t clearly justify why you are doing something overseas, as in it can’t possibly be done anywhere else and it benefits the American people,” Dr. Memoli wrote, “then the project should be closed down.”
The new restrictions, which will apply to domestic subawards as well in the future, come amid deep reductions in NIH. funding and the freezing of federal grants at many top universities, along with executive orders seeking to reshape the nation’s scientific agenda. On Monday, President Trump signed an executive order restricting a type of experimentation that can make pathogens more dangerous to humans, and ending support for the so-called gain-of-function research in countries like China.
Researchers funded by NIH. grants have historically used subawards to facilitate international collaborations, which are essential for studying conditions like childhood cancer or illnesses like malaria and tuberculosis that are not prevalent in the U.S.
Nearly Quarter of People on Long-Acting Opioids Develop Addiction, Study Reveals
More than one in five people prescribed extended-release painkillers such as OxyContin developed an addiction within a year, according to a newly released study mandated by the U.S. Food and Drug Administration (FDA).
The study, repeatedly delayed by more than a decade and released on May 5, revealed a far higher percentage of pain patients addicted to opioids than drugmakers’ sales reps claimed in their marketing materials and representations to physicians.
The FDA now faces the question of how to use this data to evaluate whether the agency should make changes to opioid regulation, limiting broad approvals of long-acting opioids for extended use. The FDA is currently holding hearings to discuss the findings and is being asked by advocates to change the drugs’ labels, which guide how doctors prescribe them.
Pharma’s Plastic Prescription Bottle Problem Gets a Paper Solution
Have you ever stopped to think about what happens to those little orange pill bottles after you finish your prescription? Every year, around 200 billion of these bottles are produced worldwide, and sadly most of them end up in landfills. In the U.S. alone, about four to five billion plastic pill bottles are thrown away each year. That’s enough plastic to circle the Earth multiple times.
While they might seem harmless, these bottles contribute significantly to the growing plastic pollution crisis because they’re often not recycled properly. Plastic has become the go-to material for packaging, including in medicine, because it’s cheap, durable and easy to produce. However, the environmental cost is huge, and the pharmaceutical industry has struggled to find a sustainable alternative.
Enter the Tully Tube, a revolutionary new pill bottle made mostly from 100% sustainably sourced paper. Developed by Parcel Health, this isn’t just any paper bottle. It’s the first one to meet the strict U.S. Food and Drug Administration regulations for food-contact packaging, making it safe to use for prescription medications.
