More than 200 pharmaceutical companies signed a statement calling for the reversal of a recent ruling that invalidated FDA's approval of the abortion pill mifepristone, in today's bite-sized hospital and health industry news from Michigan, New York, and Texas.
- Michigan: Local, state, and federal health officials are investigating reports that at least 90 employees at the Billerud paper mill in the Upper Peninsula are believed to be infected with blastomycosis — a fungus found in soil and decaying wood. Because the fungal disease does not typically transfer between people, blastomycosis outbreaks do not usually affect large groups. This outbreak indicates that employees became infected after being exposed to the same materials containing the blastomyces fungal spores. "I've been at the paper mill for about 11 years, and we have never seen anything like this," said Gerald Kell, president of the United Steel Workers Local 21 union, which represents around 670 of the mill's employees. "Roughly a dozen" employees have been hospitalized "to one degree or another" due to the disease, including at least one employee who has been hospitalized for weeks, Kell said. (Matheny, Detroit Free Press, 4/8)
- New York: Pfizer's experimental respiratory syncytial virus (RSV) vaccine was 82% effective in preventing severe infections in infants when administered to pregnant people during the second half of their pregnancy, according to trial details published last week. Overall, the study evaluated 3,570 infants. According to Pfizer, six infants whose mothers received the vaccine experienced severe illness within three months, compared with 33 infants from the placebo group who became seriously ill. In the first 180 days, the shot was 69.4% effective at preventing severe RSV infections. However, severe illness occurred within six months in 19 infants born to mothers in the vaccine group, compared with 62 infants in the placebo group. If Pfizer's shot is given FDA approval, it could become the first maternal vaccine available to prevent RSV in infants. (Reuters, 4/6)
- Texas: Following Judge Matthew Kacsmaryk's ruling that invalidated FDA's approval of mifepristone, more than 200 pharmaceutical companies signed a statement calling for the reversal of the decision. In the ruling, Kacsmaryk argued that the agency did not adequately review scientific evidence or follow the proper protocols when it approved the drug in 2000. On Monday, over 400 leaders from some of the most prominent companies in the drug and biotech industry criticized Kacsmaryk for issuing the ruling, noting that he has "no scientific training" and warning that the decision has "undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American." In addition, "[t]he decision ignores decades of scientific evidence and legal precedent," the drugmakers wrote. "Judge Kacsmaryk's act of judicial interference has set a precedent for diminishing FDA's authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry." (Belluck/Jewett, New York Times, 4/11; Wile, NBC News, 4/10)