Former US FDA Commissioner Robert Califf remains eager to encourage broader use of real-world evidence – but his blunt, pessimistic read on the state of biopharma innovation is remarkable coming from a former FDA head.
At a time of record-setting totals of new drug approvals by the US Food and Drug Administration, it is hard to find pessimists about the state of biomedical innovation.
So it was remarkable to hear one of FDA’s former commissioners, Robert Califf, offer a starkly negative take on the “Breakthrough” era during a recent Duke Margolis workshop convened on behalf of the agency
The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.
Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.
Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.
Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.
