Asthma represents one of the blockbuster markets in the pharmaceutical industry; sales of drugs from 10 companies amount to $14 billion each year. Yet despite the high-volume sales of asthma drugs, in 73% of patients the disease is poorly controlled. For pharmaceutical firms and start-ups, the complex, multifactorial disease offers tantalizing possibilities; it's an enormous, yet underserved market with many points of entry, mechanistically speaking.

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.

Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.