Could Cipla dissuade the FDA from issuing a warning letter by defending the dismissal of thousands of complaints from asthma sufferers about jammed albuterol inhalers that came to light during a site inspection? The agency’s answer came in a warning letter.
The complaints began rolling in after Cipla Limited began commercially manufacturing albuterol rescue inhalers for the US market in April 2020 at its plant in Pithampur, India, according to a 17 November FDA warning letter that skewered the Indian pharmaceutical company’s response to them.
Many of the complaints, which exceeded 3,000 by December 2022, were from patients whose metered dose inhalers failed to produce the fine albuterol mist that would
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
