Some sort of "pharmacy intervention" could aid switches, CEO Hendrickson says; board bloc is still pushing to divest the generic Rx segment but apparent second-quarter sales validation isn't enough to persuade Hendrickson to stay on.
Perrigo Co. PLC CEO John Hendrickson used the pulpit of what was likely his final earnings briefing at the helm of the OTC private label leader to urge FDA and manufacturers to make more Rx drug ingredients available nonprescription.
During Perrigo’s second-quarter earnings briefing on Aug
Three new drug applications to FDA for a statin OTC switch failed and a fourth proposal stalled before an NDA was submitted (see box)
A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.
The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.
Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.
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.
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.
