Anticipating a day when price comparisons may be a key element in prescription drug advertising, the FDA plans to study how best to present price information in physician and direct-to-consumer (DTC) ads without implying that two drugs are interchangeable. The results of the studies could dictate how drugmakers market biosimilars in the U.S. Under current FDA regulations, ads that include price comparisons must provide context indicating that the two drugs may not be comparable in terms of efficacy and safety and that the “costs presented do not necessarily reflect the actual prices paid by consumers, pharmacies or third party payers,” the agency said.
The FDA released a draft guidance on developing drugs to treat hospital-acquired and ventilator-associated bacterial pneumonia using noninferiority trial designs. In updating a 2010 draft guidance on the same topic, the new draft revises the primary efficacy endpoints, enrollment criteria, suggested primary efficacy analysis populations and noninferiority margin justification. Comments on the latest draft are due by Aug. 5.
The FDA has denied citizen’s petitions filed by Eisai Inc. and UCB Inc. to change how the agency sets the five-year exclusivity clock for new chemical entities that require Controlled Substances Act scheduling, stating that the approach the petitioners suggested is unworkable under current regulations. //