The FDA recently proposed studies designed to determine how disclosures in drug ads affect how viewers frame information.
The drugmaker has been handed a "public reprimand" by the U.K.'s Prescription Medicines Code of Practice Authority after the creative director of an unnamed agency used the company's patient support materials on its website.
The bill, introduced in March, is being considered as an amendment in the upcoming PDUFA reauthorization legislation.
The regulator also took issue with how Orexigen Therapeutics presented the risk information
The ad-tax deduction is likely once again on the table.
The former FDA commissioner said marketers need to focus on ensuring that off-label promotion is "non-misleading."
Sandoz counsel argued that Amgen's position "wrongly delays the marketing of every biosimilar."
The committee is seeking information about the companies' sales and marketing strategies.
Veeva is countersuing QuintilesIMS in the wake of allegations that Veeva mishandled its proprietary data.
PhRMA, BIO, and the Medical Information Working Group filed a citizen petition over a final rule they say raises risks for drugmakers.
But it may also increase the reporting burden for drugmakers.
The regulator is providing examples of appropriate off-label communications.
The agency issued 11 enforcement letters last year.
The agency has faced questions about how it regulates off-label communications.
Regulators said the ads distract viewers from superimposed safety information.