The bill includes two provisions that would address drugmakers' calls for clarity on sharing off-label information with payers and regulators.
Insurers and pharmacy benefit managers already have a sophisticated understanding of clinical data, the industry argued.
The FDA asked questions about the risks and benefits of allowing off-label communications.
Here are 5 statistics about off-label promotion ahead of the FDA's public hearing this week.
Spurred by recent lawsuits, the FDA is scheduled to hold a two-day hearing this week on whether to allow drugmakers more latitude in promoting therapies off-label.
Supernus Pharmaceuticals received an untitled letter over a promotional video for Oxtellar XR.
The number of warning and untitled letters has dropped in recent years. Only four letters have been sent so far this year, compared to 28 in 2012.
The FDA responded to criticism from industry about its proposed research of DTC animation.
The agency's ambitions were fueled in part by external criticism. The barbs that stung most sharply were ones suggesting a certain indifference on the FDA's part.
The agency denied Pain Therapeutics' and Durect's abuse-deterrent opioid in a complete response letter after warning the drugmakers about how they promoted the drug.
The OPDP sent its second untitled letter this week, this time to Durect and Pain Therapeutics over the presentation of Remoxy ER.
The regulator cited inconsistencies with how safety trial data was recorded in a report released ahead of the advisory committee's meeting on Wednesday.
The regulator charged Celator Pharmaceuticals with promoting an experimental drug as safe and effective even though it has not been approved.
The FDA will hold a public hearing in November to gather input on how it should regulate certain off-label communications.
PhRMA and BIO, which represent life sciences firms, developed principles about sharing truthful and non-misleading information with payers and providers.
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