House passes 21st Century Cures Act that would allow some off-label sharing

House passes 21st Century Cures Act that would allow some off-label sharing

The bill includes two provisions that would address drugmakers' calls for clarity on sharing off-label information with payers and regulators.

Pharma pushes to share off-label info with payers at FDA hearing

Pharma pushes to share off-label info with payers at FDA hearing

Insurers and pharmacy benefit managers already have a sophisticated understanding of clinical data, the industry argued.

5 questions raised at the FDA's off-label hearing

5 questions raised at the FDA's off-label hearing

The FDA asked questions about the risks and benefits of allowing off-label communications.

Off-label promotion: By the numbers

Off-label promotion: By the numbers

Here are 5 statistics about off-label promotion ahead of the FDA's public hearing this week.

Will drugmakers get what they're looking for at this week's FDA off-label hearing?

Will drugmakers get what they're looking for at this week's FDA off-label hearing?

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.

FDA charges KOL with misbranding seizure drug in promo video

FDA charges KOL with misbranding seizure drug in promo video

Supernus Pharmaceuticals received an untitled letter over a promotional video for Oxtellar XR.

Warning letters most often stem from missing risk information

Warning letters most often stem from missing risk information

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.

Drugmakers spar with FDA over proposed DTC animation study

Drugmakers spar with FDA over proposed DTC animation study

The FDA responded to criticism from industry about its proposed research of DTC animation.

Why the FDA's view of patient communication evolved over time

Why the FDA's view of patient communication evolved over time

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 FDA denies approval of abuse-deterrent opioid after promotional warning

The FDA denies approval of abuse-deterrent opioid after promotional warning

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 FDA warns drugmakers over promotion of experimental opioid

The FDA warns drugmakers over promotion of experimental opioid

The OPDP sent its second untitled letter this week, this time to Durect and Pain Therapeutics over the presentation of Remoxy ER.

The FDA criticizes Pfizer's safety study for Chantix

The FDA criticizes Pfizer's safety study for Chantix

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 FDA sends untitled letter to Jazz subsidiary over ASCO display

The FDA sends untitled letter to Jazz subsidiary over ASCO display

The regulator charged Celator Pharmaceuticals with promoting an experimental drug as safe and effective even though it has not been approved.

The FDA asks for input on off-label comms

The FDA asks for input on off-label comms

The FDA will hold a public hearing in November to gather input on how it should regulate certain off-label communications.

Lobbyists create off-label principles following FDA lawsuits

PhRMA and BIO, which represent life sciences firms, developed principles about sharing truthful and non-misleading information with payers and providers.