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.
Judge halts Praluent sales; clinical-trial data for Diclegis in question; cancer drugs to make up larger portion of total drug spending
The agency has faced questions about how it regulates off-label communications.
Sanofi sues Novo over Tresiba marketing; the FDA issues two more untitled letters; U.S. health spending rose substantially from 1996 to 2013
Senate report said certain drugmakers act like hedge funds; ViiV to develop HIV prevention drug; lawmakers to replace ACA with "universal access"
Allergan to settle allegations relating to speakers bureaus; Mylan launches generic version of the EpiPen; 20 states sue six drugmakers accused of price-fixing
Regulators said the ads distract viewers from superimposed safety information.
The previous deadline was January 9.
A California lawmaker reintroduces drug-pricing bill; France, Poland, Spain, and Sweden lobby to host EMA; drug stocks fall after Trump's comments
The bill now heads to President Obama's desk. He is expected to sign the sweeping piece of legislation.
The bill includes two provisions that would address drugmakers' calls for clarity on sharing off-label information with payers and regulators.
The CMS spent more on Harvoni than any other drug; Novartis considers selling Alcon; the EMA recommends approval of Lantus biosimilar
Trump says he will reform the FDA; pharmaceutical M&A expected to pick up; superbug causing infections in cystic-fibrosis patients
The FDA asked questions about the risks and benefits of allowing off-label communications.
FDA solicits public comment to study online character space limit; Biogen's Spinraza shows positive results in SMA study; Valeant cuts earnings forecast
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.
Here are 5 statistics about off-label promotion ahead of the FDA's public hearing this week.
Supernus Pharmaceuticals received an untitled letter over a promotional video for Oxtellar XR.
With lawmakers, patients, and physicians crying foul over pricing, drugmakers are trying to shift the narrative — with mixed results. Can a new focus on storytelling help?
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.
Now here comes the big question. Will the shareholders and directors of KaloBios and Allergan reward or punish their CEOs for what some may see as revenue-capping concessions?
Lawmakers ask for information about price of leukemia drug; Abbott writes down losses from Mylan stake; CVS Health focused on role as health brand
More drugmakers file lawsuits to prevent biosimilar competition; experimental dermatitis drug showeds promising results; pharma blames PBMs for price hikes
For some people in the industry ecosystem, the appeal of promo knickknacks endures.
Five decades ago, pharmaceuticals were the protected province of health professionals. Today we have DTC ads, the internet, and pharmacy handouts.
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.
Mylan CEO comes under fire at House Committee hearing; Abbott OxyContin reps went to great lengths to sell the pain pill; UnitedHealth drops Lantus
- Five things for pharma marketers to know: Wednesday, March 22, 2017
- Five things for pharma marketers to know: Monday, March 20, 2017
- Novartis aims to bring first oral asthma drug to market in two decades
- Drugmakers target severe asthma patients with biologics, but payers raise pricing issue
- Five things for pharma marketers to know: Tuesday, March 21, 2017
- 2017 Healthcare Marketers Trend Report: All the data in one place
- Infographic: What's next for the point of care market
- Drugmakers again boost DTC spending, to $5.6 billion in 2016
- Digital IDs become focus as drugmakers seek to track doctors' behavior online
- Some CME experts remain skeptical when it comes to social media