Legal/Regulatory

PhRMA debuts new ads in Go Boldly campaign

PhRMA debuts new ads in Go Boldly campaign

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PhRMA worked with WPP Health & Wellness and Young & Rubicam on creative for the ads.

Five things for pharma marketers to know: Friday, April 14, 2017

Five things for pharma marketers to know: Friday, April 14, 2017

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Lawmaker wants better enforcement of TV ads placed by lawyers; more toddlers are taking antipsychotics; Neurocrine puts off price disclosure of new drug

Senate committee launches investigation into opioid marketing

Senate committee launches investigation into opioid marketing

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The committee is seeking information about the companies' sales and marketing strategies.

Veeva and QuintilesIMS tussle over customer reference data

Veeva and QuintilesIMS tussle over customer reference data

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Veeva is countersuing QuintilesIMS in the wake of allegations that Veeva mishandled its proprietary data.

Industry groups petition the FDA over off-label rule

Industry groups petition the FDA over off-label rule

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PhRMA, BIO, and the Medical Information Working Group filed a citizen petition over a final rule they say raises risks for drugmakers.

FDA guidance seeks to clarify pharma comms with payers

FDA guidance seeks to clarify pharma comms with payers

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But it may also increase the reporting burden for drugmakers.

In draft guidance, the FDA defines appropriate off-label comms as being 'consistent' with the label

In draft guidance, the FDA defines appropriate off-label comms as being 'consistent' with the label

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The regulator is providing examples of appropriate off-label communications.

The FDA targeted DTC, video, unapproved drug promotion in 2016

The FDA targeted DTC, video, unapproved drug promotion in 2016

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The agency issued 11 enforcement letters last year.

Five things for pharma marketers to know: Friday, January 6, 2017

Five things for pharma marketers to know: Friday, January 6, 2017

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Judge halts Praluent sales; clinical-trial data for Diclegis in question; cancer drugs to make up larger portion of total drug spending

The FDA to study whether people can recognize misleading drug ads

The FDA to study whether people can recognize misleading drug ads

The agency has faced questions about how it regulates off-label communications.

Five things for pharma marketers to know: Wednesday, December 28, 2016

Five things for pharma marketers to know: Wednesday, December 28, 2016

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Sanofi sues Novo over Tresiba marketing; the FDA issues two more untitled letters; U.S. health spending rose substantially from 1996 to 2013

Five things for pharma marketers to know: Thursday, December 22, 2016

Five things for pharma marketers to know: Thursday, December 22, 2016

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Senate report said certain drugmakers act like hedge funds; ViiV to develop HIV prevention drug; lawmakers to replace ACA with "universal access"

Five things for pharma marketers to know: Friday, December 16, 2016

Five things for pharma marketers to know: Friday, December 16, 2016

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Allergan to settle allegations relating to speakers bureaus; Mylan launches generic version of the EpiPen; 20 states sue six drugmakers accused of price-fixing

The FDA issues untitled letters to Sanofi and Celgene over distracting ads

The FDA issues untitled letters to Sanofi and Celgene over distracting ads

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Regulators said the ads distract viewers from superimposed safety information.

The FDA extends deadline for off-label input

The FDA extends deadline for off-label input

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The previous deadline was January 9.

Five things for pharma marketers to know: Thursday, December 8, 2016

Five things for pharma marketers to know: Thursday, December 8, 2016

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A California lawmaker reintroduces drug-pricing bill; France, Poland, Spain, and Sweden lobby to host EMA; drug stocks fall after Trump's comments

Senate passes Cures Act, which opens door to use of real-world evidence

Senate passes Cures Act, which opens door to use of real-world evidence

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The bill now heads to President Obama's desk. He is expected to sign the sweeping piece of legislation.

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

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

Five things for pharma marketers to know: Tuesday, November 15, 2016

Five things for pharma marketers to know: Tuesday, November 15, 2016

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The CMS spent more on Harvoni than any other drug; Novartis considers selling Alcon; the EMA recommends approval of Lantus biosimilar

Five things for pharma marketers to know: Friday, November 11, 2016

Five things for pharma marketers to know: Friday, November 11, 2016

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Trump says he will reform the FDA; pharmaceutical M&A expected to pick up; superbug causing infections in cystic-fibrosis patients

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

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

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

Five things for pharma marketers to know: Tuesday, November 8, 2016

Five things for pharma marketers to know: Tuesday, November 8, 2016

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FDA solicits public comment to study online character space limit; Biogen's Spinraza shows positive results in SMA study; Valeant cuts earnings forecast

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?

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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.

Off-label promotion: By the numbers

Off-label promotion: By the numbers

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

FDA charges KOL with misbranding seizure drug in promo video

FDA charges KOL with misbranding seizure drug in promo video

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

Drugmakers, facing pricing criticism, sell cures in new ads

Drugmakers, facing pricing criticism, sell cures in new ads

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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?

Warning letters most often stem from missing risk information

Warning letters most often stem from missing risk information

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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.

Will Investors Reward Drugmakers That Limit Price Increases?

Will Investors Reward Drugmakers That Limit Price Increases?

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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?

Five things for pharma marketers to know: Friday, October 21, 2016

Five things for pharma marketers to know: Friday, October 21, 2016

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Lawmakers ask for information about price of leukemia drug; Abbott writes down losses from Mylan stake; CVS Health focused on role as health brand

Five things for pharma marketers to know: Monday, October 3, 2016

Five things for pharma marketers to know: Monday, October 3, 2016

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More drugmakers file lawsuits to prevent biosimilar competition; experimental dermatitis drug showeds promising results; pharma blames PBMs for price hikes

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