Legal/Regulatory

FDA guidelines for payer, off-label communications: OK as long as 'truthful'

FDA guidelines for payer, off-label communications: OK as long as 'truthful'

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Two FDA guidance documents aim to help pharma companies show the value of their drugs to payers beyond what's included in FDA labeling.

Cannabis gets the iPhone treatment

Cannabis gets the iPhone treatment

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Thanks to legalization, a new breed of startups are changing the nature of cannabis advertising.

Understanding FDA's Blueprint for Transparency

Understanding FDA's Blueprint for Transparency

The Food and Drug Administration regulates more than a third of the U.S. economy. And its new commissioner, Scott Gottlieb, is trying to shake up how it does so.

Five things for pharma marketers to know: Tuesday, January 23, 2018

Five things for pharma marketers to know: Tuesday, January 23, 2018

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FDA issues new policies for compounded drugs; U.S. doctors test CRISPR on cancer patients for the first time; Palio merged into GSW

Sandoz lines up potential third-to-market Humira copy

Sandoz lines up potential third-to-market Humira copy

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Although if approved, it's not likely to launch in the U.S. for quite some time.

NORML balances federal, local action after Cole memo reversal

NORML balances federal, local action after Cole memo reversal

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Once Attorney General Jeff Sessions reversed the Cole memo, NORML began applying pressure both locally and nationally for changes in marijuana laws.

Taxpayers Need to Cough up the Cash to Keep Federal Agencies Afloat

Taxpayers Need to Cough up the Cash to Keep Federal Agencies Afloat

As we continue to debate the proper size and role of government in society, cast your eyes on recent polls by Gallup and Pew that found the majority of Americans felt their income tax was fair.

How will the pharma industry fare in 2018 under Trump?

How will the pharma industry fare in 2018 under Trump?

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The first year of the Trump administration was kind to pharma, but it might not be so fortunate in 2018.

HHS nominee Alex Azar: Medicare Part B should negotiate drug prices

HHS nominee Alex Azar: Medicare Part B should negotiate drug prices

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Alex Azar, previously a senior executive at Eli Lilly, proposed granting Part B the authority to negotiate lower prices.

OPDP issues third enforcement letter of 2017

OPDP issues third enforcement letter of 2017

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The FDA's Office of Prescription Drug Promotion issued a warning letter to Amherst Pharmaceuticals and Magna Pharmaceutical.

Limits on pharma payments to doctors back on policy menu

Limits on pharma payments to doctors back on policy menu

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A mini wave of state-level rule-making has thrust the issue of restrictions on pharma payments to medical professionals back into the spotlight.

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

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

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AbbVie to pay $140 million to AndroGel patient; Trump likely to roll back birth-control mandate; patients more likely to respond to expensive drugs

Five things for pharma marketers to know: Tuesday, September 19, 2017

Five things for pharma marketers to know: Tuesday, September 19, 2017

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Only three of the seven FDA-approved biosimilars are available for sale; Teva to sell off women's health portfolio; the FDA approves GSK's COPD combo

The FDA issues its second enforcement letter of 2017

The FDA issues its second enforcement letter of 2017

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The OPDP has only issued two letters in 2017, compared to 11 last year.

Johnson & Johnson in breach of U.K. rules over Nicorette marketing

Johnson & Johnson in breach of U.K. rules over Nicorette marketing

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Johnson & Johnson has breached the U.K.'s drug regulation code in three places in promotions for smoking cessation product Nicorette.

Five things for pharma marketers to know: Wednesday, July 26, 2017

Five things for pharma marketers to know: Wednesday, July 26, 2017

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Jury says AbbVie fraudulently misrepresented risks of AndroGel; Celgene settles False Claims Act lawsuit; Amgen reports more Repatha prescribers

Five things for pharma marketers to know: Wednesday, July 12, 2017

Five things for pharma marketers to know: Wednesday, July 12, 2017

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Former sales reps for Insys plead guilty to kickback allegations; digital health funding on the rise; PhRMA launches campaign about drug costs

The FDA attempts to understand how disclosures affect drug ads

The FDA attempts to understand how disclosures affect drug ads

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The FDA recently proposed studies designed to determine how disclosures in drug ads affect how viewers frame information.

Astellas reprimanded by U.K. drug regulator

Astellas reprimanded by U.K. drug regulator

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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.

What marketers need to know about tax reform, off-label promotion, pricing

What marketers need to know about tax reform, off-label promotion, pricing

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The ad-tax deduction is likely once again on the table.

Amgen, Sandoz argue biosimilar patent case to the Supreme Court

Amgen, Sandoz argue biosimilar patent case to the Supreme Court

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Sandoz counsel argued that Amgen's position "wrongly delays the marketing of every biosimilar."

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