Off-label

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.

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

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

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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

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

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.

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

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

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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 asks for input on off-label comms

The FDA asks for input on off-label comms

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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

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

Califf's Plans May Be Tempered By Election

Califf's Plans May Be Tempered By Election

FDA Commissioner Robert Califf has two plans for what he wants to achieve during his tenure. One is long-term. The other ends in early 2017.

Five things for pharma marketers to know: Tuesday, May 31, 2016

Five things for pharma marketers to know: Tuesday, May 31, 2016

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Lawmaker calls for investigation of Purdue; Jazz to acquire Celator; Intercept's liver drug is approved

The FDA's Actions Open Door to 'Truthful, Non-Misleading' Marketing

The FDA's Actions Open Door to 'Truthful, Non-Misleading' Marketing

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That change is coming about in the wake of a string of First Amendment-based losses for the FDA in federal courts around the country.

Five things for pharma marketers to know: Wednesday, March 9, 2016

Five things for pharma marketers to know: Wednesday, March 9, 2016

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Amarin settles with the FDA over off-label promotion suit; mobile apps often share medical information with third parties; drug spending rose 12% in 2014

2016 May Bring More Warning Letters, Guidance from FDA

2016 May Bring More Warning Letters, Guidance from FDA

It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.

The FDA settles with Pacira, rescinds warning letter

The FDA settles with Pacira, rescinds warning letter

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The FDA withdrew a 2014 warning letter related to Pacira Pharmaceuticals' marketing of its painkiller Exparel as part of a settlement reached by both parties this week.

Industry watches Pacira's off-label case against the FDA

Industry watches Pacira's off-label case against the FDA

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The drugmaker had sued the FDA in September over marketing restrictions for its painkiller, Exparel.

Off-label cases against the FDA move forward

Off-label cases against the FDA move forward

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Amarin begins legally promoting off-label uses of its prescription fish-oil drug, while Pacira sues the FDA over the label for its pain drug, Exparel.

Five things for pharma marketers to know: Wednesday, September 9, 2015

Five things for pharma marketers to know: Wednesday, September 9, 2015

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Pacira sues the FDA over marketing limitations; nonprofit says PCSK9 inhibitors are priced too high; GSK's Breo fails to extend life

Amgen settles off-label case with states

Amgen settles off-label case with states

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State attorneys general accused the drugmaker of violating state consumer protection laws.

What to expect in wake of the Amarin ruling: more truthful off-label talk from pharma

What to expect in wake of the Amarin ruling: more truthful off-label talk from pharma

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But don't expect the floodgates to open. Marketers still have to take a legal route to promote such information.

Judge grants relief to Amarin in off-label case

Judge grants relief to Amarin in off-label case

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The decision, a setback for the FDA, allows the drugmaker to move forward with plans to legally promote some off-label information.

21st Century Cures, Amarin Court Case Advance

21st Century Cures, Amarin Court Case Advance

Pharma's efforts to evolve restrictions about off-label marketing move forward.

House expected to vote on 21st Century Cures

House expected to vote on 21st Century Cures

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The legislation would allow drugmakers to share information about their products beyond what is included on the FDA-approved label.

Amicus briefs pile up in Amarin lawsuit

The Medical Information Working Group and the Washington Legal Foundation filed briefs in support of Amarin.

Amarin lawsuit about more than fish oil

Amarin lawsuit about more than fish oil

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An FDA letter says there was no need to go to court but experts tell MM&M this lawsuit highlights an issue that is bigger than a single pill.

21st Century Cures bill advances to House floor

21st Century Cures bill advances to House floor

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The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.

Lawmakers advance 21st Century Cures draft; proposal would allow sharing of off-label economic data

Lawmakers advance 21st Century Cures draft; proposal would allow sharing of off-label economic data

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The draft would allow drugmakers to share off-label economic data with payers, a practice that until now has been considered taboo, and require the FDA to assess patient experience data in regulatory decisions, in addition to boosting funding for the NIH.

Five things for pharma marketers to know: Thursday, March 12

Five things for pharma marketers to know: Thursday, March 12

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The SEC said some company drug prices can be made public, 23andMe launched an R&D division, and Public Citizen is asking the FDA to withdraw a proposal it says will undermine drug safety information.

Study shows Lucentis at Eylea disadvantage

Study shows Lucentis at Eylea disadvantage

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An NIH study shows possible limit to Lucentis's appeal.

Five things for pharma marketers to know: Wednesday, February 11

Five things for pharma marketers to know: Wednesday, February 11

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BMS loses breakthrough therapy status, Gilead's pricing comes under fire in Europe, and pharma fights Italy's off-label Avastin use.

Roche seeks new Lucentis indication

Roche seeks new Lucentis indication

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The company is seeking a diabetic retinopathy indication.

Pfizer settles off-label Rapamune case for $35M

Pfizer settles off-label Rapamune case for $35M

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The drugmaker will dole out $35 million in a deal with 41 state attorneys general after a New York County Supreme Court judge said Wyeth allegedly promoted the immuno-suppressive drug improperly.

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