Pharma's efforts to evolve restrictions about off-label marketing move forward.
The legislation would allow drugmakers to share information about their products beyond what is included on the FDA-approved label.
The Medical Information Working Group and the Washington Legal Foundation filed briefs in support of Amarin.
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.
The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.
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.
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.
An NIH study shows possible limit to Lucentis's appeal.
BMS loses breakthrough therapy status, Gilead's pricing comes under fire in Europe, and pharma fights Italy's off-label Avastin use.
The company is seeking a diabetic retinopathy indication.
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.
FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic communications environment.
Researchers found that limiting sales rep access and interactions reduces off-label prescriptions for the previously detailed drugs, while also upping off-label prescriptions of the drugs that had not been promoted.
The FDA's proposed upgrade to its off-label distribution guidelines has some new features, but experts say it is unclear if this means more dollars will flow toward reprints.
Endo settled off-label charges for $192 million, resolving civil "whistleblower" suits filed by two sales reps and a physician.
The company will shell out $2.2 billion over allegations of marketing misconduct for Risperdal, Invega and Natrecor.
Abbott's Depakote lawsuits roll on; IMS buys mobile health firm's assets; BI shutters a chemical plant; and the healthcare reform back-and-forth continues.
Pfizer settles Rapamune lawsuits; Moody's downgrades GSK; Astrazeneca pursues anemia medication; Mallinckrodt drugs gets priority review
HPV vaccine price cut; Merck files new allergy med with FDA; GSK pursues online transparency; Walgreens ready for greater nurse autonomy; Epocrates ranks high among docs with tablets.
It was an all-in-one news day for the drug maker which, by the way, saw sales rise 2% for the first quarter, compared to the same period last year.
Endo gets a new president, Allergan settles a Botox case
HHS wants input for its TXT4Tots childhood advice program, Gilead releases some Hep. C clinical trial data, and Shire settles with the DOJ over disputed marketing practices.
An expert witness in a 2008 lawsuit highlights holes in clinical data, and finds that corporate and published trial data do not necessarily correspond.
Amgen "marketed the spread" between the price practices pay for Aranesp and that patients pay as a means of driving sales—to the point of having speakers tell docs that they could make a million more each year by prescribing the Amgen anemia drug over its competitor, Procrit.
A federal appeals court has overturned the conviction of a drug rep for detailing a drug off-label on First Amendment grounds, ordering the lower court to retry the case.
Elsevier launches new drug class overviews, a whistleblower accuses Abbott and Genzyme clears the way for Lemtrada.
The proposed changes center around non-cancer related pain and seek to alter how drug companies can talk about these pain meds.
GlaxoSmithKline will pay $3 billion to settle state and federal charges that it promoted antidepressants Paxil and Wellbutrin for unindicated uses and withheld safety data on diabetes drug Avandia.
FDA issues may deter drugmakers from engaging in social media, but that's no excuse to ignore what audiences are saying on these platforms, say pharma and device firms.
Allergan removed records from its website that had detailed payments made to doctors from the middle of 2010 through first-half 2011.
As US pharma continued its quest for a Grand Prix at the Lions Health international festival of creativity, MM&M went on location to Cannes, France. Missed our coverage from June? Now, we're giving you an opportunity to catch up on some of what you missed. Download our e-book on the two-day festival, recapping the event, rounding up the best of the speakers, offering perspective and listing all of the winners. Click here to download.
The most recent MM&M Skill Sets Live event surveyed a range of issues relating to one of the hottest promotional spaces in healthcare. Speakers and panelists at the morning-long session, including promotional- and multichannel-minded executives from GSK, Epocrates, Treato and Montefiore Medical Center, weighed in on topics designed to help marketers demystify the challenges associated with non-personal promotion. Click here.