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 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.
The drugmaker had sued the FDA in September over marketing restrictions for its painkiller, Exparel.
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.
Pacira sues the FDA over marketing limitations; nonprofit says PCSK9 inhibitors are priced too high; GSK's Breo fails to extend life
State attorneys general accused the drugmaker of violating state consumer protection laws.
But don't expect the floodgates to open. Marketers still have to take a legal route to promote such information.
The decision, a setback for the FDA, allows the drugmaker to move forward with plans to legally promote some off-label information.
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.
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