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 will hold a public hearing in November to gather input on how it should regulate certain off-label communications.
PhRMA and BIO, which represent life sciences firms, developed principles about sharing truthful and non-misleading information with payers and providers.
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.
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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.
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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.
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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.
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