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The bill, introduced in March, is being considered as an amendment in the upcoming PDUFA reauthorization legislation.
The former FDA commissioner said marketers need to focus on ensuring that off-label promotion is "non-misleading."
An analysis of claims data found that an off-label settlement for one Eli Lilly drug did not significantly change how often it was prescribed off-label after the settlements.
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In short, he'll be further along the learning curve than anyone ever tapped for the nation's number-one public health regulatory slot.
In short, the Trump team, I predict, will seek to tweak FDA.
The regulator is providing examples of appropriate off-label communications.
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The previous deadline was January 9.
The bill includes two provisions that would address drugmakers' calls for clarity on sharing off-label information with payers and regulators.
Insurers and pharmacy benefit managers already have a sophisticated understanding of clinical data, the industry argued.
The FDA asked questions about the risks and benefits of allowing off-label communications.
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.
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.