REMS For Opioids, LABAs May Be Driven By PBM “Feedback” Mechanism

FDA is considering whether pharmacy benefit managers and their databases could be used to increase safe prescribing of long-acting and sustained-release opioids and long-acting beta agonists.
A contract study of prescribing patterns for the two classes of drugs and the development of strategies to promote safer prescribing practices could be part of FDA’s efforts to curtail [...]

F.D.A. Panel Urges Limits for Avastin

An advisory committee recommended on Tuesday that the Food and Drug Administration revoke approval of the drug Avastin as a treatment for breast cancer, saying the drug was not helping patients.
The 12 to 1 vote represents a stinging setback for Avastin, which is now the world’s best-selling [...]

Panelist Who Backed Avandia Gets Fees From Glaxo

One of the panelists who voted in favor of the diabetes drug Avandia at a Food and Drug Administration advisory meeting last week is a paid speaker for the drug’s maker, GlaxoSmithKline PLC, according to the company and its records.
The panel voted 20-12 to keep Avandia on the market, though most of the members wanted [...]

Doctors say it’s already over for diabetes drug Avandia

In the grand scheme of treating diabetes, it might not matter much whether the Food and Drug Administration halts sales of the drug Avandia.
An FDA committee of outside experts met last week to provide advice on whether any regulatory action — from stronger warnings to removal — [...]

Avandia on Trial: An FDA review panel shows more wisdom than the drug’s critics.

Critics of the pharmaceutical industry were frustrated this week as an FDA review panel voted to allow Avandia to remain on the U.S. market, despite concerns that the diabetes drug may increase heart attacks. Those who thought Avandia should remain a patient-doctor option were frustrated too, as the panel also voted for severe new restrictions. [...]