REMS Templates Get Nod From FDA, With Nudge From Pharmacists

Pharmacist groups asked FDA to create a few common templates for risk evaluation and mitigation strategies so they can better anticipate and implement the programs into their practices.
REMS seem to be recreated for each drug that needs one. Steven Russek, a pharmacist with Medco Health Services and Accredo Health Group, said creating three or four [...]

FDA Approves Momenta/Sandoz’ Lovenox Generic Without Need For Clinical Studies

FDA approval of Momenta’s and Sandoz’ generic version of Sanofi-Aventis’ Lovenox (enoxaparin) suggests the agency is willing to find a way around requiring clinical efficacy and safety data for future biosimilar approvals.
In granting approval of the first low molecular weight heparin generic on July 23, FDA rejected Sanofi-Aventis’ arguments asserted in a citizen petition that [...]

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 [...]

Senate Panel Retains White House’s FDA Spending Levels, Weighs Generic Fees

Even though a Senate panel cleared Thursday (July 15) an FDA spending bill at the same level as the president’s request of $2.5 billion, but $55 million less than proposed last month by a House subcommittee, the panel upped appropriations in some drug center activities by drawing on funding from the commissioner’s discretionary spending slush [...]

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. [...]

FDA panel says Avandia should stay, but with restrictions

Faced with conflicting and less-than-conclusive scientific evidence, a Food and Drug Administration advisory panel recommended Wednesday that the controversial diabetes drug Avandia remain on the market — but with tighter supervision and increased warnings about the danger of heart attacks.
Advisory recommendations are not binding and the FDA [...]

FDA to consider fate of diabetes drug Avandia

A large clinical trial of Avandia, sponsored by its maker, “was inadequately designed and conducted to provide any reassurance” that the controversial diabetes drug does not increase cardiovascular risk, a Food and Drug Administration scientist wrote in a memo released Friday.
The lengthy memo by Thomas Marciniak, a medical team leader in the Division of Cardiovascular [...]

FDA Faces Avandia Decision

WASHINGTON—Against a backdrop of legal maneuvering and internal struggles at the Food and Drug Administration, a panel of outside medical experts will convene Tuesday to debate whether the agency should pull diabetes drug Avandia from the U.S. market.
Avandia, which some studies have linked to increased [...]