FDA advisory committee decisions on re-reviews of major products in diabetes and anemia and first-time reviews in obesity and thombosis could make July a landmark month – and keep FDA in the headlines.

Most important from its potential impact on the overall drug review climate and management ethos at FDA will be the second re-review of GlaxoSmithKline PLC’s diabetes drug Avandia (rosiglitazone) on July 13-14 at a Joint Meeting of the Endocrinologic & Metabolic Drugs Advisory Committee and Drug Safety & Risk Management Advisory Committees. FDA now says that it will be ready to present a meta-analysis of multiple trials of Takeda Pharmaceutical’s Actos (pioglitazone hydrochloride) to put the Avandia cardiovascular concerns in context of similar broadly marketed thiazolidinedione for the same indication. (See “Broken RECORD: New Themes, Same Old Story for Avandia,” The RPM Report, March 2010.)(See “Avandia revisited: Will New Findings Lead To Reevaluation of Drug Center’s Structure,” The RPM Report, February 2010.)

On July 15, the Endocrinologic & Metabolic Drugs Advisory Committee will review Vivus’ obesity drug Qnexa (phentermine/topiramate) – presenting the first public view of FDA’s opinion of the three pending obesity drugs. (See “The Year of the Unpartnered Blockbuster? High Profile Applications Raise Big Questions,” The RPM Report, January 2010.)

Coming after a two-day review of post-marketing safety issues with Avandia, Vivus is likely to catch the advisory committee in a cautious mode. But the sponsor will get one break: FDA will not also be looking at post-marketing safety issues around an existing obesity drug, Abbott’s Meridia (sibutramine) right before the Qnexa discussion. FDA has previously talked about conducting a sibutramine review this summer. It is not on the agenda for the July meeting but FDA says that a public meeting is still anticipated at a later point during the year.

On July 20, the Oncologic Drugs Advisory Committee will review Genentech’s Avastin (bevacizumab) for breast cancer.

FDA’s proposal for a class-wide opioid REMS will be presented at a July 22-23 Joint Meeting of the Anesthetic & Life Support Drugs and Drug Safety & Risk Management Advisory Committees. (See “Opioid Class-Wide REMS: ‘A Self-Propagating Purgatory,’” The RPM Report, June 2010.)

On July 28, the Cardiovascular & Renal Drugs Advisory Committee with review AstraZeneca PLC’s Brilinta. (See story, above).

In addition, July 26-27 are tentatively scheduled for the Blood Products Advisory Committee. The Cardiovascular and Renal Drugs Advisory Committee also has a July 29 date – a possibility for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) or ESA safety in the kidney disease population.