Consumers Union Petition
Petition for Better Reporting of Drug Side Effects
I support requiring all drug ads to include a 1-800 number and website so citizens can report drug side effects (petition docket 2008P-0012/CP1).
All too often, drug advertisements fail to present the benefits and risks of using prescription drugs in an accurate and balanced way. It is [...]
S. Sen. Grassley: Secures independent review of FDA approvals based on narrow health benefits - FierceBiotech
In his letter to the GAO, Sen. Grassley asks for an investigation into FDA’s use of surrogates for product approval and whether FDA has appropriately followed up drugs approved initially based on surrogate markers. He cites recent examples of [...]
Avastin Distribution Change - Open Letter
I read today’s WSJ Health Blog on Avastin thinking that Genentech had appeased eye specialists by maintaining distribution of Avastin to compounding pharmacies, but after reading the above open letter, I’m confused about Genentech’s actions in the recent past and about what it’s planning to do in the near future. [...]
Hey…sorry for the layoff time here at Pharma’s Cutting Edge. You can breathe a bit easier now that I’m back. Pun intended.
I’ve covered Exubera’s peri-approval and launch highlights in these pages, so now that Pfizer has pulled its marketing plug amidst ridiculously low sales of the first inhalable insulin I figured I’d a retrospective of those posts [...]
PDUFA H.R. 3580 (2007)
In a 405-7 vote, the U.S. House passed legislation reauthorizing PDUFA. The full-text link to the approved legislation is above. Here are some highlights of the bill focused on amendments to laws affecting regulation of drugs (devices are also covered under the bill), which must now be passed by the Senate without [...]
