This is an older article that appeared on Forbes.com last October. However, it’s got important information for those who want to know how the FDA operates on drug approvals, and how that might be influenced by outsiders (in this case investors in the pharma company Arena).
FDA responds to outraged Arena investors about obesity drug rejection

By Matthew Herper
The Medicine Show
Forbes.com

The Food and Drug Administration issued responses yesterday to investors in Arena Pharmaceuticals who complained that the agency’s treatment of the company was unfair, saying it “regrets” not putting an expert on animal toxicity on a key expert panel but indicating that its review was thorough.

“In hindsight, FDA regrets that no toxicologist participated in the meeting,” the letter states. But the FDA says it took steps to make sure Arena’s product, a weight loss drug called lorcaserin, got a fair shake. A team of FDA toxicology experts reviewed the data, which was also discussed by the Center for Drug Evaluation and Research’s Executive Carcinogenicity Committee. The results of these discussions were provided to an expert panel that voted 9-5 that lorcaserin should not be approved right now. The FDA confirmed the accuracy of the letter.

The FDA also argued that increasingly strict conflict of interest policies and calendar conflicts also make it difficult to fill expert panels with “optimal” experts. (This has proved true with other drugs. I’ve been told the FDA had a lot of trouble finding people to serve on an expert panel for Eli Lilly’s blood thinner Effient.)
FDA Advisory Committees are a key part of the drug approval process, but the FDA is not bound by their votes. The agency basically argues that in cases where there was some bias in the vote, it takes that into account in making its final decision. In its letter, the FDA noted that the lorcaserin panel contained experts in endocrinology, cardiology, pharmacology, health policy, epidemiology, biostatistics, internal medicine, and clinical research.

The key to whether the outraged Arena investors have a case is whether the FDA buys the argument that were it not for the scary way cancer studies in rats were presented to the panel, the advisers would have voted to approve lorcaserin. I don’t think the FDA has buy into this argument. The panel seemed honestly torn about whether to approve the drug. These days, its only the slam dunks that are getting through on the first try.

Scott Ferguson, an Arena investor who sent me the FDA response, says that the panel should have based more of its discussion on how patients who completed therapy on lorcaserin did, not including those who dropped out of the study. Unfortunately for weight loss drugs, clinical researchers tend to favor an analysis that includes those who stop therapy precisely because it is tougher and harder for drug companies to game.

Ferguson, a member of a loose group of investors calling themselves the Blue Ocean Research Group (BORG) who met on internet message boards, said in an email that for him and others, this isn’t just about the money they have lost on Arena stock. “We spend $170 billion a year as a country treating obesity related diseases. Obesity cuts peoples lives short by decades. The completer weight loss experienced by lorcaserin patients will reduce those patients risks from turning into a full blown Type II diabetic by 58%. How the benefits of lorcaserin don’t outweigh the almost no risk, is beyond me.”

What is very interesting — and fairly new — is for investors to be taking such great lengths to try and sway the FDA’s decision. The only recent precedent was in the case of Dendreon’s prostate cancer treatment Provenge, which generated a lot of noise but probably did not speed up the eventual approval of that product.

The FDA’s full response to Ferguson and other BORG members is below. A decision on lorcaserin is expected today, but could come later.

Update: The FDA says its responses were intended as communications to individuals. Letters were sent separately to ten physical addresses and about 90 email addreses by the Division of Drug Information in CDER’s Office of Communications, which routinely responds to letters from the public.