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Thoreau-FDA.com

Industry Insider: FDA gripes aired on the internet
The Star Ledger: Thursday, July 24, 2008

A group of dissident current and former Food and Drug Administration employees have launched a website, Thoreau-FDA.com, to express their complaints about the agency and to expose what they consider to be improper conduct by those in charge.

In their launch last week, they raised the question of whether managers have the legal or ethical right to direct subordinate scientists to agree to product approvals when those scientists feel they cannot give their personal support.

The purpose of the site, according to its founders, is to “engage U.S. FDA commissioner Andrew von Eschenbach, his successors and FDA upper managers in a public question and answer dialog … to end the entrenched process flaws in FDA’s pre-approval drug review and post-approval regulatory enforcement systems.”

One key flaw, they said, is “the abuse of FDA staff, who do their jobs by making publicly known the existence of harmful and deadly products already approved for, and in, the market.”

Julie Zawisza, a spokeswoman for FDA, said von Eschenbach has set up a system for FDA staff to “feel valued, respected and supported — in a number of areas — but importantly, in expressing their scientific views.”

She said decisions must be made based on science and law in the interest of public health, even if there is disagreement. But Zawisza insisted the process is fair.

“This is an utterly open and transparent process, and our staff are encouraged to express their views and voice their concerns at any time to anyone.” she said. ” I must point out that this does not necessarily mean that one’s professional or personal views will override those of others, or de facto result in an agency decision that any one individual or group of individuals favors or supports.”

— Robert Cohen

Glaxo’s counsel coup

Dan Troy, former chief counsel for the Food and Drug Administration, is joining GlaxoSmithKline as senior vice president and general counsel on Sept. 2.

It’s a coup for Glaxo, since Troy is widely known for being supportive of the pharmaceutical industry.

“Dan shares our vision that it is critical in today’s health care environment that we deliver differentiated products of real value to patients and payers,” Glaxo chief executive Andrew Witty said in a statement. “His wealth of experience in the regulatory legislative area will be of enormous benefit to us and, ultimately, to patients.”
During his tenure at the FDA, according to published reports, Troy instructed agency staff to issue fewer warning letters in the belief they were being ignored, which critics say led to less-effective enforcement of advertising violations.

He also laid the groundwork for the current legal battle over pre-emption, which says FDA approval supersedes state law claims challenging safety, efficacy or labeling. Drugmakers and the FDA argue agency actions are the final word on safety and effectiveness.

A case goes before the U.S. Supreme Court this fall, and the ruling could determine whether patients can sue a drugmaker through state law when a product already has been approved by the FDA.

Troy’s appointment also comes as a Justice Department investigation of Glaxo’s handling of its Paxil antidepressant is widening. Last month, the drugmaker confirmed a previously disclosed Justice Department investigation of marketing practices now includes the U.S. Attorney’s Office in Boston and is being coordinated by the agency in Washington.

This followed a demand by Sen. Chuck Grassley, the ranking Republican on the Senate Finance Committee, for an FDA investigation. More recently, the same committee began probing Martin Keller, a Brown University psychiatrist, for his role in studying Paxil.

Troy is a partner at the Sidley Austin law firm in Washington, D.C., where he represents drugmakers and trade groups on issues concerning the FDA and government regulations.

— Ed Silverman/Pharmalot.com

Roche: Doping detective

Italian cyclist Ricardo Ricco, riding in the Tour de France, was caught doping after Roche planted a traceable molecule in a banned stamina-building drug he had taken, according to the World Anti-Doping Agency. The 24-year-old was kicked out of the race last week after testing positive for EPO, or erythropoietin.

Roche included a molecule in the third generation of EPO, called Continuous Erythropoiesis Receptor Activator (CARA), that acted as a flag in drug tests showing when an athlete was using the substance, John Fahey, WADA’s chief, told the Australian Broadcasting Corp.

Until this year’s Tour, the CARA EPO, which is released into the body more slowly than its predecessors, had been thought to be virtually undetectable by drug testers. Fahey said cooperation with drugmakers is the way to fight drug cheats.

“There’s more and more of this occurring,” Fahey said in an interview with Australian Broadcasting. “The more cooperation the scientists can have with the drug companies in the detection of performance-enhancing drugs, the greater the likelihood is they will be detected when tests are undertaken.”

— Ed Silverman/Pharmalot.com