As it is now, drugs companies are trusted to remove unreliable data and are not required to report any fraudulent activity to the FDA until they actually submit the application.
The agency also says it plans to clarify which adverse events in clinical trials must be reported to the review boards that monitor the studies. Other proposed change includes the standardization of forms used to collect information and a revision of the rules on how patients may qualify to participate in clinical trials.
However, people who are tempted to think that the FDA is capable of changing under the agency's current team of politically appointed officials, had better think again.
According to an article by Russell Mokhiber and Robert Weissman, for Common Dreams on August 2, 2006, Dr Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, was recently a member of a panel debating the topic of: "Government Science Panels: Fair and Balanced?" which was moderated by National Public Radio's Snigdha Prakash, and sponsored the Center for Science in the Public Interest.
Dr Nissen spoke about the conflict-of-interest problems "evident at the highest levels of the FDA," the article says.
"For years," Dr Nissen said in describing FDA leadership, "we had an interim FDA Commissioner, Lester Crawford, who shortly after confirmation, abruptly resigns, apparently because he and his wife owned stock in regulated companies."
"Then the administration appointed Andrew Von Eschenbach as interim commissioner, creating another conflict," he noted.
"In his role as director of the National Cancer Institute," Dr Nissen said, "Von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict."
But even worse, he said, "the administration appointed Scott Gottlieb as deputy commissioner."
"He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter," Dr Nissen stated.
"Between them," he said, "Drs. Von Eschenbach and Gottlieb have whined incessantly about the need to speed drug development."
"So while the American people worry about the safety of drugs," he continued, "the top FDA leadership tells us we need faster drug approval."
On November 12, 2005, the Boston Globe reported that prior to his job at the FDA, Dr Gottlieb worked for the PR firm of Manning Selvage & Lee and that his clients included Roche, the manufacturer of Tamiflu, and Sanofi-Aventis, the maker of Ketek, and the parent company to the nation's sole flu vaccine maker.
According to the Globe, the Manning PR firm paid Dr Gottlieb a monthly retainer of $12,500 for nine months, for working on projects that involved eight companies. Other firms regulated by the FDA that he was involved with include Inamed Corp, a company seeking the return of silicone gel implants to the market.
Between May and July 2005, Dr Gottlieb also was paid $9,000 for consultant work performed for VaxGen, a company that won an $878 million government contract to supply the US with 75 million doses of anthrax vaccine.
In any event, no matter who's in charge, the Senator from Iowa is keeping the heat on. In July 2006, he wrote a letter to the Daniel Levinson, the Inspector General at the Department of Health and Human Services, asking for an investigation into whether Dr Brian Harvey of the FDA, conspired against Dr Graham by providing Merck with details about Dr Graham's presentation on Vioxx, prior to the hearing in 2004 to help the company refute his testimony.
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