FDA compromised by drugs companies
from the drugs industry and pressure from Congress, the editor of a
top medical journal...
The U.S. Food and Drug Administration is compromised by funding from the drugs industry and pressure from Congress, the editor of a top medical journal said on Friday, Reuters reports. Richard Horton of The Lancet accused the world's most powerful drug watchdog, which regulates over $1 trillion worth of products, of endangering the lives of people in its handling of GlaxoSmithKline Plc's (GSK) controversial bowel drug Lotronex and being a servant of the pharmaceutical industry. The FDA approved Lotronex in February 2000, but the company voluntarily withdrew it from the market nine months later after the deaths of five patients who had been taking it. Senior FDA officials are now trying to reintroduce it, Horton said. "This story reveals not only dangerous failings in a single drug's approval and review process but also the extent to which the FDA, its Center for Drug Evaluation and Research (CDER) in particular, has become a servant of the industry," he wrote in an editorial in the British journal. According to Horton, serious side effects from Lotronex were evident during the pre-approval process and shortly afterwards, but the FDA kept the product on the market. In response to Horton's accusations, the FDA told Reuters that it had been holding discussions with GlaxoSmithKline about issues surrounding Lotronex. Victor Raczkowski, the deputy director Office of Drug Evaluation III which oversees the department that reviewed Lotronex said the editorial was a misrepresentation of the FDA and how it works and he denied that the review process was secretive or that opinions had been suppressed. "The FDA is a large scientific organisation. We have many people who have worked in the review. We expect and encourage them to be frank about their scientific opinion," Raczkowski said. The Lancet said scientists within the FDA who raised concerns about the drug's safety were sidelined and excluded from future discussions. An independent review of research found serious flaws, but calls for more studies were ignored. "That is where there has been a terrible failure in evaluating the safety of this drug," Horton told Reuters. "The FDA is not only compromised because it receives so much funding from industry, but because it comes under incredible Congressional pressure to be favourable to industry. " he added. The agency monitors the safety, labelling, import, transport, storage and sale of food ingredients, drugs, cosmetics and surgical supplies
