Another Banner Day at FDA
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The Bush administration spent the last eight years trying to weaken and dismantle the US Food and Drug Administration (FDA). I thought the carnage at the agency would end in the waning days of one of America’s worst leaders. Sadly, I was mistaken.
As many of you may know, FDA regulations forbid drug companies from promoting off label use of previously approved drugs. Not surprisingly, drug companies were able to find loop holes in the regulations and off-label drug promotion reached unprecedented levels in the early 2000s. In response, the agency embarked on an aggressive, unrelenting campaign to combat off label drug promotion by drug manufacturers. This effectively changed the way in which pharmaceutical sales representatives interacted with physicians in the past few years. No longer would there be unsolicited gifts, lavish pizza lunches for office personnel or tickets to local sporting events. Neither the drug makers nor physicians were happy about the rule changes but the revised guidelines helped to lessen off label promotion of previously approved drugs. That said, it came as something of shock late last year, when FDA officials proposed a new set of guidelines that would ease the restrictions on off label drug promotion.
The new rules would allow drug makers to supply physicians with copies of published research reports describing off label uses of drugs that were previously approved for other therapeutic indication. As you might have guessed, the drug companies are ecstatic with the new guidelines. Who needs pens, mugs or pizza when you can simply hand a physician a reprint of article that show that off label use of an approved drug can treat potentially life threatening medical conditions. What an ingenious way to boost sales of extant drugs for new indications without having to spend larges of money trying to win regulatory approval for them. While this would be a financial boon to the pharmaceutical industry, I don’t think it would be in the best interest of patients who may be prescribed a drug that hasn’t undergone the rigorous scrutiny of controlled, human clinical trials.
Many congressional democrats and drug industry critics opposed the guidelines when they were first proposed last year. But, like many other times over the past eight years, the Bush administration prevailed. Today, the agency announced (with little fanfare) that the new off label drug use guidelines would go into effect—one week before Barack Obama is inaugurated as President.
Until next time…
Good Luck and Good Job Hunting!!!!!!!!!
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Although there are some Bush era midnight regulations that were not approved by the end of the Bush administration, there are many more that have been pushed through, including the very concerning Marketing of Off-Label Use of FDA-Approved Drugs. As BioJobBlogger so eloquently described, the implications of this newly approved reg are far reaching. For example, there is the ongoing debate regarding the efficacy of first generation anti-psychotic drugs vs. second-generation atypical antipsychotic drugs. While both types of antipsychotics are effective, they both carry specific risks, including an increased risk of sudden cardiac death at higher doses. Here’s the twist, for many individuals suffering from serious mental illness, the benefits of these drugs outweigh the risks; however, there are cases where some antipsychotic medications have been used off label to treat patients who do not have a primary diagnosis of a serious mental illness like schizophrenia, but rather, suffer from dementia. While freedom of choice is important for physicians, patients, and families, the loosening of off-label drug use could easily create situations where clinical decisions are based on limited data or “selective” data produced by pharmaceutical companies. This is particularly worrisome in areas of the country where medical resources are scarce and prescribing protocols are driven by economics
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