New Off-Label Drug Use Guidelines: FDA Simply Has It Wrong
By law, drug makers are prohibited from marketing or promoting (in any way) their medicines for uses that have not been approved by FDA. But, somewhat paradoxically, physicians who are licensed to practice in the US can prescribe drugs for uses beyond FDA-approved indications, a practice known as off-label use. The agency is no stranger to the issue of off-label drug use and has vigilantly policed the industry over the last decade to prevent the practice. Drug makers including Pfizer, Astra Zeneca, Eli Lilly, Amgen and others have been targeted by federal prosecutors for off-label marketing practices. Click here to see which types of drug are commonly prescribed for off-label use.
However, in something of a policy reversal, FDA officials proposed last Friday new guidelines that would allow pharmaceutical companies to use peer-reviewed medical journal articles to promote drugs for unapproved uses. The proposed guidelines will replace a law that expired in 2006 law. Under the expired law, companies had to submit copies of the articles to FDA for review before sending them to physicians. Under the new proposal, drug companies don’t have to submit articles to the FDA before distributing them to physicians. The agency says it will not punish companies for distributing literature on off-label use if they adhere to certain practices. Articles should not be false or misleading and should come from a peer-reviewed journal that is not influenced by a company. The proposal also says companies should attach a disclaimer to the materials indicating FDA has not reviewed them.
I, along with Congressional Democrats, most notably Henry Waxman (D-CA), am totally baffled by the proposed new guidelines.According to Mr. Waxman, the new guidelines would create a “large loophole” in laws against off-label promotion. “It’s a conflict of interest for the company to be promoting sales when they haven’t been able to establish that a drug is safe and effective through the rigorous FDA process,” he said. Not to mention that a company could save hundreds of millions of dollars by not conducting clinical trials to gain approval for an off-label indication. Risperdal, a Johnson and Johnson medication that is approved to treat serious mental disorders like schizophrenia, bipolar disorder and irritability associated with autism was used off label 66% of the time and brought in $4.2 billion in 2006. If you were the CEO of J & J would you spend any additional monies to win approval for new indications for Risperdal?
I would think that by now the agency would have figured out that drug manufacturer are incapable of policing themselves; there is simply too much money at stake. And, unfortunately, profits will always come before patient safety. In my opinion, the proposed guidelines are another egregious example of just how much influence the pharmaceutical and biotechnology industries have at FDA. The Bush administration has done everything in its power to destabilize and emasculate the agency. The American public no longer has confidence in FDA and the products that it approves. Something has got to change to restore a sense of wellness in America!
Until next time…
Good Luck and Good Job Hunting!!!!!
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Still reeling from lawsuits filed last week by ex-sales reps’ alleging improper marking of Enbrel to treat patients with psoriasis, Amgen was subpoenaed on Monday by New Jersey's attorney general regarding allegations that the company promoted Enbrel for unapproved uses.
