FDA: Free Speech vs. Patient Safety

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Posted on Jul 18, 2014

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A pharmaceutical sales reps job is to go into a healthcare facility and try and sell their new drug. For example, if they were trying to get a drug that can be used to treat seizures they could also tell the doctor that it could also combat alcohol dependence. That little bit of extra information might be what hooks the doctor to consider the drug and use it for his patients. Of course they would have to give a list of data that would back up what they were saying. Is this right? Should the sales rep do this when they are trying to sell? An article recently published on Washington Post.com discusses this issue.

For many years the Justice Department has been trying to pursue companies who have been doing this sort of "off-label" marketing. The FDA has also stated that sales pitches should not include information on uses that have not been approved by the agency.

But this is a long running conflict between the drug regulators and the drug makers over how these companies promote their drugs for unapproved uses. This outcome can affect doctors and the patients. The FDA is now reviewing its rules on what kind of data drug companies should be allowed to distribute to doctors regarding "off-label" uses, as well as how they should respond to unsolicited questions from physicians about those uses. By the end of the year the FDA should have new guidelines, so they say.

Critics say that allowing the companies to give this type of information to the doctors could benefit them and their patients, while some of the skeptics say that the industry could try and exploit this "loosening of restrictions" (as The Washington Post reports) to hype the unapproved uses of the drugs which could expose patients to ineffective and potentially harmful treatments.

The issue that the FDA faces, is if the First Amendment legal challenges prove successful, this would then "turn back FDA's proactive role in American medicine and jeopardize the safety of patients" reported the Washington Post. Doctors do not have time to sift through all the literature they get from the sales rep on the actual uses and the "off-label" uses and so it would hard decipher what is legitimate and what is not, so they go with what is being said by the sales rep most of the time. 

Prescription errors are a common form of medical malpractice. The FDA wants to strengthen this regulation to keep the patients safe. 

So where is the balance between safety and medications that can help patients?  It probably depends on the specifics - the doctor, patient and condition.

For the pharmaceutical companies, it is about profit. For FDA and drug regulators, it's about keeping the patients safe giving them proven cures and treatments. 

But most of the time, patients are caught in the middle.

For more information on this story, it can be found on The Washington Post website. 


Frank R. Kearney, Attorney-at-Law
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