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Does Corporate ‘Free-Speech’ Trump Drug Safety?

Here’s an article that highlights an issue affecting not just whistleblowers, but all Americans. The headline in the Washington Post says it all:

“FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rules”

It seems that when individuals sue major corporations they are lucky to have any recognition of their First Amendment rights. Corporations, however, are another issue and many of them are now suing for taking “confidential” information and making it public. It’s a shrewd, tactical shift as many business groups have lost billions of dollars in False Claims Act suits, most notably pharmaceutical giants who market their drugs for purposes other than those approved by the U.S. Food and Drug Administration (FDA). The drug companies argue they merely want to protect their First Amendment right to Freedom of Speech for commercial activity. The First Amendment is a glorious thing. But does it provide for an unalienable right to sell a product for an unsafe use under the United States Constitution?

For an answer to that question, let me direct you the text of a speech made by FDA Commissioner Margaret. A Hamburg, MD; a speech which was only partially quoted in the Post’s article and which expressed understandable concern. The full speech can be found on the FDA’s website, and it includes this historical note:

Back in 1902, the Martin H. Smith company advertised for a “remedy in the treatment of coughs, bronchitis … asthma, laryngitis, pneumonia, and whooping cough.” According to the company—and I quote: “From scientific investigations in hospitals, clinics and sanitariums and the personal investigations by prominent physicians, no other preparation has more successfully withstood such critical scrutiny. No other preparation has had its therapeutic value more thoroughly defined or better established.”

What was this wonder drug, you might ask? It was heroin.

That’s not me saying so, that’s the FDA commissioner. Interestingly enough, the Washington Post did not include that portion of the speech in their article. It kind of makes you wonder.

The newspaper did quote the commissioner as saying these lawsuits “would turn back FDA’s proactive role in American medicine and jeopardize the safety of patients, as well as the future of innovation and medical progress,” which was taken from the same speech.

The historical facts cited by Hamburg, however, are key to the issue. The reason that off-label and misbranding of drugs matters is that advertising a drug for unapproved use is — to put it bluntly – extremely dangerous.

The Post at least quoted Harvard Medical School Professor Aaron Kesselheim, as saying, “Who gets to decide what qualifies as ‘truthful’ information when it comes to sharing data about unapproved drug uses? Is it what the company with a financial conflict of interest says it is? Or is it what a scientist at the FDA says it is? That’s the central tension here.” You can read the full article here.

Yes, we know that drug trials take time. They are increasingly complex. Drugs themselves are more complex. The drug companies would like to “share” more “truthful” information, and they would like the approval process to go faster.

Fine, let them support increased funding for the FDA to have as many scientists as needed to handle the approval process as fast as possible. The drug companies complain the rules are not clear, but an off-label case or a misbranding case is not easy to win absent very strong evidence. What is clear is that these companies have had to pay large sums of money to settle such cases. So now comes the push to make the rules “clearer.” That euphemism is employed by one drug company representative in the Post’s article.

Clearer is fine. But weaker is not.

Be aware. Let’s watch this process.