POTUS gets a Warning Letter

  • by: Peter Pitts |
  • 04/06/2020
If a pharmaceutical company actively promotes one of its products for conditions other than those approved by the Food and Drug Administration, it’s considered “violative behavior” and often results in what’s known in the regulatory world as a “warning letter” -- official correspondence from the FDA  ordering the firm to cease and desist from such communications. But can the FDA send a warning letter to the President of the United States?

President Trump keeps championing the drug chloroquine as a potential cure for COVID-19. While there is anecdotal evidence that this drug might help ameliorate the symptoms of the coronavirus, it is by no means a cure – and the plural of anecdote isn’t data. Trials to actually collect scientifically valid evidence about the effectiveness of chloroquine are only just beginning. These programs can be expedited but they mustn’t be rushed.

So, what’s wrong with the President sharing some potential good news? Nothing as long as it’s in the proper perspective. That’s what was missing from the President’s remarks, perspective. False hope has many unintended consequences. There are already reports of people hoarding chloroquine causing shortages for patients who, for example, must use it regularly to manage their rheumatoid arthritis. And unfortunately, but not unexpectedly, there have been reports of over-dosing and death.

Proper scientific trials of chloroquine and other compounds that might ease the symptoms and shorten the duration of COVID-19 must be fast-tracked – but they cannot be ignored or trivialized. Science is like that and that’s why physicians such as Dr. Anthony Fauci and FDA Commissioner Steven Hahn are such important members of the President’s task force. Information about new drugs and new uses for existing ones must be truthful accurate and non-misleading. In the Age of COVID, that’s a crucial public health trifecta.

As Rudyard Kipling reminds us, “Words are, of course, the most powerful drug used by mankind." This is precisely what the FDA reminds drug companies in its warning letters. When it comes to matters of medical and regulatory science, let the experts take the lead.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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