Thursday, June 18, 2020

Quick explanation of FDA's Emergency Use Authorization/Retraction for hydroxychloroquine and chloroquine

The Trump administration arranged on March 28 for 30-60 million tablets of hydroxychloroquine and certain (unapproved, unlicensed) chloroquine tablets to be donated by manufacturers to the National Strategic Stockpile (NSS) under an Emergency Use Authorization (EUA).  The official who signed the EUA is the FDA's Chief Scientist, Denise M. Hinton.  Denise Hinton is a nurse with a master's degree, an Air Force retiree who has achieved the rank of Rear Admiral in the Public Health Service. While she is probably very accomplished, I can find no scientific credentials.  Chief scientist at FDA?

The FDA document that granted the EUA authorization made clear that the hydroxychloroquine products that entered the NSS under this authorization may have expired or not met "requirements regarding current good manufacturing practice (GMP) otherwise applicable..."  

In revoking the EUA, Admiral Hinton wrote,
While HCQ that has been distributed from SNS is no longer authorized under the EUA for the authorized use to treat hospitalized patients for COVID-19, FDA-approved HCQ can be distributed in interstate commerce. The CQ products covered by the EUA are not approved by FDA for any indication and therefore cannot be legally introduced into interstate commerce.
In other words, some of the hydroxychloroquine, and all of the chloroquine covered in the EUA could not legally be sold in the US:  it was adulterated, according to the FDA definition. Yet millions of doses were released to the states for use by hospitals, for patients who were not entered into clinical trials. One has to wonder if patients who received adulterated chloroquine or hydroxychloroquine drugs from the national stockpile got the same benefit expected from drug that was not adulterated?

Pandemic countermeasures covered and distributed under an EUA provide almost complete liability protection to their manufacturers in the event of injuries. DHHS assumes limited product liability  under the Countermeasures Injury Compensation Program

The retraction of the EUA, therefore, means that currently available chloroquine drugs, obtained through commercial channels and not the EUA, should be of expected quality (no known GMP or expiration issues) and subject to ordinary regulations regarding liability.  This is a big plus for consumers, as the product should be more reliable and manufacturers are liable if it isn't.  It is also a huge plus for DHHS, which will no longer be liable for injuries that might develop from the use of inferior drugs under an EUA.

Furthermore, according to a statement by DHHS Secretary Alex Azar, medical practitioners are permitted to prescribe these drugs, obtained commercially, just as they would any off-label pharmaceutical.  It is estimated that 20% of prescriptions are for off-label use of approved drugs in the US.

While the meaning of the FDA's issuing and retracting the EUA has been hailed by the media as evidence the drug does not work for Covid, I think there is an entirely different explanation for FDA's moves.

1.  Only hospitalized patients or those entered into clinical trials testing hydroxychloroquine were allowed by FDA to receive the drug from the NSS under the EUA.  Almost all clinical trials of treatment waited until patients were severely ill before starting the drug. This ensured that few patients would receive HCQ, and get none from the national stockpile, at the onset of illness, when the disease is most treatable and the drug most likely to demonstrate an effect.

The EUA did not permit supply of the drug to outpatients.

2.  Providing adulterated, non-approvable and sometimes expired drugs to patients makes you wonder whether the drugs are adequately potent and safe. Might supplying questionable drugs further muddy the water about the efficacy of the chloroquine drugs, in addition to providing them to patients too late?

3.  Whenever an EUA is issued for a drug, let the patient beware!  The reasons to issue an EUA are to remove manufacturer liability from the product, and to allow use of products that may be substandard, and lack FDA approval.  Accepting a drug under an EUA takes away the right to seek damages from the manufacturer for an injury.  So going back to standard ways of obtaining drugs protects consumers.

4.  The FDA actions were explained and reported in a manner that made medical providers frightened to prescribe the drugs, limiting access to patients. This made it much harder to learn if the drug worked well when used early, in mild cases, at preventing much more severe illness. 

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