Can FDA learn les­son from plane crashes?

The Buffalo News - - LIFE COLUMNS - By Joe and Teresa Grae­don

When the Boe­ing 737

Max 8 air­plane crashed in Ethiopia, the Fed­eral Avi­a­tion Ad­min­is­tra­tion was crit­i­cized for mov­ing slowly to ground th­ese air­planes. Many other coun­tries pulled this air­craft out of ser­vice while the FAA was in­sist­ing that the plane was safe to fly.

A few days later, the fed­eral agency re­versed course and an­nounced it would ground all the Max 8 air­planes af­ter all. Why was the FAA slower than other coun­tries? Are there lessons from this de­ba­cle that might ap­ply to the Food and Drug Ad­min­is­tra­tion and phar­ma­ceu­ti­cals?

The air­line in­dus­try has one huge ad­van­tage over the phar­ma­ceu­ti­cal in­dus­try: There are two fed­eral agen­cies that over­see air traf­fic. One is the FAA, which ap­proves air­craft.

The other is the Na­tional Trans­porta­tion Safety

Board, or NTSB. This is the agency that springs into ac­tion when some­thing has gone ter­ri­bly wrong, such as an air­plane crash. Con­se­quently, the ap­provers are not put in the awk­ward po­si­tion of hav­ing to de­ter­mine that they might have made a mis­take.

China was the first coun­try to ground the Boe­ing Max 8 air­planes, within less than a day of the crash. Other coun­tries rapidly fol­lowed suit. It was more than two days later when the FAA took ac­tion.

Even though the FAA took a few ex­tra days, it still moved a lot faster than the FDA of­ten does. Some­times it can take months or even years for the FDA to act af­ter it learns about a se­ri­ous drug prob­lem. There is no in­de­pen­dent in­ves­tiga­tive agency equiv­a­lent to the NTSB that can look into drug safety.

The re­sult of this bu­reau­cratic boon­dog­gle is that the same or­ga­ni­za­tion that ap­proves med­i­ca­tions is also re­spon­si­ble for in­ves­ti­gat­ing prob­lems. If it dis­cov­ers a se­ri­ous ad­verse re­ac­tion af­ter a medicine has been on the mar­ket for a while, the FDA might not move as fast as a neu­tral or­ga­ni­za­tion.

Take trogli­ta­zone (Rezulin), for ex­am­ple. It was ap­proved in 1997 over the ob­jec­tions of the FDA med­i­cal reviewer. He wor­ried that this di­a­betes medicine would harm the liver and the heart. Bri­tish reg­u­la­tors re­moved it from their mar­ket in De­cem­ber of that year.

In the U.S., how­ever, the FDA did not take ac­tion to with­draw Rezulin un­til 2000. That was de­spite one of its own safety of­fi­cers sound­ing the alarm about liver fail­ure.

An­other ex­am­ple of the FDA’s slow re­ac­tion time is the de­con­ges­tant phenyl­propanolamine. This drug had been in­cluded in cold reme­dies and diet pills for half a cen­tury. The FDA fi­nally re­quested its re­moval in 2000 be­cause it es­ti­mated that PPA was re­spon­si­ble for hun­dreds of strokes each year.

Per­haps it is time to sep­a­rate the drug ap­proval process from the process of in­ves­ti­gat­ing drug safety fail­ures. A sep­a­rate and com­pletely in­de­pen­dent or­ga­ni­za­tion, like the NTSB, might help pro­tect the pub­lic from drug dis­as­ters.

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