Could stream­lin­ing FDA ap­proval process re­duce pa­tient safety?

Sun Sentinel Broward Edition - - VOICES & OPINION - By An­thony J. Messina

Pres­i­dent Don­ald Trump has pro­posed “stream­lin­ing” the reg­u­la­tory process for new­drug ap­pli­ca­tions, which may prove to be ben­e­fi­cial in re­duc­ing the end con­sumer price point on new ther­a­peu­tics and drugs, de­crease the cost of re­search and devel­op­ment, and al­low­for smaller bio­phar­ma­ceu­ti­cal com­pa­nies to ef­fec­tively bring their prod­ucts to mar­ket with­out the in­volve­ment of larger stake­hold­ers. How­ever, I am­left with great skep­ti­cism when it comes to mod­i­fy­ing an in­ves­ti­ga­tional process that has been im­mensely im­proved since the 1960s. If any of this “stream­lin­ing” eases the stan­dards to which clin­i­cal tri­als are held today, we could be plac­ing pa­tients at risk and be left with in­ef­fec­tive drugs flood­ing the mar­kets.

Clin­i­cal tri­als aim to pro­tect the pub­lic fromi­nad­e­quate, un­eth­i­cal and dan­ger­ous ther­a­peu­tics by con­duct­ing a se­ries of con­trolled in­ves­ti­ga­tions which ex­am­ine the safety, tol­er­a­bil­ity and side-ef­fect pro­file of any new drug de­vel­oped with the in­ten­tion to be mar­keted for hu­man use. The Food and Drug Ad­min­is­tra­tion (FDA) then uses th­ese clin­i­cal tri­als, and the re­sults which they pro­vide, as their as­sess­ment tool to de­ter­mine ap­proval. The FDA has held the re­spon­si­bil­ity to pro­tect the pub­lic’s health by as­sur­ing ad­e­quate safety, ef­fi­cacy and se­cu­rity of hu­man drugs in theUnited States since 1906. Through reg­u­la­tions, the FDA en­sures that the health ben­e­fits of any drug sold within their ju­ris­dic­tion out­weigh their known risks.

Pres­i­dent Trump is­sued an ex­ec­u­tive or­der on Jan. 30 aimed at de­creas­ing reg­u­la­tions— elim­i­nat­ing two reg­u­la­tions for ev­ery new one is­sued. This has the po­ten­tial to greatly re­lax the stan­dards of drug ap­proval. In a meet­ing held by Trump and phar­ma­ceu­ti­cal ex­ec­u­tives he stated,“We’re go­ing to get the ap­proval process much faster,” which is a dan­ger­ous state­ment to make if the ra­tio­nale be­hind cur­rent reg­u­la­tions are not con­sid­ered, es­pe­cially if the so­lu­tion is to sim­ply elim­i­nate the re­quire­ments for FDA ap­proval. Re­duc­ing the ex­ist­ing stan­dards for drug ap­proval­would al­low­for a “faster process,” and it­would also al­low­for more in­ef­fec­tive drugs to be mar­keted and cause a re­duc­tion in the safety stan­dards the FDAwas es­tab­lished to main­tain.

In an ef­fort to­move to­ward im­prove­ment, I be­lieve a bal­ance must be struck be­tween de­ter­min­ing safety and ef­fi­cacy among a con­trolled investigation, while re­duc­ing the ex­ces­sive cost of bring­ing new drugs to mar­ket. Safety must re­main para­mount, and any pro­posed im­prove­ments can­not be forced overnight or with the swipe of a thought­less sig­na­ture.

Just as time has gone into im­prov­ing this in­ves­ti­ga­tional process to iden­tify con­traindi­ca­tions and drug side ef­fects, the process of dereg­u­la­tion must uti­lize this same care­ful and ev­i­dence based ap­proach.

In or­der for a drug to be ap­proved, the ben­e­fit of the ther­a­peu­tic must out­weigh the po­ten­tial or iden­ti­fied risk to the pa­tient. This is called the ben­e­fit-risk ra­tio. If the stan­dards of ef­fi­cacy, which can be cor­re­lated to pa­tient ben­e­fit, is al­tered in this equa­tion, the al­low­able side-ef­fect pro­file may in­crease.

Trump’s cuts could re­duce the cost of drug devel­op­ment, how­ever, that cost re­duc­tion will be con­sumed by the in­creased cost of health care due to the treat­ment of the ad­verse drug re­ac­tions and the in­di­rect cost of in­ef­fec­tive treat­ments that should have never been mar­keted.

Clin­i­cal tri­als and the FDA’s reg­u­la­tions do not re­strict or iden­tify ev­ery harm­ful drug from be­ing mar­keted, how­ever, the reg­u­la­tions which have been es­tab­lished have al­lowed physi­cians and pa­tients to be more in­formed about their med­i­ca­tions, and drove medicine to­ward in­no­va­tion and cures.

As it stands, the med­i­cal com­mu­nity lacks knowl­edge on the long-term ef­fects of many of the drugs on the mar­ket, and ifwe choose to sup­port a stream­lined ver­sion of clin­i­cal tri­als and drug devel­op­ment to save the phar­ma­ceu­ti­cal com­pa­nies a buck, I am­cer­tainwe will learn a lot less about fu­ture med­i­ca­tions, de­crease safety, and be far less in­no­va­tive as a coun­try.

An­thony J. Messina, of Port St. Lu­cie, is a SOCRA cer­ti­fied clin­i­cal re­search pro­fes­sional.

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