Innovation is being hindered by regulators

CPhI World­wide the world’s largest phar­ma event – tak­ing place in Madrid Octo­ber (9–11) and orga­nized by UBM (part of Infor­ma plc) – releas­es the first part of its 6^th Annu­al Report with a stark warn­ing from Girish Mal­ho­tra, Pres­i­dent of EPCOT Inter­na­tion­al, that reg­u­la­tors are hold­ing back the industry’s abil­i­ty to innovate.
The report’s find­ings fore­see reg­u­la­tors induc­ing ‘inno­va­tion iner­tia’ with­out a change of phi­los­o­phy, but encour­ag­ing­ly – for con­tract ser­vice providers at ICSE – pre­dict CDMOs can poten­tial­ly form a key part of the solu­tion, as they have strong eco­nom­ic incen­tives to inno­vate process and man­u­fac­tur­ing improvements.

“The prob­lem we have present­ly is that for man­u­fac­tur­ing tech­nol­o­gy inno­va­tions to be suc­cess­ful phar­ma com­pa­nies (brand and gener­ics) need to have an eco­nom­ic and com­mer­cial incen­tive. It is this incen­tive that dri­ves for­ward inno­va­tion and advance­ment. But the reg­u­la­tors – in par­tic­u­lar the FDA – are still dic­tat­ing approach­es to indus­try with­out ask­ing what the com­mer­cial jus­ti­fi­ca­tions are to sup­port them.”
Girish Mal­ho­tra, Pres­i­dent of EPCOT International

Ana­lyz­ing the neg­a­tive impact, Mal­ho­tra argues that if reg­u­la­tors do not stop dic­tat­ing approach­es, valu­able process advances could poten­tial­ly be lost. In his view, the cGMP prac­tice guide­lines essen­tial­ly force a ‘cul­tur­al dog­ma’ in phar­ma com­pa­nies, where their main aim is to meet reg­u­la­tions rather than to encour­age to inno­vate. He also ques­tions whether these rec­om­men­da­tions are being intro­duced by peo­ple that have ‘hands on’ expe­ri­ence in process devel­op­ment, design, com­mer­cial­iza­tion and/or oper­a­tion of phar­ma­ceu­ti­cal plants.
The report high­lights that for phar­ma­ceu­ti­cal com­pa­nies with patent­ed prod­ucts there is lit­tle incen­tive to inno­vate due to the short patent life after new drug dis­cov­ery, abil­i­ty to secure their demand­ed sell­ing price and long approval times. How­ev­er, Mal­ho­tra has sug­gest­ed that by short­en­ing approval times, com­pa­nies will be incen­tivized to inno­vate, com­pete on a cost and qual­i­ty basis, and allow them to cap­ture a big­ger mar­ket. Under his guide­lines, not only would drug afford­abil­i­ty improve, but drug short­ages could also decrease, align­ing with the man­u­fac­tur­ing phi­los­o­phy of max­i­miz­ing prof­its, whilst retain­ing prod­uct qual­i­ty and safety.

“This report high­lights a num­ber of impor­tant long-term issues for the indus­try and phar­ma man­u­fac­tur­ers, sup­pli­ers and CDMOs – whose efforts to inno­vate in process devel­op­ment and for­mu­la­tion are often report­ed to be ham­pered by long reg­u­la­to­ry path­ways. It’s also why we have a num­ber of experts pre­sent­ing at CPhI this year to dis­cuss how the reg­u­la­tors and indus­try should tack­le process time­lines, whilst safe­guard­ing patients. The agen­da will also explore new man­u­fac­tur­ing approach­es, such as, con­tin­u­ous pro­cess­ing and QbD.”
Tara Dou­gal, Head of con­tent – Phar­ma at UBM