La­belling fi­asco is a bit­ter pill to swal­low

Pa­tients in US have lit­tle re­course when ‘de­fec­tive’ gener­ics cause them harm

Business Day - Business Law and Tax Review - - FRONT PAGE - AL­TAIR RICHARDS

THE US Supreme Court re­cently struck down the de­ci­sion and award of a state of New Hamp­shire court in favour of a pa­tient, rul­ing 5-4 that pa­tients do not have a right to claim against generic phar­ma­ceu­ti­cal man­u­fac­tur­ers for the “de­fec­tive de­sign” of medicines.

The is­sue in this case was whether a per­son who is in­jured by the side ef­fects of a generic drug can sue the man­u­fac­turer on the ground that the generic drug, tak­ing into ac­count the in­for­ma­tion on the prod­uct label, is un­rea­son­ably danger­ous.

It was com­mon cause that the in­juries suf­fered by the pa­tient, Ms Bartlett ( Mu­tual Phar­ma­ceu­ti­cal Co v Bartlett ), were ap­palling, namely third de­gree burns over most of her body as­so­ci­ated with Stevens-John­son Syn­drome and toxic epi­der­mal necrol­y­sis. All agreed that th­ese con­di­tions are recog­nised, but rare, ad­verse events linked to the non-steroidal anti-in­flam- ma­tory medicine in ques­tion, sulin­dac, and that the label of the medicine did not dis­close the pos­si­ble oc­cur­rence of th­ese ad­verse events.

At the rel­e­vant time, how­ever, Mu­tual Phar­ma­ceu­ti­cal’s sulin­dac prod­uct and prod­uct label were in ac­cor­dance with the re­quire­ments of the Food and Drug Ad­min­is­tra­tion (FDA) and the Fed­eral Food, Drug and Cos­metic Act (FDCA). It is im­por­tant to note that in terms of this leg­is­la­tion, a generic man­u­fac­turer in the US may not uni­lat­er­ally make changes to a medicine’s for­mu­la­tion or label. In con- trast, the orig­i­na­tor/brand-name man­u­fac­turer of a medicine is per­mit­ted to up­date its warn­ing la­bels as and when it be­comes aware of new safety risks prior to ob­tain­ing FDA ap­proval.

The court found that be­cause the FDA had ap­proved the sulin­dac prod­uct and the label, a state court could not im­pose dam­ages for harm from us­ing the prod­uct.

The de­ci­sion in Mu­tual Phar­ma­ceu­ti­cal Co was in align­ment with the court’s 2011 find­ing in PLIVA v Mens­ing that generic man­u­fac­tur­ers could not be held li­able for fail­ing to warn pa­tients about the side ef­fects of a medicine be­cause they are re­quired by fed­eral law to use the same safety label as the brand-name ver­sion of the medicine.

With about 80% of all medicines dis­pensed in the US be­ing gener­ics, re­course by pa­tients in the event of harm has been se­verely limited.

Un­doubt­edly this is a vic­tory for generic man­u­fac­tur­ers in the US, but are there risks to pa­tients of sim­i­lar court de­ci­sions in SA?

The regis­tra­tion, la­belling and postreg­is­tra­tion phar­ma­covig­i­lance re­quire­ments for medicines are gov­erned by the Medicines and Re­lated Sub­stances Act in SA. The Medicines Con­trol Coun­cil (MCC) is the statu­tory body charged with the reg­u­la­tion of medicines.

There are some im­por­tant dif­fer­ences be­tween the reg­u­la­tory frame­work in the US and SA.

Al­though generic man­u­fac­tur­ers will be guided by the con­tent of the orig­i­na­tor safety in­for­ma­tion and other contents of the orig­i­na­tor medicine pack­age in­sert, there is no le­gal re­quire­ment in this coun­try for the generic pack­age in­sert to mir­ror the orig­i­na­tor pack­age in­sert. In fact, the generic pack­age in­sert word­ing should al­ways dif­fer due to the orig­i­na­tor hav­ing copy­right in its pack­age in­sert and it may also re­flect dif­fer­ent ap­proved in­di­ca­tions. By way of ex­am­ple, some in­di­ca­tions may still be un­der patent pro­tec­tion and there­fore can­not be in­cluded in the generic in­sert.

Im­por­tantly, nei­ther the orig­i­na­tor nor the generic man­u­fac­turer may change its pack­age in­sert with­out the prior ap­proval of the MCC.

In terms of the MCC’s guide­lines, in the event that a phar­ma­ceu­ti­cal man­u­fac­turer (orig­i­na­tor or generic) be­comes aware of an ad­verse reaction to its medicines, the MCC, through its National Ad­verse Drug Event Mon­i­tor­ing Cen­tre, must be no­ti­fied im­me­di­ately and an ap­pli­ca­tion for the amend­ment of the pack­age in­sert should be sub­mit­ted to­gether with the orig­i­nally ap­proved in­sert, a pro­posed amended in­sert and mo­ti­va­tion for the amend­ment. In the event that the ad­verse drug reaction is se­vere, the MCC has made pro­vi­sion for ur­gent safety up­dates to pack­age in­serts or for “dear doc­tor” alert let­ters to be sent to health­care pro­fes­sion­als.

In short, as generic man­u­fac­tur­ers bear their own re­spon­si­bil­ity for the for­mu­la­tion and la­belling of medicines reg­is­tered by them with the MCC and for ad­verse event re­port­ing in re­spect of such medicines, they do not have any pro­tec­tion from claims sim­i­lar to that cre­ated by the FDCA in the US.

Good news for South African pa­tients. Or is it?

A se­ri­ous chal­lenge for both in­dus­try (orig­i­na­tor and generic) and for pa­tients in SA is the amount of time it takes for pack­age in­sert changes to be ap­proved by the MCC. At present, a nor­mal pack­age in­sert amend­ment may take longer than three years to be ap­proved and ap­proval for an ur­gent pack­age in­sert amend­ment may take six to 12 months.

Dur­ing the ap­proval pe­riod — other than in the most se­ri­ous cases where a “dear doc­tor” let­ter is called for — up­dated safety and other in­for­ma­tion about a medicine is not be­ing com­mu­ni­cated to pa­tients and health­care pro­fes­sion­als.

It is some­what cold com­fort that South African pa­tients are able to sue generic man­u­fac­tur­ers for dam­ages un­der the Con­sumer Pro­tec­tion Act or the law of delict in the event of harm caused by an undis­closed dan­ger of a generic medicine. Surely pa­tients (and man­u­fac­tur­ers) would pre­fer for the MCC to have per­mit­ted the dan­ger to have been timeously dis­closed to the pub­lic, prior to the harm oc­cur­ring.

Pic­ture: THINKSTOCK

DOU­BLE WHAMMY FOR PA­TIENTS The court found that be­cause the FDA had ap­proved the sulin­dac prod­uct and the label, a state court could not im­pose dam­ages for harm from us­ing the prod­uct

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