A Message from Kathleen Jaeger: The Resurgence of Drug Misinformation Campaigns

Many state governments have promotedthe use of generic medicinesthrough adoption of generic substitutionand other laws. These policies aredesigned to ensure that a state's citizensreceive the highest quality of care at themost affordable price. Consequently,increases in generic utilization havesaved consumers and taxpayers billionsof dollars in prescription drug costs. Arecent resurgence in efforts by specialinterest groups to "carve out" or exemptcertain therapeutic classes of medicinefrom generic substitution requirements(such as prior authorization and preferreddrug lists), however, may significantlyinfluence prescribing practicesand spur needless increases in US healthcare costs.

Today, as with narrow therapeuticindex (NTI) drugs in the mid-to-late1990s, some brand manufacturers arearguing that certain classes of drugs arenot safe for generic substitution. Aslucrative patents expire on brand drugs,special interest groups representingbrand manufacturers have renewed theirefforts to maintain market share by wagingmisinformation campaigns throughoutthe country. By July 2005, over 20states had passed legislation, and moreare considering legislative proposals thatwould prevent the substitution of genericmedicine for patients with conditionssuch as epilepsy, mental health disorders,and HIV/AIDS. (eg, see NC GEN.STAT. § 90-85.28, [exempting conditionssuch as "HIV/AIDS (and) mental illnesses" from generic substitution requirements]).A 2006 bill in Tennessee suggested thatall prescribers and pharmacists "remainaware of the potential public safety andhealthcare implications that generic?drug product[s] may have on personswith epilepsy." Deliberately misleadingscare tactics such as this are intended tocreate a public perception of genericmedicines as being poor-quality andunsafe substitutes for brand drugs. Thiscould not be further from the truth.

The term NTI drug refers to a drug thatcould yield significantly different resultswhen its quality or potency varies onlyslightly. The past controversy surroundingNTI drugs was based on the misconceptionpromoted by some brand manufacturersthat an approved generic drugcould vary beyond a safe and effectiverange of potency of its brand counterpartand still be placed on the market.

In 1998, the FDA responded to theNTI controversy, stating that "productsevaluated as therapeutically equivalentcan be expected to have equivalentclinical effect whether the productis a brand name or generic drugproduct." True to its mission toadvance public health by making medicinesmore affordable,the FDA hassteadfastly supportedits determinationthat a generic medicineis interchangeablewith its brandcounterpart. The samepolicy remains today.

In order to gain approval,generic drugsmust undergo rigoroustesting to demonstratetheir equivalenceto the brandedcounterpart. The FDArequires that a genericdrug contain identicalamounts of thesame active ingredientas the brandname product, andthat the generic drugmeet the same highstandards for identity, quality, and purity.The FDA has stated that its strictbioequivalence standards account forprecise degrees of variation betweenproducts, so that additional testing ormonitoring is unnecessary when apatient is switched from a brand to ageneric—in the FDA's words, "the goalpostswould always be scaled to thevariability of the [brand drug]." In onesurvey covering more than 400 samplesof 24 marketed brand and genericdrugs, all products were found to meetthe established criteria for purity andquality. Regardless of whether the drugis prescribed for treating epilepsy,mental health disorders, HIV/AIDS, orany other medical condition, a genericsubstitute is equally as safe and effectiveas the brand drug.

It is important to note that, when abrand manufacturer alters a manufacturingprocess or makes changes to aformulation, it may be required todemonstrate equivalence between thenew product and the old product toensure that the drug has the samesafety and effectiveness. In theseinstances, brand companies rely onexactly the same testing procedures asthose used by generic manufacturersto demonstrate equivalence betweenthe generic product and its brandcounterpart. The FDA has stated that, ifa generic drug is substituted for abrand, "the physician, pharmacist, andpatient have the FDA's assurance thatthe physician should see the same clinicalresults and safety profile?any differencesthat could exist should be nogreater than one would expect if onelot of the innovator's product was substitutedfor another."

In light of the FDA's long-standing policy,the recent campaigns waged by somebrand manufacturers to carve out entiretherapeutic classes from generic substitutionlaws are not only misleading, theyare misguided and needless. Carve-outswill result in patients who suffer fromepilepsy, mental health disorders, orwhatever particular medical condition isthe subject of the carve-out having lessaccess to affordable generic medicine.More broadly, carve-outs will needlesslyincrease the cost of prescription drugs forconsumers and taxpayers.

Pharmacists, physicians, policy makers,and patients alike should be aware of thefacts about generic substitution, so thatthe influences of special interests are notallowed to put profits before publichealth.

Kathleen Jaeger, GPhA president andchief executive officer