This article is more than 5 years old. Information may no longer be current.
Press FDA to balance disparities among branded drugs, generics
Click Here to Manage Email Alerts
It is a scenario with which we are all too familiar. In the midst of a hectic day, a staff member catches you between patients, stating “Mrs. Jones’ pharmacy is on the phone, and the glaucoma medication you prescribed is tier 3 on her insurance formulary. They want to substitute a generic.” Ugh. On one hand we always want to do what is best for our patients, including prescribing affordable medications. On the other hand, Mrs. Jones’ glaucoma has been recalcitrant, and the branded medication you prescribed seems to be the best option. Unfortunately, the reality of today’s fast-paced health care world rarely affords us the time to “conference” with the patient, pharmacist and insurer to resolve this dilemma. So, we simply acquiesce and agree to the generic.
If this seems familiar to you, you are certainly not alone. Today, generic medications account for approximately three out of every four prescriptions dispensed in the U.S. annually. What has led to generics’ meteoric rise could be construed as the perfect storm.
Since the Waxman-Hatch Act’s inception in 1984, the U.S. Food and Drug Administration has not held generics to the same rigorous methodology mandated of branded innovator medications in bringing a product to market. Generics merely have to demonstrate similar bioequivalence to their branded counterparts – the same active ingredient, concentration, dosage and delivery route. No lengthy, cost-prohibitive trials.
Playing off of this competitive advantage, insurers and pharmacies have been quick to embrace generics as a means by which to improve their own bottom line. With the government, insurers and pharmacies squarely behind generics, and patient skepticism slowly dwindling, it is no wonder generic use has skyrocketed over the past decade. And it is no wonder prescribers find themselves in a somewhat precarious position.
As caregivers, we often form strong alliances with branded pharmaceutical companies early in our career. We see them as trusted partners, shouldering the onerous task of discovering and developing innovative medications to treat everything from infection to glaucoma. In short, they provide us the tools necessary to better care for our patients. We realize these advances do not come easily and understand the significant costs associated with bringing a new medication to the market. So, we embrace and prescribe branded innovator medications … until a generic comes along. So the trend continues.
In the larger scheme of things, the core question is whether generics will ultimately “gut” innovative pharmaceutical companies, effectively squeezing research and development and thwarting new medication development. It almost seems unfair.
Whether or not generics have enjoyed an unfair competitive advantage may soon be a moot point. Just last month the FDA reaffirmed its proposal requiring generic pharmaceutical companies to update product labels if they learn of any safety and/or efficacy issues related specifically to their products. Historically, such label changes have been required only of branded medications, a mandate that has arguably increased brand product liability risk while at the same time “shielding” generics. If the FDA’s proposal comes to fruition, patients and doctors alike will be alerted to safety and efficacy issues related to a particular generic manufacturer’s product. While consumer groups applaud the FDA’s proposal, generic pharmaceutical companies argue that it will increase their liability exposure and drive generic medication costs up. No surprise there.
In the final analysis, we need a healthier balance between branded and generic medications. We must press the FDA to further streamline its regulatory pathway, thereby allowing branded pharmaceutical companies to bring new medications to the marketplace in a more cost-effective fashion … and ultimately at a lower cost to society. In addition, while labeling changes are necessary for generic manufacturers, we must also press for tort liability reform. Only in this fashion will affordable generics be available for those who might otherwise go without. It really is all about balance, for without it, innovation and options will no longer exist.