Testimony on Generic Labeling at FDA

March 27, 2015

Generic Labeling Testimony at the Food and Drug Administration

Docket No. FDA-2013-N-0500

I am Paul Brown and I represent members of the Patient, Consumer, and Public Health Coalition.

Last year, 17 members of our Coalition, which includes patients, consumer advocates, scientists, and physicians, submitted comments to the FDA strongly supporting its proposed rule on generic drug labeling.

The proposed rule would allow generic drug manufacturers to update their labeling as new information becomes available.  Patients and consumers deserve up-to-date information about the prescription drugs that they use. It is essential that all prescription drugs (not just brand named drugs) carry accurate safety warnings, and all manufacturers remain attentive to potential health hazards.

Even though the FDA has post-approval requirements for brand-name and generic drugs, these requirements are not as effective as they should be for generic drugs. Makers of generic drugs are not allowed to initiate labeling changes when necessary. Generic drug companies should be permitted to use the same procedures as brand manufacturers to update their warning labeling. This would ensure that consumers are alerted to risks and hazards at the earliest possible time.

Nearly 80% of prescriptions filled in the U.S. are for generic drugs.[1]  Millions of Americans rely on these generics to provide the same benefits as brand-name drugs—at a lower cost.    However, patients and doctors are not aware that generic drug makers could not provide the most up-to-date safety information on the label. Moreover, since the 2011 Supreme Court decision (Pliva v. Mensing), patients who are harmed by a generic version of a prescription drug have been unable to seek relief from the drug’s manufacturer.  If patients knew that they could not rely on the accuracy of labels of generic drugs or seek legal redress if they are harmed by generic drugs for risks that were known but not on the label, patients would demand brand name drugs.  And that would result in skyrocketing medical costs. On average, the cost of a generic drug is 80 to 85 percent lower than the brand name product. In 2010 alone, the use of FDA-approved generics saved $158 billion.1

From a fairness and public health perspective, a patient’s ability to be informed of the risks of a drug and to be able to seek legal relief when harmed by inadequately labeled drugs should not depend on whether the drug was a brand-name or generic version.  This is especially outrageous since “many generic drugs are made in the same manufacturing plants as brand name drug products,” according to the FDA.1

The generic drug industry argues that their costs would increase, if they were held liable for harms (such as injuries or deaths) caused by their products. They also claim that having different warnings on generic drugs and brand name drugs would confuse patients.  These claims are not credible.  Prior to the 2011 Supreme Court case, generic drug makers were held responsible for failing to warn consumers and were also highly profitable at the same time.

When a generic drug causes harm and nobody is held liable, the costs to injured patients do not magically disappear. Those costs are paid by patients, private insurance companies, or government programs such as Medicare, Medicaid, or the Department of Veterans Affairs.

Under pressure from Congress and industry, the FDA is increasingly willing to approve new drugs on the basis of studies done on few hundred patients for a short period of time.  Yet it is often not until the medication is taken by tens of thousands of patients for more than a decade that we learn about all the important side effects.  By that time, generic versions of the drug are widely used, and sometimes are by then the only versions used. When the original company stops selling the “brand name drug,” which often happens when they can’t compete with cheaper generics, no one is currently responsible for updating the label.

We strongly support the use of generic drugs and find it disturbing that generic drug manufacturers are putting their financial interests before the health and safety of patients.  It is equally disturbing that individuals and organizations that receive funding from generic drug companies have used their clout to support the generic drug companies’ wishes.

The FDA’s proposed rule would allow generic drug makers to update their safety labels. It will help improve the health of the more than 7 million Americans represented by our coalition members and for all Americans. It will provide the most current information about the risks, hazards and side effects of drugs to both physicians and patients. In addition, legal accountability is a powerful incentive for generic drug makers to take post-market monitoring more seriously.

Members of the coalition strongly urge the FDA to adopt the proposed rule in its current form as soon as possible.

The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or pb@enter4research.org

 

[1] Food and Drug Administration. “Facts About Generic Drugs” webpage. http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm