FDA regulations regarding generic drug warnings need an update

by Mandy Hicks

2015-05-01 15.52.57For people who take a medication, the warnings that comes along with it are the most important protection they have from harmful side effects. New information emerges every day about drugs and its potential side effects. Under the current Food and Drug Administration regulations, getting a proper warning included with drug information is harder than it should be for makers of generic drugs, and the Food and Drug Administration is considering steps to fix that.

Since November 2013, the FDA has been considering new rules for generic drugs that would allow manufacturers to expedite the process of revising labels to add warnings or information that is critical for consumers taking these drugs. This can include updating dosage amounts, safety and efficacy information.

Under the current rules, generic drug manufacturers must follow the warning labels provided by the brand name drug.  The proposed changes would allow generic drug manufacturers to change the warning labels on drugs if new information is discovered regarding dangerous side effects of the drug.

The FDA plan is called Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. The FDA recently accepted public comments about this change and held a public hearing on it. The American Association for Justice supports this change to allow generic drug manufacturers to update information packaged with their products. AAJ’s comments to FDA are available here.

A recent statement submitted by 27 consumer health organizations and circulated by AAJ stated, “We strongly support the rule moving forward expeditiously through the regulatory approval process now. Requiring all prescription drugs to carry up-to-date safety warnings is essential for improving the safety and efficacy of all FDA approved drugs as well as for shoring up needed consumer safeguards and protections.”

The letter from the organizations explains that the new rule will allow manufacturers of generic drugs to revise the information with their medications through a process called changes-being-effected (CBE-0) process. That process is not available to generic drug makers now, only to brand-name drug manufacturers. The CBE process permits updating of label information subject to simultaneous review by the FDA – meaning that the information can be placed on the label or drug information at the same time the FDA is reviewing it.

Many patients now take generic drugs, which have the same active ingredients and efficacy as name-brand drugs, often at a fraction of the cost. In fact, many insurance companies require patients to take a generic drug if it is available. Those patients deserve quality, updated information on the drugs they take. “Extending this process to generic drug manufacturers will give physicians, patients, and their family members access to better and more accurate information about the risks and benefits of the medications they are taking, regardless of whether a drug is brand-name or generic,” the letter says.

A group of 47 members of Congress signed a letter urging FDA Commissioner Dr. Stephen Ostroff to help create this new rule as quickly as possible. The letter includes evidence that helps emphasize the urgency surrounding this matter. The Congressional letter stated that some 86 percent of prescriptions written by doctors are filled with the generic version of a drug. “In some cases, the branded drug exits the market altogether after generic entry, leaving only generic products on the market. Often, risks associated with a drug do not become known until after a drug has been on the market for an extended period of time, including after generic drugs have entered the market.”

We want to join our voices to those calling for reform for the generic label process. Generic drugs are equivalent to brand-name drugs in every way but one – their  manufacturers cannot update their labels like their brand-name counterparts and because of this cannot be held responsible if the drugs kill or injure a patient.

We believe consumers have the right to know the dangers of the medications they’re taking, and hope that the FDA will require generic drug manufacturers to participate in this process just as their brand-name counterparts do.