The FDA Should be in Charge of Warning Labels

Generic drug labels should be FDA approved.

Woman taking medicine

Generic drug labels must be FDA-approved.

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As health care grows ever more complex, patients and their caregivers are seeking reliable information about their insurance, their physicians and their medications. Yet the FDA recently proposed a rule that would result in multiple versions of the same prescription drug labels in the marketplace at the same time, creating dangerous confusion for patients, prescribers and pharmacists.

Just this month, patient advocacy, disability, veterans, minority and provider groups joined the Generic Pharmaceutical Association in raising concerns about negative impacts. Concurrently, two dozen major stakeholders in the health care supply chain – including associations representing over 40,000 pharmacies and 100,000 pharmacists – did the same. The reason such diverse organizations want the FDA to reconsider the rule is because they understand that although it sets out to improve public health, it in fact would do just the opposite.

By creating a framework under which one drug could have different warning labels, the rule would lead to confusion and uncertainty for prescribers and other health care professionals, with harmful consequences for patients. Requiring generic manufacturers to make changes prior to FDA approval would lead to a flood of labeling changes. Exaggeration of risk and inclusion of unsubstantiated warnings could discourage the use of beneficial treatments.

[Read Allison Zieve: Guaranteeing Patient Safety]

For 30 years, generic drugmakers have worked with the FDA to submit timely safety information. Indeed, FDA regulations require generic manufacturers to notify the FDA within 15 days of serious or unexpected adverse events. But the information that manufacturers have is incomplete; generic drugmakers only have access to the scientific and medical evidence for their individual products, representing a fraction of the total market for any one medicine. Because the clinical trial safety research and other drug safety data compiled by the brands is proprietary, only the FDA has access to all data from the brand drugmaker and the different generic manufacturers.

Since the FDA is the only entity with access to all the information and the expertise to evaluate and address this information, it is the only body in a position to decide whether a labeling change is warranted. And, as the gold standard of prescription drug review, the agency is the best, most trusted authority to protect patient safety. That is the FDA’s mission and responsibility.

Unfortunately, the FDA proposal authorizing a generic manufacturer to unilaterally change its safety labels would mean that one company would issue new labels while not having complete data and information on a drug’s safety. Since a brand drug has, on average, eight generic equivalents, that could mean eight different labels.

[Check out our gallery of political cartoons.]

Generic medicines currently make up 84 percent of prescriptions in the United States. The average generic medicine costs 80 to 85 percent less than the brands, and generic drugs have resulted in more than $1 trillion in savings in the last 10 years alone. Hundreds of millions of Americans, especially the most vulnerable patients, have benefited from the current system, where safety label decision–making authority for generic medicines rests with the FDA.

We urge the FDA to listen to the patient advocate, disability, minority, veterans and health care industry voices, and stand behind the bedrock principle they support: Generic drug labels must be FDA-approved and grounded on scientific evidence.