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Sign of Industry Influence: FDA Reconsidering Generic Labeling Rule

Feb. 26, 2015


Sign of Industry Influence: FDA Reconsidering Generic Labeling Rule

Bowing to Pressure, Agency Considers Industry Alternative to Patient Safety Rule Due Out Later This Year

Contact: Angela Bradbery (202) 588-7741
David Rosen (202) 588-7742

The U.S. Food and Drug Administration (FDA) is allowing industry pressure to delay and possibly endanger a significant patient safety rule it proposed in 2013 in response to a Public Citizen petition (PDF).

The agency should resist pressure from the pharmaceutical industry, which is putting profit above patient safety, and instead finalize a rule that will protect patients, Public Citizen maintains.

At issue is whether generic drug manufacturers have any responsibility for providing doctors and patients with new-found information about risks posed by the companies’ products.

The FDA’s proposed rule would give generics manufacturers the option to update labeling to provide warnings about newly discovered risks to patient safety without obtaining prior approval from the FDA – much as brand-name manufacturers have been able to do for nearly 30 years.

The FDA has not yet finalized the labeling rule, but the agency stated in December that it expected to do so in September 2015.

The generics industry has been lobbying hard against the rule. In November, the GPhA (the generics trade group) and PhARMA (the brand-name trade group) sent the FDA a joint alternative to the FDA proposal. The industry alternative essentially says that after a generic manufacturer enters the market with a particular medication, neither the generic nor the brand-name manufacturer can update the safety warnings without prior FDA approval.

The alternative is bad for three reasons:

(1) It would mean fewer updates, as no company would be required to, or have incentive to, request updates;
(2) It would mean slower updates, as the FDA would have to pre-approve every warning update; and
(3) It would mean that no company could be held accountable to injured patients for failure to warn about newly discovered risks.

In December, U.S. House of Representatives lawmakers indicated that they wanted the FDA to meet with the industry to discuss the proposal. Last week, the FDA announced that it is reopening the comment period until April 27 and holding a public meeting on March 27 to discuss the industry proposal.

For patients, the industry’s proposed alternative is a lose-lose idea.

The FDA’s original proposal reflects the reality that information about serious risks often comes to light after generic versions of a medication are on the market. (See Public Citizen’s report documenting this.) Under current rules, generic manufacturers are not permitted to update warnings to reflect new safety information unless instructed to do so by the FDA. The FDA’s original proposal would have solved that problem, but the industry’s alternative would exacerbate it.

Under a longstanding FDA rule, adopted in the 1980s at the urging of the pharmaceutical industry, brand-name manufacturers are permitted to make safety updates without prior FDA approval. That rule enables updated warnings to reach physicians and patients as soon as possible. After generics enter the market, however, brand-name market share drops precipitously, and brand-name manufacturers are much less vigilant about labeling updates. Further, brand-name manufacturers often stop making a product for which there is a generic version and, at that point, are not monitoring the product or considering labeling updates.

The FDA’s proposed rule would promote patient safety by extending to generics manufacturers the ability to make labeling updates, and by providing a process for other makers of a particular medication promptly to follow suit.

It is critical that the FDA not cave to industry pressure. It should finalize its proposed rule, which would protect patients by ensuring they have the updated safety information possible as soon as possible.

The benefits of the FDA proposed rule, and the lack of factual support for criticisms of it, are explained in Public Citizen’s petition for rulemaking (PDF), which led to the proposed rule; Public Citizen’s comments (PDF) in support of the proposed rule; and the organization’s congressional testimony (PDF) supporting it.

We urge you to let your readers know that the pharmaceutical industry is trying to throw a wrench into a critical patient-safety measure. For questions, contact one of the people listed above.