Generic Industry Slams FDA's Proposed Generic Drug Labeling Rule

Posted 29 January 2014 | By Alexander Gaffney, RAC 

The Generic Pharmaceutical Association (GPhA), the US generic pharmaceutical industry's main trade group, has released a whitepaper calling the US Food and Drug Administration's (FDA) proposed rule to overhaul generic drug labeling safety updates seriously flawed.


Generic drugs are those submitted to the agency through an abbreviated new drug approval (ANDA) application and approved under the 505(j) pathway of the Federal Food, Drug and Cosmetic Act (FD&C Act).

Once an existing drug's marketing and patent exclusivity has expired, generic drug manufacturers can file an ANDA with FDA to approve their drug based on safety and efficacy data from the original drug their application references, also known as the reference-listed drug (RLD). Instead of conducting new trials, they are required to submit data, such as bioequivalence data, showing that their drugs are for all intents and purposes identical to the RLD.

If approved by FDA, the drugs are required to contain the exact same labeling with respect to the claim for which they obtained approval. For example, if the RLD contains a warning that the drug could cause a heart attack, the generic drug would be required to list that side effect as well.

However, this labeling paradigm does not work both ways. Under present statutes and regulations, if a generic drug manufacturer is made aware of a risk that is not present on the RLD, they are not able to unilaterally update the label on their drug. Instead, they must ask the owner of the RLD (if they even still exist, which is not always the case) to do so on a voluntary basis, or can petition FDA to update the label. While the Supreme Court has ruled in two cases that this restriction shields generic companies from legal liabilities, public health advocates and FDA have expressed their concern that this asymmetry in labeling authority could harm patients.

As a result, FDA recently proposed granting generic drug manufacturers the authority to update their safety labeling on a unilateral basis using a changes being effected 0-day (CBE-0) application. The application essentially allows a company to immediately make changes to a label while FDA reviews it for appropriateness.

FDA's proposed regulation would leave a temporary discrepancy between the labeling of the RLD and its generic competitor(s), but said changes would eventually be harmonized for both the RLD and the generic(s).


The reaction to FDA's proposed rule has been almost universally negative. Industry analysts have panned it as being statutorily suspect, if not outright illegal. Dozens of US congressmen and senators have said the rule violates both the spirit and the letter of the 1984 Hatch-Waxman Act.

Even branded pharmaceutical companies have raised concerns, noting that needing to decide which safety issues raised by generic companies are worthy of inclusion on the RLD label opens them up to legal liabilities.

As we wrote earlier in January 2014: "Given near-unanimous pushback from industry and now a block of influential legislators, FDA's generic drug labeling rule is either dead in the water or headed toward a rocky rollout and likely legal challenges."

GPhA Opposition

And with today's release of GPhA's whitepaper, FDA now has another opponent to deal with: The generic drug industry.

GPhA's paper largely mirror complaints made previously by other entities, mainly that the regulation is not in keeping with the Hatch Waxman Act.

"The Proposed Rule would permit ANDA applicants to make CBE-0 changes to labeling and issue 'Dear Health Care Provider' letters immediately upon submission of a CBE-0 - something the Supreme Court already stated the statute does not allow," the group wrote. "The FD&C Act requires labeling to be the same as the RLD, and the preamble to FDA's regulations implementing the Hatch-Waxman Amendments correctly explained that consistency between labeling of the RLD and ANDA not only is required by the statute, but also is essential to avoid confusion in the marketplace."

The group's comments to FDA continue on to state that the proposed rule, as written, "raises significant concerns for the generic drug industry, the country's healthcare system, and the nation's citizens" by jeopardizing the availability of low-cost generic medicines. The changes, they argued, would drive some generic companies out of business by increasing their legal liabilities, causing drug shortages and healthcare prices to increase. In the future, some drugs might never have a generic competitor, GPhA predicted.

The organization also said it took offense to FDA's assumption that a recent court decision, Pliva vs. Mensing, "altered"-i.e. reduced-incentives for generic drug manufacturers to conduct postmarketing surveillance.

GPhA noted that generic drug companies are still statutorily required to conduct said surveillance, and that even absent regulatory obligations, generic drug companies exist in part due to a desire to "prove clear and meaningful information about their products to patients and healthcare providers."

The proposed rule remains open to comments through 13 March 2014.


GPhA Whitepaper

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