Regulatory Focus™ > News Articles > FDA's Battles Over Generic Drug Labeling Continue on a Smaller Scale

FDA's Battles Over Generic Drug Labeling Continue on a Smaller Scale

Posted 28 January 2014 | By Alexander Gaffney, RAC

There has been no shortage of tension between the US Food and Drug Administration (FDA) and generic drug manufacturers as of late. And if a recent spat between FDA and Hospira is any indication, don't expect that tension to ease any time too soon.


As Regulatory Focus has explored at length, FDA is currently in something of a one-sided fight against the branded pharmaceutical industry, the generic pharmaceutical industry and legislators. FDA has hoped to update its labeling regulations to allow generic manufacturers to temporarily change their labels to reflect newly found safety risks.

This, numerous experts have said, is plainly prohibited under the 1984 Hatch Waxman Act, which requires the generic drug to have the same label as the reference-listed drug at all times.

For its part, FDA has cited legal authority from the Federal Food, Drug and Cosmetic Act (FD&C Act, 21 USC 301) and the Public Health Service Act (PHS Act, 42 USC 201), both of which provide FDA with the legal authority to regulate drug products and their labeling. FDA says that FD&C Act Section 502 allows it to consider a drug misbranded if it bears inadequate directions for use or insufficient warnings, for example.

From Macro to Micro Generic Issues

But that issue has been very much a macro-level one, affecting nearly the entire pharmaceutical space. Meanwhile, others like it are being debated more behind the scenes.

Take for example a 2014 docket notice concerning applications to market generic versions of Hospira's sedative Precedex (Dexmedetomidine Hydrochloride Injection). The drug remains covered by at least one method-of-use patent, US Patent Number 6,716,867 (the '867 patent), while an earlier patent (5,344,840) expired in September 2011.

On 15 January 2014, FDA sent an email to generic applicants of the drug to explain that it wanted input on three related issues, the most important of which being the following: Does the '867 patent preclude all other method-of-use patents such that FDA would be unable to approve any additional indications? Or conversely, would ANDA applicants be able to "carve out" an acceptable use by adding "new words to the approved indication to limit the indication"?

Hospira: Omission, not Addition

In comments, Hospira has come out strongly against FDA's question, saying that to "add new words" would be an explicit violation of the Hatch Waxman Act. "There is no basis for adding new words to an approved indication to support a section VIII statement. The law is clear: FDA regulations state that a generic product label must be 'identical in … conditions of use' to the branded label, 'except that conditions of use for which approval cannot be granted because of … an existing patent may be omitted." (Emphasis original)

The key word there, Hospira says, is "omitted"-not added or invented. The company noted that to change this would not only be contrary to the law, but also contrary to FDA's own longstanding practices.

"The agency has long permitted only 'omissions of words or phrases' from the RLD's labeling-not adding new words to artificially limit the scope of an approved indication," it wrote.

"An unprecedented ruling permitting generics to add new words to seek approval for a subset of an indication would raise a host of administrative and safety concerns," Hospira continued. "Each indication with new words would become a brand new subset indication never supported by a proper clinical trial," raising questions about the safety and efficacy of the "new" indication.

Other questions-"Would the FDA permit just a few new words or would generics be permitted to propose new sentences and entire new paragraphs? And how finely could generics slice up the approved indication to attempt to avoid a use code?"-would also be raised, Hospira said.

And as there are no regulations, compliance policy guides or guidance documents in this area, FDA would effectively be making it up as it went along, the company implied. Instead, FDA should keep to its longstanding policy and not approve any labels which overlap "at all" with the brand's use code.

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