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What Happens When Drug and Device Labeling Regulations Meet National Security Concerns?

Posted 29 July 2014 | By Alexander Gaffney, RAC

What Happens When Drug and Device Labeling Regulations Meet National Security Concerns?

There exists in the US a stockpile of healthcare products that, one hopes, will rarely need to be used.

Known as the Strategic National Stockpile (SNS), the stockpile contains drugs and medical devices intended to be helpful in the case of a national emergency, such as an outbreak of disease, a terror attack, natural disaster or other unforeseen events.

Background: The SNS

Technically the “stockpile” is not a single store of products, but rather a collection of strategically placed warehouses containing products of national importance and overseen by the Centers for Disease Control and Prevention (CDC).

But like all stockpiles, such as food stockpiles, the SNS has a problem: time.

Its products, after being purchased by the CDC, go unused for years, sitting in temperature-controlled facilities awaiting a time when they might be needed.

But until then, the government must ensure that the products will still work as intended and bear straightforward instructions for use—a job that is left up to the US Food and Drug Administration (FDA).

Under a February 2012 rule, Exceptions or Alternatives to Labeling Requirements for products Held by the SNS, FDA is permitted to grant exceptions or extensions to labeling requirements, which would otherwise “render such products misbranded” under section 502 of the Federal Food, Drug and Cosmetic Act.

Explained FDA: "Under this rule, the appropriate FDA center director may grant exceptions or alternatives to certain regulatory labeling requirements applicable to medical products that are or will be included in the SNS if he or she determines that compliance with the labeling requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of medical products that are or will be included in the SNS."

FDA may grant these exceptions if it determines that “an exception or alternative [will] ensure that the labeling … includes information necessary for the safe and effective use of the product given the product’s anticipated circumstances of use.”

Of Expirations and Labels

So what happens when a product exceeds its originally-determined expiration date? Must the US government re-purchase those medications and devices?

Not necessarily.

In a 2006 study, FDA found that nearly 90% of products stored in the SNS were still effective one year after their labeled expiration date. FDA generally extended those products' shelf lives 66 months beyond their posted date of expiry based on evidence generated from periodic stability testing and other evaluations.

In other words, FDA is fine with holding on to medicines long after they are thought to be useless—so long as they aren't.

But FDA also uses its labeling update authority in other ways as well.

As explained in a recent Federal Register notice, FDA is occasionally called upon by companies to update the labeling of various products in the SNS, thereby exempting them from federal labeling requirements.  FDA said it typically only receives one or two responses from drug and device manufacturers a year to update the labeling on their products.

The new labeling is generally meant to ensure that the products are accompanied by information that offers clear instructions for use, relevant warnings and "other information." For example, if a product stockpiled in the SNS has been issued new black box warnings by FDA since being stockpiled, updates might be printed out to accompany the products.

Importance to Unapproved Products

Labeling updates are also meant to apply to products that have not been approved by FDA, such as investigational products purchased by the Biomedical Advanced Research and Development Authority (BARDA).

In fact, FDA's labeling exception authority is especially important for investigational products, FDA explained in 2012. Under normal circumstances, once a product is approved, it must bear the FDA-approved labeling before it is marketed or distributed. Therefore, when an investigational product contained within the stockpile was approved, it would ordinarily need to be returned to the manufacturer for re-labeling—"a potentially time-consuming, costly, and labor-intensive process," FDA explained.

The labeling exceptions allow both manufacturers to avoid recalling their products from the SNS for re-labeling, allowing FDA, the CDC and manufacturers to keep their respective costs down.

Similarly, if a drug exceeds its expiration date but is still useful, FDA's authority allows it to avoid the cost of requiring a manufacturer to re-label the products each time with the new expiration date.


Federal Register

Categories: Regulatory News

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