Angie Drakulich
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At the beginning of each month, I get an automatic email notification from FDA noting the latest drug shortages that exist
in the US market. As of early June, there were about 130 product types listed on FDA's drug-shortage webpage. Most of the
affected products are cancer medications, anesthetics used for patients undergoing surgery, emergency medications, and intravenous
electrolytes. Sterile injectables dominate the list and are prime targets for shortages because of limited production lines
and capacity challenges, explains the FDA webpage. The reasons given for the various shortages include everything from manufacturing
delays to increased market demand to material (API) shortage to product discontinuation.
FDA points out that shortage information is provided "voluntarily by manufacturers" and that the agency "cannot require firms
to report the reason for shortage or duration of the shortage or any other information about shortages." This may soon change
however. Earlier this year, FDA issued a draft guidance, Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage. The guidance is meant to address growing concerns about drug shortages, which have tripled from 61 in 2005 to 178 in 2011,
states the draft guidance. In 2011, FDA tracked over 250 drug shortages. These shortages can prevent patients from getting
the crucial medications they need, when they need them. In addition, shortages can lead to larger problems. For example, in
late May, FDA warned the public about a counterfeit version of Adderall being sold on the Internet—the counterfeit version
contained the incorrect API. The drug just happens to be on the shortage list due to API supply issues.
Although the agency cannot do anything to stop drugs from being discontinued—that is the manufacturer's choice—it can do something
about supply and quality problems that lead to shortages and about the way shortages are reported and tracked. A goal of the
guidance is therefore to increase communication between industry and regulators in an effort to protect the public health.
Reporting planned discontinuations of life-saving drug products to the authorities has been a requirement of manufacturers
since about 1997 under Section 506C of the Food, Drug, and Cosmetic Act. However, the new draft guidance goes further by clarifying
who has responsibility for such reporting: the "sole manufacturer," defined by the draft guidance as "the only applicant currently
supplying the US market with the drug product" where drug product includes specific strength, dosage form, and route of administration.
The draft guidance also redefines the term "discontinuance" to include "any interruption of manufacturing of a drug product
described in paragraph (b)(3)(iii)(a) for sale in the United States that could lead to a potential disruption in supply of
the drug product, whether the interruption is intended to be temporary or permanent."
In October 2011, FDA reminded manufacturers via letter of their mandatory reporting requirement and encouraging them to voluntarily report any disruptions in supply that
could lead to a product shortage. That same month, President Obama ordered FDA to "use all available administrative tools
to expand the Agency's efforts to combat the problem of drug shortages." The new draft guidance aims to carry out that order
and to further enforce Section 506C. The draft document specifically calls out certain actions that may lead to a temporary
or permanent drug supply problem, such as delays in acquiring active or inactive ingredients, equipment failures, and manufacturing
shutdowns, whether for maintenance or routine matters. Manufacturers will need to notify FDA of these issues if they could
lead to a disruption in supply. The agency also asks industry in the draft guidance to notify it on a voluntary basis (the
above items would be mandatory with the final guidance) when certain problems could "reasonably" be expected to lead to a
drug shortage or disruption (e.g., stability concerns, facility transfer, etc.)
I have high hopes for the guidance. In 2010, for example, 38 shortages were prevented because companies notified the agency
of potential problems. Just as we tell our children, it's always best to tell the truth—even if it hurts a little to do so—because
in the end, it's simply the right thing to do.
Angie Drakulich is the editorial director of BioPharm International.
