Do safety and quality have to take a hit?
Associates Between the years 2005 and 2011 the number of new drug shortages quadrupled to 251, posing a significant risk to public health. President Barack Obama issued a directive to the FDA in 2011 to develop a plan to address the problem.
In 2011 the U.S. Government Accountability Office provided testimony to the Committee on Health, Education, Labor, and Pensions,
regarding a study to ascertain the true drug shortage situation and
to determine whether a formal FDA program would be required.1
The study concluded that the current regulatory framework was
insufficient to prevent drug shortages and the FDA should be given
more power in terms of notification of potential or impending drug
shortages so a remediation plan could be implemented.
While the drug shortage figure declined to 117 in 2012, there
were still more than 300 ongoing shortages at the end of the
2013. Figure 1 illustrates the number of new drug shortages by
year from 2005-2012 and shows that shortages predominantly
affect sterile injectable products. This reflects the FDA’s focus on
preventing nationwide shortages of these critical drugs.
In response to this and several other key issues related
to the FDA’s authority and ability to protect the public, the
Food and Drug Administration Safety and Innovation Act
(FDASIA) was enacted in July 2012.2 This legislation has
expanded the FDA’s authority and strengthened the agency’s
ability to safeguard and advance public health in a number of
ways. FDASIA consists of four directives:
• Giving the authority to collect user fees from industry to
fund reviews of innovator drugs, medical devices, generic
drugs, and biosimilar biological products
• Promoting innovation to speed patient access to safe and
• Increasing stakeholder involvement in FDA processes
• Enhancing the safety of the drug supply chain
The FDA identified two central internal goals to achieve that
In response to the President’s Executive Order3 and to
ensure the safety of the drug supply chain, the FDA issued a
Strategic Plan4 in October. The agency broke the action plan
into internal initiatives within the agency and external initia-
tives by key industry stakeholders.
address the root causes of both short and long term shortages.
The first was to strengthen the FDA’s mitigation response, to
focus on elements involving better communication with the
agency and other chief stakeholders, maximize the agency’s
ability to respond to a shortage, and improve database tracking
to allow better resolution in problem areas. One key element
of the initiative was to clarify the role of manufacturers with
regard to notifying FDA about supply disruptions, and mitigate
impending shortages. If the FDA could be notified earlier of
an impending drug shortage, then the agency could not only
enhance public communication of the potential drug shortage
issue but also begin discussions on countermeasures.
The second program goal was to develop long-term prevention strategies to tackle the underlying causes of supply disruptions and shortages. To achieve this the FDA identified ways
to promote and sustain manufacturing and product quality
improvements through positive incentives. Organizations such
as the International Society of Professional Engineers (ISPE),
for example, have created a centralized forum for discussion
amongst industry executives called the International Leadership
Forum (ILF) that is tasked with addressing industry challenges
at a global level. This forum is one example where industry and
FDA are working together to develop pragmatic solutions to
address drug shortages. One approach being discussed is to use
regulatory science to identify early-warning signals of shortages.
These plans can be described as primarily defensive since
the FDA has no direct control over drug shortages. The agency
outlined key factors for drug manufacturers to consider, such
as manufacturing incentives that encourage high-quality manufacturing to help reduce the occurrence and severity of shortages, or the availability of data on manufacturing quality that
would help buyers such as hospitals, pharmacies, and other
group purchasing organizations make purchasing decisions.
Any disruption in supply is exacerbated if there is limited
Figure 1. Number of New and Prevented Shortages by Dosage Form, 2005-2012.
■ Injectables - Prevented
■ Injectables - New ■ All - Prevented All ■ New
Source: Date from FDA’s internal drug and biologics shortages databases