Reducing Prescription Drug Shortages
The White House
Office of the
Press Secretary
For Immediate Release
October 31, 2011
EXECUTIVE ORDER
REDUCING PRESCRIPTION DRUG SHORTAGES
By the authority
vested in me as President by the Constitution and the laws of the United States
of America, it is hereby ordered as follows:
Section
1.
Policy. Shortages of
pharmaceutical drugs pose a serious and growing threat to public health. While a
very small number of drugs in the United States experience a shortage in any
given year, the number of prescription drug shortages in the United States
nearly tripled between 2005 and 2010, and shortages are becoming more severe as
well as more frequent. The affected medicines include cancer treatments,
anesthesia drugs, and other drugs that are critical to the treatment and
prevention of serious diseases and life threatening conditions.
For example,
over approximately the last 5 years, data indicates that the use of sterile
injectable cancer treatments has increased by about 20 percent, without a
corresponding increase in production capacity. While manufacturers are currently
in the process of expanding capacity, it may be several years before production
capacity has been significantly increased. Interruptions in the supplies of
these drugs endanger patient safety and burden doctors, hospitals, pharmacists,
and patients. They also increase health care costs, particularly because some
participants in the market may use shortages as opportunities to hoard scarce
drugs or charge exorbitant prices.
The Food and
Drug Administration (FDA) in the Department of Health and Human Services has
been working diligently to address this problem through its existing regulatory
framework. While the root problems and many of their solutions are outside of
the FDA's control, the agency has worked cooperatively with manufacturers to
prevent or mitigate shortages by expediting review of certain regulatory
submissions and adopting a flexible approach to drug manufacturing and
importation regulations where appropriate. As a result, the FDA prevented 137
drug shortages in 2010 and 2011. Despite these successes, however, the problem
of drug shortages has continued to grow.
Many different
factors contribute to drug shortages, and solving this critical public health
problem will require a multifaceted approach. An important factor in many of the
recent shortages appears to be an increase in demand that exceeds current
manufacturing capacity. While manufacturers are in the process of expanding
capacity, one important step is ensuring that the FDA and the public receive
adequate advance notice of shortages whenever possible. The FDA cannot begin to
work with manufacturers or use the other tools at its disposal until it knows
there is a potential problem. Similarly, early disclosure of a shortage can help
hospitals, doctors, and patients make alternative arrangements before a shortage
becomes a crisis. However, drug manufacturers have not consistently provided the
FDA with adequate notice of potential shortages.
As part of my
Administration's broader effort to work with manufacturers, health care
providers, and other stakeholders to prevent drug shortages, this order directs
the FDA to take steps that will help to prevent and reduce current and future
disruptions in the supply of lifesaving medicines.
Sec.
2.
Broader Reporting of Manufacturing Discontinuances.
To the extent permitted by law, the FDA shall use all appropriate administrative
tools, including its authority to interpret and administer the reporting
requirements in 21 U.S.C. 356c, to require drug manufacturers to provide
adequate advance notice of manufacturing discontinuances that could lead to
shortages of drugs that are life supporting or life sustaining, or that prevent
debilitating disease.
Sec.
3.
Expedited Regulatory Review.
To the extent practicable, and consistent with its statutory responsibility to
ensure the safety and effectiveness of the drug supply, the FDA shall take steps
to expand its current efforts to expedite its regulatory reviews, including
reviews of new drug suppliers, manufacturing sites, and manufacturing changes,
whenever it determines that expedited review would help to avoid or mitigate
existing or potential drug shortages. In prioritizing and allocating its limited
resources, the FDA should consider both the severity of the shortage and the
importance of the affected drug to public health.
Sec.
4.
Review of Certain Behaviors by Market Participants.
The FDA shall communicate to the Department of Justice (DOJ) any findings that
shortages have led market participants to stockpile the affected drugs or sell
them at exorbitant prices. The DOJ shall then determine whether these activities
are consistent with applicable law. Based on its determination, DOJ, in
coordination with other State and Federal regulatory agencies as appropriate,
should undertake whatever enforcement actions, if any, it deems appropriate.
Sec.
5.
General Provisions. (a)
Nothing in this order shall be construed to impair or otherwise affect:
(i)
authority granted by law to an agency, or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating
to budgetary, administrative, or legislative proposals.
(b) This order
shall be implemented consistent with applicable law and subject to the
availability of appropriations.
(c) This order
is not intended to, and does not, create any right or benefit, substantive or
procedural, enforceable at law or in equity by any party against the United
States, its departments, agencies, or entities, its officers, employees, or
agents, or any other person.
BARACK OBAMA