Meningitis
Outbreak another Example of a Failed Regulatory Patchwork
NEW HAVEN, CT—Congresswoman Rosa DeLauro (CT-3)
announced today she will be introducing legislation to strengthen the Food and
Drug Administration (FDA)’s authority to ensure the safety of drugs from
compounding pharmacies. Such a facility is at the root of the current fungal
meningitis outbreak that has killed 11 people and sickened 119 in nine states.
These pharmacies are intended to create customized versions of medicine for
specific patients, not bulk production of medications, such as the estimated
17,000 steroid injections tied to the outbreak. Currently the pharmacies are
licensed and overseen by a patchwork of state agencies and the FDA’s guidance to
states on licensing such pharmacies was last updated in 2002. The pharmacy that
produced the potentially contaminated drug responsible for the current outbreak
has surrendered its license to the Massachusetts State Board of Pharmacy and all
compounds from the facility have been recalled.
DeLauro also sent a letter to Health and Human Services
Secretary Kathleen Sebelius requesting information about the gaps in our drug
safety system posed by compounded products and the need to better protect
patients, including those enrolled in Medicare. “I believe this outbreak and
corresponding recall make clear that strong Federal authority is needed over
these large scale compounding pharmacies to ensure that patients receive safe
and effective drugs, that we better monitor adverse events associated with these
drugs, and that there is a single entity responsible for verifying appropriate
marketing and safe drug production,” she wrote. “It is also critical that
Federal and State partners responsible for this oversight have the resources and
capacity needed to complete this work.”
DeLauro is a senior Democrat on the House of
Representatives committee that funds the FDA and a longtime champion for
strengthening oversight responsibilities and increased funding for the agency.
Details on the recall may be found hereand
information on the fungal meningitis outbreak may be found here.
The letter is as follows:
October 9,
2012
The Honorable Kathleen Sebelius
Secretary
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20202
Dear Secretary Sebelius:
I write
today out of grave concern regarding the ongoing outbreak of fungal meningitis
that has been linked to an epidural injection of a compounded drug. As of
today, more than 100 cases of fungal meningitis, including 11 deaths, have been
linked to a specific steroid injection drug produced by a single compounding
pharmacy center. This outbreak and the corresponding recall of products from
the New England Compounding Center expose dramatic gaps in our drug safety
standards that create an unnecessary risk to the public health.
I believe
this outbreak and corresponding recall make clear that strong Federal authority
is needed over these large scale compounding pharmacies to ensure that patients
receive safe and effective drugs, that we better monitor adverse events
associated with these drugs, and that there is a single entity responsible for
verifying appropriate marketing and safe drug production. It is also critical
that Federal and State partners responsible for this oversight have the
resources and capacity needed to complete this work.
As you
know, drug compounding is traditionally viewed as the creation of a specific
drug for a particular patient when there is not an alternative approved by the
Food and Drug Administration (FDA). Compounded drugs may play a valuable role
for some patients and their health care providers based on the patients’
specific health needs. A 2001 FDA survey, however, found that products from
compounding pharmacies had a “higher than expected” failure rate, thus
indicating that they may convey a different risk than other pharmaceutical
products. Another FDA survey conducted in 2006 identified clear concerns about
the safety, potency, and uniformity of some compounded drugs.
Moreover,
some compounding pharmacies have evolved into large scale operations that
produce sizeable quantities of some drugs. For example, cases in the current
outbreak are spread across nine states and more than 17,500 doses of the
potentially contaminated drug were shipped to twenty-three states. At the same
time, the FDA lacks clear authority for ensuring the safety of these products
and last updated its guidance for industry in 2002.
Because
of the current vague patchwork of Federal and State oversight and regulation of
these pharmacies, consumers are left at risk and often unaware of the
differences between these products and others. I believe that we must do more
to ensure the safety of these products for American consumers, to make certain
that consumers have the information they need to make an informed choice, and to
verify that Medicare is accurately reimbursing for the use of these products
sometimes used by our nation’s seniors.
In light
of these concerns and my intent to work to improve the safety of these products,
I would appreciate your timely response to the following questions:
· How is
your Department reaching out to health care providers and their patients to
ensure that such a large possible patient population is quickly and efficiently
notified that their health may be at risk?
· How can
your Department work with State partners to ensure that compounding pharmacies
and centers follow safe preparation techniques to minimize the risk of
contaminated products entering the marketplace?
· Which
laboratory standards does the Department consider to be the premier standard for
these pharmacy facilities? How can the Department strengthen oversight of these
centers and work to ensure that the facilities comply with appropriate
laboratory standards?
· Within
your Department’s existing authority, how can HHS encourage reporting of adverse
events with compounded drugs and monitor those adverse events? Would additional
authority, requiring the reporting of these adverse events, enable the agency to
better protect the public health and quickly communicate with patients and
health care providers?
· What
authorities does your Department believe it needs to ensure that non-traditional
compounding centers, such as the center involved in this latest outbreak and
recall, are appropriately regulated at the Federal level?
· How does
your Department ensure the safety and efficacy of compounded drugs that are
prescribed for patients enrolled in Medicare and reimbursed by the program?
· How does
your Department conduct outreach to Medicare patient and health care providers
to convey the risk of compounded drugs?
· How does
your Department ensure that Medicare reimbursements do not inadvertently
incentivize the use of compounded drugs?
Thank you
for your prompt attention to this critical public health issue. I look forward
to your response to these questions and to our continued work to ensure the
safety of the drugs used to treat American patients and to prevent future
outbreaks like these.
Sincerely,
ROSA L.
DeLAURO
Member of
Congress
Press Release found here.
No comments:
Post a Comment