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Senior Citizen Health & Medicine
Fixing Drug Safety System Requires Major Changes at
FDA, Says Institute of Medicine
'It is a widely held misperception that FDA
approval of a new drug denotes a guarantee of safety and certainty about
its risk-benefit profile.'
 September 25, 2006 – Senior citizens should be
among the Americans paying close attention to a report released Friday
by the Institute of Medicine that says the U.S. Food and Drug
Administration lacks the ability to adequately protect Americans from
dangerous prescription drugs after they reach the market. Older people
are by far the most likely to suffer from dangerous drugs. The report
suggests remedies, including a symbol on labels showing the contents are
a "New Drug."
Calling it a "scathing report," Consumers Union
said it should "set off warning bells in Congress that it must reform
the nation’s broken drug safety system now, and put in place an open
process where the pharmaceutical industry can no longer hide critical
safety information and consumers can have faith in the medicines they
take."
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Lack of clear regulatory authority, chronic
under-funding, organizational problems, and a scarcity of post-approval
data about drugs' risks and benefits have hampered the FDA, says the
report from the IOM.
Noting that resources and therefore efforts to
monitor medications' risk-benefit profiles taper off after approval, the
committee that wrote the report offered a broad set of recommendations
to ensure that consideration of safety extends from before product
approval through the entire time the product is marketed and used.
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Consumer Union Says... |
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“The nation’s
premier doctors and scientists are saying the drug safety system
is broken, and they have laid out a plan to fix it. Congress
simply can’t ignore this real problem any longer, because too
many lives are at stake,” said Bill Vaughan, senior health
policy analyst with Consumers Union, publisher of Consumer
Reports.
The IOM
recommendations echoed many supported by Consumers Union,
including mandatory registration of clinical trial results so
doctors and patients have the latest information on a drug’s
safety and efficacy; limiting advertising on new drugs; more
authority for the FDA to require pre- and post-market safety
studies and to fine safety offenders; and ensuring drug risk
information gets communicated to doctors and patients.
“The IOM report
is the first in-depth critique of the problems that exist in
assuring drug safety for all patients,” said Dr. Marvin Lipman,
Consumers Union’s chief medical adviser.
“Congress should
heed these recommendations and restore the FDA's ability to
carry out its primary mission to protect the public health and
welfare.”
Several bills
have been introduced that include many of the IOM’s proposed
reforms, but none have had a hearing. The co-chairs of the
Senate Health Committee, Sens. Enzi and Kennedy, recently
introduced legislation to reform the FDA drug safety system (S
3807).
Other pending
legislation includes clinical trial registration and FDA reform
pushed by Sens. Grassley and Dodd and Reps. Waxman, Markey,
Tierney and Ramstad (S 470/HR 3196 and S 930/HR 4429), as well
as House bills on direct-to-consumer advertising and post-market
safety, backed by Reps. Hinchey, DeLauro and others.
“Drug safety
isn’t a political issue, it’s a public health issue,” Vaughan
said.
“There are many
members of Congress on both sides of the aisle who want to give
FDA the tools and resources to do the job right and stand up to
the drug companies. This report is a real opportunity for
Congress to pass bipartisan, landmark legislation now.”
Consumers Union
also applauds the emphasis in the IOM report on opening up the
process and eliminating conflicts of interest from the
pharmaceutical industry caused by the current user fee system.
A House bill, HR
2090 (Hinchey), would restore the independence and freedom of
the FDA from the pharmaceutical industry’s payment of user fees,
which have gone primarily to drug approval while neglecting drug
safety.
The IOM also
emphasized examining safety over the cycle of a drug’s use —
including its usage years after approval when many safety issues
begin to arise. Similar measures are included in the
Enzi-Kennedy bill.
“We look forward
to working with Congress to pass legislation that will restore
consumers’ confidence in the medicines they take each day,”
Vaughan said. |
Recommendations include:
● Labeling requirements and advertising limits
for new medications
● Clarified authority and additional enforcement tools for the agency
● Clarification of FDA's role in gathering and communicating
additional information on marketed products' risks and benefits
● Mandatory registration of clinical trial results to facilitate
public access to drug safety information
● An increased role for FDA's drug safety staff
● A large boost in funding and staffing for the agency
"FDA has an enormous and complex mission -- both to
make innovative new drugs available to patients as quickly as possible
and to assess the long-term risks and benefits of these products once
they are on the market," said Sheila Burke, chair of the committee that
wrote the report.
"We found an imbalance in the regulatory attention
and resources available before and after approval. Staff and resources
devoted to pre-approval functions are substantially greater.
"Regulatory authority that is well-defined and
robust before approval diminishes after a drug is introduced to the
market. Few high-quality studies are conducted after approval, and the
data are generally quite limited.
"Many of the report's recommendations are intended
to bring the strengths of the pre-approval process to the post-approval
process, to ensure ongoing attention to medications' risks and benefits
for as long as the products are in use."
When new medications, formulations, and delivery
systems are introduced to the market, their package labels should carry
a symbol for a two-year period alerting patients and health care
providers that the products are new and that there may be uncertainties
about their risks and benefits, the report says.
It is a widely held misperception that FDA approval
of a new drug denotes a guarantee of safety and certainty about its
risk-benefit profile. In fact, eliminating all uncertainties prior to
approval could cause considerable delay in new products reaching
patients in need, the committee noted. Five years after a product is
introduced to the market, FDA should conduct a formal review of all
accumulated information about its benefits and risks.
The committee would favor a moratorium on
direct-to-consumer advertising during the period when a product carries
the symbol denoting newness, but it acknowledged the legal uncertainties
surrounding such an imposition.
Such advertising should at least explicitly note
that evidence for the product's risks and benefits are less-developed
than for older drugs, and urge consumers to talk with their physicians
about alternatives, the committee says.
Citing organizational and cultural problems within
FDA that hinder its post-approval drug safety activities, the committee
recommended a number of ways to bolster the role and expertise of its
drug safety staff.
The agency should give its Office of Surveillance
and Epidemiology -- formerly known as the Office of Drug Safety -- joint
authority with the Office of New Drugs for conducting post-approval
regulatory activities.
OSE staff members also should be part of the teams
that review each application for a new drug approval. And a six-year
term should be established for the FDA commissioner to provide greater
stability in leadership for drug safety, the report says.
FDA also needs clear authority and appropriate
enforcement tools -- such as fines and injunctions -- to ensure that
industry complies with label changes and conditions imposed on new
products upon or after approval.
FDA now has only limited ability to ask for and
negotiate with drug sponsors on these regulatory matters, and its only
enforcement option is to withdraw approval. Strengthening the agency’s
ability to react to safety problems that arise after approval would help
mitigate concerns that timely approval of drugs leads to sacrifices in
safety.
Currently, no single organization is charged with
responsibility for gathering and analyzing data on medications' risks
and benefits after approval, when safety problems may become evident as
products become more widely used. FDA should assume this role, the
report says. The agency needs the expertise and resources to pursue
more sophisticated research that can spot changes in the balance of
products' risks and benefits. FDA should communicate pertinent findings
to the public in a timely manner.
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Statement by Mike Leavitt
Secretary of Health and Human Services
I commend the Institute of Medicine (IOM) for their
thorough report, “The Future of Drug Safety,” which provides an
important appraisal of the Food and Drug Administration’s (FDA) recent
efforts to improve the safety and effective use of prescription drugs in
the United States. In its report the IOM recognized the significant
progress FDA has made in improving its management and communications
about the drug safety review process.
Admittedly, there is a tension between balancing
the risks and benefits of innovative new treatments for patients in need
of hope. All drugs have risks associated with them. We must balance
those risks against the need to efficiently get new innovations to
patients who can benefit from them. We can minimize these risks while
still pursuing necessary new technologies through innovations such as
FDA’s Critical Path Initiative that enable smarter and more personalized
medicine so we can target new drugs more effectively.
There are two steps that can be taken quickly and
that will have a dramatic positive impact on our ability to further
enhance our drug safety efforts.
First, I call on the Senate to quickly confirm Dr.
Andrew von Eschenbach as FDA commissioner. The FDA needs permanent
leadership, and Dr. von Eschenbach has the energy, the vision and the
support to bring our drug safety review process into the 21st Century.
We have excellent and dedicated scientists at FDA and they work hard to
make wise and prudent decisions about the safety and effectiveness of
drugs. Their high quality work has made the FDA an icon of trust, a
certifier of safety, an enabler of innovation and a repository of
information. But retaining that noble status requires permanent
leadership at the agency. Today’s report further underscores the need
for swift Senate action.
Secondly, Congress must ensure that health
information technology legislation support and emphasize the importance
of interoperable health records. The interoperability of health records
is an essential element to our efforts to improve drug safety and create
value in health care. Without the ability to ensure interoperability of
electronic medical records, we will lose many opportunities to improve
drug safety through the use of health information technology.
The future of improved drug safety and value in
health care relies on a drug regulation process that keeps pace with
advances in technology and science. I look forward to working with
Congress and my colleagues at the FDA to make that happen.
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The committee stressed the importance of increasing
the public's access to information on medication safety and
effectiveness. Current registration of trial data and results is
largely voluntary and is not adequately systematic or standardized, the
committee concluded.
Congress should require companies to register all
phase II through phase IV clinical trials on the federal Web site
ClinicalTrials.gov if data from the studies is to be submitted to the
agency. Registration should include summaries of all studies' results,
regardless of the outcomes.
The advisory committees that FDA consults as a
source of independent insight on questions about new products have
attracted criticism because the agency allows individuals with financial
ties to the pharmaceutical industry to serve. Noting that the agency
does not impose limits on the number of committee members waived to
serve despite financial ties, but also acknowledging that a
zero-tolerance policy is unrealistic, the report recommends that a
substantial majority -- at least 60 percent -- of advisory committee
members be free of significant financial involvement with companies
whose interests may be affected by their deliberations. FDA should
issue waivers for the other committee members very sparingly.
It is widely acknowledged that FDA is severely
underfunded, and implementing the report's recommendations will require
additional financial and staff resources. The report calls on Congress
to appropriate a substantial increase in both funding and personnel for
FDA.
The committee favors appropriations from general
revenues, noting that all Americans have an interest in a robust drug
safety system and that increasing attention to FDA's post-approval drug
safety responsibilities should not occur at the expense of pre-approval
activities. However, if appropriations are not sufficient, Congress
should lift most of the restrictions on how the agency can apply fees
paid by drug sponsors, which for the most part can now be used only for
pre-approval activities.
The study was sponsored by the U.S. Food and Drug
Administration, the National Institutes of Health, Agency for Healthcare
Research and Quality, Centers for Medicare and Medicaid Services, and
the Department of Veterans Affairs. Established in 1970 under the
charter of the National Academy of Sciences, the Institute of Medicine
provides independent, objective, evidence-based advice to policymakers,
health professionals, the private sector, and the public. The National
Academy of Sciences, National Academy of Engineering, Institute of
Medicine, and National Research Council make up the National Academies.
A committee roster follows.
Pre-publication copies of
The Future of Drug Safety: Promoting and Protecting the Health of the
Public are available from the National Academies Press; tel.
202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu.
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Daily Report by KaiserNet.org
 IOM
Report Calls on FDA To Improve Consumer Safety;
Recommendations Include Restrictions on Prescription Drug
Advertisements, Increased Post-Market Drug Reviews
FDA
must implement "major changes" to ensure the safety of new
prescription drugs, according to a report released on Friday
by an
Institute
of Medicine committee, the
New York
Times reports (Harris, New York Times, 9/23).
According to the report, FDA currently cannot ensure the
safety of new prescription drugs because of inadequate
funds, cultural and structural problems, and "unclear and
insufficient regulatory authorities" (Wilde Mathews, Wall
Street Journal, 9/23). The IOM Committee on the Assessment
of the United States Drug Safety System issued the report at
the request of FDA. The report makes a series of
recommendations for FDA to improve prescription drug safety,
such as:
● A requirement that packages for new
prescription drugs for two years include a symbol to inform
patients that the safety profile of the medication is not
fully established;
● A restriction on direct-to-consumer
advertisements for new prescription drugs for the first two
years (New York Times, 9/23);
● A requirement that FDA reevaluate
the safety and effectiveness of new prescription drugs
within five years of approval;
● Additional authority for FDA to
impose fines on pharmaceutical companies;
● A requirement that pharmaceutical
companies register all clinical trials they sponsor in a
federal database accessible by patients and health care
professionals;
● A requirement that most FDA
advisory committees members have no potential conflicts of
interest with the pharmaceutical industry; and
● A six-year term of office for the
FDA commissioner.
The 15-member committee unanimously
approved the recommendations (Vedantam,
Washington
Post, 9/23). According the report, FDA "needs a
more nuanced set of tools to signal uncertainties, to reduce
advertising that drives rapid uptake of new drugs or to
compel additional studies in the actual patient populations
who take the drug after its approval." The report also finds
that a 1992 law under which pharmaceutical companies pay
user fees to finance reviews of new prescription drugs has
limited "the ability of reviewers to examine safety signals
as thoroughly as they might like" (New York Times, 9/23).
Committee Member Comments
Committee Chair Sheila Burke, deputy secretary and chief
operating officer of the
Smithsonian Institution, said, "We found an
imbalance in the regulatory attention and resources
available before and after approval. Staff and resources
devoted to pre-approval functions are substantially greater.
Regulatory authority that is well-defined and robust before
approval diminishes after a drug is introduced to the
market" (Bridges,
AP/Chicago
Sun-Times, 9/24).
Susan Ellenberg, a committee member and
associate dean for clinical research at the
University
of Pennsylvania School of Medicine, said, "You
will never get to the place where there's zero risk, but we
want to get as close as you can without going so far that
it's a disadvantage to people who need the new drugs" (Fallik,
Philadelphia Inquirer, 9/23).
Committee member R. Alta Charo, a
bioethicist at the
University of Wisconsin-Madison, said that
clinical trials conducted prior to the approval of new
prescription drugs might not provide an accurate safety
profile for the general population. "A drug tested in a few
hundred or thousand people is very different when used by
millions, especially over long periods of time and in
conjunction with other supplements," Charo said. Charo also
said that FDA has "a lack of collaboration among divisions,
tensions (and) inappropriate management" (Washington Post,
9/23).
Reaction
Senate Finance Committee Chair Chuck
Grassley (R-Iowa) said that the report is a "watershed
moment for FDA reform." Grassley said, "Public safety is at
stake, along with the credibility of our nation's drug
safety agency. If Congress and the administration do not act
based on the clear-cut assessment of this premier review
committee, then political leaders will be abdicating their
responsibilities to the American people" (Cohen,
Newark
Star-Ledger, 9/23).
Acting FDA Commissioner Andrew von
Eschenbach said that the agency in recent months has
improved efforts to ensure the safety of new prescription
drugs through a number of measures. He added, "I'm committed
to taking additional steps and will look to the initiatives
recommended by the Institute of Medicine to ensure we
continue to fulfill our mission" (Rockoff,
Baltimore
Sun, 9/23).
Steven Galson, director of the FDA
Center for
Drug Evaluation and Research, said, "Our drug
safety staff and the office of new drugs work together both
in the preapproval and in the post-approval setting, so the
dichotomy people are using is really not accurate"
(Philadelphia Inquirer, 9/23).
Pharmaceutical Research and Manufacturers of America
Senior Vice President Caroline Leow in a statement said, "It
is essential to make sure that efforts to improve the drug
safety system do not hurt patient access to medicines needed
to treat a range of debilitating diseases and medical
conditions. It is also important to remember that all drugs
have risks and the FDA has an effective system that weighs
benefits and risks throughout the lifecycles of medicines"
(Baltimore Sun, 9/23).
Bill Vaughan, senior policy analyst for
Consumers Union, in a statement said, "The
nation's premier doctors and scientists are saying the drug
safety system is broken, and they have laid out a plan to
fix it. Congress simply can't ignore this real problem any
longer, because too many lives are at stake" (Carey,
CQ
HealthBeat, 9/22).
New Coalition Announced
In related news, former
HHS
Secretary Tommy Thompson and
Center for
Science in the Public Interest Executive Director
Michael Jacobson on Monday plan to announce the formation of
the Coalition for a Stronger FDA,
USA Today
reports (Rubin, USA Today, 9/25).
The coalition also will include former
HHS secretaries Donna Shalala and Louis Sullivan, the
American
Heart Association and the
Biotechnology Industry Organization. According to
the
AP/Washington Times, the FDA "budget has trailed
the increases given to other public health agencies, most
notably"
NIH
and
CDC. Thompson said, "The ultimate object is to
get the FDA the resources needed for them to do the job"
(AP/Washington Times, 9/25).
Broadcast Coverage
Several broadcast programs reported on the report:
● ABCNews' "World News Tonight": ABCNews correspondent Lisa
Stark discusses the report (Stark, "World News Tonight,"
ABCNews, 9/22). Video of the segment is available
online.
● NBC's "Nightly
News": The segment includes comments from Charo;
Galson; and David Graham, an FDA safety official; and a
woman whose father died after he used the COX-2 inhibitor
Vioxx (Bazell, "Nightly News," NBC, 9/22). The complete
segment is available
online
in Windows Media.
● NPR's "All
Things Considered": NPR health policy
correspondent Joanne Silberner discusses the report (Silberner,
"All Things Considered," NPR, 9/23). The complete segment is
available
online
in RealPlayer. |
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