[e-drug] US Institute of Medicine calls for major changes at FDA

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E-DRUG: US Institute of Medicine calls for major changes at FDA
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BMJ  2006;333:673 (30 September), doi:10.1136/bmj.333.7570.673 
http://bmj.bmjjournals.com/cgi/content/full/333/7570/673

US Institute of Medicine calls for major changes at FDA
New York Janice Tanne

The US Institute of Medicine last week called for fundamental changes to
the country's Food and Drug Administration to improve drug safety. Its
report says that the agency should be funded better and that a greater
emphasis on post-marketing surveillance is needed.

The report also calls for the FDA's culture and management and its
system of funding to be changed. Some of the agency's income comes from
user fees paid by drug companies.

It says, "Recent drug safety events have called into question FDA's
regulatory decision making and oversight processes, and caused the
public to question its ability to accomplish a balanced evaluation of
safety and efficacy of the drugs it reviews and, after their approval,
of their performance under real life conditions."

The FDA had requested the report, which was prepared by a committee
chaired by Sheila Burke, chief operating officer of the Smithsonian
Institution in Washington, DC. Among the experts was Alasdair
Breckenridge, chairman of the UK Medicines and Healthcare Products
Regulatory Agency.

The FDA spends a lot of effort approving drugs through its Center for
Drug Evaluation and Research, which depends for more than half its
funding on fees paid by drug companies. It exerts much less effort on
post-marketing surveillance, the report says.

The centre is "excessively oriented toward supporting speed of approval
and insufficiently attentive to safety." The committee said that
Congress should introduce safety related goals when the act relating to
pharmaceutical fees comes up for renewal next year.

Drug manufacturers should be required to make results of most drug
trials involving humans publicly available, it said.

The committee recommended that the FDA follow the safety profile of a
drug over its entire life cycle, placing a black triangle symbol (as
used in the United Kingdom) on new drugs or new combinations and
evaluating new data on new drugs ("new molecular entities") no more than
five years after their approval. Advertising directly to consumers
should be restricted during the black triangle period.

To support improvements in drug safety and efficacy the committee called
for greater funding from Congress for resources and personnel. It
suggested that the FDA use large automated healthcare databases to look
for patterns of drug use and adverse events and to implement active
surveillance of drugs and diseases.

Concerns about the independence of advisory committee members "have cast
a shadow on the trustworthiness of the scientific advice received by the
agency." The report recommends that the FDA require "a substantial
majority" of advisory committee members to "be free of significant
financial involvement with companies whose interests may be affected by
the committee' s deliberations."

The report also says that the FDA must improve staff morale, retain
professional staff, strengthen the transparency of its operations, and
restore its credibility.

Instability in the office of FDA commissioner should be remedied by
appointing a commissioner for a six year term. During President Bush's
nearly six years in office there has been a permanent commissioner for
only two years. Approval of Dr Andrew von Eschenbach, the acting
commissioner, has been delayed again by senators demanding approval of
drug imports from Canada and removal of the abortifacient mifepristone
from the market.

Many of the recommendations require action by Congress, which is not
likely to happen until next year.

The Future of Drug Safety: Promoting and Protecting the Health of the
Public is available at http://national-academies.org