EDITORIAL - NEJM: Blueprint for a Stronger Food and Drug Administration

[Guest guest]

The New England Journal of Medicine

Editorial

October 9, 2006

" Blueprint for a Stronger Food and Drug Administration " :

Over the past 5 years, a series of recalls of highprofile

prescription medications has aroused serious

concern about the safety of the nation's drug

supply. Faced with a crisis of confidence, the Food

and Drug Administration (FDA) in 2004 called

on the Institute of Medicine (IOM) of the National

Academies to conduct a comprehensive review of

the safety of prescription drugs. The IOM assembled

a distinguished review committee, and after

nearly a year and a half of deliberations, a draft

of the committee report became public on September

21 (www.iom.edu/CMS/3793/26341/37329.

aspx). The committee recommends a number of

specific reforms that we believe should serve as

a blueprint for a stronger system of drug regulation.

The committee emphasizes the need for improved

monitoring of the safety of drugs after

they have been approved and introduced into the

marketplace. It points out that the FDA Center

for Drug Evaluation and Research (CDER) devotes

considerably more resources to the drug-approval

process than to post-marketing surveillance. This

imbalance must be corrected. Over half of CDER's

financial resources are derived from user fees paid

by the pharmaceutical industry, and these fees

are earmarked for speedy drug approval. The

committee recommends that more of CDER's financial

resources come from general appropriations

and that user fees also support post-marketing

surveillance of drug safety. CDER, which

has been chronically underfunded, needs sufficient

financial resources to strengthen its drugsafety

staff. The FDA must have the authority to

require pharmaceutical companies to conduct follow-

up clinical studies on newly detected adverse

effects of drugs, as well as the authority to enforce

the completion of such studies and their submission

to the agency.

The committee calls for greater transparency

in communicating adverse drug effects to physicians

and patients. It agrees with the International

Committee of Medical Journal Editors that all

clinical trials beyond phase 1 must be registered

in a public database. The committee also proposes

that the packaging materials for each newly

approved drug carry a black triangle as an indication

to consumers that the drug has been approved

only recently and that the information about its

safety is incomplete. Notably, the committee calls

for a 2-year moratorium on direct-to-consumer

advertising after a new prescription drug has been

approved.

In recent years we have witnessed a growing

politicization of the FDA. To strengthen the agency's

leadership, this trend must be stopped. The

decisions that the FDA commissioner and staff

make about the nation's drug supply should be

based solely on scientific evidence and should be

independent of political considerations.

We face a mounting public health crisis in

drug safety, and definitive action must be taken.

The critical issues of financing, transparency, and

independence must be addressed. The IOM committee's

report is a crucial starting point, and we

urge Congress to implement its recommendations

and give them the highest priority.

Copyright © 2006 Massachusetts Medical Society.

http://content.nejm.org/cgi/reprint/NEJMe068237v1.pdf

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