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Institute of Medicine Committee on the Assessment of the U.S. Drug Safety System

Comments Presented During Meeting Two: July 19, 2005

Alison Rein, MS

Assistant Director, Food & Health Policy

National Consumers League

 

Good afternoon, and thank you for the opportunity to share my thoughts on the U.S. drug safety system with the distinguished members of this IOM committee.  My name is Alison Rein, and I am the Assistant Director of Food and Health Policy at the National Consumers League.  NCL is a private, non-profit organization that uses education, research, advocacy, investigation, publications, and public/private collaboration to accomplish its mission of representing consumer interests on marketplace and workplace issues.  Formed in 1899, we are the nation's oldest consumer advocacy organization.

For over 100 years, NCL has provided government, businesses, and other organizations with the consumer's perspective on numerous social concerns, including drug safety.  We are gratified, therefore, that the IOM has been asked to conduct an independent assessment of the current system for evaluating and ensuring drug safety post-marketing in the United States – as we believe it requires considerable modification.  Improvements to the drug safety system will help restore the public’s confidence - which has been badly shaken during the past year – and the actions we take now will help ensure the health of future generations. 

Let me begin by saying that NCL is encouraged by the FDA’s recent establishment of the Drug Safety Oversight Board (DSB), as well as its intention to develop and disseminate important emerging drug safety information via the “Drug Watch” system.  We are particularly pleased to see that CDER plans to develop drug information sheets for both patients and providers, and we hope that the Agency will have adequate resources for promotion and dissemination of these tools.  While many of the details for these efforts have not yet been determined, we are hopeful that they will improve drug safety.  We caution, however, that they are in no way sufficient to the task. 

In the interest of time, I will confine my comments to the drug safety activities that are – or should be – ongoing within the FDA.  In general, NCL believes that the FDA should be granted greater authority – through enabling legislation – to regulate and enforce post-market drug safety processes.  This legislation should include giving greater organizational status and resources to post-market drug safety at the FDA.  It should also grant the FDA specific authority to at least do the following:

§             Invest resources in the expansion and improvement of the MedWatch system

The current MedWatch system relies primarily on adverse event data reported by drug manufacturers and physicians.  However, the requirement of drug manufacturers to submit relevant events is severely constrained by the Agency’s lack of authority and resources to audit records and impose penalties for non-compliance.  Provider entries into the system also are insufficient, and should be supplemented with many more reports directly from patients.  To achieve this, however, FDA needs to promote the system’s features to consumers – perhaps via public service announcements, pharmacy brochures, package inserts, and product labels.  With increased volume of reports to the system, the Agency would have access to much richer data for surveillance purposes, and would be able to take a more proactive approach in looking for safety signals.  As part of this effort, FDA should also revamp both the telephone and Internet interfaces to make them more user friendly, and develop a separate event report form that is easier for consumers to use.

§             Require product sponsors to initiate and complete safety trials as deemed necessary by the new Drug Safety Oversight Board

In recent reports from both the FDA and lawmakers, it has been revealed that – as an unintended consequence of the “fast track” approval process - many sponsor companies either stall or forgo completion of their required post-marketing safety studies.  It may be that this non-action is appropriate in certain circumstances, but it is also likely that the public health would be best served by having faster access to more complete drug safety information.  To this end, NCL supports granting FDA the authority to require timely completion of these studies where appropriate, and the ability to impose restrictions and penalties for non-performance.   

One such mechanism for penalty might be to restrict a drug sponsor’s ability to engage in direct to consumer advertising until all required studies have been completed, reviewed by the agency, and deemed satisfactory for the purposes of establishing the product’s safety. 

§             Subject all direct to consumer advertising to FDA scrutiny prior to deployment

In general, NCL believes that more study is needed to fully understand the impact of direct to consumer advertising on safe use of approved drug products.  In the interim, NCL supports granting FDA the authority to require disclosure of all direct to consumer advertising pieces prior to deployment.  This would enable agency staff to review and, if necessary, revise the materials so that they accurately reflect the evidence base required for safety effectiveness promotion claims.  NCL also would like the see the agency consider mechanisms for limiting advertising and detailing efforts directed at potentially inappropriate target audiences, and prolonging the period of time between drug approval and initiation of product promotion.

Finally, NCL would like an entity appropriate to the task to conduct a study of alternative mechanisms for approval and distribution of drug products in the U.S.  Through such an evaluation, we may identify opportunities to enhance the drug safety system.  For example, it has been suggested that our current use of only two indicators of drug status – approved and denied – hampers our ability to learn more about product safety before launch.  Perhaps the agency should have a third option of “provisional approval,” which would allow for limited exposure of the product to appropriate patients, and provide additional post-approval safety data in an applied setting.  In a similar vein, it has been suggested that efforts to communicate drug safety information to consumers are limited by the fact that products are available in only one of two ways: by prescription and over the counter.  It is possible that creation of a third approval class of drugs – pharmacy only – could enhance pharmacy / patient communications and limit consumer exposure to inappropriate medications.  Of course, both of these ideas – and many others - require thorough evaluation.

NCL firmly believes that none of the proposed FDA measures will slow or impede the flow of important life-saving therapies to patients.  Rather, they will ensure that the attention and resources applied over the past decade to speeding treatments to patients will be matched with equal focus on ensuring the safety of those products once on the market.