Report Calls for Sweeping Changes At the FDA

The most significant change in FDA policy will likely have to come from Congress, in the form of an increase in funding. Without this, says the committee, the FDA will remain engaged in a diplomatic dance with manufacturers, rather than in a position of authority: 'FDA lacks the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements and instead relied on the prospect of productive negotiations with industry. Although the agency historically had made effective use of its 'bully pulpit' to compel sponsor compliance, this process leaves potentially critical regulatory action vulnerable to a subjective and highly variable process of exercising individual or agency influence, and to the vicissitudes of changing politics and attitudes toward regulation. That is why FDA's authorities must be clarified and strengthened to empower the agency to take rapid and decisive actions when necessary and appropriate.'

With that money in hand, the FDA could presumably better perform its job, particularly those extra regulatory powers the committee wants it to have, to include the ability to require postmarket risk assessment and risk management programs. To compel these, the committee stated, the FDA might condition a company's right to distribute a new drug on its compliance with agency drug label recommendations. In fact, the committee recommends that Congress amend the Food, Drug and Cosmetics Act to require a symbol on certain packages ' for new drugs, those whose delivery system has been changed or those that include a new combination of active ingredients ' if they have been on the market for fewer than 2 years. While the label is required, the FDA should impose a moratorium on direct-to-consumer advertising.

The committee also wants the FDA to have increased rule enforcement tools such as the ability to impose fines and injunctions or the option of withdrawing approval of a drug.

Going Forward

The report makes clear that the Institute of Medicine committee members believe drug manufacturers have too much power, and a shift toward increased FDA strength is needed if the agency is to optimally do its historic job. However, with its current corporate culture and vulnerability to political influence, the prospects for improvement are slim. Independence and increased power, possible only through a fresh infusion of funds, are needed. Scolds the committee, 'An agency whose crucial mission is to protect and advance the public's health should not have to go begging for resources to do its job.'

Janice G. Inman, Esq., is Editor-in-Chief of this newsletter.

In September, the Institute of Medicine of the National Academy of Sciences, a congressionally created entity dedicated to the study of policy matters pertaining to the public health, issued the results of the study of federal drug safety policy commissioned by the Food and Drug Administration (FDA). The resulting report, titled 'The Future of Drug Safety, Promoting and Protecting the Health of the Public' and published in the Archives of Internal Medicine, has been widely anticipated in light of recent publicity surrounding Vioxx' and other drugs that, subsequent to FDA-approval, proved more dangerous than thought. The authors' goals in carrying out the study included gaining a better understanding of the FDA's current role and the roles of other actors in the process and assessing how changes in these organizations and systems could help promote increased drug safety and better public confidence. The committee's bottom line assessment was that major changes in the way the FDA is organized and funded are needed.

Some Organizational Changes

The Center for Drug Evaluation and Research (CDER) at the FDA weighs the risks and benefits of new drugs, but thorough oversight of approved medications is lacking, claims the report. Several changes must be made if this situation is to change. Some of these adjustments include:

• Stabilizing the leadership of the FDA by having the President appoint the FDA Commissioner for a 6-year term. The Commissioner could be removed only for cause;
• Having CDER appoint an Office of Drug Safety staff member to each New Drug Application review team;
• Having CDER employ more expert staff and train its present staff to expand their expertise in a number of areas; and
• Posting all new drug application review packages on the Agency's Web site.

One of the main issues of contention between the public and the FDA has been that pharmaceuticals manufacturers are seen as being financially and politically involved with FDA personnel, leading to at least a perception of Agency bias toward promoting drug company interests. To combat this, the committee of the Institute of Medicine recommends that the majority of the members of FDA-related advisory committees be unconnected by any financial involvement with the drug companies whose products are being analyzed.

The most significant change in FDA policy will likely have to come from Congress, in the form of an increase in funding. Without this, says the committee, the FDA will remain engaged in a diplomatic dance with manufacturers, rather than in a position of authority: 'FDA lacks the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements and instead relied on the prospect of productive negotiations with industry. Although the agency historically had made effective use of its 'bully pulpit' to compel sponsor compliance, this process leaves potentially critical regulatory action vulnerable to a subjective and highly variable process of exercising individual or agency influence, and to the vicissitudes of changing politics and attitudes toward regulation. That is why FDA's authorities must be clarified and strengthened to empower the agency to take rapid and decisive actions when necessary and appropriate.'

With that money in hand, the FDA could presumably better perform its job, particularly those extra regulatory powers the committee wants it to have, to include the ability to require postmarket risk assessment and risk management programs. To compel these, the committee stated, the FDA might condition a company's right to distribute a new drug on its compliance with agency drug label recommendations. In fact, the committee recommends that Congress amend the Food, Drug and Cosmetics Act to require a symbol on certain packages ' for new drugs, those whose delivery system has been changed or those that include a new combination of active ingredients ' if they have been on the market for fewer than 2 years. While the label is required, the FDA should impose a moratorium on direct-to-consumer advertising.

The committee also wants the FDA to have increased rule enforcement tools such as the ability to impose fines and injunctions or the option of withdrawing approval of a drug.

Going Forward

The report makes clear that the Institute of Medicine committee members believe drug manufacturers have too much power, and a shift toward increased FDA strength is needed if the agency is to optimally do its historic job. However, with its current corporate culture and vulnerability to political influence, the prospects for improvement are slim. Independence and increased power, possible only through a fresh infusion of funds, are needed. Scolds the committee, 'An agency whose crucial mission is to protect and advance the public's health should not have to go begging for resources to do its job.'

Janice G. Inman, Esq., is Editor-in-Chief of this newsletter.