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Risk Management
The New Era of Risk Management

by Louis A. Morris, Pharmaceutical Executive, May 2004

DA has issued the industry a new charge-pay closer attention to risk management. Now that prescription drug user fees have helped the agency
approve candidates more rapidly, FDA has returned to its basic mandate: assuring that marketed pharmaceuticals are safe. In the past, that meant clear labeling with adequate directions and warnings based on clinical trials. The agency now believes that product safety extends beyond warning labels and wants to ensure that prescriptions are used safely as well. As a result, it is asking the pharma industry to demonstrate products' safety before approval and to further control their use after approval.


First, it is important to understand what "risk management" means today. Traditionally, pharma companies have mitigated risks by assessing safety throughout clinical trials and through post-marketing surveillance. Product labels have always specified the parameters for safe use, promotional communications have been limited to approved indications, and fair-balance statements have conveyed the meaningful risks. Those things have not changed. Now, however, FDA wants greater assurances that pharmaceuticals will be used as safely as possible. As Deputy FDA Commissioner Lester Crawford recently said, "There was a time when we put the drug out there and didn't worry much about it. That is changing."

For pharma companies intent on developing drugs as rapidly as possible and launching products on a foundation that uniquely promotes the product's benefits, contemporary risk management presents new challenges. It means that companies must better assess products' risks, more fully evaluate their meaning and implications, communicate the known risks more completely, and institute systems that minimize risks and maximize safe use.

That will require more careful thought and new forms of evidence, backed by research, about how products will be used when they reach the market. It will also require coordinated planning by companies' regulatory, clinical development, and marketing teams. It will require increased reliance on epidemiologists to understand user populations' prescribing and utilization proclivities, and it will call for pharma companies to modify questionable patient behavior through targeted communications and specialized distribution systems.

This article reviews the background and recent history of the new era in risk management and how it has affected drug development and marketing. It also outlines how pharma companies must adjust their planning to take into account each of the four essential risk management functions: identification, evaluation, communication, and systems development.

Tolerance Shift
Culture can change slowly as new ideas replace old concepts, or it can change rapidly as dramatic events shift public views in an instant. The 1999 release of the Institute of Medicine's report, "To Err is Human: Building a Safer Health System," is the instant that ushered in the new era of risk management. Based on research by Lucian Leape of Harvard University, the report stated that 44,000-98,000 Americans die each year from medical errors, more than from car accidents or breast cancer. Although those figures include unavoidable adverse drug reactions, they had an immediate and far-flung impact on the public.

In reaction, numerous public health agencies and private sector organizations initiated programs to reduce medical errors, and FDA responded with a series of initiatives to better manage medical product risk. Those initiatives and a new philosophical perspective on risk management were summarized in an internal FDA report to the commissioner in May 1999. It defined a safe medical product as "one that has reasonable risks, given the magnitude of the benefit expected and the other alternatives available." Unlike most federal publications, in which the report itself is the culmination of work on a project, that report established a blueprint for future FDA actions to better manage medical product risks.

The most dramatic evidence of changing tolerance for drug risks is the number of product withdrawals in the past few years. The General Accounting Office reported that in each half decade since the late 1970s, two to four drugs have been removed from the US market. Yet, in the past four years, at least ten therapies have been pulled. (see "Off the Market") The relative safety of the product, compared with others on the market, was a key issue in several withdrawals. With the Rezulin (troglitazone) withdrawal, for instance, a Health and Human Services' press statement said,"FDA took this action after its review of recent safety data...showed that Rezulin is more toxic to the liver than the other two drugs." Similarly, with Baycol (cerivastatin), Dr. John Jenkins of FDA was quoted in the New York Times as saying, "Baycol really stood out as being different. Baycol did not offer any benefits beyond those of the other statins. But it carried a potential risk, and that leads to a conclusion that it is no longer safe to be marketed."

The failure of physicians and patients to comply with product directions and warnings was an additional factor in product withdrawals. CDER Director Janet Woodcock said in an April 4, 2000, presentation at Temple University, "We've had to withdraw drugs from the market that would have been safe if used according to label instructions." Thus, in this new era of risk management, safety means more than describing risks on the product label; now the expectation is that manufacturers must influence safe drug usage.

To enforce the new drug safety standards, FDA has reorganized its Center for Drug Evaluation and Research and created an Office of Drug Safety. Through increased user fees, it seeks to fund the hiring of 100 new employees during the next five years.

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