Pulling the Plug
by Isaac Wilson
January 2007
Retiring a failed product is never an easy process, particularly when the withdrawal is for safety reasons. Adhering to a risk management process can help companies keep the damage under control.
The decision to withdraw a product—especially a top–seller or a flagship brand—is not made lightly or quickly. The often impassioned response of the general public, regulatory agencies and governmental bodies can make the decision even more difficult.
Although the development of drugs can be stopped during any phase of the development process, those that are withdrawn post–launch for safety reasons are usually the most memorable, since the consequences typically are widely communicated by the media. Although preventing the causes of withdrawals is the best defense, having a solid risk management process in place helps pharmaceutical and biotech companies minimize the damage to revenue and reputation.
Living with Uncertainty
Because drug safety is a paramount issue, close attention to any and all safety signals throughout the development process is critical. “The emergence of relatively low–cost and increasingly available data–based safety signal–detection methods is likely to drive an explosion in the number of safety signals detected,” says Eric Morfin, director of the project management office at Novartis Vaccines and Diagnostics, Emeryville, Calif., USA, and chair of the Newtown Square, Pa., USA–based Project Management Institute’s Pharmaceutical Specific Interest Group. Paying attention to these signals and managing the risks can eliminate some of the uncertainty in launching a new drug.
According to Morfin, an efficient risk management process typically includes four steps: development of internal guidelines, risk identification, risk analysis and risk response planning. The process looks at risks systematically and is integrated with a company’s project management and product development practices. This allows for the identification of possible corrective actions and more importantly, preventative actions, Morfin says.
Even though most large pharmaceutical companies have risk management processes in place, post–launch withdrawals often occur because process wasn’t applied during the development process, Morfin says. Strict adherence to risk management process can help identify potential safety issues early in the development process, thus reducing the likelihood of later withdrawal.
However, even with a risk management process in place, the unpredictable nature of drug development can test even the most fastidious plan. “Some companies look at the business side and don’t pay enough attention to the science. That’s when they put themselves at risk,” says Ray Sanchez–Pescador, associate director of product portfolio management for Genentech Inc., South San Francisco, Calif., USA. Designing trials to elucidate as much information as possible can help prevent later withdrawal of a drug, he says. “Patient safety comes first,” he says.
Plan Ahead
In addition to having an efficient risk management process in place, companies must “have a predefined process for dealing with a risk that surfaces after launch, including the ultimate withdrawal of the drug,” Morfin says. Although a withdrawal process is never ideal, having a strategy for handling this unexpected event is crucial to protect the company and, more importantly, the public. “My advice is to be ready, have a plan, be open and honest, and reinforce the parent brand by being smart and responsible,” Morfin says.
The logical starting point is to recognize that drug development is a volatile process, and there is always potential for issues to arise, Morfin says. “Also, learn that safety is the No. 1 issue for society, and that is what corporate brands need to stand for—safety and responsibility.”
To ensure an effective withdrawal process, Morfin suggests taking the following actions:
Survey. After launch, actively monitor the use of the drug to learn of any side effects not identified during the development process.
Analyze. Have comprehensive and rigorous systems in place for detecting and rapidly evaluating such effects, including mechanisms for highlighting those that require immediate attention.
Identify. Strive to determine whether certain types of patients may be more susceptible to the risks associated with a particular treatment and what the early indicators of this might be.
Act. Take appropriate corrective action to avoid risks presented by the product.
When a company begins the process of withdrawing a drug, public relations can be as important as risk management. According to Morfin, taking personal responsibility, acting quickly and communicating openly and fully with all relevant constituencies are critical components of a skilled approach to a withdrawal.
Ultimately, corporate responsibility to patients is crucial for preserving a company’s reputation, Sanchez–Pescador says. “At the end of the day, patients need to be able to trust the company.”
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