National Tort Reform Needed

By Rob Wright, Chief Editor, Life Science Leader magazine

Drug development is a very laborious and expensive process of which Dr. Paul Chew is acutely aware. As the chief science officer (CSO) and chief medical officer (CMO) for Sanofi U.S., Chew knows that companies and FDA continue to evaluate safety information from consumers after medications are launched. Very often, patients have multiple concomitant illnesses, as well as multiple concomitant drug therapies. Although companies will evaluate the effects of gender, age and race, as well as special populations, patient variety can be more fully evaluated after approval. It is not possible to test all of the possible scenarios prior to launching a new drug. That is why there is a means by which companies can modify safety labeling after a drug has been brought to market, should a safety issue arise when a product is exposed to millions of patients.

Some might advocate doubling the sample size. However, doubling the sample size does not significantly increase the power to find outliers. "Rare events," explains Chew, "Are sometimes only found after a product's been on the market for a year or two, when you have enough experience. If companies have made their best effort, conducted due diligence in conducting trials and surveillance, with timely disclosure to the FDA, then there should be some form of acknowledgment of this in terms of litigation," explains Chew. "I think we'll have to acknowledge that you can't know everything about every product and safety at the time of a product's launch," he says. National Tort Reform combined with effective regulatory guidance and company due diligence could be just the pill the doctor ordered for encouraging innovation in drug development while balancing patient safety and patient access to new therapies.