University professor proposes changes to US drug safety system

In a report published in the Journal of the American Medical Association, Dr Brian Strom, professor of public health and preventive medicine and chair of the department of biostatistics and epidemiology at the University of Pennsylvania School of Medicine, has analyzed the limitations of the current system of drug-safety monitoring.

Dr Strom has also proposed a solution that he claims addresses overly aggressive early marketing practices, an absence of incentives to complete post-marketing safety studies, direct-to-consumer (DTC) advertising that can promote non-critical use of ‘blockbuster’ drugs, the current trend toward delaying drug approval, and public misunderstanding about the safety of drugs.

He proposes an alternative approach with three elements: conditional approval, an empowered FDA, and a complementary nongovernmental organization.

When a drug is initially approved, it should ideally enter a period of conditional approval, Dr Strom says. In this period, marketing, especially DTC, would be restricted. Drug labels would need to be clearly marked to state that the drug’s approval is conditional and has only been studied in a limited number of patients.

Removal of label caveats would depend on the outcome of subsequent studies and their findings, depending on the numbers of individuals in the studies, and the risk and novelty of the drug, as well as addressing all premarketing safety questions.

“The current system is moving toward a delay in drug approval, still followed by optional postmarketing studies,” noted Dr Strom. “Instead, the proposed approach would be conditional approval followed by postmarketing studies required before the condition is removed.”

Secondly, Dr Strom maintains that the FDA needs an increased ability to regulate drugs after marketing so that it can require post-marketing studies and labeling changes as a rule, rather than those changes being subject to negotiation between the regulatory agency and industry. It also needs substantially more resources for the postmarketing study of drug safety, he says.

Dr Strom also proposes that an independent, nongovernmental organization is needed for nonregulatory tasks that are not within the mission of the FDA. Since many of these tasks are academic in nature – for example, performing postmortem examinations in the event of drug disasters or developing new pharmacoepidemiological methods – he suggests that the Agency for Healthcare Research and Quality (AHRQ)-funded Centers for Education and Research in Therapeutics (CERTS) or the Institute of Medicine (IOM) might play a role.