Change in Policy at FDA May Result in Improved Drug Safety

Posted on | September 9, 2008 | Comments Off on Change in Policy at FDA May Result in Improved Drug Safety

On June 30, 2008, the Food and Drug Administration (FDA) shifted authority on drug safety regulatory issues from the Office of New Drugs (OND) to a shared responsibility between OND and the Office of Surveillance and Epidemiology (OSE). Under the new policy, the drug review and drug safety offices will share equal responsibility on “significant safety issues” for pending and approved products, such as post-marketing studies and clinical trials, and safety labeling changes. Joint authority between OND and OSE was recommended in the Institute of Medicine report The Future of Drug Safety: Promoting and Protecting the Health of the Public, released in September 2006.

Prior to this change, OSE was responsible for identifying drug safety concerns and possible corrective measures to improve product safety and protect the public health, yet only OND had the authority to recommend that these products be withdrawn from the market. Now, OSE will have a formal role in drug regulation and can work with OND to take action regarding postmarketing safety. When the IOM released The Future of Drug Safety, its authors believed joint authority would help break down cultural barriers as both staffs work toward the common goal of evaluating and ensuring drug safety and efficacy over a product’s lifecycle.

In the current environment, in which the brand names of drugs are well-known and pharmaceutical companies advertise during prime time TV, consumers are making choices about their medications that they previously delegated to their doctors. They have come to rely on the FDA for its recommendations as they weigh the benefits against the risks. Well-publicized cases, such as Merck’s removal of the arthritis and pain-relief drug rofecoxib (Vioxx®) from the market when concerns were raised about its health risks, can result in consumer confusion by the conflicting information available to them.

While direct impact from this change in authority may be hard for the general public to see, these changes within FDA may result in improved surveillance and ultimately improved drug safety. Under the new policy, the two offices will take a more active and coordinated approach to monitoring products for adverse effects during postmarketing, which will help identify problems at an earlier stage. The collaboration also will provide for a more informed discussion among policymakers when considering whether to request a medication be withdrawn from the market.