Many would agree that “fast” doesn’t often describe the U.S. Food and Drug Administration. But the agency is taking steps to change its reputation and expedite some of its pharmaceutical drug processes.
For example, the FDA says it is now making it easier and faster for health care professionals and patients to get the most up-to-date drug safety information on the more than 18,000 drugs available on its website. Its improved Drug Safety Labeling Changes Program, now managed by CDER’s Office of Communications, enables the agency to post the latest safety information about a medicine almost at the same time they approve a change, as opposed to once a month, says Mary E. Kremzner, U.S. Public Health Service, in an FDA Voice blog post.
When a physician or other health care professional prescribes a patient’s medicine using an e-prescribing system, the new safety information now displays much faster. Within days of FDA approval of new drug safety information for a drug product, the information is entered into the safety labeling changes database. Health IT vendors that provide clinical and drug information support for hospitals and pharmacies are then alerted to integrate the safety labeling changes data into their systems, Kremzner says. Instead of waiting weeks for the monthly release of all safety labeling updates, this information is now accessible in days.
The public can access the information as well, now in a searchable database. Keying in the drug name yields a comprehensive listing of the labeling changes related to safety for that product.
“Our new program is a game-changer for health care professionals seeking to provide the best quality care for their patients,” Kremzner says.
THE MUTUAL RELIANCE INITIATIVE
Another way the FDA is responding more quickly is through the Mutual Reliance Initiative (MRI).
In order to address concerns surrounding the rapid increase in imported drugs from nations where the FDA devotes limited inspection resources, the FDA created an expanded inspectorate. Thus, “investigators and inspectors from FDA and trusted partners, such as those in the European Union, would work together, rely on each other’s inspections, avoid duplicating inspections, and conduct more inspections in areas where the increase in drug manufacturing has greatly increased, like in China and India,” says Dara Corrigan, J.D., FDA’s associate commissioner for global regulatory policy, in FDA Voice.
To meet that challenge, FDA responded with the Mutual Reliance Initiative. The concept is simple, Corrigan explains, “EU country inspectors inspect in their respective countries, FDA inspects the manufacturing facilities in the United States, and the EU and FDA would rely upon each other. This would avoid duplication, lower costs and enable the regulators to devote more resources to other parts of the world where there is greater risk. The savings would be considerable — over the last five years, about 40 percent of FDA’s drug inspections were performed in the EU.”
The MRI was actually launched in May 2014, when FDA and EU assembled dedicated teams to assess the risk and benefits of entering into a mutual recognition agreement. FDA was invited to observe the EU’s Joint Audit Program, in which two EU nations audit the inspectorate — the regulatory authority — of another member. FDA first observed the audit of Sweden’s inspectorate by auditors from the United Kingdom and Norway. Since then, FDA has observed an additional 12 audits of drug inspectorates across the EU with more audit observations planned through 2017, Corrigan says.
In addition, the FDA hopes to sign an agreement with the EU soon and is working to complete assessments of the capability of the drug manufacturing inspectorates of two to four countries within the EU. These first steps with the EU will lead toward FDA’s goal of an expanded inspectorate, containing investigators and inspectors from FDA and across the EU. “These collaborations will enhance our ability to evaluate risk, produce better data, and minimize public health risk globally,” Corrigan said.