How Regulatory Science is Changing

December 15, 2016

USC has a top-notch regulatory science program and in my Bioengineering Seminar this semester, one of our speakers, Dr. Michael Jamieson, a leader in the USC Reg Sci department came to discuss the challenges of developing combination products for national and international markets in today’s medical drug and device landscape.

Did you know?  The FDA now has offices in China and India to inspect the quality of goods because active ingredients in pharmaceutical products are made in these countries.

A drug is defined by its indication/one disease state but devices usually have an intended use and sometimes can have specialized indications. The main difference is that devices “do not achieve primary intended purpose through chemical action and don’t depend on being metabolized” and theoretically can work for multiple disease states, but there can be gray areas. Each product is reviewed either by the drug group or device group in the FDA so the decision is based on the primary mode of action of the product. An inhaler is a drug but a drug eluting stent is a device.

Did you know? Different regulatory systems of different countries are unlikely to be harmonized internationally for political reasons so selling your device or drug depends on the country you are in.

The FDA’s concern with devices attached to drugs is whether the device alters the drug’s behavior if it had not been attached? For example, nanoparticles are attached to chemotherapy drugs making them ineffective until they reach areas where the ph is 4, which only occurs at tumor sites. Would the nanoparticle – a safe transport device – affect how the drug works?

The Office of Combination Products in the FDA are referees who will help a company decide which direction – a device, drug, or biologic – a product should go in. Devices are cheaper and get to market faster so companies benefit by arguing for a device.

Did you know? All these regulations are in the 21 CFR 820 for devices and 210/211 for drugs and useful for biomedical engineers to know.

Published on December 15th, 2016

Last updated on August 29th, 2017