Questions raised with Devices Referencing Drugs over potential regulatory pathways in the US

A public hearing was held by the US Food and Drug Administration (FDA) to look into the scientific, regulatory and legal challenges with devices referencing drugs (DRDs) and the proposals to regulate such products. “DRDs are medical devices that reference an already-marketed drug when the drug maker does not want to work with the device sponsor to pursue the new use.”

The FDA sees three situations where DRDs could be recommended:

  1. Enhancing the safety or effectiveness of the marketed drug for its existing approved indication
  2. Use with the approved drug for an indication for which the drug is not approved
  3. Providing other benefits, for example enhanced user comfort or convenience such as a change in dose, route or rate of administration.

The FDA states that “DRDs have the potential to advance the public health by offering new uses with approved, marketed drugs that might not otherwise be developed, because the drug sponsor does not wish to pursue the new use,”.

Although the FDA is aware that collaboration is not always possible, the agency would prefer to see collaboration between drug and device sponsors as scientific, regulatory and legal issues could be agreed between the companies.

“FDA believes that a premarket approval (PMA) would generally be the appropriate device marketing application because … DRDs are expected to represent a new intended use or raise different questions of safety or effectiveness as compared to a legally marketed predicate device,” the agency states.

The FDA suggests that DRD sponsors could address the following issues: safety and effectiveness of the new indication of the drug; user confusion and medication error; postmarket change management; postmarket safety and data reliance.

Although challenges may arise, for example, changes to the drug after the DRD is on the market may develop safety and effectiveness issues; the DRD sponsor would need to ensure it is able to address any issues. Such changes could be more easily coordinated where both companies are working together. If sponsors do not have an agreed relationship keeping up with changes to a drug could be difficult.

FDA also notes that for legal purposes, “DRD sponsors must be able to provide the data to demonstrate safety and effectiveness of a new use of a drug without relying on proprietary information that they do not have rights to use.”

At the public hearing, the FDA heard from speakers representing various industry interests. Different opinions were also voiced, for example, DRDs may raise logistical challenges for dealing with postmarket surveillance or actions such as product recalls. A word of caution is that if the FDA were to make the regulatory pathway for DRDs too simple it could discourage collaboration.

To read the Federal Register notice in full, please click here.