New Harvard Study: Drug Approval FASTER Than Devices

Pity the poor medical device manufacturer. The Food and Drug Administration (FDA) sets them on a longer road to device approval than it does the makers of blockbuster drugs. According to Fink Densford, reporting on a recent Harvard Business School study, new medical devices on average take 34% longer to get approval from the FDA than do drugs.

The lead investigator was Ariel Stern. He and his colleagues examined 30 years of FDA data (1977-2007) and compared the processing time for new drugs against that used to evaluate high risk medical devices. They found that new medical devices, on average, took 34% longer to get FDA approval than did new drugs.

Examples of pioneering devices examined in the study were pacemakers, coronary stents, implantable cardioverter defibrillators, tracheal and bronchial tubes, prosthetic limbs, and intraocular implants.

Stern wrote in his working paper Innovation under Regulatory Uncertainty: Evidence from Medical Technology that the average time required for devices to get approval is 7.2 months longer than pioneering drugs. He conservatively estimated the cost of the additional delay at $6.7 million “This comes on top of the estimated average of $94 million to bring a new high-risk device to market, ” he said.

These costs of delay represent a particular burden for smaller companies. Delays can represent a large part of their research and development costs, which, Stern says, “prohibits pioneering development by smaller firms in the medical device field.”

The comparison between the tasks taken on by small medical device companies as compared to small drug firms is striking. Small device firms work on follow-up applications where they submit from 14% to 21% of all new device FDA applications. Small drug firms, however, made up 36% to 54% of new drug supplications and only 11% to 46% of drug follow-on applications

Stern says that some of the reason for the delay on medical devices can be blamed on the fact that drug testing at the FDA has been streamlined for drugs but not for devices. Stern further explained that the FDA categorizes devices by their function, not their underlying technology. “That kind of labeling can lead to excessive testing on devices that have already been approved by the agency for other uses, ” Stern is quoted by Densford as saying.