Building Regulatory Muscle: FDA Seeks Greater Authority on Medical Devices, Drugs, and More

ANCOR is sharing this article by Politico Pro because the Food and Drug Administration (FDA) oversees medical products and devices used by our members in their work assisting people with disabilities.

As written by Politico Pro:

“The White House is pushing Congress to give the FDA new power over such matters as generic drug labeling, medical device shortages, device approval pathways and medical product transparency in its fiscal 2020 FDA budget request.

The agency wants explicit authority to be able to update the labels of generics drugs whose branded counterparts are no longer on the market when the label becomes outdated, including to update the uses of the product. Generic drug labels must mimic their brand-name counterparts, but once a brand stops marketing the drug and monitoring it for new safety events, there can be gaps in key information for patients.

The FDA also wants permission to establish a faster “progressive approval pathway” for medical devices that are intended to treat or diagnose a life-threatening or irreversibly debilitating disease. These devices, which ordinarily would go through FDA’s premarket approval or de novo device approval pathways, could obtain provisional approval based on a demonstration of safety and performance. They would then need to follow up with a demonstration of safety and effectiveness to stay on the market.

The latest requests were contained in fiscal 2020 budget documents the White House released on Monday to augment the formal rollout of the spending blueprint last week.

[…]

To address possible device shortages, the agency wants the authority to require manufacturers to notify FDA of an anticipated significant interruption in the supply of an essential device. It also wants to require manufacturers of devices deemed “essential” to periodically update the agency on manufacturing capacity. And FDA wants to be able to temporarily import devices when needed during a shortage.

FDA wants to improve medical device safety by obtaining congressional authority to order manufacturers to install more cybersecurity capabilities in devices and publicly disclose cybersecurity vulnerabilities.

The agency also wants to publicly disclose more of the information that drug and device makers send it in annual reports, periodic safety updates or other submissions. Regulators often can’t disclose such information in public forums without company approval. The agency wants Congress to let it publicly disclose a summary of any safety or effectiveness data or other information if FDA determines that it is appropriate for public consideration.”