Consumer advocates aren't happy about the 5-year user fee reauthorization bill for the device and drug industries, which is now moving rapidly through Congress. That's because the bill is giving industries a quicker pathway to FDA approval for certain products.
MedCity News reports that the bill passed through the House Energy and Commercial Committee last week in a unanimous vote, following similar progress in the Senate's Health, Education, Labor and Pensions Committee last month. And device companies will get a lot of the changes they asked for, as the article explains in a good breakdown of some of the emerging details of the final measure. Device companies, for example, will be allowed to avoid a new efficacy-related clinical trial for follow-on devices in the 510(k) approval process if regulators rule that any changes are minor compared to previously approved devices. Drug companies, in turn, gain an easier route toward accelerated approval for drugs that treat life-threatening conditions. And benefiting both industries, the new reauthorization cuts out a requirement that FDA advisory committee members may not have any financial conflicts of interest.
"Industry heavily lobbied both sides of the aisle to get provisions favorable to industry," Michael Carome, deputy director of Public Citizen's Health Research Group, told MedCity News. "They were very successful."
Industry groups, including the device lobbying association AdvaMed, issued statements that said the bill was a positive step that boosts regulatory resources, improves transparency and makes the regulatory approval process more transparent, the article notes. Device and drug companies have long argued that a smoother and quicker regulatory path, where possible, enables vital treatments to reach patients sooner. But consumer groups such as Public Citizen point to the slew of device and drug recalls in recent years as a reason to tread more carefully. (Defective metal-on-metal hip replacements, anyone?)
Of course, the measure does balance out in some areas. As the article points out, both industries are paying significantly higher user fees to fund the FDA even as they gain the easier approval path for certain products. And regulators are gaining more power too: They'll now be able to require medical device companies to implement a barcoding system for products within three months, so they can track their merchandise during necessary recalls. The FDA's Sentinel electronic tracking system will also be expanded to identify medical devices and drugs with any safety problems.
- read the MedCity News story