Medical Device Makers Will Double Fees for Faster FDA Reviews

Feb 1st, 2012 | By | Category: Media Reports

Mesh medical device after removal

Medical device makers want to get their products into the marketplace faster.

The U.S. Food and Drug Administration (FDA) needs more operating capital to review medical devices.

The two have formed an informal agreement that was leaked to Bloomberg on Wednesday, February 1 (here). Under the proposed plan, medical device makers would pay $595 million over the next five years, roughly double the budget of the last five years, and the FDA would provide more predictable and “transparent” medical device evaluations.

Congress still must give the pact the okay, but it represents a significant jump from the current finding of $295 million that is set to expire on September 30.

An FDA spokeswoman, Karen Riley, told Bloomberg the two sides are “close to an agreement” over the Medical Device Users Fee which would mean the agency could hire about 200 more scientist reviewers, reports AP.  The quid pro quo would mean the FDA would increase the number of meetings with industry in advance of an approval submission for a new device, presumably to smooth the transition to market.

AP reports (here) that this agreement resulted from “more than a year of closed-door meetings between industry and the FDA” which continued beyond the January 15 deadline imposed by the FDA. Background story here.

Industry complains that Europe has faster more predictable reviews, however the recent PIP breast implant scandal now rocking Europe, background here, as well as the defective synthetic mesh implants are examples of what can result with less regulation, not more.

Drugmakers pay the agency a review fee as well, about 60 percent of the cost of FDA reviews of new pharmaceuticals.

The FDA had said it needed more like $805 million while the industry offered half as recently as December.

Slow Device Reviews?

On average it took the FDA 73 days to in 2010 to review a 510(k) application which is an exchange of paperwork with the manufacturer naming a predicate device the new device is substantially similar to. The 510(k) is supposed to be used for low-to-moderate risk devices, however transvaginal mesh and metal-on-metal hip implants have both been brought to market under the 510(k) process.

The Institute of Medicine in a report issued August 2011, here, said the 510(k) process was ‘fatally flawed” and should be abolished in favor of a new tighter, regulatory system.

And Consumers Union (CU) has just launched its SafePatientProject.org to abolish the practice of using a predicate device as an entre into the marketplace, and establish patient registries requiring manufacturers to track the safety and efficacy of its devices after they are used on patients. CU says that 700 different medical devices are recalled every year since 2005 which are responsible 5,000 American deaths in 2009.

About 90 percent of the approximately 4,000 medical devices applications brought to the FDA for approval are ushered in under the 510(k) fast-track approval process. #

Tags: , , , , , , ,

2 Comments to “Medical Device Makers Will Double Fees for Faster FDA Reviews”

  1. jane akre says:

    WSJ Tonight- “For the first time, the agency will have hard-and-fast goals for how long it can take to approve devices on average before they go to market.”

  2. Jane Akre says:

    Statement of Diana Zuckerman, PhD, President of the National Research Center for Women & Families on the MDUFA agreement in principle:

    “The total amount of user fees is not as important as the fee per review. If the total fees go up 100% over 5 years (which is what I’ve heard) and the work load goes up 150% (which would not be surprising), that’s a cut in the value of user fees, not an increase.

    ” What FDA needs is an increase in fees per review, so that the reviews will be more thorough (whether 510k or PMA) and so that some of the user fees can be used for monitoring recalls, post-market surveillance, and other important work.

    ” The largest companies (such as J & J) pay a user fee of $1.8 million to submit a drug application, $220,000 to submit a device PMA, and just over $4,000 to submit a 510k. Surely, these large companies could afford at least $10,000 for each 510k and at least $600,000 for each PMA. If they paid that amount, it would greatly increase CDRH’s resources and that money could also be used to keep user fees down for the very small device companies (and hence not stifle innovation). I don’t think J & J would even notice those increases. In fact, it is unlikely they would notice if the 510k fee was $30,000 or even $50,000.

    ” For example, when J & J (DePuy) submitted the 510k for their metal on metal ASR hip implant, the company paid a user fee of less than $4,000. Since then, FDA had to calculate the adverse reactions, review the data on the high revision rate, work with the company regarding the recall of that device, and respond to Congressional and media questions about that defective device. Why shouldn’t the company help pay for all that extra FDA work necessary because their device was defective?

    ” Hundreds of hip and knee models have been recalled in recent years, affecting hundreds of thousands (perhaps millions) of patients. Each revision costs at least $35,000, usually much more. If the standards were higher for the applications to FDA, and if each user fee was higher, FDA would have more resources pre-market and post-market, fewer patients would be harmed, and medical costs (to Medicare, VA, insurance companies and patients) would be reduced.

    ” FDA may require PMAs for future metal on metal hip implants. If they do, and if the user fees are similar to current fees ($220,000) or even 50% higher ($330,000), that still means that FDA loses about a million dollars in their uncompensated resources every time they do a PMA for a hip that was previously a 510k. We think (and Consumers Union agrees) that all hip implants should go through a PMA review, which requires clinical trials and inspections. But, with the current user fees, it is unlikely that FDA has sufficient resources to do the right thing, and require clinical trials and inspections for each hip application (i.e. a PMA application). You can see that FDA has a financial incentive to keep to the status quo, because they probably can’t afford to spend a million dollars on each of dozens of PMA reviews for hip and knee applications.

    ” The main message: the total increase is less important than the fee per review. On top of that, if the agreement requires more meetings between FDA staff and industry, which I have heard it does, that is also going to use FDA resources for extra work, providing less user fee money to be spent on doing their job of carefully reviewing applications.”

Leave a Comment