In the fall, FDA and Health Canada launched a pilot program allowing authorized third-party inspectors to cover US and Canadian requirements in a single inspection. It was viewed as a step toward eventually having a single authority inspect for worldwide requirements, which industry has said it wants.
So how many U.S. firms have expressed interest in taking advantage of the program so far? One. This was reported by Larry Kessler, director of CDRH’s Office of Science and Engineering Laboratories and chair of the Global Harmonization Task Force, at the AAMI/FDA International Conference on Medical Device Standards and Regulation held in March.
Kessler said that CRDH obtained a list from Health Canada of all U.S. plants it plans to inspect in 2007, and sent a note offering the joint inspection to all firms whose plants are also on the list for an FDA inspection this year, a total of about 150. Almost all Canadian inspections are done by third parties, so these firms would have to hire an outside inspector anyway.
He offered two possible explanations for the lack of interest. One, firms may already be under contract for 2007 with a Canadian third-party inspector who is not authorized to do simultaneous U.S. inspections, and don’t want to break their contracts and go through the process of finding someone else. Two, and more foreboding, there may be a perception that “if you do badly [on a multi-nation inspection], you won’t be able to market your product anywhere in the world. That’s not the way it should work. Yet, it’s a legitimate fear.”
There is a disconnect between what industry says it wants and what it seems willing to do. Industry needs to drop the pretense of wanting a single inspection covering multiple authorities if firms aren’t willing to participate in pilot programs.
– From MD&DI’s blog
Experts who advise FDA on the approval of a medical device or drug could soon be facing much tougher rules. In efforts to further limit conflicts of interest, FDA’s new draft guidance proposes stringent guidelines for advisory committee members and those who want to participate in meetings regarding the approval of a device or drug. Potential participants will no longer be able to advise on a product if they have related financial interests exceeding $50,000. These include interests in the company whose product is being discussed or one of its competitors. A person who has interests $50,000 or less can apply for an exemption, but he or she won’t be allowed to vote. Comments on the draft will be accepted for the next 60 days.
– From MD&DI’s blog
FDA and industry know what they want out of MDUFMA II, as negotiations are just about complete. The stumbling block, however, is Congress. Congressional Democrats are unhappy with the pharmaceutical industry, and the device industry could get caught up in their wrath, TheHill.com reported in a feature last week. Congressional Democrats want to tie reauthorization of the pharmaceutical user-fee program to new drug safety requirements. MDUFMA is likely to be bundled with the pharma bill, which could lead to delays in its reauthorization as the pharma battle plays out, and/or more stringent safety requirements mandated for devices, too. A hearing on pediatric drug and device safety will take place Thursday.
Any legislation, including new safety requirements, concerning the device industry should be made based on what makes sense for the device industry and the patients it serves. Merely grafting drug legislation onto devices could be burdensome or, in the worst case, harmful.
– from MD&DI’s blog.
As of the morning of Monday, March 5, details of the MDUFMA reauthorization agreement between FDA, Congress, and industry had not yet been released, but AdvaMed president Stephen Ubl shed some light on them at the previous week’s American Institute for Medical and Biological Engineering annual meeting. He shared three points:
1. “We are reducing fees across the board for applications — whether PMAs or 510(k)s.”
2. “The year-to-year increases will be more predictable. There will be no more compensation adjustment, which made the system more volatile.”
3. “We estimate that the new goals will bring performance improvements for FDA reviewers and significantly reduce review times.”
He also noted that “other device trade associations” — a reference to the Medical Device Manufacturers Association — support the agreement. This is in contrast to the original act of 2002, which MDMA did not support, and was not involved in the negotiations to craft it.
Is this rosy outlook an indicator of a better system on the horizon? We’ll see.
– From MD&DI’s blog.
According to Janet Trunzo, executive vice president of regulatory affairs at AdvaMed, the end of negotiations for the next version of MDUFMA is near. Speaking at the annual meeting of the American Institute for Medical and Biological Engineering on February 28, Trunzo told attendees to expect a press release about the proposal within days. The negotiations involving the user fee system have been between AdvaMed, FDA, and key members of Congress. MDUFMA must be reauthorized by the end of September, and there’s been a lot of closed door discussion about how it should be restructured, along with whether any of the other provisions should be changed. Stay tuned for more information about the proposed agreement.
– from MD&DI’s blog.
