 |
 |
 |
Orthopaedic Device Forum Present:
Presentation by Larry Pilot, JD Mr. Larry Pilot, a partner in the Washington, DC law firm, McKenna, Long & Aldridge, discussed his experiences with administrative and product liability law with the Orthopaedic Device Forum (Forum) Previously, Mr. Pilot was employed by the Food and Drug Administration (FDA) as a Special Assistant to the Commissioner. He was responsible for the development of the FDA’s regulatory program for medical devices, before and after the passage of the Medical Device Amendments of 1976. In addition, he provided counsel to the Pharmaceutical Manufacturers Association, now PhRMA, and the American Pharmaceutical Association. | ||||||
|
Mr. Pilot described experiences with various FDA regulatory pathways. He questioned whether the Medical Device User Fee Modernization Act of 2002 (MDUFMA) has enhanced review times. The Forum discussed the FDA’s performance in meeting the MDUFMA goals. The Forum discussed the burden of demonstrating safety and effectiveness. Orthopaedic surgeons noted that regulatory processes would be easier without the need to prove effectiveness, especially when the effectiveness of many orthopaedic products requires 10 or more years to establish. Forum members discussed pay-for-performance initiatives and whether they might assist in providing evidence of effectiveness. The Forum conceded that pay-for-performance would lead to efficacy measurements and eventual technological stagnation. Mr. Pilot provided a perspective on the history of FDA. He cited the decision to apply the regulatory pharmaceutical approach to the review of medical devices, particularly the definition of effectiveness. Mr. Pilot stated that rethinking the provisions for defining the effectiveness of medical devices would be beneficial to regulatory processes. The group then discussed actions needed to improve the regulatory process. Forum members decided that educational efforts directed towards key stakeholders and members of Congress was the most important and immediate action.
Approval of April 17-18, 2005 Summation Report Members and government liaisons reviewed and approved the summation report from the April 2005 meeting of the Orthopaedic Device Forum. Participants disclosed potential conflicts of interest.
Forum Compilation Document. Forum members and government liaisons provided feedback on the most recent draft of the Forum Compilation document. An AAOS liaison noted that the mission statement and biologics section had been added. The strengths, weaknesses, opportunities, and threats (SWOT) analysis was removed and the title was selected, “The Orthopaedic Device Forum: The First Ten Years.” An executive summary will be added. After changes are incorporated, the document will be circulated for final review prior to distribution. Prioritizing Projects – 1-3 year Horizon All NIH institutes engage in strategic planning sessions and NIBIB is finalizing their draft strategic plan which is available at: www.nibib.nih.gov
Members discussed a timeline for the prioritized activities. The Forum reached consensus to address combination products and research & education as the priority projects for 2006. A Forum member suggested that a representative from the Office of Combination Products be included in future meetings to help define primary mode of action and frame submissions appropriately. A group of experts will be developed within the Forum to help define issues and develop plans related to the priority areas. To that end, two workgroups were initiated to address the selected priority areas. The Combination Products Group will address the challenges of properly identifying and submitting combination products for review. A proposed approach is to select a product as a representative for a class of combination products. Recombinant products and growth factors used in conjunction with devices were nominated as a potential class of devices worthy of future study. The Combination Products Group will focus on these topics and report to the Forum. A second workgroup was formed to address the priority areas of research and education. Several Forum members expressed their support for a one-day workshop to revisit the original concerns over legislative interpretations that led to the formation of the Orthopaedic Device Forum. The topics and timeline for this workshop are to be defined by the workgroup and will be reported on at the November meeting.
Forum Member Transition Issues The Forum has many long-term members and must assess member transition issues. Forum members discussed developing job descriptions for each member organization and aligning those with overarching Forum goals.
Standards Update The American Society for Testing and Materials (ASTM) reactive materials symposium highlighted changes and opportunities on the horizon. Beta titanium, oxidized zirconium, and metallo-diamond, and tantalum products are anticipated in the next few years. The Medical and Surgical materials F-04 Committee Week will be held November 8 – 11, 2005 in Dallas, TX and will revisit laboratory versus clinical wear. The planning committee is seeking new topics for future meetings and is continuing to focus on orthopaedic surgery. A Forum member questioned the sterility of bioengineered metal products, FDA guidelines for sterilization, the impact of sterilization technique on materials used, and the issue of residues. A researcher will contact the tissue-engineered medical products division (TEMPS) of ASTM to add this to their agenda. The International Standards Organization (ISO) technical committee (TC) 150 meeting will be held October 8 – 16, 2005 in Korea and address future product development and global harmonization. The October 2005 edition of the American Academy of Orthopaedic Surgeons (AAOS/Academy) Bulletin will feature standards articles designed to help the fellowship understand the importance of standards. The Academy has also developed a joint announcement with ASTM to underscore World Standards Day and the continuing collaboration between the two organizations to develop orthopaedic standards.
FDA Guidance Update The subcommittee reviewed and provided suggestions for updating the ceramic ball hip systems guidance. Many subcommittee and ad hoc members deliberated in raising questions about how to reformulate the guidance document. One member noted that the inclusion of ceramic cups would result in a guidance on articulation aimed at pre-market approval (PMA) devices. Members stated that structural liability issues are as important on the acetabular component as the femoral head. The subcommittee recommended separate guidance documents for 510k and PMA ceramic devices, updating the 510k document, and suggested the ceramic/ceramic articulation for the PMA document. The guidance group will move forward with 510k guidance revision and incorporate ISO and ASTM standards. AAOS staff will survey Forum members to develop a prioritization list for guidance documents and the CDRH priority list will be circulated to Forum members.
Educational Program Previous CDRH educational programs have included spinal implants and joint arthroplasty. Upcoming topics cover orthobiologics – bone grafts and beyond and soft tissue reconstruction, ACL substitutes, and cartilage. Forum members are in contact with the CDRH staff college to secure funding and proposals have been submitted for a 2-year series of multi-center seminars (one-hour seminars each month). The Forum agreed that the seminars have been a worthwhile activity. A member asked if Centers for Medicare and Medicaid Services (CMS) staff could attend the FDA seminars. A CMS staff member stated that CMS personnel should be able to participate, as a staff member of the Department of Health and Human Services (HHS). A FDA staff member reported that verbal approval was acknowledged for two upcoming seminars. Submissions for funding requests should be submitted prior to the end of the fiscal year to ensure adequate funding for the following fiscal year. A Forum member inquired about industry supported seminars and whether the FDA could attend. A FDA liaison said that they could not solicit an industry-funded seminar; however, the Orthopaedic Surgical Manufacturers Association (OSMA) should contact Lynn Rice, Director of the Office of Communication, Education, and Radiation Programs, for clarification.
Biologics Issues At the April Forum meeting, Forum members suggested that a representative from the Biotechnology Industry Organization (BIO) should be added to the group. It was discussed whether the representative should be an OSMA member, as industry representation on the Forum is from OSMA. Several companies do not belong to OSMA, but are BIO members might be interested in acting as a biologics representative.
Military Issues DOD funding: Prior to 2004, a line item did not exist for orthopaedic research in the Department of Defense (DOD) budget. The AAOS Washington, DC office worked to add extremity trauma language to the budget. In 2005, a line item was requested - $15 million in the House of Representatives. These funds will be managed out of the Institute of Surgical Research (ISR) in San Antonio, TX. The AAOS is working to change the current thinking on military research funding. While the immediate needs of the military may not parallel the orthopaedics research communities needs, there is overlap. Raising awareness in Congress and among policy makers is an important goal. The first step is securing a line item appropriation.
CDRH Update CDRH staff are preparing the cemented knee guidance for notice and comment in the Federal Register. The artificial disc guidance was reviewed for good guidance practices and is anticipated to be displayed for notice and comment. The clinical hip guidance has been delayed, but should be moving towards completion in the near future. Finally, the femoral stem guidance will be displayed for comment soon and the polyethylene document should be updated in the next year. The CDRH and the Center for Biologics, Evaluation and Research (CBER) are assessing the draft pre-clinical and clinical cartilage guidance document. It will take approximately 6-8 weeks to follow through with the sign-off process for each group. The ASTM division of TEMPS drafted a pre-clinical cartilage CDRH has contracted with a technical writing group to draft guidances more quickly. The cemented knee guidance is being reviewed by the technical writing group. In terms of choosing guidance document priorities, the offices within CDRH communicate their priorities to the Center, subsequently the Center selects from that listing. Current priorities are defined by:
CMS A Medicare Coverage Advisory Committee (MCAC) on kyphoplasty and vertebroplasty was held in May 2005. CMS will convene a MCAC meeting on the treatment of non-union fractures in October. Coverage with evidence development (CED) was created as a way to promote new technology. Products lacking rigorous evidence needed for coverage and for items that would not normally be covered can get coverage while collecting data. The data collection is required for payment. This is viewed as an option with infrequent use, targeted at promising technology that is lacking evidence. Published data must demonstrate potential benefit and safety. CMS is exploring the use of guidance documents as a means for communicating their activities to the public. These documents would be designed for the public-at-large and be written in plain language.
Registry The AAOS joint registry project continues to be on hold while the general counsel resolves the dissolution agreement with the vendor. Recent passage of the patient safety legislation, as well as pay-for-performance proposals, provides new opportunities for the moving the project forward.
CBER CBER is currently recruiting a new deputy director, which will be a one-year rotating detail. CBER will be holding liaison meetings with the BIO and the International Society of Cell Therapy (ISCT). ISCT will hold a public symposium with the FDA in September covering all cell therapies, with a one-day pre-conference on cardiac therapies. The September advisory committee meeting will review the overall research program. Other upcoming activities include a long-term follow-up on gene therapy culminating in the drafting of a guidance document, the development of a policy governing cord blood, and defining cell processing devices as equipment or devices. Additionally, CBER guidance document priorities are under development.
OSMA Update Current topics on OSMA’s agenda include metal-on-metal hip guidance, discussion of up-classifications occurring in Europe, an update on clinical data guidance, and bringing biologics into OSMA. There is an OSMA subgroup working on the artificial disc replacement guidance. To date, 10 pages of comments have been received and the vice-president of OSMA has distributed these comments to the Forum subcommittee. A FDA liaison suggested electronic distribution of the document, to facilitate the FDA’s consideration of the comments.
AAOS BOD Update Restructuring of the AAOS volunteer configuration is pending and there is a possibility for some impact on Forum activities. The current structure may provide some overlap, in both councils and committees, which could be reduced or consolidated. Pay-for-performance (P4P) initiatives are underway at CMS. There are several process measures for surgery that may be implemented by CMS. Concerns that cost-effectiveness and efficiency measures may stifle technology development may provide an impetus for involvement by the Forum. AAOS Biological Implants Committee The committee is engaged in the following activities:
AAOS Biomedical Engineering Committee The committee is engaged in the following activities:
| |||||||