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Originally Published May 1998
OUR VIEW
Continuing the Battle in Washington
Despite the sweeping changes at FDA, medical device manufacturers must continue their efforts to influence the regulatory policies that shape the industry.
Steve Northrup, executive director, Medical Device Manufacturers Association
After Congress approved and President Clinton signed the Food and Drug Administration Modernization Act of 1997, medical device manufacturers may have believed that the majority of the work to be done in Washington was behind them. Nothing could be further from the truth.
In my opinion, there is plenty of work to be done in Washington this year. Although many observers thought 1998 would be a quiet year for the industry following our labors on the FDA Modernization Act, a host of issues remain for the Medical Device Manufacturers Association (MDMA) and your company to consider.
The implementation of the Act is, of course, just as important as the Act itself. MDMA will be watching the agency closely to ensure that the regulations based on the new law, including rules and statements on labeling and packaging, adhere to the intent of Congress. FDA's Center for Devices and Radiological Health has already produced a number of reasonable and valuable guidances on the new law's provisions, but many significant policies will be implemented later this year.
Since MDMA speaks for the innovators and entrepreneurs in the medical device industry, the association is also developing strategies that would bring some welcome clarity and rationality to the coverage and reimbursement policies of the federal Health Care Financing Administration (HCFA), which runs the Medicare program. These issues are so important for our members that we've prepared an in-depth series of workshops and speakers at the MDMA Annual Meeting, to be held in Washington, DC, May 14—16.
As the advocate for the industry's innovators, MDMA will work with HCFA and private payers toward developing technology assessment processes and standards that are open, rational, and appropriate to the medical device industry. We will also look to spur HCFA, insurance companies, and managed-care organizations to support the process of technological innovation.
In addition, MDMA is working to ensure that medical device regulations are not destroyed by the regulation of tobacco products as medical devices, and to impress upon Congress the importance of confirming a new FDA commissioner who understands and is committed to working with the agency's regulated industries. Finally, MDMA is working with research and patient advocates to secure significant increases in funding for the National Institutes of Health (NIH), since NIH's extramural grants to academic medical centers are a major component of our industry's infrastructure.
The executives of several small and innovative device companies created MDMA in 1993 to be the Washington watchdog for the entrepreneurial sector of the industry. From defeating medical device user fee proposals in 1993 and 1994 to winning approval of the FDA Modernization Act of 1997, MDMA has become our nation's leading advocate for policies that enable innovative and entrepreneurial device companies to flourish.
Medical device manufacturers must remain vigilant in Washington, and MDMA provides a cost-effective way for companies to influence the policies that shape our industry. Most companies in this industry don't need to open their own Washington office, but every company needs to support a group that looks out for the general interests of their industry. Whether you join MDMA or another organization, you should support and get involved in the trade association that you believe best represents your company's concerns.
Steve Northrup is executive director of MDMA, a national trade association based in Washington, DC, that represents independent manufacturers of medical devices, diagnostic products, and healthcare information systems. For more information, contact MDMA at 202/496-7150.
