An MD&DI April 1997 Column
Medical Device Manufacturers Association (MDMA) executive director predicts that 1997 will be an important year for device manufacturers as well as for FDA.
The device industry in Washington has rarely been more active or united than it was during the first quarter of this year. White House, FDA, and Capitol Hill representatives probably saw more of industry from January through March than they had since the battle over user fees in 1993 and 1994 (which industry subsequently won).
These recent industry attempts to influence government will continue until Congress enacts legislation that creates a regulatory environment conducive to keeping companies, R&D, and employees in the United States. As we have learned from past attempts to modernize FDA, getting legislation enacted is much more difficult than blocking it. With this in mind, nothing less than enactment of the Medical Device Modernization Act of 1997 should be acceptable to us.
The two primary areas in which industry must remain engaged in 1997 are the search for a new FDA commissioner and the development of legislation that will benefit both industry and public health. Such legislation would include modernization of FDA through the creation of a more predictable approval process and enforcement environment, and improvement of liability laws for raw materials suppliers to make necessary materials more accessible and litigation less likely. Industry should be able to pursue these agenda items without the threat of paying user fees to FDA to make product approval determinations regardless of device classification or company size.
THE NEW COMMISSIONER
It won't be easy to find someone who not only wants to be the next FDA commissioner--given the political pressures involved with the position this year--but also meets both White House and industry criteria. The nominee must be prepared for lengthy Senate confirmation hearings, be able to answer questions about FDA's controversial regulation of tobacco, contend with the controversy surrounding the likely approval of RU-486 (the French abortion pill), continue to adhere to Vice President Al Gore's "Reinventing Government" recommendations to streamline FDA, and maintain a rapport with Gore, who will probably run for president in 2000. Also, because consumer groups such as Public Citizen will have input on the selection of the nominee, anyone who is deemed too friendly to industry might have trouble being confirmed. However, the Naderites and the plaintiffs' bar would have a tough time getting an antiindustry nominee through this Senate.
With all the different constituencies vying for influence on the decision, it will be impossible to accommodate everyone.
First and foremost, it is imperative that the nominee work with industry and not against it to bring FDA into the next century. To benefit the public as well as themselves, industry must remain engaged throughout the confirmation process.
A commissioner who will be able to work successfully with industry must have a proven managerial background in a multidivisional organization that has been subject to FDA regulation. Given that the commissioner's job is largely administrative, understanding how FDA deals with companies would be a more important qualification for the position than a medical or scientific background would be.
During the confirmation process, the industry nominee would also need to be able to articulate which areas at FDA will need internal administrative changes and how better interactions with the device and health-care industries can be developed. David Kessler was confirmed as FDA commissioner by the Senate with a voice vote in 1990, but that will not be the procedure this time. Congress is now aware of the amount of power wielded by the FDA commissioner, and will be far less likely to view the confirmation process as a mere formality.
After all, Kessler's FDA was directly responsible for the current biomaterials crisis, which has a negative impact on every patient needing a device implant in this country. The medical device industry is now being forced to expend enormous time and resources in Washington to push a legislative solution to this crisis through Capitol Hill.
A successful candidate for commissioner will be one who can define a regulatory vision, demonstrate a willingness to work with the industries subject to regulation by FDA, admit FDA's past errors (such as the biomaterials policy), demonstrate proven management successes, and describe how FDA can be modernized. MDMA intends to be a part of choosing such a candidate.
Kessler's departure will directly affect FDA's Center for Devices and Radiological Health (CDRH). The impact will be largely positive, but not a panacea. The problems that industry faces will not vanish with the appointment of a new commissioner--be he [FDA deputy commissioner] Michael Friedman or someone from outside the agency. I prefer the latter choice. The need for legislative and regulatory changes will be the same regardless of who the commissioner of FDA is. But with a new management team in the commissioner's office, there should be a renewed commitment from FDA leadership to modernize some of the archaic interpretations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that affect the medical device industry.
As the search for a new commissioner continues, so will efforts to change current legislation. It has been 20 years since the enactment of the 1976 amendments to the FD&C Act, and time has shown which parts of the legislation are working and which are not.
Changes are certainly needed to get FDA caught up with the technological advances of the private sector. Regardless of who succeeds Kessler, the improved relations made in the last 18 months between industry and FDA through grassroots meetings cannot be overlooked. These meetings, of which MDMA has been a part, have already paid dividends with the recently implemented preannounced inspection program. This program should be supported by the entire medical device industry.
INDUSTRY AND LEGISLATION
Traditionally, there have been only a limited number of companies that have been involved in shaping medical device policy in Washington. This involvement has been changing. The massive consolidation of the industry with mergers and acquisitions, the impact of HMOs, and the likely diminished growth of Medicare and Medicaid this year mean that more companies, large and small, must work together. There will be more battles to fight in 1997, and companies have an obligation to their customers to participate in the development of device policy by telling lawmakers about the issues that affect them.
MDMA was successful in ensuring that medical device user fees were not authorized by Congress in 1994, and also helped to pass the Export Enhancement Act of 1995. In 1996, MDMA brought the need for major reforms in the medical device approval and enforcement processes to the attention of many lawmakers. These accomplishments were possible only because many concerned individuals in industry joined MDMA in the fight.
As Richard Martin, CEO of Physio-Control Corp. (Seattle) and MDMA chairman, put it in the November issue of MD&DI, "You cannot stand on the sidelines and expect to make the plays."
The bureaucratic and monolithic system of government by which this country is ruled is too big and has grown too fast, but despite its excesses, it is still the best system in the world. Industry did not design the system and cannot change it, but the system can and does work if industry participates in it properly.
Enactment of the Export Enhancement Act of 1995, which largely eliminated FDA's involvement in granting export certificates, is a good example of what industry members can accomplish when they work together. This legislation affects every U.S. medical device company that exports. In another related area, through MDMA's educational efforts on Capitol Hill, we helped develop a congressional oversight mechanism to hold FDA accountable to the law. If industry must abide by the rules, so must FDA.
In the trade area, device companies increasingly participated in export opportunities available through the U.S. Department of Commerce and the U.S. Trade Representative's office. The U.S. export trade surplus is at an all-time high, $5.1 billion. Medical device companies that have not participated in some of these export programs should strongly consider doing so. The U.S. Commerce Department programs can assist companies that are looking for better market penetration around the globe.
EXPECTATIONS FOR 1997
In 1996 industry came closer to having the Medical Device Reform Act of 1995 (H.R. 3201) and the FDA Modernization and Performance Act of 1995 (S. 1477) than it ever did before, but neither bill passed for a variety of reasons. Those reasons were mostly political.
One of the primary reasons was that representatives of Kessler's FDA misrepresented the intent of legislative reform. However, the entire device industry is currently united in this effort because it is the only way to succeed. The Medical Device Modernization Act of 1997 was introduced by last year's champion in the House of Representatives, Congressman Joe Barton (RTX), in late February. Members of the medical device industry must also make their cases for the reforms needed at CDRH, or MDMA's efforts will inevitably suffer the same fate they did in the last session.
I do not believe that comprehensive FDA reform legislation, involving foods, drugs, and cosmetics, will be possible with the slim majority that the Republicans currently have in the House. However, I do believe that if MDMA can get its device bill introduced early in the session, support the bill with targeted fly-ins on May 1517, and garner the unequivocal support of the entire medical device industry, we will be able to achieve our goal of safe, predictable, and globally harmonized device approval and enforcement processes at FDA.
On the legislative front, industry is faced with 73 new members of the House and 15 new senators. Many of these lawmakers campaigned as friends of small business and regulatory reform, which should mean they will tend to support industry causes. For the device industry, the 104th Congress was mainly about educating key decision makers on Capitol Hill and the Clinton administration about industry issues. The 105th Congress should concentrate on enactment and implementation of a new device law.
Industry has an advocate in Senate majority leader Trent Lott (RMS), who has long been a friend of small business and who no longer needs to worry about an upcoming presidential election. Another advocate, the vocal Senator Dan Coats (RIN), will spearhead the movement for device-specific legislation through the Senate Labor Committee this year.
The new chairman of this committee, Senator Jim Jeffords (RVT), who replaced retired Senator Nancy Kassebaum (RKS), has not been as focused on FDA-related issues, but may become more focused in the months to come. He has indicated that no FDA reform bills will go through his committee until a new commissioner is in place, which could slow the process in the Senate. This leadership team on the Republican side will be paired with spirited Democratic leaders such as Senators Chris Dodd (D CT) and Barbara Mikulski (DMD). This bipartisan team will be suited to push for a device-specific bill in the early summer of 1997.
Industry's issues of concern are highly specialized and, if they are going to be widely accepted, must be articulated in terms that the layperson can understand. There are a limited number of congressional members, and fewer staffers, who understand the concerns that a regulatory affairs officer might have in filing a 510(k). In reality, it is doubtful that more than a handful of members truly know the difference between a 401(k) and a 510(k). The medical device industry has come a long way in the last three years, but there is still a long way to go. With industry working together, 1997 will be a very interesting and productive year.