An MD&DI March 1997 Column
The chairman of the Health Industry Manufacturers Association and chairman and CEO of Medtronic, Inc. (Minneapolis), offers a prescription for improving FDA's relationship with industry.
If there is one piece of advice I would give to David Kessler's successor at FDA, it would be this: Be a strong advocate for patients. To most people that sounds like a simple prescription, but anyone who is familiar with the development of medical technology in the United States knows that patients are often ill served by a regulatory process that is unpredictable and prone to delay.
In recent months, some gratifying improvements have been made to this process, but much more is needed to ensure that breakthrough medical therapies will reach patients quickly.
Meeting the needs of millions of patients for cutting-edge, as well as safe and effective, medical technology should be the primary goal of our industry, and it should also be a primary goal of FDA. After all, it is the patients, not the medical device companies, who suffer most when the development of an important new technology is stifled or delayed. Putting the interests of these patients first at FDA would be a major step toward revitalizing innovation and smoothing the path of product development.
What are some of the most objectionable characteristics of this obsolete and unwieldy regulatory system? Long product review time is just one element.
Increased FDA enforcement activity of recent years, which has been inconsistent and unpredictable, has also been troubling. The occasionally baffling and contradictory instructions issued by the agency have caused confusion for many companies.
Perhaps most insidious of all, however, has been the agency's impact on product development, prolonging the gestation period for a breakthrough product in ways that are both obvious and subtle. The agency has an impact on the development of a product that is far wider than just the review process.
For example, the prolonged period necessary to negotiate a randomized trial protocol to obtain an investigational device exemption is followed by additional time to conduct trials and complete the review process. To make matters worse, an end date to the process is so unpredictable that adequate organizational, sales, production, or financial planning cannot be done.
Without this planning, the research and development cost of a major new product is three times what it was in 1990. The bulk of funds are being spent not on research and product development, but on clinical trials. Compared with the regulatory systems of other industrialized nations, the U.S. regulatory structure is slow and overly complex, as well as highly unpredictable.
The U.S. regulatory environment is particularly inhospitable to small companies, which are the sources of many of the breakthrough products and much of the innovative thinking in the medical device industry. The smallest, most fragile companies in our industry must negotiate the same labyrinthine FDA requirements that the largest medical device companies do, but without the benefit of the big regulatory affairs staffs that large companies can afford.
Instead of presiding over an agency that regards new technology with doubt and suspicion, a patient advocate in the commissioner's chair would understand that FDA must be in partnership with industry to develop devices that will reach patients as expeditiously as possible. After all, rapid technological advances have been essential for making U.S. health care the most effective in the world. The U.S. medical device industry has been in the forefront in developing products that make faster, less invasive diagnosis and treatment possible, and facilitate delivery of care in the home and other cost-effective settings. Thanks to achievements in fields such as implantology, imaging, biomaterials, electronics, in vitro diagnostics, and biotechnology, medical devices are more sophisticated and effective than ever. Most important, these medical devices have substantially improved health care for patients.
Putting the needs of patients first will also help the new FDA commissioner deal with the complex and changing forces facing the medical device industry. Today, as we approach the millennium, medical technology is advancing faster than ever. Electronic information now moves across continents at the speed of light. Product cycles in many high-technology fields--any that involve computer technology, for example--are measured in months. Some types of medical devices today can become obsolete in the years it can take FDA to review them.
Concurrently, managed health care is transforming the marketplace for medical technology. The focus in the marketplace today is on cost-effectiveness and demonstrable patient outcomes, making it increasingly complicated to market a new technology once it has been approved. In addition, the marketplace for medical technology in this new era is becoming truly global as barriers to international trade continue to fall.
The regulatory process at FDA must take these new realities into account. To their credit, some people at the agency do recognize the changed circumstances for industry and are trying to make FDA more responsive. Thanks to the influence of these people, a new approach to the medical device industry seems to be developing at the agency, and it is coming not a moment too soon.
The signs that this new approach is needed are evident. Many U.S. patients have been deprived of newer, more advanced generations of devices to which European patients already have access. The U.S. patients have had to go abroad to take advantage of these technologies. In addition, U.S. device firms are moving production and research facilities to other countries.
Medtronic has been among the companies shifting research and development and manufacturing operations overseas. Between 1993 and 1995, all 15 of its major new products or ventures were developed, tested, and produced in Europe, and all of them were made available to patients overseas long before they were introduced in the United States.
Medtronic is just one company, but its experience is typical of what has been happening across the industry in reaction to a U.S. regulatory system that is outmoded in terms of today's technology. Understandably, a cumbersome, delay-prone system that was created three decades ago has been overwhelmed by the rapid-fire demands of technological progress. Yesterday's regulatory system is simply not conducive to innovation in the United States today. That is a major reason why so many manufacturing operations have moved overseas.
Europeans seem to recognize that evaluating the effectiveness of therapies is an inexact science, and requiring evaluation to be done through a regulatory process can result in very long delays in getting technologies to market. The European system is no less committed to patient safety than the U.S. system is. But Europeans are conscious of the need to carefully balance regulation with the impact of unnecessary delays on patients who can benefit from innovative therapies. They concentrate their resources on the safety and efficacy of the device instead of on the efficacy of the therapy. The European regulatory process is careful not to inject itself into the practice of medicine.
Should FDA simply adopt the European regulatory system wholesale? Some in the industry are saying that FDA should do just that.
A wiser approach, however, would be to combine the best elements of the European regulations with the best of U.S. regulations to create a reasonable, safe, and much more efficient global regulatory system.
A new session of Congress and a new FDA commissioner will offer industry a chance to explore some new ideas. Industry must seize this opportunity and engage Congress and FDA in discussions about creating a healthy, rather than hostile, environment for innovators.
To ensure such a friendly climate for innovation, some industry members and senior officials at FDA are already beginning to look for ways to get safe and effective technologies to patients faster by reviewing the process in its early stages of design and development. Industry must provide information to FDA officials about ways the agency can accelerate the development of a product. The goal should be improvement not just in product review time, but in overall product development time, of which actual product review is but a part.
If Congress and the new FDA commissioner choose to act to speed up product development, here are four steps they can follow.
- Identify and eliminate unnecessary regulatory requirements that increase the time it takes for a manufacturer to develop a new product.
- Reduce review times for premarket approval (PMA applications). FDA has already greatly improved the review times for 510(k)s, but an expedited review process for PMA applications still needs to be established.
- Speed up the product review process with the use of authorized third-party review bodies, starting with 510(k)s.
- Conditionally approve new medical technologies that have been shown to be safe for patient use, subject to postapproval studies made to demonstrate effectiveness. Approval would be withdrawn whenever these studies show that the risk/benefit ratio of a technology is not acceptable.
If U.S. patients are to receive the latest and best in medical technology, government, industry, and the medical community must work as a team, not as adversaries. The regulatory process must serve the needs of patients and innovators alike. The new FDA commissioner will have a challenging job description.