For Immediate Release
Contact: Jim Manley
202-224-2633
September 23, 1997
As the result of the Senate vote yesterday
rejecting the Reed amendment, the FDA reform
bill still includes an important provision
that seriously threatens the public health--a
provision that must be removed before this
legislation becomes law. This provision
encourages device manufacturers to lie to the
FDA and forces FDA to approve medical devices
that have not been adequately tested to
assure that they are safe and effective.
Three weeks ago the Secretary of HHS
identified this provision as one that would
lead her to recommend a veto if it were not
removed.
Every major public health and consumer organization that has taken a position on this provision strongly opposes it. It is supported only by those who seek to profit by abusing public health.
While the Reed amendment was defeated yesterday and I anticipate that the bill itself will be adopted by the Senate today, this is not the end of the story. There are many procedural steps that must be taken before this bill can become law, including action by the House, reconciliation of the bill passed by the House and Senate and signature by the President. There will be many more opportunities for extended debate before this bill can even go to conference--and I believe that, in the end, the public interest will prevail.
I intend to discuss this provision at some length during the course of today's debate, but I would like to begin by reviewing the reasons we embarked on an FDA reform bill in the first place and how much we have been able to improve the original bill.
There are few more important agencies of the federal government than the Food and Drug Administration. The FDA is responsible for assuring the nation's food supply is pure and healthy. The FDA provides a guarantee that the drugs and devices we rely on to cure or treat diseases are safe and effective. If it does its job well, the FDA can speed medical miracles from the laboratory bench to the patient's bedside. If the agency does its job poorly, it can expose millions of Americans to unsafe or ineffective medical products and jeopardize our food.
The main purposes of the FDA reform bill was
to reauthorize the Prescription Drug User Fee
Act of 1992, known as PDUFA. PDUFA is one of
the most effective regulatory reform programs
ever enacted. Under PDUFA, the pharmaceutical
industry pays user fees that cover part of
the cost of FDA's drug approval and
regulatory functions. With these additional
resources, the FDA has been able to hire
additional personnel, so that drugs can be
reviewed more promptly. As important as these
additional resources were, equally important
were the specific performance targets for
speedier drug review negotiated between
industry and the FDA as part of PDUFA
agreement. The combination of specific
performance targets, additional resources,
and the dynamic leadership of Dr. David
Kessler, the former FDA commissioner, has
created a regulatory revolution at FDA.
To listen to some of speeches we have heard
on the floor during the course of this
debate, you would think that the Food and
Drug Administration was a regulatory
dinosaur, mired in the past, cumbersome and
bureaucratic, imposing unnecessary and costly
regulatory burdens on industry, and denying
patients speedy access to life-saving drugs.
That is a myth that those who want to destroy
the FDA in the service of an extreme
ideological agenda or in the interest of
higher profits at the expense of patient
health would love you to believe.
But it isn't true. The FDA's regulatory
record is the envy of the world. It sets the
gold standard for protection of patient
health and safety.
In recent years, in partnership with Congress and the administration, the FDA has responded to growing criticism of delays in approving new products by taking impressive steps to improve its performance. The Prescription Drug User Fee Act of 1992 was one of the most effective regulatory reform programs ever enacted. The bill established a new partnership between the industry and the agency. The industry agreed to provide additional resources; the agency agreed to measurable performance standard to speed the review of products. Every goal set by that legislation has not only been met, it has been exceeded.
Today, the FDA is unequalled in the world in its record of getting new drugs to quickly to market without sacrificing patient protection. In fact, last year, average review times in the United States were twice as fast as in Europe. Fifteen new drugs were approved in both the European Union and the United States--and in 80 percent of the cases, the U.S. approved the new drugs either first or at the same time as the European Union. More companies chose the U.S. for the introduction of breakthrough drugs than any other country.
In addition to speeding review times, the FDA has taken far-reaching steps to reduce unnecessary regulatory burdens on industry and modernize its regulatory processes. More needs to be done, but these steps have added up to a quiet revolution in the way the FDA fulfills its critical mission.
When the Prescription Drug User Fee Act was originally passed, the device industry refused to agree to the user fees that would give the FDA the additional resources and performance standards that have contributed so much to the Agency's outstanding record on drugs and biologics. But even in the device area, the FDA's recent achievements have been impressive.
So-called 510(k) applications--devices which are approved based on their substantial equivalence to a device already on the market--account for 98% of all device submissions. The FDA has now essentially eliminated its backlog. Last year, it reviewed 94% of these devices within the statutory time frame--compared to only 40% just four years ago.
Even in the area of Class III devices, where the most problems remain, the FDA has improved its performance substantially. According to a study by the General Accounting Office, median review times dropped 60% between 1991 and 1996. A recent survey of device industry executives reported that the business climate for the industry is the best in the five-year history of the survey. The sponsor of the survey attributes this favorable response, in large measure, to improvements at FDA, and concludes, "The agency has not only reduced the product approval delays that slowed new product introductions, but, perhaps more importantly, has also greatly reduced both executives' and investors' uncertainty about the timeliness of future product introductions." In a recent FDA report, the agency set new targets for even quicker review of class III devices.
The agency is doing a good job now, and it will be doing an even better job in the future. Improvements can always be made, but there is no justification for weakening the FDA's power to protect the public based on the myth that it is denying patients prompt access to needed new products.
As I noted earlier, the most important aspect of this legislation is its reauthorization of the PDUFA program. The new PDUFA program was negotiated between the FDA and industry and expands the existing program by setting additional performance targets. It puts a special emphasis on expanding early cooperation between FDA and industry, so that the drug development process- not just the regulatory review process--can be speeded up.
In addition to PDUFA reauthorization, however, the legislation contains a number of other provisions changing the way the agency does business, particularly in the area of medical devices. As originally introduced, the bill included many extreme provisions that posed significant threats to the public health. It was important that these provisions be modified before the legislation could be allowed to move forward.
I complement Senator Jeffords and other members of the committee on their willingness to compromise on these unacceptable proposals over the many months we have worked on this bill, especially during the period after the markup. I would like to review a number of these provisions for the members of the Senate, so that they understand the changes this legislation makes and the pitfalls that have been avoided. These compromises must not be undone as this bill moves further through the legislative process.
The following is a list of some of the important compromises which have been made since the committee markup of the bill.
1. Preserving state oversight of safety of cosmetics. This compromise assured that the states will be able to continue to regulate the safety of cosmetic products. The Gregg proposal in the underlying bill would have barred states from any regulation whatsoever of cosmetics, even though the FDA has neither the authority nor the staff to regulate these products. The compromise allows states to continue their regulation unless a specific inconsistent regulation has been issued by the FDA in a particular area.
2. Safeguards for off-label use of drugs. This important compromise will allow companies to circulate reputable journal articles about off-label use of drugs but will ultimately enhance the public health and safety because the FDA will be given the opportunity to review, comment on, and approve articles which the companies will circulate. The compromise also requires companies to undertake studies on the safety of their drugs for the specific off-label use and submit applications to the FDA for approval of their drugs for these uses within three years. Currently, companies are circulating articles promoting off-label use without FDA review or approval. Manufacturers are also never conducting the studies which would lead to ultimate FDA approval or disapproval of the off-label use.
3. Fast track approval. This is one of the most important new initiatives in the legislation. Fast track approval will provide the same streamlined availability now available only to patients with cancer or AIDS for drug treatments, including breakthrough therapies and biotechnology advances, for patients with any life threatening disease.
Providing access for patients to information about clinical trials for serious or life threatening diseases and expanding access to drugs still under investigation for patients who have no other alternatives. This compromise will assure that patients suffering from serious or life-threatening diseases will have available to them information about ongoing clinical trials relating to these diseases. The compromise provides patients with expanded access to new investigational therapies, without exposing patients to unreasonable risks.
4. Streamlining FDA procedures by involving outside experts and third-party reviewers. In order to expedite some product reviews, the compromise authorizes the Secretary to contract out to third-party reviewers when it will improve timeliness, but not when it will reduce quality. For medical devices, the compromise establishes in law an already existing pilot program for reviewing devices by outside third parties. The compromise limits the review only to Class I and certain low-risk Class II devices and specifically excludes higher-risk devices, which if not safe and effective, could cause substantial impairment to human health. The FDA will also not have to expend resources on unnecessary reports which may be duplicative of other reports already required to be filed by the agency.
5. Improved consultation between
manufacturers and FDA. The compromise
increases the requirements on the FDA to
consult with device manufacturers and
specifically to work toward achieving
agreement on what set of data needs to be
provided by the device manufacturer before
approval can be granted. In addition, the
device manufacturers are required to supply
progress reports to the FDA, and in
particular, report significant deficiencies
in the device which have developed during the
review period.
-Tightening up the process for FDA approval
of medical devices. The FDA will now be
required to accept the classification made by
the manufacturer unless questions are raised
within a specific period of time. The
compromise also tightens up time frames
within which the FDA must make a final
decision on a device application.
6. Preserving FDA environmental impact statements. The original bill would have eliminated environmental impact statements from FDA applications. The compromise ensure that the bill does not undermine environmental protections provided by the Environmental Protection Act.
7. Strengthening safety protections of
medical devices.
-
Safety and effectiveness of devices. The FDA
will still require device manufacturers to
file supplemental applications when they are
making changes to their manufacturing
procedures which may affect the safety and
effectiveness of the devices.
- Tracking of devices after approval. The
compromise ensures that FDA can require
surveillance of products after they have been
approved for as long as needed to protect the
public health. The compromise requires
limited recordkeeping by device distributors
so that patients using devices will be
readily identifiable if there is a health
problem.
8. Other Issues:>br>
- Safety standards for drugs. Supplemental
applications for drug approvals need to meet
the same safety standards as the original
application.
- Health care economic
information. Only valid and supportable
health economic claims may be made by drug
manufacturers.
- Health claims for food products. This
compromise assures that the nutrition
labeling act is not undercut or weakened, and
that any health claims by food manufacturers
have to be substantiated.
I am proud of the progress that has been made. We have reached constructive compromises on more than 20 items. But there is one item on which the majority has been unwilling to compromise so far --and it is a serious enough threat to the public health that it jeopardizes the chance for prompt enactment of everything else in this bill.
The issue is clear:
*Will
medical
devices be approved based on false or
misleading labels?
*Will dangerous medical devices that have not
been tested for safety and effectiveness to
be foisted on the American people?
*Will unscrupulous companies like the U.S.
Surgical Corporation be rewarded for
deceiving the FDA?
*Will their be a higher value placed on the
profits of the powerful than the health of
the American people?
Section 404 of the FDA bill requires the FDA to approve a medical device based on the use claimed on the label submitted by the manufacturer, even if that label is false or misleading. It prevents the FDA from requiring the manufacturers show their product is safe and effective for purpose for which it will really be used-as opposed to the purpose falsely claimed on the label. It stands twenty years of progress toward safer and more effective medical devices on its head.
Nothing better shows the need for the Reed-Kennedy amendment than the recent history of the Advanced Breast Biopsy Instrumentation system, an device developed and marketed by the U.S. Surgical Corporation. This attempt to mislead the FDA and foist an untested machine on women with breast cancer shows why it is critical that Section 404 not be passed in its current form.
Another example involves the large number of patients who have suffered serious fractures and who benefit from orthopedic implants that help the broken bones to heal. In some cases, these implants are designed to be removed after the healing is complete. In other cases, to avoid further surgery or to strengthen the bone, the implants are left in place.
Under this legislation, a manufacturer of plates and screws approved for short-term use could modify them in a way that clearly shows they are intended for long-term use. The FDA would be prohibited by this bill from looking behind the false and deceptive label and requiring the manufacturer to show that the device will not degenerate or weaken the bone during long-term use.
Pedicle screws are a clear example of just such behavior by manufacturers. Originally designed to hold long bones in place after a fracture, they were modified by the manufacturer so that they could be used to make the spine more rigid, with the goal or reducing painful back problems. But the many manufacturers of these screws did not present safety and effectiveness data to the FDA for this new use. The result: the screws sometimes broke and sometimes caused spinal fractures. Re-operation rates ranged from 14 to 52 percent--and patients suffered permanent pain and disability. This is exactly the kind of unethical behavior by manufacturers that this bill encourages.
The vast majority of medical device manufacturers meet high ethical standards. Most devices are fully tested and evaluated by the FDA before they are marketed. But as many examples make clear, if the FDA does not have adequate authority to protect innocent patients, the result can be unnecessary death and injury to patients across the country. There is no justification -- none whatever -- for Congress to force the FDA to approve devices with false or misleading labels. And there is certainly no justification for giving a competitive advantage to unscrupulous companies who will exploit this gaping loophole in the law.
Companies that hope to benefit by weakening the FDA are powerful and profitable. They believe they have the votes to push this disgraceful provision through the U.S. Senate. Today, they probably do have the votes. But if the American people truly understand what is at stake, I do not believe they will permit this dangerous provision to become law. When the vote comes on Tuesday, we will see how many Senators are willing to stand with the American people--and how many are willing to vote in favor of false and misleading labelling.
The legislation we are considering has many constructive elements. But it does not deserve to go forward unless this disgraceful provision is removed. False or misleading labels should have no place in approval of medical devices. Unscrupulous manufacturers do not deserve a free ride at the expense of public health. I intend to continue to fight to modify this provision so that public health can be protected, and I believe that we will ultimately be able to reach a compromise that will not sacrifice the public interest to the profits of greedy manufacturers. We have been successful in assuring that every other objectionable provisions of this bill has been modified so that the public health is protected. This provision must be changed as well.
