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Statement of AdvaMed
We
thank the Committee for holding this Hearing today on Import Safety. AdvaMed
represents over 1,600 of the world’s leading medical technology innovators and
manufacturers of medical devices, diagnostic products and medical information
systems. Our members are devoted to the development of new technologies that
allow patients to lead longer, healthier, and more productive lives. Together,
our members manufacture nearly 90 percent of the $86 billion in life-enhancing
health care technology products purchased annually in the United States, and nearly 50 percent of the $220 billion in medical technology products purchased
globally. Exports in medical devices and diagnostics totaled $25.5 billion in
2005, and imports were $23.7 billion. The
medical technology industry directly employs about 350,000 workers in the U.S.
The medical technology industry
is fueled by intensive competition and the innovative energy of small companies
– firms that drive very rapid innovation cycles among products, in many cases
leading new product iterations every 18 months. Accordingly, our US industry succeeds most in fair, transparent global markets where products can be adopted
on their merits, and intellectual property rights are protected. We strongly
support the Administration’s effort to expand market access for US products
abroad through the World Trade Organization (WTO) negotiations and new free
trade agreements (FTAs), as well as oversight of market access barriers in
countries with which we have strong trade relationships. In addition, we
believe U.S. participation in trade agreements is most effective when
provisions are enforced.
Import Safety
AdvaMed believes ensuring the safety and effectiveness of
medical technology is a shared responsibility between government, industry and
users – wherever the product is designed and manufactured. Government
establishes and enforces the laws and regulations intended to provide patients
with medical technology that is as safe as possible and functions as intended.
Manufacturers have the obligation to make products and establish quality
management systems that comply with these laws and regulations. Both parties
have an interest in promoting public confidence in the medical technologies
used in health care delivery.
U.S. Food and Drug Administration (FDA) regulations
governing the sale of medical devices in the U.S. are recognized around the
world as providing U.S. patients high quality medical devices. Any medical device sold in the U.S. – including all
imported medical devices or devices made with components produced overseas –
will have undergone a review and approval process by the FDA, including
inspections of the manufacturing facilities for higher-risk products. Medical
devices also are subject to FDA’s post-market surveillance requirements. While AdvaMed
members are confident in the safety of their own products, the U.S. Government
has much better access to information to assess whether medical devices being
imported into the U.S. meet FDA requirements. We welcome measures that will
ensure consistency in the requirements applied in practice to
domestically-produced and imported medical devices.
We believe that communication
between governments, involving industry in the process, is very important.
AdvaMed has developed good working relations with key regulatory agencies in
many countries. Our approach with both foreign governments and industry is to
seek ways to improve information on best practices, communication and
appropriate regulatory systems.
Over the years, AdvaMed and its
members have conducted – and continue to conduct -- seminars and training
programs for government officials on best regulatory practices. By improving
understanding of international best practices, we believe the safety and
effectiveness of medical devices – along with patient access to those
technologies -- will be enhanced world wide.
Information Sharing
Under U.S. regulations, the medical technology industry is
required to provide FDA information to assist in its enforcement of regulatory
requirements. Such information includes pre-market evidence, which enables FDA
to evaluate the safety and effectiveness of a product before it is sold in the U.S. The industry also provides FDA considerable post-market information, including
adverse event reports and notice of significant changes in product design or
manufacture, and is subject to ongoing facility inspections.
The U.S. FDA has access to more information on the U.S. medical technology industry than any other regulatory agency in the world has on its
industry. Some of this information is business sensitive and confidential. In
the right hands, necessary information can help ensure unsafe products do not
reach patients and/or that appropriate and timely corrective action may be
taken by industry and government.
In the wrong hands, this same information can prevent safe
products from improving patients’ lives and be used to block market access.
Regulators in other countries who either do not understand, or do not want to
understand, or react inappropriately to, the meaning of FDA’s information can
cite it to unfairly deny access for U.S. medical devices. Many other countries
use industrial policy to foster exports and discourage imports. We ask that
U.S. Government officials recognize these imbalances – regarding the extent of
information available, the understanding of regulatory data, and/or the
differences in available resources – in FDA compared to the rest of the world
when determining information sharing arrangements between governments.
In particular, we make the following recommendations.
- FDA should provide information to foreign governments only to the
extent it receives comparable information in return. Since the task of the
Interagency Working Group’s activities is to determine ways to protect
Americans from unsafe imports, U.S. negotiators should focus on defining the
information foreign governments are willing to provide the U.S., and respond accordingly.
- FDA should provide foreign authorities safety information only on
the specific medical technology products that are actually sold in the other
country’s market. Information on other products, which might be similar to
products sold in another country, could be misunderstood and/or misused – e.g.,
as an inappropriate excuse to deny access.
- If information on specific products sold in a foreign country is
shared with foreign authorities, FDA should ensure that the information is used
appropriately for safety reasons, which might require training for foreign
regulators and/or conditions for denying access to any future data if
conditions are not met.
- If FDA provides foreign authorities information on a situation
labeled a “recall” in the U.S., that term should not be used with foreign
authorities unless a product is being removed from the U.S. market. No other country uses the term “recall” for the broad range of actions, characterized
by FDA as “recalls.” While the Global Harmonization Task Force (GHTF) term
“field safety corrective action” would be most appropriate, an alternative
would be for FDA to simply describe the action taken, without labeling the
action a “recall.”
- FDA inspection reports should not be shared with foreign
authorities without obtaining a company’s approval. Such reports contain
sensitive and confidential information. Many countries’ regulatory systems
are still evolving, and their inexperience with FDA inspections could cause
them to over-react. Even if confidential information is redacted from FDA
submissions, a foreign government is likely to require the U.S. firm to provide all information as a condition for sales.
Appropriate Regulatory Systems
The GHTF provides excellent guidance documents, with strong
emphasis on quality management systems and international standards, as the
basis on which to develop regulations for medical devices. The U.S., Europe, Japan, Canada and Australia are founding members of the GHTF and make use of GHTF
guidance documents. Many countries outside of the GHTF membership are
developing their own regulatory systems for medical devices and tend to rely
inappropriately on regulations for pharmaceuticals and type testing, instead of
quality management systems. The result is that some countries’ regulations and
actions do not reflect best international practices and cannot control safety
and effectiveness as well as appropriate medical device regulations based on a
quality management systems approach. In addition, some foreign regulations
often impose more stringent regulatory procedures on imported products – which
can be effectively blocked at the border – than on domestic products.
FDA should press for a quality system approach as the basis
for medical device regulation and the elimination of type testing, especially
testing that is redundant and unnecessary. Foreign countries’ resources could
be better used for developing a modern regulatory framework than being expended
on outdated, costly and inappropriate procedures. This approach would be
consistent with the Interagency Working Group’s recommendation to use a “video”
instead of a “snapshot” to evaluate imports. Such an approach to assessing and
controlling imports, from design to post-market surveillance coupled with a
risk management philosophy across the product life cycle, are well-established
principles in the medical device sector (FDA quality systems regulation and
international medical device quality management systems standard ISO 13485).
We support their broader application throughout the supply chain. This
approach would also encourage international regulatory harmonization.
We recommend that U.S. and foreign governments, in cooperation with U.S. and foreign industry, launch an initiative to
assist other countries interested in improving their regulatory regimes for
medical technology. This initiative could focus on greater reliance on
the quality management systems approach, international standards and perfecting
post-market surveillance systems.
Conclusion
AdvaMed and its members strongly
endorse government regulations that promote the safety and effectiveness of
medical technology in the U.S. and abroad. It is in the best interest of
patients, clinicians, and our industry that only the highest quality of medical
technology is allowed to be placed on the market in any country. We have made
recommendations which we believe will achieve these objectives without imposing
barriers delaying or preventing U.S. medical technology from entering other
countries.
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