Mr. Chairman and Members of the Subcommittee:
The Food and Drug Administration (FDA) appreciates the
opportunity to submit this statement for the record. In keeping
with the theme you set for the hearing, this statement will focus
on FDA's efforts providing for the electronic submission and
dissemination of data and our comments on your legislative
proposal, H.R. 2715, the Paperwork Elimination Act of 1995.
As you know, FDA's primary statutory mandates are in the Federal
Food, Drug, and Cosmetic Act, the Public Health Service Act and
the Fair Packaging and Labeling Act. Our mission under these
statutes is to protect, promote and enhance the public health by
implementing statutory provisions designed to ensure that food is
safe and otherwise not adulterated or misbranded; that human and
veterinary drugs, human biological products and medical devices
are safe and effective; that cosmetics are safe; and that
electronic product radiation is properly controlled.
FDA-regulated products must be truthfully and accurately labeled
and in compliance with all applicable laws and regulations.
While FDA principally serves the general public in its health and
safety mission, FDA also recognizes it has responsibilities to
the industries that it regulates. Industry demands speedier
product approvals to help offset the large sums of research
dollars expended to develop new products. The public demands
timely access to medical innovations, especially life-saving
innovations, but without sacrificing health and safety. FDA sees
its mission as meeting both these goals simultaneously. We are
using new information technology to better serve the regulated
industry which develops the innovative products welfare charged
with reviewing and the consuming public which rightfully expects
timely access to new or improved products but with the same
assurances of their safety and effectiveness as they have come to
expect from the FDA.
Congress recognized the need for FDA to adopt modern technologies
in 1987 when it added Section 711 to the Food, Drug, and Cosmetic
Act directing FDA to "automate appropriate activities of the Food
and Drug Administration to ensure timely review of activities
regulated under this Act." In 1993, Vice President Gore's
National Performance Review (NPR) recognized the power of
information technology to reinvent government and reengineer
agency practices to increase the speed and efficiency of
government functions. The NPR set an objective of expanded use
of new technologies and telecommunications to create an
"electronic government." And last May, when he signed the
Paperwork Reduction Act of 1995 (PRA), President Clinton
reemphasized his commitment to reducing the paperwork burden
through the use of new technology when he said:
Today, I want to add another dimension to this effort: From
this point forward, I want all of our agencies to provide for the
electronic submission of every new Government form or demonstrate
to OMB why it cannot be done that way. The old way will still be
available, but I think once people see how fast and efficient
electronic filing can be, we'll see less paperwork and more of
these. So, we're trying to do our part to act in good faith the
way these Members of Congress intended the executive branch to
act.
STRATEGIC APPROACH
FDA is using a strategic approach to address the challenges of
implementing information technology for the 21st Century. To
keep our information systems as flexible and up-to-date as
possible, FDA tries to keep its computer systems environment one
that is open to evolving technologies. We have an Information
Systems Architecture initiative which concentrates on the
development of a common information technology infrastructure
throughout the Agency. Our objective is to take full advantage
of the evolving capabilities offered by information technologies
and electronic communication to facilitate information exchange
between the FDA, industry, and the public. More readily
accessible information; easy-to-use systems interfaces; and fully
integrated databases, information systems, and analytical tools
will combine to enhance the productivity of FDA personnel and
facilitate the exchange of information with industry and the
public, for both programmatic and administrative purposes.
While many of the factors that influence FDA's environment will
change over the next decade, one thing will not change: the
Agency is and will continue to be an information-intensive
organization. FDA must collect, analyze, and maintain
significant amounts of data collected from pre-market approval
and post-market surveillance of regulated products.
Our systems serve both big and small business -- we try to make
any system we develop accessible to both. It is FDA's objective
to provide the most efficient information systems we can to
lighten the reporting burden on business as well as consumers.
HIGHLIGHTS OF RECENT ACTIVITY
FDA's information activities often serve multiple communities
simultaneously. However to provide some order in presenting our
activities, we will categorize some of our recent activities by
the primary client group affected: consumers and users of
regulated products, industry generally, and small business
specifically.
SYSTEMS SERVING CONSUMERS OR PROVIDERS OF FDA REGULATED PRODUCTS
INTERNET HOME PAGE. The FDA Home Page is an agency initiative,
designed to improve the efficiency and effective dissemination of
information via the Internet. For example, guidance documents to
assist in development of food additive petitions are available
through the home page, as is information on food, cosmetics,
human and animal drugs, biologics, medical devices and
radiological health products. In addition, FDA is beginning to
receive information from
both industry and the general public via Internet, and is
exploring ways to institutionalize and optimize use of this
technology.
ADVERSE EVENTS REPORTING. The MEDWATCH program, an upgrade and
enhancement of earlier systems, was introduced in June 1993 to
enhance the effectiveness of postmarketing surveillance of all
medical products regulated by the FDA, e.g., drugs and biologics
as well as medical devices and special nutritional products such
as medical foods, dietary supplements, and infant formulas. The
program has four general goals: 1) to increase awareness of drug-
and device induced disease, 2) to clarify what should (and should
not) be reported to the agency, 3) to make it easier to report,
and 4) to provide regular feedback to the health care community
about safety issues involving medical products. The MEDWATCH
program is supported by more than 100 organizations -
representing health professionals and industry - which have
signed on as MEDWATCH partners to help achieve these goals.
To facilitate reporting, there is a one-page, postage-paid,
voluntary form for health professionals who choose to report
directly to the agency and/or the manufacturer. A 24-hour
toll-free number (1-800-FDA-1088) is also available for health
professionals to report by phone, to request forms either via fax
or mail, or to obtain a copy of the FDA Desk Guide to Adverse
Event and Product Problem Reporting, which includes examples of
events to report, completed sample forms, and also blank forms
with instructions. Providers may also report to the FDA
electronically (on-line) by calling 1-800-FDA-7737, or fax a
report on 1-800-FDA-0178. Currently the majority of adverse
events reports are received via the manufacturers in computer
print-out form that have to be re-entered into FDA's data system.
The Adverse Events Reporting System (AERS) is an effort to
strengthen the database systems and processes of our postmarket
surveillance programs. To support the database, we will
encourage and facilitate electronic reporting of adverse events
by industry and health care providers. The AERS initiative will
provide a database of adverse events information and enhanced
evaluation capabilities.
SYSTEMS SERVING INDUSTRY GENERALLY
VIDEO TELECONFERENCING. Video teleconferencing enhances
communications with regulated industry, especially between the
product sponsor and the FDA reviewers during the review process.
Several small manufacturers have taken advantage of this new
technology which allows both parties to see and hear each other
during the session in addition to allowing them to modify a
submission interactively. This system also provides a medium for
training Agency and industry personnel.
FORMS AVAILABILITY. FDA is Participating in efforts of our
parent Department of Health and Human Services, currently in the
conceptual stage, to make forms accessible via the Internet.
This system will give industry direct access to a library of
forms they currently must solicit either verbally or in writing.
NEW DRUG AND BIOLOGIC APPLICATIONS. FDA's Center for Drug
Evaluation and Research (CDER) and Center for Biologics
Evaluation and Research (CBER) have for years been exploring
electronic submissions of portions of new drug applications,
including data sets and data summaries. CDER has received over a
hundred electronic submissions. With the passage of the
Prescription Drug User Fee Act of 1992 (PDUFA) Congress
established specific goals for reducing the time it takes to
review new drug and biologic product applications. Despite the
progress made with electronic submissions, the current process
for reviewing applications is time-consuming and paper intensive.
With money obtained from user fees, the agency has begun the
Submission Management and Review Tracking (SMART) Program. SMART
currently supports CBER and CDER through several pilot projects.
The program will facilitate submission of product applications
electronically, and will improve the Agency's ability to process,
track, and archive submission data. SMART will provide automated
tools to help managers in making informed decisions, determine
the status of applications, and assess the efficiency of the
review process, and to assist reviewers in accessing, analyzing,
sharing, and producing relevant information.
ELECTRONIC RECORDS AND SIGNATURES. In the Federal Register of
August 31, 1994, FDA proposed regulations that would define the
circumstances which would permit the agency to accept electronic
records, electronic signatures, and handwritten signatures
executed to electronic records as equivalent to paper records and
handwritten signatures executed on paper. These regulations
would apply to all records required under FDA regulations
(Chapter I, Title 21 of the Code of Federal Regulations). Under
the proposed rule, firms could choose to use electronic forms of
recordkeeping for records they are required to maintain. Firms
could also submit data to the agency electronically when the
agency has announced its ability to accept such electronic
submissions.
The intended effect of this proposed rule is to promote the
optional use of electronic maintenance and submission of
information, reduce paperwork burdens, improve data reliability,
and enhance agency efficiency and responsiveness in a manner that
is compatible with FDA's ability to promote, protect and enhance
the public health. This is a significant rule that we are
working hard to finalize.
SYSTEMS OF PARTICULAR BENEFIT TO SMALL BUSINESS
IMPORT SURVEILLANCE. Import brokers are mainly small businesses.
Operational and Administrative System for Import Support (OASIS)
is an automated system designed to facilitate inspection and
clearance of imported products regulated by FDA. The amount of
paper import brokers provide to FDA as part of the entry process
was reduced by 85% through application of information systems
technology. A 1995 cost/benefit study by Booz-Allen and Hamilton
shows that the import industry will save more than $1.2 billion
over the period from 1994 through 2001 because of paperwork
reduction and expediting of the entry process.
In February 1996, 80 percent of all shipments of FDA-REGULATED
products processed in the electronic system received a final
clearance within minutes after the electronic data was submitted.
These short clearance times are a great improvement over the one,
two or more days that it took to clear products before
automation. This system also allows FDA to focus its scarce
resources on those import shipments that are suspected of not
meeting regulatory requirements.
ELECTRONIC MEDICAL DEVICE APPLICATIONS. Based on results of a
pilot study begun in 1994, the Center for Devices and
Radiological Health (CDRH) has started accepting medical device
applications in electronic form for Premarket Notifications
(so-called 510k's), Premarket Approval (PMA) Applications, and
Investigational Device Exemptions (IDE). The applications were
developed specifically with the small manufacturer in mind. They
do not require expensive, sophisticated equipment. Already a
dozen such applications have been processed. one medical device
manufacturer has estimated a 20% savings in document submittal
time resulting from this approach.
SMALL PURCHASES. Our Office of Facilities, Acquisitions, and
Central Services has initiated a pilot project using electronic
data interchange (EDI) for product acquisition, soliciting small
businesses, receiving quotations and awarding purchase orders
electronically for a small number of requirements.
TOLL FREE NUMBERS. 1-800 telephone numbers as well as
FAX-on-DEMAND and FLASH FAX, are being used in various programs
throughout the agency to expedite information exchange with
consumers, health professionals, and the industry. Each of the
Agency's thirteen 800 numbers has a target constituency and
purpose. Examples include: the Seafood Safety Hotline, MEDWATCH
mentioned earlier, the Advisory Committee Hotline, the orphan
Product Development Information Line, and lines providing
assistance in the areas of drugs, medical devices, biologics and
general consumer information. Using these technologies to
disseminate information to over a half million callers each year
has significantly reduced the paperwork burden on the Agency.
CASE STUDY OF RAPID TECHNOLOGICAL CHANGE
What follows is a short case study of how the agency is changing
and adapting its services to industry to keep pace with the rapid
change of technology. This chronicles efforts of the Division of
Small Manufacturers Assistance in FDA's Center for Devices and
Radiological Health (CDRH), to assure that any use of new
technologies is of advantage to the small device manufacturer.
ELECTRONIC DOCKET. In 1994 CDRH established an Electronic Docket
which includes publicly available documents such as guidance
memoranda, talk papers, and press releases. A comparison of
accesses to the Electronic Docket with the Public (paper) Docket
found the Electronic Docket to be considerably more popular, with
thousands of accesses a month on the Electronic Docket, compared
to tens of accesses to the public docket. These findings
resulted in discontinuation of the paper docket. The major
advantage of the electronic docket was the addition of 510k
application status listings. Small manufacturers no longer had
to telephone a reviewer to find out the status of their Premarket
Notification (510k) but could find out via simple access from a
personal computer.
CDRH INTERNET ROME PAGE. With the introduction of the Internet
CDRH decided to convert the Electronic Docket to make that same
information available on CDRH's Home Page on the World Wide Web.
The advantage to the small manufacturer is that more information
is available in a more easily searchable manner. Statistics show
that this mechanism is now taking precedence over the Electronic
Docket, which may be phased out in the near future.
In summary, as demonstrated by the listing of alternative
technologies and the case study, while many of the factors that
influence FDA's environment will change over the next decade, one
thing will not change: the Agency is and will continue to be an
information-intensive organization. FDA must collect, analyze,
and maintain significant amounts of data from pre-market approval
and post-market surveillance of regulated products. The
judicious implementation of alternative technologies will be an
absolute necessity for the agency to gain the efficiencies needed
to enhance our services to the public and the regulated industry
within the budget constraints of the foreseeable future.
COMMENTS ON H.R 2715
We have one technical comment. In Section 5(a) of the proposed
legislation, the words "when appropriate" should be inserted
before the semicolon. This change is consistent with the wording
of the other sections of the proposed legislation and is
necessary because, in some cases, electronic maintenance,
submission, or disclosure of information would not serve the
purposes of the Food, Drug, and Cosmetic Act and its regulations;
for example, it is important that FDA be able to continue to
require that low acid canned foods be physically marked with a
can code. This is critical in the event of a manufacturing or
handling failure that requires the identification of potentially
hazardous product.
If we may paraphrase, the stated purpose of H.R. 2715 is to
promote the sponsorship and use of alternative information
technologies to: (1) minimize the burden of federal paperwork
demands on small businesses, and (2) more effectively enable
Federal Agencies to achieve the purpose of the Paperwork
Reduction Act. As you saw from the list of highlights above, FDA
has been working for many years to incorporate alternative
information technologies in our system. As you know, these types
of changes do not happen quickly. They take planning and money.
For a number of years, the agency has been investing some of our
scarce resources in this large effort to take firmer control of
the many demands being made on us. It is not clear what
additional impetus the provisions of H.R. 2715 would provide. We
are already moving in the direction envisioned by H.R. 2715
propelled by the needs of our clients for more information
provided as quickly as possible, the budgetary constraints of our
times demanding that we seek more efficient means of fulfilling
our mission, and encouraged by Section 711 of the FDC Act, the
National Performance Review and most recently by the President's
own statement.
Thank you again for giving us the opportunity to present our
views on this important topic.
