I. INTRODUCTION
Mr. Chairman and Members of the Committee, I am Dr. Michael A.
Friedman, Acting Commissioner of Food and Drugs. I am pleased
to be here today to reconfirm the commitment of the Food and Drug
Administration (FDA or the Agency) to full and timely
implementation of the FDA Modernization Act of 1997 (FDAMA or
the Act). The seriousness of this commitment is demonstrated, I
believe, by the progress the Agency has made on implementation to
date. I would like to acknowledge the leadership of this
Committee in enacting FDAMA and on the range of issues
involving FDA. We appreciate the opportunity that FDA had to
work with Members of Congress on FDAMA, which represented the
culmination of several years of effort by the Administration,
Congress, industry, and consumers to reach agreement on this
important legislation.
Recognizing the priority you gave to enactment of FDAMA, FDA
has been working very diligently on implementing FDAMA
consistent with the timeframes set forth in the Act. There is much
work still to be done. FDAMA touches virtually every aspect of
FDA's activities. In enacting FDAMA, Congress affirmed FDA's
role as a promoter and protector of the public health of American
citizens. While you endorsed many actions that FDA already had
taken to streamline its operations, you also required the Agency to
implement significant changes. It is important to note that
while FDAMA focuses on streamlining requirements and procedures
necessary to make products available to consumers, it does not
lower the standards by which medical products are introduced into
the marketplace. You also required the Agency to focus
additional attention on accountability for its performance, both
in terms of the Agency's day-to-day decisions and in terms of our
ability to comply with the statutory mandates under which the
Agency operates.
Coming at this time of vigorous scientific growth, implementing
FDAMA is one of the most demanding challenges faced by the
Agency in its 92 year history. It has been a challenge, albeit one I
believe we have substantially met, to promulgate the many
regulations and guidances, and take the other steps, necessary to
effectuate the changes set forth in the statute. We are
thoroughly committed to meeting this challenge.
We also are committed to fulfilling all of the Agency's statutory
obligations, as intended under FDAMA, but this is a commitment
the Agency will be severely challenged to meet. FDA's
obligations have grown enormously, fueled by rapid scientific and
technological developments, increased complexity of regulated
products, additional statutory responsibilities, and mushrooming
global trade. The magnitude of this challenge can be illustrated
by a number of measures, most particularly resources. As the
Committee is aware, the Congressional Budget Office estimated the
cost of compliance with an earlier version of the legislation at
$50 million, and yet the Agency has not received any additional
resources for implementation. Most of this estimate represented
the cost of coming into full compliance with statutory deadlines
and requirements.
FDA remains committed to a continuous effort to improve
management efficiencies and to increase collaborative
arrangements with the various components of the regulatory
community, both in the U.S. and abroad. I am hopeful that our
consultations with Agency stakeholders as required under Section
406(b), which are described later in the testimony, will be
helpful to both FDA and the Congress as we assess how best to
meet the Agency's statutory obligations. As I indicated in my
testimony before the Health and Environment Subcommittee on
April 23, 1997, the Agency, the Department of Health and Human
Services and the Administration are committed to working with
Congress on a bipartisan basis to promote and protect public
health as best we can.
II. FDAMA IMPLEMENTATION REQUIREMENTS
As outlined in a July 13, 1998 letter to Chairman Bliley,
implementation of FDAMA includes the development of numerous
regulations, guidances, notices and reports, as well as
completion of other tasks. In total, the Act explicitly requires
us to issue 17 regulations, 11 guidance documents, 6 notices and
9 reports, and to complete 18 other discrete tasks, such as
conducting studies or compiling lists. In addition, in order to
have full and proper implementation of the new directives, FDA
has needed to make numerous conforming changes to existing
regulations, and to issue guidance to clarify new provisions. We
are proud not only of the number of tasks that we have completed
to implement FDAMA, but also of the timeliness with which we
have completed these tasks. Since November 21, 1997, to
implement FDAMA, FDA has issued a total of 9 final rules, 2
proposed rules, 28 guidance documents (25 final and 3 draft), 10
notices and 1 report.
FDA has met all but three of the FDAMA deadlines. Those three
exceptions were: 1) the issuance by the Center for Veterinary
Medicine (CVM) of guidance on supplemental applications (Section
403), 2) the report to Congress on the food contact substances
program (Section 309), and 3) the issuance of guidance on
general/specific use for devices (Section 206(c)(1)). The CVM
supplemental application guidance obligation was inconsistent
with a requirement under the Animal Drug Availability Act of
1995, as explained in a May 18, 1998 letter to Chairman Bliley.
The food contact substances report was a very complicated issue
for the Administration and was completed and sent to Chairman
Bliley on May 29, 1998, missing the deadline by less than 60
days. A draft general/specific use guidance was available for
comment on May 22, 1998, but the final guidance, which was due
August 18, 1998, remains under review.
The Agency continues vigorous efforts to comply with all FDAMA
deadlines. The current status of all the FDAMA initiatives is
set forth in Attachments A and B. Respectively, these are a list
of FDA's completed initiatives to date and FDA's FDAMA
implementation chart.
III. HIGHLIGHTS OF FDAMA IMPLEMENTATION
As I indicated above, FDAMA touches virtually every aspect of
FDA's activities. The Act addresses everything from the types of
evidence most appropriate for premarket review of devices to the
availability of appeal and administrative review procedures for
Agency decisions. Some of these provisions clarify longstanding
Agency practices or procedures, others codify important practices
to assure their full and consistent application, and still others
establish important new programs for the Agency to administer.
FDAMA also reauthorizes, for five more years, the Prescription
Drug User Fee Act (PDUFA) of 1992. In its first five years, the
program enabled the Agency to reduce to 15 months the 30-month
average time that used to be required for a drug review before
PDUFA. This accomplishment was made possible by FDA
managerial reforms and the addition of 696 employees to the
Agency's drugs and biologics programs, which was financed by
$329 million in user fees from the pharmaceutical industry. The
performance goals identified for the reauthorization focus on efforts
to maintain review times achieved in the first five years and to
reduce drug development times.
I would like to focus on a few of the additional more significant
provisions of FDAMA, summarizing briefly our implementation
efforts.
A. Section 112: Expediting Study and Approval of Fast Track
Products
No area of FDA's responsibility has been more closely scrutinized
by Congress, industry, health care professionals, and the public
than the approval process for new drugs, or more specifically,
the speed with which new therapies of demonstrated effectiveness
and safety are made available to those who need them. We
continue today to approve drugs in time periods that are as fast
or faster than any country in the world with a comparable system
of scientific rigor and public health commitment without
compromising scientific standards. At the same time, we must
continue to look for ways to further expedite the process.
Prior to FDAMA, FDA had established a number of different
mechanisms aimed at streamlining the development and approval
process for new therapies for serious and life-threatening
conditions. Section 112 of the Act, generally referred to as
"fast track" authority, adds a formal, statutory mechanism to
enhance this effort. Under this mechanism, drugs that may
constitute significant therapeutic breakthroughs can be
identified and designated early in the development process,
allowing early interaction between the Agency and sponsor in
order to streamline the development and approval process for such
drugs.
We very much understand the significance of this provision to
patients with serious or life-threatening illnesses. Section 112
builds upon the existing accelerated approval mechanism in
current FDA regulations, found at Title 21, Code of Federal
Regulations, Section 314.510. In part, Section 112 amends the
FDC Act by providing explicit statutory authority for FDA to
approve a drug based on surrogate or clinical endpoints, if
applicable, and to require post-marketing clinical studies. This
statutory language is similar to that of FDA's current
"accelerated" approval regulations. In addition, under
Section 112, FDA may consider for review portions of a marketing
application before the complete application is submitted.
Beginning review of a section of an application in appropriate
cases also can help to expedite review and approval decisions.
Section 112 requires the Secretary of Health and Human Services
to issue a guidance describing the policies and procedures that
pertain to fast track products by November 21, 1998. FDA is in
the process of developing the fast track guidance. On
September 16, 1998, FDA's Center for Drug Evaluation and
Research (CDER) and the Center for Biologics Evaluation and
Research (CBER) with the Drug Information Association (DIA)
held a satellite videoconference with several thousand participants at
over 60 downlinks that addressed, among other topics, fast track
products.
It should be noted that FDA is not waiting for issuance of this
guidance in order to implement this section. CBER recently
approved a new biological drug for metastatic breast cancer
in four and a half months. CBER worked closely with the sponsor
to allow information to be submitted for review as soon as it was
available under the rolling review provisions. This type of
rolling submission allowed review of information earlier in the
process. FDA will continue to work with sponsors to implement
the fast track provisions as promising new products are developed
to treat serious or life-threatening conditions and demonstrate
the potential to address unmet medical needs.
B. Section 111: Pediatric Studies of Drugs
Very few prescription medications approved for marketing in this
country are studied, let alone approved for use, in pediatric
populations. Pediatricians too often have little or no specific
information about appropriate uses and doses for children because
most drugs are developed and tested solely in adult populations.
This is particularly troubling given that children often
metabolize drugs differently than adults, and drugs often have
different side effects and/or toxicities in adults than in
children. FDA has tried for several years to address this
problem through regulation and guidance intended to encourage the
testing necessary to add pediatric uses to the label.
Section 111 adds an important incentive to encourage companies to
develop this important information on pediatric uses of
prescription drugs. Under this section, FDA may request
pediatric studies to support pediatric labeling for a drug. This
section permits certain applications an additional six months of
exclusivity if, in accordance with the requirements of the Act,
the sponsor submits requested information relating to the use of
the drug in the pediatric population.
Section 111 required the Secretary, after consultation with
experts in pediatric research, to develop, prioritize, and
publish by May 20, 1998, an initial list of approved drugs for
which additional pediatric information may produce health
benefits in the pediatric population. On March 16, 1998, FDA
published a draft list and draft criteria in the Federal Register
for the purpose of soliciting additional input from interested
parties. FDA compiled this draft list after meetings and/or
consultations with, and based on recommendations from, the
American Academy of Pediatrics, the Pharmaceutical Research and
Manufacturers Association (PhRMA), the National Institutes of
Health, the Pediatric Pharmacology Research Units Network, the
National Pharmaceutical Alliance, the Generic Pharmaceutical
Industry Association, the National Association of Pharmaceutical
Manufacturers, and the United States Pharmacopeia (USP). The
final list was published on May 20, 1998.
On June 29, 1998, FDA issued a guidance document for industry
that describes how studies may qualify for pediatric exclusivity.
FDA already has issued written requests for pediatric studies for
several drugs.
C. Section 122: Radiopharmaceuticals
Section 122 requires FDA to issue new proposed regulations
governing radiopharmaceuticals used for the diagnosis or
monitoring of disease. This section required the Secretary,
after consultation with patient groups, associations, physicians,
and industry, to issue a proposed rule within 180 days, and a
final rule within 18 months after enactment.
On February 27, 1998, FDA held a public meeting for the purpose
of obtaining input on drafting a proposed rule. Approximately 50
individuals from patient groups, academic institutions, health
professionals' organizations, and industry attended the meeting
and/or submitted written comments. On May 22, 1998, FDA
published a proposed rule in the Federal Register with provisions
that address: general factors to be considered in determining
safety and effectiveness, possible indications for use,
evaluation of effectiveness, and evaluation of safety. The final
rule, which is required to be published by May 1999, is expected
to reduce the burden on industry by clarifying the requirements
for development of radiopharmaceuticals.
D. Section 123: Modernization of Regulation
Section 123 requires significant changes in the biological drug
approval process outlined in Section 351 of the Public Health
Service Act. These changes reduce the burden on industry of the
amount of information a company needs to submit for approval of a
new biological drug and combines the product and establishment
license applications. CBER worked closely with industry to
develop a new streamlined license application process, the
Biologics License Application (BLA). This partnership resulted
in a proposed rule published in the Federal Register on July 31,
1998 to implement the BLA. To further communication with
industry, CBER held a public workshop on September 2, 1998 that
was attended by approximately 120 representatives of the
biologics industry.
E. Section 127: Application of Federal Law to Practice of
Pharmacy Compounding
Section 127 creates a special exemption to ensure continued
availability of certain compounded drug products prepared by
pharmacists to provide patients with individualized therapies not
available commercially. This section, however, seeks to prevent
manufacturing under the guise of compounding by establishing
parameters under which the practice is appropriate and lawful.
Section 127 describes the circumstances under which compounded
drugs qualify for exemptions from certain adulteration,
misbranding, and new drug provisions of the FDC Act. This
section is due to take effect November 21, 1998. FDA has made
considerable progress in implementing this complex section of the
Act. Section 127 requires FDA to create an advisory committee on
compounding, to develop and promulgate at least three different
regulations, and to develop a standard memorandum of
understanding for use with the States.
FDA already has created a Pharmacy Compounding Advisory
Committee, which will hold its first meeting (open to the public)
on October 14, 15, and 16, 1998. The Agency also is in the
process of developing the list of bulk drug substances that may
be used in pharmacy compounding. On April 7, 1998, FDA
published a notice in the Federal Register requesting nominations
for this list. FDA received nominations for approximately 30 bulk
drug substances. FDA has been evaluating the nominations and has
consulted with the USP, as required by the section, regarding the
nominated substances. FDA is developing a proposed rule that
will contain the list of bulk drug substances that may be used in
pharmacy compounding and expects to consult with the Advisory
Committee regarding this list.
Another high priority task for the Agency is developing the list
of products that may not be used in pharmacy compounding because
they have been withdrawn or removed from the market on the
grounds that they are not safe or not effective. FDA expects to
publish this list as a proposed rule very soon and take this list
to the Advisory Committee.
F. Section 210: Accreditation of Persons for Review of
Premarket Notification Reports
Section 210 expands an ongoing pilot program under which FDA
accredits outside -- so called "third party" -- experts to
conduct the initial review of Class I and low-to-intermediate
risk Class II devices. This section specifies, however, that an
accredited person may not review devices that are permanently
implantable, life-supporting, life-sustaining, or for which
clinical data are required.
The FDA must accredit persons to conduct initial 510(k) reviews
no later than one year after enactment. Following review by an
accredited party, FDA must act within 30 days of receipt of the
accredited party's recommendation to make a determination with
respect to the initial classification of the device.
On May 20, 1998, FDA issued a list of 147 types of low-to-
intermediate risk devices eligible for third party review. This
represents a very significant expansion of the list of devices
which were eligible under FDA's pre-FDAMA pilot program. The
Agency plans to review the list of eligible devices on a regular
basis.
On May 22, 1998, FDA published a notice in the Federal Register
establishing criteria to accept or deny accreditation to
applicants who submit requests to become accredited persons to
perform 510(k) reviews. FDA must respond to a request for
accreditation within 60 days of receipt. A draft guidance for
staff, industry, and third parties also was published on May 22
containing additional information regarding applications for
accreditation of third party reviewers, as well as additional
information about the Agency's plans for implementation of the
third party review program.
On July 20, 1998, FDA began accepting applications from
prospective accredited persons. Currently, six applications have
been approved and two have been denied. Additional applications
are under review. A list of the approved accredited persons was
issued on October 2, 1998. This list will be updated as new
third parties are accredited. FDA is currently planning to
provide periodic training sessions for accredited persons, with
the first session scheduled for October 14-16, 1998. The Agency
will accept 510(k) reviews and recommendations from accredited
persons beginning November 21, 1998.
G. Section 204, 206, and 212: Risk-Based Regulation of
Medical Devices
FDAMA complements and builds on FDA's recent measures to
focus its resources on medical devices that present the greatest risk
to patients. For example, Section 204 permits FDA to recognize
consensus standards and to accept a declaration of conformity to
those standards as a way to meet some or all of the data
requirements in premarket submissions. FDA has recognized 174
standards to date, with many more presently under review. FDA
expects that reliance on consensus standards will expedite the
clearance of premarket notifications and permit FDA to focus on
more complicated, higher risk devices.
On February 19, 1998, FDA published a guidance for industry and
reviewers on the recognition and use of national and
international consensus standards. On February 25, 1998, a
notice was published in the Federal Register announcing the
availability of this guidance, publishing the initial list of
recognized standards, and announcing the Agency's policy on
updating the list.
Similarly, Section 206 exempts from premarket notification
Class I devices that are not intended for a use that is of
substantial importance in preventing impairment of human health,
or that do not present a potential unreasonable risk of illness
or injury. On February 2, 1998, FDA published a notice in the
Federal Register announcing a list of Class I devices that it
considered to be exempt from premarket notification effective
February 19, 1998.
Premarket notification also will not be required for specified
Class II devices. On January 21, 1998, FDA published a notice in
the Federal Register announcing a list of Class II devices the
Agency identified as now exempt from premarket notification. On
February 19, 1998, FDA issued a guidance to establish procedures
for additional Class II devices to be exempted on FDA's own
initiative or by petition of an interested person.
Finally, Section 212 directs FDA to focus its postmarket
surveillance efforts on higher risk devices. On February 19,
1998, FDA issued guidances on procedures to determine application
of postmarket surveillance strategies and on procedures for
review of postmarket surveillance submissions.
H. Section 303 and 304: Health Claims for Food Products and
Nutrient Content Claims
Sections 303 and 304 expand procedures under which health claims
and nutrient content claims are authorized by statute. These
sections permit use of these claims based on current, published,
authoritative statements from a scientific body of the U.S.
Government with official responsibility for public health
protection or research directly relating to human nutrition (such
as the National Institutes of Health or the Centers for Disease
Control and Prevention), or the National Academy of Sciences.
FDA has 120 days to review notifications of these claims and can,
for example, prevent a claim from being used in the marketplace
by issuing a regulation. FDA may prevent a claim from going
forward, if the conditions established under these sections are
not met. On June 11, 1998, FDA issued a guidance for the initial
phase of implementing these sections. In February 1998, FDA
received one notification for nine health claims under this new
authority and responded to this notification within the 120-day
period.
I. Section 401: Dissemination of Information on New Uses
Section 401 amends the FDC Act to permit drug, biologic, and
device manufacturers to disseminate certain written information
on a use of a product that is not described in the product's
approved labeling to health care practitioners, pharmacy benefit
managers, health insurance issuers, group health plans, and
Federal and State government agencies. The Act authorizes such
dissemination, provided the company makes a commitment to file,
within a specified timeframe, a supplemental application based on
appropriate research to establish the safety and effectiveness of
the unapproved use. It also provides for limited exemptions from
the requirement to submit a supplemental application. This
section, due to take effect on November 21, 1998, abolishes the
long-standing prohibition on dissemination by manufacturers of
information about unapproved uses of drugs, biologics, and
medical devices.
On June 8, 1998, FDA published a proposed rule in the
Federal Register that specifies the type of "off-label" or
unapproved use information that can be disseminated, and under
what conditions. On July 8, 1998, FDA's Office of Consumer
Affairs held an open public meeting on Section 401 for consumer
and patient groups, health care professionals, and industry. 129
participants attended. The comment period on the proposal ended
on July 23, 1998. FDA currently is evaluating the many comments
received and plans to issue a final rule prior to the
November 21, 1998 implementation date.
IV. INTERNAL FDAMA TRAINING ACTIVITIES
FDA's Centers have conducted extensive internal training and
orientation for their employees on FDAMA implementation. These
include a wide variety of training, such as meetings,
videoconferences, and brown bag lunches. Highlights include the
Center for Devices and Radiological Health (CDRH) FDAMA
Priority Provisions meetings on January 14, 1998 and February 4,
1998 where approximately 543 employees attended. CDRH also
conducted five meetings during March and April, 1998, on FDAMA
510(k) changes with 323 employees in attendance.
CDER held a series of training sessions on FDAMA in each CDER
building that reached over 700 employees. Other briefings have
been held on specific topics, e.g., each division was briefed on
pediatric issues in a total of 18 meetings. CDER also gave a
presentation to a group of over 200 employees entitled, "The
Future of Drug Regulation," including FDAMA. CDER has
scheduled three additional CDER-wide sessions on FDAMA topics
in the Fall 1998 Scientific Rounds series.
CBER held an overall FDAMA implementation briefing on
January 9, 1998 with approximately 500 employees in attendance
and approximately 20 sessions of meetings/briefings for internal
reviewers. In addition, CBER employees also attended many CDER
and CDRH FDAMA training sessions to ensure consistent
implementation of FDAMA initiatives.
Finally, most of FDA's Centers have created extensive FDAMA
sites on the Agency's webpage listing their rules, guidance, and other
activities in progress. A copy of FDA's FDAMA implementation
chart is available on the webpage and is updated regularly. FDA
also created a series of public dockets on the webpage pertaining
to specific sections of FDAMA through which interested persons
could have access to recommendations and other information
submitted to FDA on these sections. These dockets were in
addition to those already established in connection with
implementation of other FDAMA provisions.
The Office of Regulatory Affairs (ORA) prepared a
section-by-section analysis of FDAMA to identify those provisions
relevant to ORA programs and activities. This analysis was
provided to ORA managers at Headquarters and FDA District
Offices to ensure that all ORA personnel, including field
investigators, were made aware of the statutory requirements under
FDAMA. Formal presentations also were made at two senior-level
management conferences that provided a FDAMA overview and a
focused discussion of those provisions most relevant to the Agency's
inspectional and enforcement obligations. The presentation
materials were then shared with District Offices to be used for
further FDAMA informational briefings to district personnel.
V. OVERALL CONSULTATION WITH EXTERNAL GROUPS
A. General Meetings
FDA has held numerous meetings with external stakeholders, in
addition to the ones already highlighted above, relating to
implementation of FDAMA. These meetings, examples of which
are described below, addressed many different aspects of the
Agency's implementation of FDAMA.
- On December 3, 1997 (Part I), and February 25, 1998
(Part II), CDRH and the Food and Drug Law Institute
held nationwide videoconferences on medical device
aspects of FDAMA.
- On January 6, 1998, FDA met with the Patient Coalition,
including representatives from Project Inform, National
Women's Health Network, Center for Science in the
Public Interest, Pediatric AIDS Foundation, AIDS Action
Council, Public Citizen, National Organization for Rare
Disorders, National Breast Cancer Coalition, Consumer
Federation of America, Alzheimers' Association,
American Foundation for AIDS Research, and Institute
for Women's Policy Research on FDAMA provisions of
interest to them.
- On March 12, 1998, FDA met with pharmaceutical
companies, including representatives from BIO, PhRMA,
Lilly, Zeneca, Proctor & Gamble, Schering-Plough,
Pharmacia and Upjohn, Serono, and MedImmune.
- The CDER/CBER and DIA satellite videoconference on
September 16, 1998 mentioned earlier also addressed
FDAMA sections on pediatric labeling, information on
clinical trials for serious diseases, manufacturing
changes, pharmacy compounding, and communicating with
stakeholders, in addition to fast track products.
- On September 16, 1998, CVM held a briefing for the
Animal Health Institute on the progress FDA has made in
implementing FDAMA sections that affect CVM.
Approximately 30 individuals attended the meeting
representing various manufacturers of animal health
products.
- On March 20, 1998, the Office of Consumer Affairs held
a National Consumer Forum on FDAMA with an attendance
of 75 participants. The Office of Consumer Affairs
also conducted a meeting with the National Consumer
League on March 13, 1998, and the Consumer Federation
of America on May 27, 1998.
B. Section 406(b) Stakeholder Meetings
Section 406(b) of FDAMA requires FDA to consult with our
stakeholders prior to submitting a statutory compliance plan to
Congress on November 21, 1998. FDA held eight meetings to hear
the views of our stakeholders. Six of the eight meetings were
Center specific. The remaining meetings were a health
professionals meeting and a general FDA issues meeting. FDA also
made a concerted effort to have FDA speakers at other meetings
talk about the 406(b) process and invite input from patient and
consumer groups, health care professionals, and industry
representatives attending those meetings.
The two Federal Register notices announcing the stakeholder
meetings requested that oral or written public comments focus on
how the Agency can best meet the six objectives outlined for the
compliance plan in Section 406(b) by addressing seven questions
related to each objective. An information packet, made available
on the FDA webpage, also was referenced as a good source of
background information for any individuals or groups who wished
to make a presentation at a meeting or submit written comments.
The general meeting held on September 14, 1998, focused on FDA
issues, themes, and priorities that developed out of the previous
stakeholder meetings. Of particular interest to the Agency were
the stakeholder views on FDA's consumer protection obligations
and the approaches that should be used to fulfill them.
During the entire stakeholder process FDA heard from more than 75
different speakers at meetings attended by more than 600 people.
Although views presented were diverse, some very distinct themes
emerged from the meetings. I would summarize them as follows:
- Stakeholders want FDA processes to be equitable, open and
transparent.
- Stakeholders want reliable, unbiased, useful information on
the products FDA regulates.
- Stakeholders want improved communication with FDA.
- Stakeholders believe that FDA should collaborate with other
Federal and State agencies, academia, and international
organizations to achieve synergy in protecting the public health.
- Stakeholders generally commended FDA for its reengineering
of its processes to make them even more efficient and effective
and believe these activities should be continued as well as efforts to
reduce the stakeholders' burdens of complying with regulatory
procedures.
- Many stakeholders believe that certain FDA responsibilities
are traditional government functions and should be adequately
funded through government appropriations.
- Despite the recognition of the success of the PDUFA program
in improving review times, many stakeholders (both consumers
and industry) spoke in opposition to user fees, especially if they
are used to reduce current budget authority.
FDA believes this consultation process with our stakeholders is
extremely important to guide the Agency in developing a realistic
plan for meeting our public health obligations. As mentioned
above, we are concerned about the growing gap between our
statutory obligations and the limited resources available to meet
those obligations.
FDA presently is compiling information and drafting documents to
meet the statutory time frame of publishing a plan by
November 21, 1998. The plan will address each of the six
objectives referenced in Section 406(b) and will highlight the
feedback received from stakeholders as well as FDA's plans and
needs to meet its statutory obligations.
VI. CONCLUSION
Thank you for the opportunity to testify on our progress on FDAMA
implementation today. As evidenced by my testimony, I believe
FDA has accumulated an impressive record on implementing the
new Act, especially considering the number of tasks required in a
year's timeframe. The Agency will continue to work with
Congress, other agencies, patient and consumer groups, health
care professionals, and industry to complete the remainder of the
tasks and fully implement the statute. We believe that these
collaborative efforts will result in continued high standards for
FDA's products and consumer protection. Let me assure you again
that FDA is committed to the successful implementation of FDAMA
by the statutory deadlines.
