[U.S. FOOD AND DRUG ADMINISTRATION]

OCTOBER 7, 1998

STATEMENT BY

MICHAEL A. FRIEDMAN, M.D.

ACTING COMMISSIONER

FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES


BEFORE THE

COMMITTEE ON COMMERCE


U.S. HOUSE OF REPRESENTATIVES

OCTOBER 7, 1998



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:

    1) Stakeholders want FDA processes to be equitable, open and transparent.

    2) Stakeholders want reliable, unbiased, useful information on the products FDA regulates.

    3) Stakeholders want improved communication with FDA.

    4) Stakeholders believe that FDA should collaborate with other Federal and State agencies, academia, and international organizations to achieve synergy in protecting the public health.

    5) 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.

    6) Many stakeholders believe that certain FDA responsibilities are traditional government functions and should be adequately funded through government appropriations.

    7) 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.

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