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FDA's Progress/Success in Implementing the Food and Drug Administration Modernization Act of 1997 (FDAMA or Modernization Act)


Statement of

Linda A. Suydam, D.P.A.
Food and Drug Administration

before

the House Committee on Energy and Commerce

May 3, 2001

INTRODUCTION

Mr. Chairman, Members of the Committee, I am Linda Suydam, Senior Associate Commissioner at the Food and Drug Administration (FDA or the Agency). I am very pleased to be here today to discuss the Agency's progress and success in implementing the Food and Drug Administration Modernization Act of 1997 (FDAMA or Modernization Act). FDA has made a strong commitment and given high priority to implementing the Modernization Act in a manner consistent with the letter and spirit of the law.

FDAMA is an important addition to FDA's legislative framework. As you know, it was passed after a thorough congressional examination of the Agency's policies and programs; it addressed virtually all of them comprehensively; and it settled a debate about FDA's role by reaffirming the Agency's vital importance for public health protection. This is a law we can all be proud of.

FDA thanks the Committee for the diligent, comprehensive work it performed in drafting FDAMA, and, in particular, for adhering to the principle that underscores the benefits of this legislation; that FDAMA made improvements without changing the high public health standards FDA is charged with upholding. Only by maintaining these high standards and ensuring regulatory decision-making based on sound science can future legislation, such as the reauthorization of the Prescription Drug User Fee Act and the pediatric exclusivity provision, serve to effectively promote and protect the public health consistent with FDA's historic mission.

FDAMA added new mission objectives that call on the Agency to carry out all of its operations-domestic and foreign-in cooperation with its stakeholders. This emphasis on FDA's need to extend its regulatory cooperation is so essential for our operations that these objectives are included among the five fundamental principles that offer the best strategy for meeting FDA's formidable challenges in the future. These principles are:

  • Base all FDA operations and programs on strong science, as the principal guarantee of the high quality of FDA's public health protection.
  • Make regulatory decisions in the context of each product's total life cycle, to ensure its safety and effectiveness when it is in wide use.
  • Consider our decisions also from a global perspective, to take into account the numerous international developments and factors that affect public health in the United States (U.S.).
  • Use leveraging as the primary means for maximizing the effects of FDA's actions.
  • Maintain FDA's traditionally high public health standards, because they always will be critical for ensuring effective health care delivery, consumer confidence, and a level playing field for the competitiveness of U.S. industry.

Over the past three and one-half years, FDA has worked diligently to implement this new law, which, as we stated, touches nearly every aspect of the Agency's mission.

We have met nearly every statutory deadline, issued dozens of regulations, guidance documents, Federal Register notices, and reports to carry out the goals of this wide-reaching law (see Attachment).

I would like to begin with two key provisions of FDAMA - reauthorization of the Prescription Drug User Fee Act and the pediatric exclusivity provision. The pediatric exclusivity provision will expire on January 1, 2002, and the fee authority of the Prescription Drug User Fee Act will expire on September 30, 2002. Maintaining these authorities is important to the Agency, and we look forward to working with the Committee during the reauthorization process.

PRESCRIPTION DRUG USER FEE ACT

The most concrete expression of the leveraging principle in FDAMA was the reauthorization for five more years of the Prescription Drug User Fee Act of 1992 (PDUFA). As you know, PDUFA authorizes FDA to receive manufacturers' user fees in return for achieving performance goals agreed to by Congress, the pharmaceutical industry and our Agency. The result is expedited access to a greater number of important new therapies. PDUFA is nearing the end of its second five-year term and, therefore, I will examine in greater depth our experience with PDUFA I and II.

During the eight-and-a-half years of PDUFA, the Agency's performance has met the highest expectations. While adhering to rigorous standards for safety and effectiveness, FDA has met virtually all of the program's review goals. PDUFA I was directed at reducing drug review times. During PDUFA I, FDA exceeded all of its performance goals and significantly reduced review times. PDUFA II included some performance goals to further reduce review times, but most of the performance goals were directed towards reducing clinical drug development time. These goals included accelerated consultations on critical drug development issues, timely resolution of major disputes, and rapid handling of other clinical drug development issues such as clinical holds.

Under PDUFA II, FDA has exceeded almost all of its performance goals resulting in a continued reduction in review times. In addition, drug development times also have decreased significantly. According to the Tufts Center for the Study of Drug Development, the clinical development time for new molecular entities declined by 22 percent from the early to the late 1990s.

Not only has FDA significantly reduced review times as a result of the PDUFA programs, but it has also significantly reduced approval times, and, therefore, the time it takes to get new drugs to market. Total approval time is the time from the initial submission of a marketing application to the issuance of an approval letter for that application. It includes both FDA's review time and the time the sponsor spends answering deficiencies noted by FDA and can encompass several review "cycles."

The median total approval time for new drug and biologic applications submitted in Fiscal Year (FY) 1999 dropped to 11.6 months from 20.1 months in FY 1994. Given the progression of PDUFA II review goals, median total approval times could drop to 10 months in FY 2001 or FY 2002 if the current rate of first review cycle approvals is sustained.

Median total approval time for priority applications submitted in FY 1999 was six months, less than half the median total approval time for priority applications submitted in the early PDUFA years. Priority applications, a subset of all applications, have a PDUFA review performance goal of six months.

Drugs are now reviewed in the U.S. as fast or faster than anywhere in the world, without compromising the very stringent standards that Americans have come to expect. This is remarkable, particularly in light of the fact that over the past seven years, pharmaceutical firms have introduced 234 new molecular entities into the market-a sizable increase over prior decades. Although European pharmaceutical companies dominated the industry ten years ago, U.S. companies now have an overwhelming lead in world markets.

Let me take a moment to mention the products themselves. Drug and biologic approvals in 2000 included a large number of products that represent significant advances over the products that were previously available. Important new therapies brought to market in the past year include: three new drugs to treat cancer; the first protease inhibitor approved to treat HIV infection in children as young as six months; four drugs to treat heart disease and circulatory disorders of the nervous system; a malaria treatment effective in areas where the disease is resistant to other anti-malarial drugs; the first anti-inflammatory corticosteroid that can be used in a nebulizer by very young children; the first in a new class of antibiotics; a treatment of cancer-in-situ in the absence of associated invasive cancer of the bladder; the first multivalent conjugate pneumococcal vaccine for infants and toddlers under the age of two; the first drug to reduce the severity of neck and shoulder muscle contractions and the resulting abnormal head position and neck pain associated with cervical dystonia; the first thyroid replacement drug to undergo a stringent FDA review; three new drugs and five new uses of existing drugs for "orphan" patient populations of 200,000 or fewer; and 13 new pediatric uses for already approved adult drugs.

In the biotech area, 2000 saw the approval of products that delay the time to disease progression in malignant osteopetrosis; reduce the signs and symptoms of rheumatoid arthritis in patients with inadequate response to methotrexate; and delay structural damage in patients with moderately to severely active rheumatoid arthritis. These are only a few exciting examples of products that are being made available to the patients who need them.

For the industry, PDUFA provides huge benefits:

  • Drug companies' products are able to take fuller advantage of granted patent terms, which yields additional revenues, because they come on the market more quickly due to shorter development and review times.
  • The development of guidance documents, earlier meetings and increased FDA reviewing staff have made the processing of submissions more understandable and predictable, and therefore provide a more consistent and dependable basis for companies to develop plans for production and other activities.
  • In addition, FDA's guidance and consultation received by drug sponsors under PDUFA help them improve the quality of their product applications, which reduces the cost of drug development.

One measure of these advantages to the industry is that between 1996 and 1998, nearly 80 percent of new drugs world-wide were first launched in the U.S. due to the favorable regulatory climate.

For FDA, PDUFA has also brought significant benefits:

  • The performance goals have helped streamline the management of drug and biological product reviews.
  • The program's requirement for comprehensive product reviews and responses has resulted in improved quality of the application process.
  • Most important of all, the fees have enabled the Agency to hire additional medical and other specialists, and to upgrade the technology that is essential for the success of the program.

PDUFA has provided the Agency with some challenges. Between 1994 and last year, the number of review goals to be met by FDA has tripled. The number of PDUFA submissions has grown by 64 percent, from not quite 1,500 in FY 1993 to almost 2,500 in FY 2000. In addition, there are other industry meeting and procedure goals in PDUFA that add up to more than 3,500 FDA actions a year, most of which occur before an application submission (and fee collection). These actions are connected with the preparation, scheduling, conduct, follow-up and tracking of formal meetings requested by industry that may involve as many as 10-20 FDA staff and 15-30 industry representatives. Another notable trend has been the upsurge in drug advertising directed to consumers (DTC) and physicians.

PEDIATRIC EXCLUSIVITY

FDAMA's pediatric exclusivity provision in section 111 (section 505A of the Federal Food, Drug, and Cosmetic Act), like PDUFA, is also scheduled to sunset in 2002. FDAMA's pediatric exclusivity provision is helping to ensure access to, and safe use of therapies for children whose treatment has historically been hampered by inadequate information about the safe and effective use of drugs in the pediatric population. Providing adequate pediatric use information for drugs and biologics has long been a high priority for the Agency. We are pleased to report that the industry's response to the incentives offered by this provision has been enthusiastic. As you know, in June 1998, we issued written guidance to communicate to industry our plans for implementation of the pediatric program, and updated this document in October 1999, to provide additional information to industry.

The results speak for themselves. Between June 1998, when the guidance document was published, and April 1, 2001, FDA has received over 218 proposed pediatric study requests. Through our ongoing work using mechanisms such as our Pediatric Advisory Subcommittee, we will continue to move toward our goal of having adequate pediatric use labeling information for all drugs used in children.

The purpose of encouraging pediatric studies is to provide needed pediatric efficacy, safety and dosing information to physicians in product labeling. Of the 28 drugs granted pediatric exclusivity, 18 drugs have newly approved labeling for pediatric use. Labeling changes are expected approximately 6-12 months after the studies have been submitted. Of the 18 drugs whose labels have already been changed, four were new molecular entities for which pediatric labeling was available at the time of initial approval. The 14 remaining marketed products now have complete labeling in the relevant pediatric population.

Studies of six of these products resulted in identification of significant changes in dosing or adverse events either specific to or newly defined in the pediatric population.

Two examples of these clinical findings are:

  • Midazolam (Versed) - higher risk of serious life threatening situations in children with congenital heart disease and pulmonary hypertension who need lower doses than predicted to prevent respiratory compromise;
  • Gabapentin (Neurontin) - need to use higher doses in children less than five years of age in order to control seizures and new adverse events such as hostility and aggression identified in children less than 12 years old.

As required by the pediatric exclusivity provision, the Department issued a report to Congress in January 2001, on the experiences under the new law. The Report stated that the pediatric exclusivity provision has done more to generate clinical studies and useful prescribing information for the pediatric population than any other regulatory or legislative process to date. Experience with the provision has also revealed several categories of products and age groups for which this approach has not worked. For example, the exclusivity provision does not address the drugs that have no patent protection and sponsors have no economic incentive to study these products.

FDA looks forward to working with the Committee to reauthorize PDUFA and the pediatric exclusivity provision. FDA believes that when drafting new authorizing language, the following principles should be taken into account:

  • FDA's high public health standards must be maintained and enhanced.
  • The integrity of FDA's decision-making must be preserved.
  • FDA must possess an adequate science base for the programs it implements.

IMPLEMENTATION OF OTHER FDAMA PROVISIONS

With the tools provided by FDAMA, FDA is becoming a stronger, better Agency, one whose actions remain firmly based in science to promote and protect the public health.

The value of a strong, science-based FDA cannot be overstated - it reaps public health benefits for both individual citizens and the nation as a whole. An FDA that sets and meets high scientific standards provides a high level of assurance to our citizens; (1) assurance that product risks are minimized; (2) assurance that consumers receive reliable information to assess and manage the remaining risks in concert with a health professional, or on their own; and (3) assurance that reviews for new products are conducted in a predictable and timely manner, giving patients early access to new safe and effective products.

FDA's procedures should provide consumers with confidence in the decisions it makes about the products that they take and give to their families, and provide industry with the confidence that the Agency's decisions are fair and based in science.

From an economic standpoint, a strong, high-performance FDA stimulates innovation, enhances U.S. competitiveness in global markets, provides a level playing field for industry, and strengthens the domestic economy as a whole by inviting increased foreign investment and contributing to reduced health care costs.

I would like to focus today on how FDA's implementation of the Modernization Act is helping to enhance the public health by producing the following outcomes: (1)increase access to new medical products; (2) provide more effective management of FDA's limited resources; (3) make our regulatory processes more effective and efficient; and (4) increase consumer and industry confidence through collaboration.

ACCESS TO MEDICAL PRODUCTS

There are a number of FDAMA provisions, in addition to PDUFA and pediatric exclusivity, that help ensure greater patient access to medical products.

Fast Track

The first of these is the fast track provision in section 112. In the fast track provision, Congress codified FDA's accelerated approval regulations and thus codified our approach to expedited drug development. Fast track is meant to facilitate the development, and expedite the review, of drugs that are intended to treat a serious or life-threatening condition and that demonstrate the potential to address a serious unmet medical need.

Since the passage of the Modernization Act, we have granted fast track designation to a wide range of therapies - not just for AIDS and cancer drugs, as some believe, but for drugs to treat atherosclerotic vascular disease, acute stroke, diabetes, adult respiratory distress syndrome and pancreatitis, and genetic abnormalities of infants. As of March 2001, FDA's Center for Drug Evaluation and Research (CDER) had received 108 requests for fast track designation - 69 were granted, 25 denied, and 14 are still pending. As of March 31, 2001, FDA's Center for Biologics Evaluation and Research (CBER) had received 62 requests for fast track designation-38 were granted, 23 denied, and one is still pending.

Since we began implementing this provision, CDER and CBER have approved nine novel products, including Herceptin, a monoclonal antibody for metastatic breast cancer (in 4.7 months), Enbrel for rheumatoid arthritis (in 5.8 months), Ziagen for HIV (in 5 months), and Pneumococcal Conjugate Vaccine for the prevention of streptococcus pneumoniae in infants and children (in 7.5 months). In addition, three marketed products were approved for new indications under the fast track program: Remicade for rheumatoid arthritis, Gamma interferon for osteopetrosis, and Taxotere for non-small cell lung cancer. As implemented by FDA, this program is plainly helping to ensure that important therapies for serious and life-threatening illnesses are being brought as quickly as possible to the patients who need them.

To provide clear information to industry regarding participation in the fast track process, last fall we issued a guidance document that defines the criteria for qualification for the fast track drug product development program, sets out the process for designation as a fast track drug product, and describes programs for expediting development and review of fast track products. The Agency has received feedback that commends this document as an excellent resource for sponsors who are interested in receiving fast track designation for their products.

Supplemental Applications

Just as it is important to get the most complete information about all patient populations on a drug's label, it is also important to get all of the information about a drug's uses on the label. This is why Congress directed FDA to take steps to encourage the submission of supplemental applications for new uses for approved medical products, and steps to ensure that such applications are acted upon expeditiously. Since enactment, the Agency has made programmatic changes in CDER, CBER, the Center for Devices and Radiological Health (CDRH), and the Center for Veterinary Medicine (CVM) to encourage supplemental applications for new uses, and ensure that the Agency acts on the applications that it receives in a timely manner. The Agency has also issued guidance that clarifies what is needed to demonstrate effectiveness for a new use.

Expanded Access to Investigational Therapies

Congress and FDA realized that there are times when a patient's interest is best served by getting an investigational medical product as quickly as feasible, sometimes before a complete evaluation and review can be finished. The expanded access provision (section 402) of the Modernization Act was included in the legislation to facilitate access by patients with serious or life-threatening illnesses to promising, yet unapproved new products. By codifying and expanding this program, the statute ensures that this program will continue to provide expanded access to patients in the future.

Humanitarian Use

Congress also recognized that there are limited circumstances when there are too few subjects to justify a full-scale evaluation of a medical device. The humanitarian use device provision (section 203) provides an easier path to market for devices used to treat rare conditions or diseases. Under this provision, a manufacturer is not required to meet the effectiveness requirements in the statute, but rather must show that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk from its use. Since implementation of the Modernization Act, CDRH has approved 21 humanitarian use devices, including: a fetal bladder stent, to treat urinary tract obstruction in unborn babies; an electrical bladder stimulator for urinary incontinence for use in children for the treatment of neurogenic bladder disease secondary to spina bifida; a pulmonary valve for children under age four with absent or diseased valves; and an extracorporeal immunoabsorption system for treatment of patients with hemophilia A and B who have inhibitors to Factor VIII and IX coagulation factors.

Postmarketing Studies

On April 30, 2001, FDA's regulations implementing section 130 of FDAMA which requires sponsors of approved drugs and biologics to report annually on the status of postmarketing commitments became effective. These regulations modified existing reporting requirements for new drug application (NDA) drug studies and created a new reporting requirement for biologic products.

FDA may request postmarketing studies to provide additional important information on how a drug works in expanded patient populations or to identify safety issues that occur at very low frequency or in special patient populations. In the case of drugs and biologics approved under accelerated approval regulations, postmarketing studies are performed to confirm a drug or biologic's long-term clinical benefit when approval was granted based on studies using surrogate endpoints.

These new regulations were of special interest to patient and consumer advocates who were concerned about timeliness of applicants in completing postmarketing commitments and of FDA in reviewing study results and modifying drug labeling. The regulations will provide FDA with a mechanism to monitor study progress through the annual submission of study status reports. FDA will post the status of postmarketing studies on its public website and publish in the Federal Register an annual summary of industry progress in fulfilling postmarketing commitments. FDA has committed to timely review and evaluation of completed studies and to requiring timely modification of drug and biologic labeling where appropriate.

EFFECTIVE MANAGEMENT OF FDA RESOURCES

Part of meeting the Agency's mission to protect and promote the public health involves effective management of FDA's resources. There are several FDAMA provisions that reduce the Agency's workload in some areas so that those resources can be provided to areas with the greatest public health risk.

Third Party Review

One such provision is the device third party review program (section 210), which provides an alternative review mechanism for low-to-moderate risk devices, thereby allowing FDA to target its scientific review resources on higher-risk devices. There are currently more than 670 types of devices eligible for review by third parties, and 12 accredited third party organizations. CDRH recently expanded the program to include all devices eligible for review by third parties under the statute and has been working with industry representatives to encourage greater use of this new approach.

User Reporting

Another provision that allows the Agency to focus its resources is section 213, device user reporting. Prior to passage of FDAMA, all device user facilities were required to report serious adverse events to FDA. Under FDAMA, FDA now has authority to establish a sentinel system for user reporting, which would have a representative sample of hospitals and other user facilities reporting serious adverse events to FDA. The Agency has already conducted a pilot sentinel system, which was very successful. FDA is working to put an expanded sentinel system in place. This initiative could ultimately ease the reporting requirements for user facilities and enhance the value of reports the Agency receives.

MORE EFFICIENT AND EFFECTIVE REGULATORY PROCESSES

FDAMA includes a number of provisions that streamline and expedite FDA's product review processes by ensuring that sponsors know what is required, and by eliminating unnecessary requirements. Clearly, PDUFA helps the Agency make decisions in a more timely manner. At the same time, PDUFA and other aspects of the statute ensure that FDA's decisions are consistent and predictable. FDA's regulatory requirements are clarified, providing industry with information on how to most effectively comply with the applicable laws.

Meetings with Sponsors

Both as part of the PDUFA agreement formalized as part of the PDUFA performance goals and as part of a separate FDAMA requirement (section 119), the Agency is committed to meeting with drug sponsors to discuss and reach agreement on the design and size of clinical trials. Any agreements reached can only be changed under limited circumstances. Similarly, the device provisions provide for early meetings with potential sponsors to focus on the type of valid scientific evidence needed for device approval and to reach agreement on a study plan. These provisions are ensuring that industry knows up front what is required and does not waste time conducting unnecessary studies.

In addition, many provisions of the Modernization Act are premised on the principle that regulatory requirements should not exceed what is required to promote and protect the public health.

Premarket Notification

An example of matching regulatory requirements to meet public health risk is the premarket notification provision in section 206. More than 75 Class II types of medical devices have been exempted from premarket notification requirements, enabling manufacturers to get their products to market and the patients who need them more rapidly. The types of devices exempted include: clinical laboratory equipment and test kits, kidney stone dislodgers, clinical thermometers, biofeedback devices and physical rehabilitation devices. In addition, pursuant to this section, all but a limited number of reserved Class I devices are also exempt from 510(k) premarket notification.

Manufacturing Changes

FDAMA also streamlines the process for drug and device sponsors to make changes to certain manufacturing processes. For example, the provision on scope of review in section 205 permits device manufacturers to notify FDA 30 days before instituting certain types of manufacturing changes instead of submitting a premarket approval (PMA) supplement. This means that the device manufacturer can often start marketing a device made under this new process at least five months sooner than usually would have occurred before FDAMA. The device industry has already used this provision 215 times. The drug provision permits drug manufacturers to make minor and moderate manufacturing changes without prior approval of a supplemental application. The biologics industry has submitted 2623 notifications of changes requiring a supplement submission 30 days prior to distribution of the product made using the change. In addition, industry has submitted 482 notifications of changes requiring a submission that may be implemented as soon as the submission is made.

Least Burdensome Means

Section 205 of FDAMA is similarly premised on the principle that regulatory requirements should not exceed what is required to promote and protect the public health. This provision requires FDA, in consultation with the applicant, to consider the "least burdensome" appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval. The requirement to consider the least burdensome means applies to both existing statutory paths to market: premarket notifications (510(k)s) and premarket approval applications (PMAs and Product Development Protocols). While FDAMA does not change the standards for premarket review, it clarifies that the Agency's review is to support the substantial equivalence or safety and effectiveness of medical devices.

To foster a collaborative approach to the implementation of section 205 of FDAMA, CDRH hosted a meeting with stakeholders on January 4, 1999, to solicit comments and suggestions regarding the least burdensome approach to medical device development and evaluation. CDRH heard formal presentations at that meeting and also received written comments. As a result of communication with our stakeholders, FDA determined that the issue of highest concern is when clinical data would be required for devices.

In January of 2000, CDRH formed a Least Burdensome Steering Committee consisting of senior managers within the Center. In addition, representatives of FDA participated in a Least Burdensome Industry Task Force aimed at addressing the least burdensome provisions. The Agency has been reporting the results of this collaborative effort on FDA's website so that interested parties can contribute their ideas and track FDA's progress in this area. While the main focus of the group has been in developing and articulating the concept and principles that underlie the least burdensome requirement, several guidances have been developed to help reduce unnecessary burdens in bringing new devices to market. All of these guidances are on our least burdensome website. Most recently, the Center completed a draft guidance entitled, "The Least Burdensome Provisions of FDA Modernization Act of 1997: Concept and Principles." This document, which contains the Agency's interpretation of the least burdensome provisions, will be posted shortly on FDA's website.

While developing the guidance, FDA has been working to implement these provisions. Training sessions for CDRH staff and advisory committee members have been conducted and will be expanded once the new guidance is final. Even without a final guidance, however, FDA has many examples of successful use of the least burdensome approach. For example, FDA reviewers approved a pediatric indication for a marketed cardiac ablation catheter without requiring a prospective clinical study because reviewers determined that existing literature supported the device's safety and effectiveness in children. Patient registries and literature were also used to support the approval of a bone cement for fixation of a hip prosthesis.

Abbreviated Study Reports

Another example of process improvements is the provision on data requirements in section 118, which directs FDA to issue guidance on when abbreviated study reports may be submitted in NDAs and biologics license applications (BLAs), in lieu of full reports. On September 13, 1999, FDA published a final guidance that describes when abbreviated reports and synopses can be used to submit effectiveness data. This guidance not only provides clarity, it should also ensure that industry is not submitting more information than is required by the Agency.

Device Standards

Congress and FDA also recognized that industry's ability to rely on standards will help to streamline the approval or clearance of medical devices. Under the provision on device standards in section 204, CDRH recognized more than 567 consensus standards that manufacturers may use to satisfy portions of device review requirements, thus simplifying and expediting product review. Of these 567 recognized standards, over 100 were proposed by industry for recognition as a result of active solicitation by CDRH. A few examples of consensus standards nominated by industry and recognized by CDRH include: standards that can be used to describe and select the necessary biocompatibility testing; most American Dental Association specifications for dental materials and devices; and certain standards for safety requirements for electromedical equipment, covering over 30 individual standards on mechanical limits electrical safety considerations for electrically powered devices.

At the same time, CDRH is trying to broaden the impact of the standards recognition program mandated by FDAMA. CDRH is enlisting its stakeholders in setting priorities for developing standards that can be recognized in the future and encouraging manufacturers to incorporate recognized standards as part of their product specifications, which allows extremely brief product descriptions, and thus, less lengthy 510(k)s.

Single Biologics License

In addition, FDAMA has helped to streamline the processes for submissions from industry by codifying the modernization of certain biologics regulations. In October 1999, FDA issued a final rule to implement the modernization of regulations provision in section 123, which requires manufacturers to make a single submission for a biologics license, instead of separate applications for the establishment license and the product license. When FDA first proposed to streamline the biologics application process for specified products, industry representatives indicated that the change would result in considerable savings of time and money. Since the implementation of the single application/single license approach, industry representatives have confirmed this to be the case.

Dispute Resolution

While many of the provisions in the Modernization Act are designed to facilitate agreement between FDA and industry on regulatory requirements, inevitably, there will be disputes that remain. Section 404, the provision on dispute resolution, requires the Agency to clarify the processes for resolving scientific disagreements, including requests for advisory panel review. While our existing regulations and procedures have worked well to resolve many disagreements, the Agency is taking steps to enhance its dispute resolution processes.

First, the Agency revised Title 21, Code of Federal Regulations section 10.75 to clarify the availability of review of scientific disputes by an advisory panel. CDRH created a medical devices dispute resolution panel, and issued a draft guidance that describes how that panel will be used to resolve scientific disputes. CDRH also issued a general guidance document that provides an overview of all of the Center's dispute resolution processes and has appointed a CDRH ombudsman. CDER and CBER have developed guidance to explain their processes as well.

CONSULTATION WITH CONSTITUENCIES

We have worked to ensure that everyone affected by the Agency's actions has a voice, and that each voice is heard. While all of these voices may not share the same viewpoint, we have found that this open discourse can engender confidence.

FDAMA has contributed significantly to the Agency's effort to collaborate in a credible and reliable way with our constituencies. For example, section 406(b) of the Modernization Act directs the Agency to consult with our constituencies to ensure that we fulfill our statutory mandates and that we communicate clearly with our stakeholders. We have held a series of meetings, during which we have listened to those outside the Agency. We hosted a national interactive videoconference that was simulcast to interested parties in eight different cities. During our national broadcast, we had senior staff at each of the locations to hold a more focused communication with members of consumer groups and the regulated industry in these areas of the country. During these meetings, we received useful feedback on the Agency's performance, as well as constructive suggestions as to how the Agency can continue to improve.

Public Meetings

Finally, FDA has held many public meetings to discuss implementation of specific provisions. For example, CDER and CBER have held several public meetings on implementation of certain provisions. These include four public meetings on the implementation of the positron emission tomography (PET) provisions, three public meetings on the radiopharmaceuticals provisions, and advisory committee meetings on pharmacy compounding.

CONCLUSION

FDA has been fully committed to implementation of FDAMA. However, while devoting time, energy, and resources to this effort, we also have worked to meet our other responsibilities. They include: protecting the safety of the nation's food supply and blood supply, reviewing new food additives to ensure their safety, speeding our reviews of new generic drugs and medical devices and developing a comprehensive regulatory strategy for dietary supplements-which involves the implementation of another complex statute.

I am proud of the work that the Agency has done in fulfilling our FDAMA commitment to Congress and to the American people, and I hope that you share this sentiment. Thank you for the opportunity to be here today.