Human Drugs

^1/Reflects enacted levels adjusted for the 0.22 percent rescission, accounting for $530,000 in the Human Drugs program.
^2/  Reflects decrease in base funding from FY 2001 of $249,000, for Human Subject Protection & Bioterrorism.
^3/Pay increases shown on separate line, and not reflected in individual increase areas.

Historical Funding and FTE Levels

MISSION

• Ensure the safety and effectiveness of all drug products used for the prevention, diagnosis, and treatment of disease.
• Ensure the prompt approval of safe and effective new drugs so that patients can enjoy the benefits provided by therapies to treat and prevent illness and disease.
• Review premarket applications for new and generic drugs in a timely and quality manner, as well as new and generic drug supplemental applications.
• Monitor adverse drug events to detect safety problems that only become evident after the approval and actual use of a drug.
• Evaluate reports of adverse events, medication errors and product defects associated with drug products.
• Use postmarketing surveillance reporting, and the collection and analysis of drug product samples to evaluate compliance with quality standards and labeling requirements.
• Conduct inspections to determine if fraudulent drugs are marketed in commercial channels, and evaluate foreign and domestic compliance with GMPs.
• Oversee the orphan product program that reviews and approves requests for orphan product designations, which includes granting sponsors seven years of marketing exclusivity. Award grant funding to defray costs of qualified clinical testing incurred in connection with the development of drugs for rare diseases and conditions.

REQUESTED INCREASES

Pay Increase + $10,222,000

FDA’s request for funds to cover pay cost increases is vital to the Agency because personnel are so essential to accomplishing its mission.  Pay increases have a major impact on FDA because the Agency is more people-intensive than many other government agencies.  Payroll accounts for over 60 percent of the total FDA budget.  This has a significant impact on all activities in FDA, particularly the field.  The costs of the pay increases are necessary to ensure the integrity of the Agency's work in the Human Drugs Program, especially as responsibilities continue to grow with its involvement in the entire life cycle of a pharmaceutical (pre-clinical studies to postmarket surveillance of medication errors or potential adverse events).

In order to maintain the level of activities carried out in FY 2001, FDA is requesting $40,000,000 million to cover the cost of the FY 2002 pay raise, annualization of the FY 2001 pay raise, anticipated within grade increases, and one extra day of pay.  The Human Drugs Program portion of this increase is $10,222,000.

Imports & Inspections +  $5,500,000 and 24 FTE   (Budget Authority +$4,000,000 and 19 FTE; Proposed User Fees +$1,500,000 and 5 FTE)

Congress mandated bi-annual inspections of drug establishments in Section 510 (h) of the Federal Food, Drug and Cosmetic Act [“...every such establishment engaged in the manufacture, propagation, compounding, or processing of a drug or drugs...shall be inspected ... at least once in the two year period beginning with the date of registration...”].  

Budget Authority

FDA needs to improve its regulatory assessment of drugs and drug products manufactured in foreign sites and imported into the United States.  Foreign inspections allow FDA to identify and correct problems in the manufacture, distribution, or sale of human drug products.  Funding will allow FDA to:

• Evaluate findings and act against violations in an increased numbers of on-site inspections, especially where foreign manufacturing sites have shown evidence of quality problems such as non-uniformity of dosage units, cross-contamination of one drug with another, lack of sterility and mix-ups in labeling and packaging;
• Negotiate cooperative regulatory agreements with Switzerland, Canada and Mexico;
• Execute existing cooperative agreements regarding foreign drug manufacturing with the European Union, Australia and Japan; 
• With new foreign registration authority granted under FDAMA, establish accurate lists of foreign manufacturers exporting to the U.S.;
• Improve existing electronic systems for tracking and evaluating foreign manufacturers by entering all required approval data. Analyze these new data and report requirements; and,
• Write new compliance programs for enhanced monitoring of foreign manufacturers. One such program will be on inspecting the distribution of foreign-source drug chemicals to find counterfeits. Another will be on new inspection approaches.

Domestically, FDA is currently only inspecting 28 percent of human drug establishments and 22 percent of the registered human drug manufacturers, repackers, relabelers, and medical gas repackers.   These inspections are necessary to ensure that firms adhere to the terms and conditions of a drug approval described in the application, and that the drug is manufactured in a consistent and controlled manner.  Inspections allow FDA to identify and correct problems in the manufacture, distribution, or sale of human drug products. FDA's ability to perform statutory inspections is seriously impeded because the program is not fully funded to meet the statutory schedule of once every two years. There are many other non-statutory human drug inspections that FDA needs to perform that compete with this already under funded area. This includes inspections at excipient manufactures, manufacturers of precursor materials for active pharmaceutical ingredient manufacturers, warehousing and distribution operations, importers and office only locations for record reviews. All of these facilities require coverage in order to ensure overall quality and purity of human drugs.  In FY 2002 FDA will:

• Improve collection and analysis of risk data to enhance management decision-making and improve the efficiency and effectiveness of inspections and sample analysis;
• Evaluate findings and act against violators in an increased number of on-site inspections, especially where domestic manufacturing sites have shown evidence of quality problems such as non-uniformity of dosage units, cross-contamination of one drug with another, lack of sterility and mix-ups in labeling and packaging;
• Update inspection and sample analysis programs for inspecting domestic manufacturers; and,
• Provide outreach to industry (e.g., facility evaluation, inquiry responses, education leveraging, etc).

Proposed User Fees

FDA proposes to collect $1,500,000 in user fees assessed for activities related to import program operations, including funds for the Operational and Administrative System for Import Support (OASIS), that are consistent with provisions of the World Trade Organization (WTO) agreements. The OASIS system is one of many import services that substantially reduce the risk of potentially harmful imported drug products from reaching the American market place.  The importer/broker community benefits through faster turn-around times, elimination of large volumes of paperwork, and reduced costs of doing business.  OASIS will give FDA staff access to historical information to better target products and firms at high risk, the ability to plan inspections more effectively, and the ability to share findings from inspection and lab analyses with other offices.  In FY 2002 FDA will:

• Increase coordination with the U.S. Customs Service to improve the effectiveness of cargo control activities at ports, and the monitoring of human drug products that have been refused entry pending exportation or destruction (follow-up-to-refusals); and,
• Modernize the Operational and Administrative System for Import Support (OASIS) import data processing system to provide import reviewers with rapid and direct access to information necessary to make entry decisions about human drug products.

Patient Safety/AERS + $4,100,000 and 17 FTE

Under 21 United States Code 355 (the new drug provisions of the Federal Food, Drug, and Cosmetic Act), FDA is granted authority to take action on the sale of pharmaceuticals if the Agency discovers imminent hazard to public health.  FDA must collect safety information to determine where the hazards exist.

As reported in the 2000 report “To Err is Human: Building a Safer Health System,” it is estimated that over 98,000 Americans die yearly from medical errors.  Many of these medical errors are adverse events associated with the use of FDA-regulated products – drugs, biologicals, and medical devices.  FDA is committed to conducting additional research on methods of identifying risk and reducing the occurrence of adverse events associated with pharmaceuticals.  Increased funding will allow FDA to monitor and respond to an increased number of suspected adverse events associated with the use of FDA’s regulated products.  During FY 2002 FDA will:

• Complete FDA’s new on-line adverse event reporting system (AERS) for drugs and biologics, and provide rapid assessment of injuries and deaths associated with the use of these products;
• Develop links to hospital-based information systems to better support hospital staff working on the "front lines" of patient safety.   This includes improving the reporting systems to address under-reporting and incomplete reporting of medical errors, as well as increased use of other electronic systems to monitor problems with use of drug products.  Access to drug utilization databases can also provide the Agency with data on patient drug use by individuals in an ambulatory care or inpatient setting;
• Increase FDA’s capacity to do the multi-factor analysis necessary to correctly identify the sources of safety problems and potential solutions.   This includes establishing links to safety databases maintained within community-level healthcare delivery systems and regional-level safety surveillance systems, and adding to expertise in medical epidemiology and statistical analysis;
• Develop linkages to government and private health care databases. Access to broad-based health information databases will allow for more rapid exploration of potentially serious drug-related problems and more rigorous investigations than currently possible;
• Expand educational and training programs for health care providers and the public to promote the safe use of products;
• Investigate reported errors and develop error reduction strategies with manufacturers and the medical community; and,
• Upgrade field investigational data systems to complement agency error tracking systems, and to provide better information on the incidence of medical errors.

Human Subject Protection + $4,300,000 and 20 FTE

Under Section 505 of the Federal Food, Drug, and Cosmetic Act, the Human Drugs Program is responsible for reviewing data submitted in research and marketing applications for new drug products and determining the safety and effectiveness of these products.

To fulfill this important public health mission, the Human Drugs Program conducts on-site inspections and verifies the quality and integrity of data submitted to the Agency, thereby assuring that drug approval decisions are sound. Another purpose of these inspections is to protect the rights and welfare of the human subjects who participate in clinical trials.  To accomplish these goals, the program currently conducts and reviews the reports of approximately 700 bioresearch monitoring (BIMO) inspections of clinical trial study sites, Institutional Review Boards (IRBs), sponsors, and contract research organizations (CROs) annually.

This program is severely stressed due to the increased complexity of the products undergoing testing, the expanded number of clinical trials, and in particular, the high volume of trials performed overseas in countries with less developed standards for the conduct of such studies.  Complaints coming in to the Human Drugs Program related to clinical research have skyrocketed: receipt of 9 complaints in 1998, 103 in 1999, and 118 in 2000.  Additional staff and resources will ensure that the public health mission of the Human Drugs Program is not compromised even further.  FDA will use these resources for inspections and outreach activities, specifically to:

• Increase the number of Bioresearch Monitoring (BIMO) site inspections by approximately 80 to a total level of approximately 780 BIMO inspections annually;
• Follow-up on complaints related to clinical research, developing and issuing inspection assignments, and completing reviews of inspection reports;
• Enhance Federal coordination of the program by synchronizing operations and increasing communication between FDA’s Office of Human Research Trials and the Department of Health and Human Services’ Office of Human Research Protection;
• Improve the quality, consistency, and effectiveness of BIMO inspections by developing an investigators' certification program that provides training and practical experience, and an assurance that investigators keep pace with emerging issues in clinical research; and,
• Improve the safety and quality of foreign bioresearch activities by entering into agreements with foreign governments and participating in international regulatory standards organizations.

Current Law User Fees + $6,890,000 and 20 FTE
Prescription Drug User Fee Act II (PDUFA II)

The Prescription Drug User Fee Act of 1992 (PDUFA) authorized the assessment and collection of user fees for drug applications, establishment registrations, and product listings to enhance and expand FDA's existing review process.

The Food and Drug Administration Modernization Act of 1997 (FDAMA) reauthorized the collection of prescription drug user fees (PDUFA II) to enhance the human drug review process, including some biological products, through FY 2002.  The Act established fees for applications, establishments, and approved products.  The user fees have enabled FDA to improve its performance for drug review and approval times.  In FY 1991, the median approval time for human drug applications was 21 months and in FY 1999 the median approval time was 11.9 months.  The fees collected in FY 2002 will enable the FDA to continue to meet its PDUFA II performance goals, including:

• Review and act on 90 percent of standard original NDA and PLA/BLA submissions filed during fiscal year 2002 within 10 months of receipt;
• Review and act on 90 percent of priority original NDA and PLA/BLA submissions filed during fiscal year 2002 within 6 months of receipt;
• Review and act on 90 percent of standard efficacy supplements filed during fiscal year 2002 within 10 months of receipt;
• Review and act on 90 percent of priority efficacy supplements filed during fiscal year 2002 within 6 months of receipt;
• Review and act on 90 percent of manufacturing supplements filed during fiscal year 2002 within 6 months of receipt and review and act on 90 percent of manufacturing supplements requiring prior approval within 4 months of receipt;
• Review and act on 90 percent of Class 1 resubmitted original applications filed during fiscal year 2002 within 2 months of receipt; and,
• Review and act on 90 percent of Class 2 resubmitted original applications within 6 months of receipt.

JUSTIFICATION OF BASE

Activities Related to Increases for FY 2002
Payroll

• FDA’s Human Drugs program ensures the safety and effectiveness of all drug products used for the prevention, diagnosis, and treatment of disease.   FDA also ensures the prompt approval of safe and effective new drugs so that patients can enjoy the benefits provided by therapies to treat and prevent illness and disease.   The Agency reviews premarket applications for new and generic drugs in a timely and quality manner, as well as new and generic drug supplemental applications.
• The field component of Human Drugs inspects regulated industry, and collects and analyzes samples.  Other activities that often arise are review and management of enforcement actions, and consumer complaints, trace back efforts, and review of import entries for admissibility decisions.  These functions are inherently governmental and highly personnel intensive.

Patient Safety/AERS

• Maintain the Agency’s system of postmarketing surveillance and risk assessment program to identify adverse drug events (ADEs) that did not appear during the drug development process by collecting, evaluating and acting upon information on ADEs associated with marketed products.
• Receive adverse event and medical errors reports via the Adverse Event Reporting System (AERS) database.  FDA receives and records over 260,000 individual postmarketing safety reports (ISRs).   Adverse event reporting prompts the Agency to conduct around 50 inspections of foreign and domestic firms per year.
• Identify health hazards associated with the manufacturing, labeling, and packaging of pharmaceuticals and remove unsafe and ineffective products from the marketplace.  FDA operates the MedWatch Program directed toward health care professionals to voluntary report observed or suspected defects and quality problems associated with marketed drug products.  FDA reviews the reports to identify potential health hazards, initiates investigational follow-up and takes appropriate enforcement action.  The Agency reviews hundreds of thousands of reports per year and numerous reports result in product recalls and voluntary corrective actions by industry.
• Provide increased health education for U.S. consumers about FDA-regulated products, which may adversely impact their health.

Human Subject Protection

• Conduct inspections of clinical investigators, sponsors, monitors, Investigational Review Boards (IRBs), non-clinical laboratories, and bioequivalence facilities to ensure the protection of the rights and welfare of human subjects who participate in clinical studies.
• Verify the reliability and accuracy of data collected by regulated industry in clinical and non-clinical (animal) studies. 
• Review Establishment Inspection Reports (EIRs) pertaining to clinical investigators, sponsors, non-clinical laboratories, and bioequivalence facilities for violations and take corrective actions such as disqualification of clinical investigator ability to receive investigational drugs.
• Conduct inspections and data audits to monitor all aspects of the conduct and reporting of drug product research involving human subjects.
• Conduct inspections to assure the quality and integrity of data submitted to the Agency in support of new drug applications.

Imports and Inspections

• Focus on product quality standards and compliance by manufacturers with standards established in the good manufacturing practices (GMP) regulations to ensure that the highest possible quality products are marketed.
• Conduct field inspections and compliance actions, including postapproval human drug inspections, surveillance GMP inspections for human drugs, as well as compliance actions such as those prompted by complaints or adverse event reports. 
• Provide criminal investigation of reported product tampering; counterfeit products and other fraudulent criminal activities involving regulated drug products.  
• Perform laboratory validation of analytical methods submitted to support premarket product applications.
• Collaborate with the European Union to assess equivalence of regulatory systems to ensure imported products comply with U.S. standards.  FDA will continue equivalence assessments through FY 2002. This agreement will ultimately allow reciprocal reliance on inspections of pharmaceutical manufacturing plants between equivalent regulatory authorities and improve border operations.

Activities Related to Other Priority Areas
New Drug Application Review

• Regulate the testing of investigational new drugs (IND review) and evaluate new drug applications (NDAs) received from sponsors.  Over the past several years, FDA approvals for new drug applications (including new molecular entities and priority approvals) have ranged from 71 to over 120 per year.
• Review and act upon standard and priority efficacy supplements -- supplemental applications proposing to add a new use of an approved drug to the product labeling.  (Human Drugs Performance Goal #12004) In the recent past, FDA received between 100 and 150 applications per year for new or expanded uses of an already approved drug.  The median total approval time was 10.4 months, and median FDA review time was 10.2 months..
• Review and act upon manufacturer applications that notify FDA in advance of packaging, location, machinery, processes or supplier changes.   In the recent past, FDA received between 1,200 and 1,500 applications per year and approved nearly 90 percent of these.

Pediatric Drug Studies

• Review study requests from industry for manufacturers who conduct and file pediatric studies in response to our written requests.  (Human Drugs Performance Goal 12026)  FDA is authorized to grant six months of marketing exclusivity to manufacturers who conduct and file pediatric studies. The six months is an economic incentive so that FDA may gain additional information about a drug’s usage in the pediatric population. 

Generic Drug Review

• Support an active generic drugs program (Abbreviated New Drug Approvals or ANDA review) with a focus on expanding the availability of high quality generic drug products to the public.

Over-the-Counter Drugs

• Review over-the-counter (OTC) drugs to ensure safety and effectiveness and to help consumers understand how to best use OTC products.  There are currently over 100,000 OTC products on the market.  FDA published a final rule that will provide new, easy to understand labeling on non-prescription drugs.  

Orphan Product Development Program

• Promote the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions through the Office of Orphan Products Development (OOPD).  The OOPD administers the major provisions of the Orphan Drug Act (ODA), which provide incentives for sponsors to develop products for rare diseases.  

Clinical Pharmacology

• Continue program for research and training for clinical pharmacologists.  The Agency awarded a cooperative agreement to the University of Indiana in FY 2000 for one year to support post-doctoral training and research to study clinical pharmacology and biopharmaceutical issues related to new drug development and review.

Human Drug Related Research

• Leverage scientific capabilities to respond and contribute to major breakthroughs in pharmaceutical research and technology via continued professional development/training, and continued stakeholder collaborations.   In 1999, FDA began a collaborative effort with research scientists from academia and industry to form the Product Quality Research Initiative (PQRI).  The PQRI plans to: conduct research in the areas of pharmaceutical chemistry, biopharmaceutics, and science management; identify better test methods for assessing quality of products; and identify optimal manufacturing and management processes.

Outreach with Stakeholders

• Maintain communication lines with stakeholders.  Outreach programs include the pharmacist education outreach program to help pharmacists better explain the drug approval process to consumers, and the collaborative efforts between FDA and industry where scientific and regulatory experts discuss electronic submissions, user fees, risk management, product quality, drug safety and other issues on drug development and manufacturing.  FDA also updated “From Test Tube to Patient: Improving Health through Human Drugs,” a popular FDA publication for consumers which describes new drug development in the United States and highlights the Agency’s consumer protection role.  This report has been requested by more than 5,000 individuals and can be found at www.fda.gov/fdac/special/newdrug/ndd_toc.html.

Selected FY 2000 Accomplishments

Prescription Drug User Fee Act of 1992 (PDUFA)

• In 1997, Congress authorized PDUFA II under the Food and Drug Modernization Act of 1997 (FDAMA) for another five years.  The following table illustrates performance for PDUFA/FDAMA for the FY 1999 cohort data.

Fiscal Year 1999 Cohort (as of 12/31/00)

Review Performance for the FY 1999 Cohort

• Met or exceeded 14 of the 15 performance review goals for the FY 1999 submission cohort.  Only missed the goal for priority efficacy supplements (13 of 15 were reviewed "on time").  In addition to surpassing all goals for NDAs, surpassed all review goals for New Molecular Entities (NME), a subset of the NDA category.  The number of original NDAs filed for the FY 1999 submission cohort increased over 10 percent from 1998.

New Drug Evaluations

• Initiated 239 actions on NDAs during FY 2000, 106 of which were approvals.   The median approval time was 11.6 months, a three percent decrease in median approval time compared with FY 1999. Sixty-five of these NDAs were approved in 12 months or less. Of the 106 NDA approvals, 39 were for NMEs. Of the 39 NMEs, 12 were drugs given a priority review (products offering notable improvements over currently marketed drugs).
• Approved 23 priority applications (12 NMEs, 11 NDAs that were not NMEs, and 21 priority efficacy supplements) in FY 2000.
• For the FY 2000 submission cohort, FDA received 80 resubmissions for review, 122 NDAs, 175 efficacy supplements and 1,438 manufacturing supplements during the fiscal year.  Final on-time performance information for the FY 2000 submission cohort is not yet available.   Data will be available mid to late 2001.  Drugs approved in FY 2000 under Subpart H (Accelerated Approval) regulations are listed below.

NDAs and Supplemental NDA Approved for Accelerated Approval in FY 2000

Generic Drug Review

• Approved 232 abbreviated new drug applications (ANDAs). This is an increase over the 198 approved last fiscal year.  Examples of important first time approvals are as follows:

• Made progress in increasing the percent of originals acted upon in less than the statutory 180 days.  In the six months from November 1999 to April 2000, FDA acted on 47 percent of original applications in 180 days.  This is an increase from the 31 percent acted on in the six months beginning in April 1999.
• Took significant strides in preparation for a paperless review environment with the utilization of $1.5 million provided by Congress for satisfying information technology needs.  The funds allowed for the purchase of upgraded hardware, software, and contractual support to allow for the review of electronic submissions and to increase the overall efficiency of the review process.
• Received 101 ANDAs containing at least a portion of the data in electronic format (30 percent of all submissions).  This is an increase over last year, when 88 ANDAs were submitted with some portion in electronic format.  The increase reflects the commitment of OGD to support the Agency’s efforts in this regard.

Generic Approvals by Fiscal Year

Oncology Programs

• Launched the first regulatory website with a focus on a specific disease.   The site, called Oncology Tools (www.fda.gov/cder/cancer), can be searched by specific type of cancer or by approval therapy.
• Pediatric Oncology Projects.  Prepared a Written Request template that encourages development of oncology drugs in children; wrote guidance entitled, Pediatric Oncology Studies In Response to a Written Request; and established an Advisory Committee (Pediatric Oncology Subcommittee).
• Held monthly meetings with the National Cancer Institute (NCI) to discuss clinical trial issues to stress interaction with Department of Health and Human Services (DHHS) agencies.  Also worked with Health Care Financing Administration (HCFA), the Agency for Healthcare Research and Quality (AHRQ), the National Cancer Institute (NCI), and other DHHS agencies to develop a plan for Medicare Coverage of Clinical Trials.

Antimicrobial Resistance

• Approved Zyvox, the first of a new class of antibiotics indicated for use against resistant organisms.  Labeling encouraged use that would preserve this drug for serious diseases.  
• Published a proposed rule, Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use.  Contributed to the drafting of an interagency Public Health Action Plan to Combat Antimicrobial Resistance and to the publication of the report from the FDA Task Force on Antimicrobial Resistance.

Bioterrorism Activities

• Reviewed and approved an NDA for Ciprofloxacin for post-exposure inhalational anthrax.
• National Pharmaceutical Stockpile. Identified drugs that are potentially effective in combating a bioterrorist attack and requested submission of data to support such uses.    
• Cooperated with stakeholders on bioterrorism activities, including:
• Worked with CDC in developing “a streamlined IND” for use in the field during a bioterrorism event;
• Implemented a shelf-life extension program for drug products contained in the stockpile and worked with NIH to identify the most promising antiviral agent to be used to treat smallpox; and,
• Provided scientific and regulatory expert consultation to outside groups, including: the Center for Civilian Biodefense at the Johns Hopkins University, the CDC and the Advisory Committee on Immunization Practices (ACIP) on issues related to the use of drug products for prevention and treatment of disease due to biological agents that might be used as weapons.

Pediatric Exclusivity (Section 111 of FDAMA)

• Issued 57 Written Requests with 19 Pediatric Exclusivity determinations. Twelve were active moieties for which pediatric labeling has been approved based on studies conducted to satisfy a written request.
• Maintained and updated a pediatric interactive web page at www.fda.gov/cder/pediatric.
• Assisted in the organization and participated in the Surgeon General’s National Conference on Mental Health in Children and co-sponsored the NIMH/FDA workshop on the development of psychotropic agents for young children.

Over-the-Counter (OTC) Drug Products

• Approved twelve new drug products and/or new indications for OTC marketing.

Adverse Event Reporting System (AERS)

• Implemented a major release of AERS in May 2000.  This release provided new functionality by enhancing searching capability, becoming International Conference on Harmonization (ICH) compliant, and providing better integration for electronic submissions. These enhancements allowed FDA to improve its ability to collect and analyze medical product adverse event data and to ensure timely and appropriate action. 

Meeting the Mandates of the Quality Interagency Coordination Task Force (QuIC)

• Participated in the QuIC to address the impact of medical errors on the public health from a federal government perspective, and what can be done to address the problem.  Activities include developing standards for drug names and packaging to minimize the potential for confusion leading to medication errors.  The QuIC also calls for the Human Drugs program to continue to identify, quantify and address postmarketing safety problems.  To this end, FDA increased staffing of safety evaluators and medical epidemiologists and identified data resources (e.g. claims-linked population databases, active surveillance systems, etc.) to meet these needs.

Internet Drug Sales and Promotion

• Issued a total of 60 foreign and domestic cyber letters, 43 warning letters, four untitled letters and accomplished five injunctions, 15 seizures and 18 voluntary destructions.  Cyber letters alert the recipients that U.S. citizens are being warned about their products and that copies are being sent to the regulatory drug officials in their country and advising U.S. customs through an Import Alert.
• Seized in June 2000, approximately $1.3 million worth of Street Drug Alternatives at Hit Products a.k.a. Riverdale Organics, in Beltsville, MD.  These drugs are marketed as alternatives to illicit street drugs and generally labeled as containing botanicals or other ingredients such as vitamins, minerals or amino acids.
• Foreign Internet sales of unapproved pharmaceuticals:  As part of a joint FDA/Customs Service operation several hundred mail entries of unapproved pharmaceuticals ordered over the Internet from pharmacies in Thailand were examined and seized at JFK International Airport.

Foreign Inspections and Pre-Approval

• Reviewed approximately 227 establishment inspection reports of foreign drug establishments.  These firms manufacture or test finished drug products or active pharmaceutical ingredients intended for distribution to the U.S.
• Reviewed 1,144 NDA domestic establishment evaluation requests (EERs), 711 NDA international EERs, 1,085 ANDA domestic EERs, and 755 ANDA international EERs. 
• In support of  applications, 1,855 domestic and international establishments were evaluated for 832 NDA applications and 2,560 domestic and foreign establishments evaluations were conducted for 1,317 ANDA applications.
• Provided joint FDA/Customs Service enforcement instruction on bulk drugs to approximately 200 field personnel.  FDA has engaged a private contractor (Battelle) to examine FDA's import strategy/procedures and to develop new Information Technology products to assist in import surveillance.

Good Manufacturing Practices

• Reviewed and concurred with 28 regulatory actions, including 14 seizures and six injunctions.  These legal actions were taken due to the seriousness of the Good Manufacturing Practice (GMP) deficiencies observed at the pharmaceutical manufacturers sites and to effect corrections and to prevent adulterated products from being shipped to consumers.

Mutual Recognition Agreements (MRA)

• Established the Recall standard operating procedures in April 2000, which is now operational to facilitate rapid exchange of information on potential drug problems between the U.S. and member states of the European community.  Held a public meeting on December 8, 1999 on progress toward implementation of the pharmaceutical annex of the MRA.

Leveraging, Communications and Partnership Programs

• Improved communication with consumers and patients through seminars on risk management, safe use of drugs, new drug therapies and labeling; brochures for consumer and patient use; expanded information available via the Internet; and disseminating information about new and existing products. Expanded the pharmacist education outreach program to help pharmacists better explain the drug approval process to consumers. 
• Developed easy to read, user-friendly information for consumers in partnership with the American Pharmaceutical Association, the National Consumers League, and the National Council on Patient Information and Education.  Continued to provide consumer-focused information on new and innovative drug approvals via a new drug web page.

Office of Orphan Products Development

• During 2000, the Office of Orphan Products Development (OPD) staff reviewed 88 new sponsor requests for designation of drugs as orphan products.  As part of the request for designation, sponsors submit data that adequately demonstrate the use of their product for a disease or condition affecting fewer than 200,000 people in the U.S.  
• Based on OPD reviews, 68 drugs and biological products received designation as orphan products during the year.  The following 14 designated orphan products were approved by the FDA in 2000, bringing the total number of orphan products approved to 218 (see chart below).  These products potentially treat close to 11 million patients in the United States.

List of Orphan Product Approvals

Electronic Submissions

• Received 129 original NDA submissions in FY 2000, of which 51 percent were at least partially electronic.  Also received 131 NDA supplements and 309 NDA amendments that were at least partially electronic.

Human Drugs
Program Activity Data

^1/ ANDA actions include total of approvals, not approvables,, tentative approvals, and  faxed deficiencies.
^2/ CMC and Labeling Supplements.  Also includes global supplements.
^3/  Includes postmarket samples analyzed in St. Louis and Laurel, MD only.      

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