Other Activities

1/ Includes Salaries & Expenses, Rent, and PDUFA, where applicable.

EXPLANATION OF PROGRAM

Other Activities provides central program direction and administrative services for Agency programs to ensure that FDA's consumer protection efforts are effectively managed and that available resources are put to the most efficient use. Functions include providing agency-wide policy development in medical affairs, scientific coordination, regulatory requirements, legislation, planning and evaluation, consumer communications and public information; and management expertise and coordination in financial management, personnel, equal opportunity and agency-wide diversity program functions, contracts and grants administration, procurement property and space control, and communications systems. Other specific programs include Freedom of Information Act activities, administration of internal controls required under the Federal Managers' Financial Integrity Act, and the Small Business Program, to assist small businesses in carrying out regulatory requirements and in participating in FDA's regulatory decision-making process.

FY 2001 BUDGET REQUEST

ASSURING SAFETY/STRENGTHENING SCIENCE INITIATIVES

POSTMARKET INITIATIVES + $0.3 MILLION, 2 FTE

Internet Drug Sales + $0.3million, 2 FTE

FDA is requesting a total of $10.0 million and 77 FTE to reduce the illegal promotion, sales and distribution of approved and unapproved prescription and nonprescription pharmaceuticals via the Internet, which will protect consumers from obtaining unsafe, ineffective, and fraudulent products that present a real danger to the public health. The Internet, while promising enormous benefits to business and consumers, is also being used by unscrupulous sellers of prescription drugs and other medical products to entice consumers to buy these products without medical supervision. Drugs sold over the internet pose a number of dangers to consumers, e.g., counterfeit, contaminated, super-potent, sub-potent, or lacking in necessary warnings and other labeling. Consumers are also being enticed to purchase legitimate drugs that are unsafe when used improperly, e.g., purchases of Viagra by consumers with heart disease. During FY 1999 and 2000, sites offering such drugs grew dramatically and there have been increasing public and Congressional calls for greater FDA action.

To support this effort, FDA request $0.3 million and two attorneys for the Office of Chief Counsel (OCC) for Internet enforcement. The Office of Chief Counsel is responsible for working closely with the Center for Drug Evaluation and Research, the Office of Regulatory Affairs (including the Office of Criminal Investigations), and the Department of Justice to bring civil and criminal enforcement actions involving illegal Internet activity. Additionally, OCC will be reviewing partnership agreements on Internet enforcement between FDA and the National Association of Boards of Pharmacy and Federation of State Medical Boards.

Other Activities

Selected FY 1999 Accomplishments

• Restructured the Office of the Commissioner: Restructured the Office of the Commissioner (OC) effective June 20, 1999, to promote leadership in building effective, two-way communications between the Agency and all of its stakeholders; implement agency priorities and develop policy with primary input from Center Directors and the Associate Commissioner for Regulatory Affairs; streamline the OC to make the overall Agency more effective and efficient with roles and responsibilities clearly delineated; and retain in OC only those functions which cannot be reasonably and more effectively performed in the Centers or the Office of Regulatory Affairs.

• Food and Drug Modernization Act: Assisted in the implementation of the FDA Modernization Act of 1997 by participating in myriad working groups and by reviewing, for legal sufficiency, dozens of proposed and final regulations, guidance documents, Federal Register notices, and reports designed to achieve the principal goals of this far-reaching law, namely, greater patient access to new medical products and more effective management of FDA's limited resources.

• Food Safety: Supported the central goal of reducing food-borne illness, by ensuring that FDA efforts are legally sound, effective, and comprehensive in terms of public health protection. Participated in FDA's regulatory initiatives focused on specific commodities that present unusual risk of food-borne illness. For example, OCC developed a legal theory to permit effective enforcement of the Agency's proposed rule concerning the safe handling of shell eggs and worked closely with the Center for Food Safety and Nutrition to ensure that the process for further developing the administrative record for the agency's juice HACCP rule was procedurally sound and would result in an appropriate record. Provided substantial technical assistance to Hill staff on two separate imported food bills to ensure that the proposed legislation would properly mesh with current law and would augment the Agency's current legal authorities in this area.

• Women's Health: Implemented Take Time To Care (TTTC) FDA's public awareness campaign whose goal is to reach women with the theme "Use Medicines Wisely." It makes women who are the principal users of medications and who often administer them for family members, more aware of safe medication use with materials and interactive events led by pharmacists and other health professionals. The campaign provided materials to over 5 million Americans about safe medicine use with the messages: Read the Label, Avoid Problems, Ask Questions and Keep a Record. More than 70 National Association of Chain Drug Stores (NECKTIES) member chains participate, representing over 20,000 outlets nationwide.

• PDUFA II Information Management Five-Year Plan: Revised the PDUFA II 5 -Year Plan to correct over-optimistic assumptions made in the earlier (1998) version of the plan about the volume of fee-paying applications and total revenues FDA expects to receive from fees paid by industry. Collected and published (in the Performance Report sent to Congress in December 1998) information about the drug and biologic application workload and FDA's performance against the PDUFA goals. FDA also collected and published (in the Financial Report sent to Congress in February 1999) information about the fee revenues collected and spent, and total FDA expenditures from all sources for the process for the review of human drug and biologic applications.

• Partnering with the National Treasury Employees Union (NTEU): Successfully completed contract negotiations with the National Treasury Employees Union (NTEU). The Commissioner and the President of NTEU, along with members of both the management and union bargaining team, held official contract signing ceremony in the DHHS Deputy Secretary's Office on September 1, 1999. Our new union represents almost 6,000 professional and non-professional FDA employees nationwide, and the successful start-up period was guided by the principles outlined in the President's Executive Order 12871, which emphasizes partnerships, interest-based bargaining and alternative dispute resolution.

• Strategic Workforce Planning Initiative. Embarked on an Agency wide strategic workforce planning initiative to better utilize human resources and develop a plan for meeting future staffing requirements. Key components of the workforce planning initiative include identifying the various skills mix and competencies needed in the workforce of the future; identifying gaps in current and future human resources needs; developing strategies; and providing a roadmap for achieving our goals.

• Financial Statements. Received an unqualified opinion from independent auditors on the FY 1998 Financial Statements. The accounting standards and requirements brought about by the Chief Financial Officers Act have resulted in a marked improvement in time lines, accuracy, and credibility of financial information used for evaluation and decision making.

• College Park Building. Completed Phase I of the construction in February 1999. In May 1999, GSA announced the selection of the Charles H. Tompkins Company for the construction of Phase II, and on June 14, 1999, GSA issued Notice to Proceed. Released solicitation notice for renewal of mechanical and electrical operation and maintenance services at Federal Building-8 with provisions providing for a smooth transition to the College Park facility.

• Year 2000 (Y2K) Compliance. Provided leadership and focus for the Agency's Year 2000 compliance mandates. Successfully ensured all systems were Y2K compliant. A collateral benefit of the Y2K was the accelerated modernization of the Agency's information technology infrastructure.

Edited 3/1/2000