Food and Drug Administration Regulatory Modernization Act of 1997

Summary

Drug and Biological Products Modernization Act of 1997 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to set forth the mission of the Food and Drug Administration (FDA) and mandate annual reports by the FDA and the Comptroller General to specified congressional committees. (Sec. 3) Modifies new drug requirements regarding: (1) clinical investigation commencement; (2) application contents and review; (3) effectiveness determinations; (4) the use of scientific advisory panels; and (5) marketing approval application review by accredited persons. (Sec. 8) Provides for the accreditation of persons to review applications for new drugs or for biological product facilities. (Sec. 9) Directs the Secretary of Health and Human Services, when there is a scientific controversy between a regulated person and the Secretary regarding certain matters, to refer the issue to an existing scientific advisory panel, a special Government employee, or a non-governmental person for recommendations to the Secretary. (Sec. 10) Deems certain chemistry, manufacturing, and controls to comply with current good manufacturing practice (GMP) and prohibits actions to delay or prevent the manufacture or marketing of a drug for failure to conform to GMP. (Sec. 11) Allows a new drug manufactured in a small facility to be used to show safety and effectiveness. (Sec. 12) Allows changes in the manufacture of a new drug or a new animal drug to be made in accordance with specified validation and reporting requirements. (Sec. 13) Repeals provisions relating to the certification of drugs containing insulin or antibiotics. Allows insulin and antibiotic exports without regard to certain requirements. (Sec. 14) Requires that applications or petitions requesting conversion from prescription to nonprescription status and all matters relating to nonprescription drugs be reviewed by a single office in the Center for Drug Evaluation and Research. Allows a single scientific advisory panel to provide recommendations. (Sec. 15) Mandates an applicant-accessible information system to track applications and submissions to the FDA. (Sec. 16) Prohibits actions by the Secretary of Health and Human Services from requiring an environmental impact statement or environmental assessment unless the Secretary finds that the proposed action may have a significant effect, directly or cumulatively, on the human environment. (Sec. 17) Regulates drugs compounded by a licensed pharmacist, physician, or other licensed practitioner authorized by State law to prescribe drugs or devices. Declares null and void a proposed rule and guideline concerning GMP exceptions for positron emission tomography drug products. Prohibits proposing another regulation or guideline on the same matters. (Sec. 18) Directs the Secretary to meet with other countries to discuss regulatory requirement harmonization. (Sec. 19) Prohibits the Secretary from relying on statements not promulgated in accordance with rulemaking requirements to require any action under the FDCA. (Sec. 20) Mandates training for FDA employees on FDCA regulations and policies. (Sec. 21) Regulates: (1) the delegation of authority under the FDCA; and (2) communication to non-FDA persons regarding certain matters before completion of an investigation. (Sec. 23) Amends the Public Health Service Act to regulate biological products in interstate commerce, including requiring certain licensing and labeling. Mandates regulations regarding diagnostic testing kits using topically applied allergenic products. Applies specified FDCA provisions to all biological products and deems references in those provisions to new drug applications to include product license applications for biological products. Regulates biological product labeling and advertising. Mandates a report to specified congressional committees regarding a single license for the regulation of blood and blood products covering multiple locations under single management. (Sec. 24) Allows but limits the regulation of human tissue and cord blood. (Sec. 25) Amends the FDCA to provide for expanded access to investigational drugs. (Sec. 26) Regulates the new drug process regarding radiopharmaceuticals. (Sec. 27) Prohibits release to the public of confidential patient and donor identifying information from licensed or registered establishments. (Sec. 28) Prohibits States and subdivisions from regulating food, drugs, or cosmetics, subject to exception. (Sec. 29) Mandates a demonstration program of grants for centers to conduct research regarding specified aspects of drugs, devices, and biological products. Authorizes appropriations.

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Documents

6 official files

• Reported in House (text)

  Reported in House · EN · 7 October 1997

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• Reported in House (PDF)

  Reported in House · EN · 7 October 1997

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• Passed House amended

  summary · EN · 7 October 1997

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• Introduced in House (text)

  Introduced in House · EN · 23 April 1997

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• Introduced in House (PDF)

  Introduced in House · EN · 23 April 1997

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• Introduced in House

  summary · EN · 23 April 1997

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