H.R.3199 - Drug and Biological Products Reform Act of 1996104th Congress (1995-1996)
Summary: H.R.3199 — 104th Congress (1995-1996)
Introduced in House (03/29/1996)
Drug and Biological Products Reform Act of 1996 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to set forth the mission of the Food and Drug Administration (FDA) and mandate an annual report 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: (1) review applications for new drugs or for certification of insulin-containing drugs; and (2) conduct good manufacturing practice (GMP) inspections.
(Sec. 9) Allows applicants to declare an impasse in a review or a submission for an investigational use exemption and mandates use of a dispute resolution process.
(Sec. 10) Adds references to accredited persons to provisions relating to GMP inspections. Imposes post-inspection requirements. Deems certain chemistry, manufacturing, and controls to comply with current GMP and prohibits actions to delay or prevent the manufacture or marketing of a drug for failure to conform to GMP, subject to exception.
(Sec. 12) Allows a new drug manufactured in a small facility to be used to show safety and effectiveness.
(Sec. 13) Regulates changes in the manufacture of a new drug, biological product, new animal drug, blood, or blood component.
(Sec. 14) Repeals provisions relating to the certification of drugs containing insulin or antibiotics.
(Sec. 15) 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. 16) Mandates an applicant-accessible information system to track applications and submissions to the FDA.
(Sec. 17) Prohibits actions by the Secretary of Health and Human Services from requiring an environmental impact statement or environmental assessment.
(Sec. 18) Regulates drugs compounded by a licensed pharmacist on the order of a licensed physician.
(Sec. 19) Directs the Secretary to meet with foreign countries to discuss harmonization of regulatory requirements.
(Sec. 20) Controls the effect of the dissemination of medical texts, peer-reviewed scientific publications, and other material.
(Sec. 21) Prohibits the Secretary from relying on statements not promulgated in accordance with rulemaking requirements to require any action under the FDCA.
(Sec. 22) Mandates training for FDA employees on regulations and policies under the FDCA.
(Sec. 23) Regulates: (1) the delegation of authority under the FDCA; (2) judicial review of decisions regarding investigational new drugs and new drugs; and (3) communication to non-FDA persons regarding certain matters before completion of an investigation.
(Sec. 26) Defines "biological product" and "human tissue." Declares that blood, a blood component, an organ, milk, or human tissue is not a drug.
Prohibits subjecting computer software developed or modified by, or used in, a human tissue establishment to any premarket clearance requirement. Requires such software to be validated to demonstrate that it achieves its intended purpose before use and subjects it to the GMP requirements of the FDCA.
Requires licenses to introduce biological products, blood, and blood components into interstate commerce. Regulates licensing.
Allows regulation of human tissue only if the Secretary demonstrates that voluntary regulation is inadequate to protect the public health. Provides for such regulation.