Summary: H.R.1411 — 105th Congress (1997-1998)All Information (Except Text)

Bill summaries are authored by CRS.

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Passed House amended (10/07/1997)


Title I: Improving Regulation of Drugs

Title II: Improving Regulation of Devices

Title III: Improving Regulation of Food

Food and Drug Administration Regulatory Modernization Act of 1997 - Title I: Improving Regulation of Drugs - Amends Federal Food, Drug, and Cosmetic Act (FDCA) provisions regarding fees relating to drugs to revise and add various definitions.

Makes the fee (currently, 50 percent of the fee) for human drug applications or supplements due on submission. Mandates a refund of 75 (currently, 50) percent if the application or supplement is refused for filing. Exempts from the fee: (1) an application for a drug for a rare condition (orphan drug) or a supplement proposing a new indication for a rare condition; and (2) supplements for indications for use in pediatric populations. Allows fee refund if an application or supplement is withdrawn. Modifies requirements regarding: (1) the annual prescription drug establishment fee; (2) the prescription drug product fee; (3) fee amounts; (4) fee adjustments; (5) fee waiver or reduction; (6) assessment of fees; and (7) crediting and availability of fees (including authorizing appropriations). Terminates, on specified dates, the effectiveness of the amendments made by this paragraph.

(Sec. 102) Allows for additional deferred effective dates for the approval of certain new drug applications to allow for additional pediatric information developed by further studies. Mandates development, prioritization, publication, and annual updating of a list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. Prohibits granting a period of market exclusivity under these provisions after a specified date.

(Sec. 103) Directs the Secretary to facilitate development and expedite review of new drugs intended for serious conditions and demonstrating the potential to address unmet medical needs for those conditions. Terms such products "fast track products." Sets forth designation requirements and procedures.

(Sec. 104) Authorizes the Secretary of Health and Human Services to authorize the shipment of investigational drugs for the diagnosis or treatment of a serious disease or condition in emergency situations.

Authorizes any person, through a licensed physician, to request, and any manufacturer or distributor to provide to the physician, such a drug if specified requirements are met.

Directs the Secretary, after submission of a protocol intended to provide widespread access, to permit expanded access under a treatment investigational new drug (IND) application if certain requirements are met.

(Sec. 105) Amends the Public Health Service Act to mandate a program in the National Institutes of Health (NIH) regarding information on research relating to the treatment, detection, and prevention of serious conditions, including establishing, and disseminating information from, a data bank of information on clinical trials for related drugs and biologicals. Authorizes appropriations.

(Sec. 106) Amends the FDCA to allow a manufacturer, in certain circumstances, to disseminate to health care practitioners, pharmacy benefit managers, health insurance insurers, group health plans, or government agencies certain information on the safety, effectiveness, or benefit of a use not described in the approved labeling of a drug if the manufacturer meets certain requirements. Allows the Secretary, on ordering a manufacturer to cease dissemination, to order the manufacturer to correct information that has been disseminated. Makes failure to comply with this section a prohibited act. Terminates the effectiveness of the amendments made by this section on a specified date.

(Sec. 107) Mandates a study and report to specified congressional committees by the Comptroller General regarding the impact of, and the scientific issues raised by, section 106.

(Sec. 108) Mandates: (1) performance standards for the prompt review of supplemental applications for approved drugs; (2) final guidances regarding the approval of such supplemental applications; (3) designation of an individual in each FDA center to encourage prompt review and work with sponsors to facilitate the development and submission of data to support such applications; and (4) programs and policies to foster collaboration between the FDA, the NIH, professional medical and scientific societies, and other persons regarding such applications.

(Sec. 109) Prohibits considering health care economic information provided to a formulary committee or similar entity false or misleading if the information directly relates to an indication approved under specified provisions of the Public Health Service Act (PHSA) for that drug and is based on competent and reliable scientific evidence. Declares that the requirements of specified PHSA provisions do not apply to information provided under this paragraph.

(Sec. 110) Declares that, if the Secretary determines that data from one clinical investigation and confirmatory evidence (obtained before or after the investigation) are sufficient to establish effectiveness, the Secretary may consider that data and evidence to constitute substantial evidence.

Amends the PHSA to mandate development of guidance on the inclusion of women and minorities in clinical trials.

(Sec. 111) Amends the FDCA to regulate new drug manufacturing changes, including requiring manufacturer validation of the effects of the change and setting forth separate requirements for major and non-major changes.

(Sec. 112) Allows a new drug clinical investigation to begin 30 days after specified materials have been submitted to the Secretary unless the Secretary prohibits conducting the investigation.

(Sec. 113) Mandates guidance that describes when abbreviated study reports may be submitted in lieu of full reports with a new drug application and with a biologics license application.

(Sec. 114) Modifies new drug requirements regarding: (1) application contents and review; and (2) the use of scientific advisory panels.

(Sec. 116) Directs the Secretary, if there is a scientific controversy between the Secretary and a sponsor, applicant, or manufacturer and no specific FDCA provision or regulation provides a right of review, to establish by regulation a procedure under which that party may request a review of the controversy by a scientific advisory panel.

(Sec. 117) Regulates the development, availability, and effect of guidance documents.

(Sec. 118) Declares a compounded positron emission tomography drug adulterated if it does not conform to the compounding standards and the official monographs of the United States Pharmacopoeia (but sets expiration dates for this provision). Mandates procedures for the approval of, and good manufacturing practice requirements regarding, such drugs. Exempts, until specified dates, such drugs (if not adulterated) from new drug and abbreviated new drug approval requirements. Mandates termination of specified related notices and a related rule.

(Sec. 119) Mandates regulations regarding the approval of radiopharmaceuticals designed for diagnosis and monitoring of diseases and conditions.

(Sec. 120) Amends the Public Health Service Act (PHSA) to revise requirements regarding: (1) introducing biological products into interstate commerce, including related license approval and labeling requirements; and (2) inspection of biological product facilities. Modifies requirements regarding the certification of clinical laboratories.

(Sec. 121) Amends the FDCA to allow a pilot or other small facility to be used to demonstrate drug or animal drug safety and effectiveness.

(Sec. 122) Repeals provisions relating to the certification of drugs containing insulin or antibiotics. Allows insulin and antibiotic exports without regard to certain requirements. Declares that the antibiotic provision repeal does not apply to drugs that contain antibiotic drug ingredients that had approved or pending applications before enactment of this Act.

(Sec. 123) Sets forth an FDA mission statement. Mandates an annual report to specified congressional committees regarding FDA performance, staffing, and resources and listing bilateral and multinational meetings held by the FDA to reduce regulatory burdens, harmonize regulation, and seek reciprocal arrangements.

(Sec. 124) Mandates an information system to track applications and submissions to the FDA.

(Sec. 125) Mandates training for FDA employees on FDCA regulations and policies.

(Sec. 126) Mandates a demonstration program of grants for centers to conduct research regarding specified aspects of drugs. Authorizes appropriations.

(Sec. 127) Directs the Secretary to meet with representatives of other countries to discuss regulatory requirement harmonization.

(Sec. 128) Requires that an environmental impact statement prepared under specified regulations be considered to meet the requirements for a detailed statement under specified provisions of the National Environmental Policy Act of 1969.

(Sec. 129) Prohibits State and political subdivision requirements (inconsistent with this Act): (1) regarding the regulation of a nonprescription human drug or a cosmetic; and (2) not identical to a requirement of the FDCA, the Poison Prevention Packaging Act of 1970, or the Fair Packaging and Labeling Act, subject to exemptions and exclusions.

Adds references to nonprescription drugs to provisions authorizing inspections of places where drugs are manufactured, processed, packed, or held.

Modifies labeling requirements regarding the designation of drugs or devices by established names.

(Sec. 130) Mandates studies of: (1) mercury compounds intentionally introduced into drugs and foods; and (2) the effect on humans of mercury compounds in nasal sprays.

Mandates a study of the effect on humans of the use of elemental organic or inorganic mercury when offered for sale as a drug or dietary supplement. Directs the Secretary, if in the opinion of the Secretary such sale poses a threat to human health, to promulgate regulations restricting such sale. Prohibits such regulations, to the extent feasible, from unnecessarily interfering with the availability of mercury for use in religious ceremonies.

(Sec. 131) Requires a manufacturer that is the sole manufacturer of a drug, biological product, or device that is life supporting or sustaining or intended for the prevention of a debilitating disease or condition and that has been approved under specified provisions to notify the Secretary of a discontinuance of manufacturing of the drug or device. Directs the Secretary to distribute discontinuation information to appropriate physician and patient organizations.

Title II: Improving Regulation of Devices - Revises or imposes requirements regarding: (1) investigational device exemptions; (2) expanded access procedures permitting the use of a device for the diagnosis, monitoring, or treatment of conditions that are life- threatening or could be irreversibly debilitating; (3) premarket approval requirements (mandating a device review priority); (4) humanitarian device exceptions; (5) safety and effectiveness device standards (allowing recognition of self-certifiable standards); (6) effectiveness determinations (as used in classifying devices); (7) reliance on postmarket controls to expedite classification; (8) substantial equivalence; (9) labeling (as affecting premarket approval); (10) supplemental applications; (11) premarket notification; (12) initial classification; (13) classification panels; and (14) premarket approval application review.

(Sec. 210) Mandates accreditation of persons to review and initially classify devices.

(Sec. 211) Mandates publication of a list of types of class III devices that are not subject to regulation under specified provisions and for which the Secretary has determined that premarket approval is unnecessary, requiring each to be reclassified into class II or class I.

(Sec. 212) Modifies requirements regarding: (1) device tracking; (2) postmarket surveillance; and (3) good manufacturing practice regulations (including foreign harmonization) and inspections.

(Sec. 215) Modifies recordkeeping and reporting requirements applicable to distributors. Removes reporting requirements regarding annual report filing certifications. Removes references to distributors from provisions relating to removals and corrections. Exempts wholesale distributors who do not manufacture, repackage, process, or relabel a device from provisions requiring annual registration of producers of drugs or devices. Modifies device user facility reporting requirements. Requires, for such facilities that are hospitals or nursing homes, user reporting regulations limiting user reporting to a user subset that constitutes a representative profile of user reports.

(Sec. 217) Prohibits considering a computer software product a device solely because its primary use is related to the provision of health care.

(Sec. 218) Removes from the list of prohibited acts provisions prohibiting, on a drug's or device's labeling or advertising, any suggestion that approval of an application is in effect under, or that the drug or device complies with, specified FDCA provisions.

(Sec. 219) Modifies FDA annual report content requirements.

(Sec. 220) Requires that the information system for tracking applications and submissions to the FDA requesting agency action (mandated by section 124 of this Act) permit, with regard to devices, access by applicants.

(Sec. 221) Declares that it is the sense of the Congress that the availability of a safe, effective, noninvasive glucose meter would greatly enhance the health and well-being of all people with diabetes.

Title III: Improving Regulation of Food - Amends provisions relating to food nutrition levels and health-related claims to allow certain regulations to be effective on publication at the discretion of the Secretary of Health and Human Services.

(Sec. 302) Modifies requirements regarding petitions to issue a regulation on health-related claims.

(Sec. 303) Allows a health or nutrient content claim not authorized by the Secretary if: (1) a U.S. governmental scientific body with public health protection or research responsibility directly relating to human nutrition or the National Academy of Sciences has published an authoritative statement, currently in effect, about the relationship to which the health claim refers or that identifies the nutrient level to which the nutrient claim refers; (2) a person has notified the Secretary; (3) the claim and food are in compliance with certain requirements; and (4) the claim is stated in a way that it is an accurate representation of the authoritative statement and in a way that it enables the public to understand the information and its significance.

(Sec. 305) Requires, if a nutrient claim is made and the food contains a nutrient at a level that increases to persons in the general population the risk of a disease or health-related condition that is diet-related, that the label contain, close to the claim, a statement referring to the nutrition information elsewhere on the label.

(Sec. 307) Mandates a: (1) final determination on any pending petition that would permit red meat irradiation; and (2) report to specified congressional committees regarding the process followed in reviewing that petition.

(Sec. 308) Prohibits: (1) implementation of any requirement banning, as an unapproved food additive, lead and cadmium based paints in the lip and rim area of glass and ceramic ware before one year after the requirement is published; and (2) banning such paints on glass and ceramic ware meeting specified criteria.

(Sec. 309) Deems a food contact substance (a substance used as a component of materials used in manufacturing, packing, packaging, transporting, or holding food, but not intended to have any technical effect in the food) unsafe and the food adulterated unless: (1) there is (and the substance is in conformity with) a regulation prescribing the conditions under which the substance may be safely used; or (2) the manufacturer or supplier has notified the Secretary of the identity and intended use of the substance and the manufacturer's or supplier's determination that the substance is safe under a specified standard.

(Sec. 310) Revises oleomargarine sale and labeling requirements. Repeals provisions relating to: (1) a congressional declaration of policy regarding oleomargarine sales; and (2) noncontravention of State oleomargarine laws.