Bill summaries are authored by CRS.

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Conference report filed in House (11/09/1997)

TABLE OF CONTENTS:

Title I: Improving Regulation of Drugs

Subtitle A: Fees Relating to Drugs

Subtitle B: Other Improvements

Title II: Improving Regulation of Devices

Title III: Improving Regulation of Food

Title IV: General Provisions

Title V: Effective Date

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

(Sec. 103) 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 proposing new 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 Allows fee refund if an application or supplement is withdrawn.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).

(Sec. 107) Terminates, on specified dates, the effectiveness of the amendments made by this subtitle.

Subtitle B: Other Improvements - 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. Limits deferrals after a specified date.

(Sec. 112) Directs the Secretary of Health and Human Services, at the request of a new drug's sponsor, 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. 113) Amends the Public Health Service Act to mandate a data bank of information on clinical trials for drugs for serious or life-threatening conditions. Authorizes appropriations. Requires a determination of the feasibility of including device investigations in the data bank.

(Sec. 114) Amends the FDCA to prohibit 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 FDCA or 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. 115) 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. 116) 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. 117) 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. 118) 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. 119) Modifies new drug requirements regarding: (1) application contents and review; and (2) the use of scientific advisory panels.

(Sec. 121) 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. 122) Mandates regulations regarding the approval of radiopharmaceuticals.

(Sec. 123) Amends the 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. Declares that the FDCA applies to biological products, except that a product for which a license has been approved under the PHSA shall not be required to have a new drug application under the FDCA.

(Sec. 124) Amends the FDCA to allow a pilot or other small facility to be used to demonstrate drug or animal drug safety and effectiveness.

(Sec. 125) Repeals provisions relating to the certification of drugs containing insulin or antibiotics. Allows insulin and antibiotic exports without regard to certain requirements.

(Sec. 126) Replaces the requirement that prescription-only drugs bear the label phrase "Caution: Federal law prohibits dispensing without prescription" with a minimum requirement of a label designation "Rx only." Removes provisions requiring that certain substances be labeled "Warning--May be habit forming."

(Sec. 127) Makes specified provisions of the FDCA inapplicable to a drug product that is compounded by a licensed pharmacist or licensed physician on the order of a licensed physician or other licensed practitioner authorized by State law to prescribe drugs. Imposes other requirements regarding compounding.

(Sec. 128) Amends a specified public law to authorize grants (currently, a grant) for a pilot program for training individuals in clinical pharmacology at medical schools (currently, at a medical school without such a program). Authorizes appropriations.

(Sec. 129) Mandates regulations for over-the-counter sunscreen products for the prevention or treatment of sunburn.

(Sec. 130) Amends the FDCA to set forth requirements regarding postmarketing studies and related reports.

(Sec. 131) Requires a manufacturer that is the sole manufacturer of a drug, biological product, or device to notify the Secretary of a discontinuance of manufacture of the drug or device if it: (1) is life supporting or sustaining or intended for the prevention of a debilitating disease or condition; (2) has been approved under specified provisions; and (3) was not originally derived from human tissue and replaced by a recombinant product. 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 and reclassification; (13) classification panels; and (14) premarket approval application review.

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

(Sec. 211) Modifies requirements regarding: (1) device tracking; and (2) postmarket surveillance.

(Sec. 213) 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 regulations limiting user reporting to a user facility subset constituting a representative profile of user reports.

(Sec. 215) Expresses the sense of the Congress that the availability of a safe, effective, noninvasive blood glucose meter would greatly enhance the health and well-being of all people with diabetes.

(Sec. 216) Allows, six years after application approval, use by the Secretary of application information in approving devices, determining whether product development protocols have been completed, establishing a performance standard or special control, and classifying devices. Modifies requirements regarding referral of a proposed product development protocol to a classification panel.

(Sec. 217) Declares that device effectiveness is to be determined by well-controlled investigations, including one or more clinical investigations (currently, including clinical investigations).

Title III: Improving Regulation of Food - Amends provisions relating to food nutrition levels and health-related claims to empower the Secretary to make certain regulations effective on publication.

(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. 306) Prohibits construing specified FDCA provisions to require that a food label include a separate radiation disclosure statement more prominent than the declaration of ingredients.

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

(Sec. 308) Prohibits implementation of any requirement banning, as an unapproved food additive, lead and cadmium based enamel in the lip and rim area of glass and ceramic ware before one year after the requirement is published. Regulates the circumstances in which such a ban may be imposed.

(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. Authorizes appropriations for the notification program.

Title IV: General Provisions - Allows a manufacturer, in certain circumstances, to disseminate to health care practitioners, pharmacy benefit managers, health insurance issuers, 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 or device 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. Mandates a study and report to specified congressional committees by the Comptroller General regarding: (1) the impact of this paragraph on Department of Health and Human Services resources; and (2) the scientific issues raised by this paragraph.

(Sec. 402) Authorizes the Secretary to authorize the shipment of investigational drugs or investigational devices for the diagnosis, monitoring, 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 or device 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 or investigational device exemption (IDE) if certain requirements are met.

(Sec. 403) Mandates: (1) performance standards for the prompt review of supplemental applications for approved articles; (2) final guidances regarding the approval of such supplemental applications; (3) designation of an individual in each Food and Drug Administration (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 National Institutes of Health (NIH), professional medical and scientific societies, and other persons regarding such applications.

(Sec. 404) Directs the Secretary, if there is a scientific controversy between the Secretary and a sponsor, applicant, or manufacturer and no specific FDCA or PHSA 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, including a review by a scientific advisory panel or advisory committee described under certain provisions.

(Sec. 405) Regulates the development, availability, and effect of guidance documents. Mandates a regulation specifying FDA policies and procedures for guidance document development, issuance, and use.

(Sec. 406) Sets forth an FDA mission statement. Directs the Secretary to publish: (1) a plan bringing the Secretary into compliance with each of the Secretary's obligations under the FDCA; and (2) an annual report on the Secretary's performance under the plan.

(Sec. 407) Mandates an information system to track applications and submissions to the FDA.

(Sec. 408) Requires training for FDA employees on FDCA regulatory responsibilities and policies.

Authorizes the conduct and support, through fellowships and other training programs, of intramural research training for predoctoral and postdoctoral scientists and physicians.

Mandates fellowship and training programs, through the Centers for Disease Control and Prevention, to train individuals in disease detection and prevention methods.

(Sec. 409) Amends the PHSA to mandate a demonstration program of grants for centers to conduct research concerning drugs, biological products, and devices with regard to: (1) increasing awareness of new uses, ways to improve effective use, risks of new uses, and risks of combinations of drugs and biological products; (2) providing clinical information to providers of goods and services, benefit managers, insurers, governmental agencies, and consumers; and (3) improving care quality while reducing cost. Authorizes appropriations.

(Sec. 410) Amends the FDCA to modify requirements regarding good manufacturing practice regulations (including foreign harmonization and mutual recognition) and inspections.

(Sec. 411) 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. 412) Prohibits State and political subdivision requirements (inconsistent with this Act): (1) regarding the regulation of a nonprescription human or veterinary drug or the labeling or packaging of 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 exception.

(Sec. 413) 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 religious ceremonies.

(Sec. 414) Mandates programs and policies that foster collaboration between the FDA, the NIH, and other science-based Federal agencies.

(Sec. 415) Authorizes a contract with any organization or individual with relevant expertise to review, evaluate, and make recommendations on part or all of any application or submission regarding approval or classification of an article or biological product. Authorizes use of that authority when such a contract will improve a review's: (1) timeliness unless using such a contract would reduce the quality or unduly increase the cost of the review; or (2) quality unless using such a contract would unduly increase review cost.

(Sec. 416) Allows a person who submits an application or submission to submit a request regarding: (1) classification of the article as a drug, biological product, or device; or (2) the FDA component that will regulate the article.

(Sec. 417) Requires (currently, allows) a foreign establishment that manufactures, processes, etc., a drug or device to register with the Secretary. Authorizes cooperative arrangements with officials of foreign countries to ensure that means are available to determine whether drugs or devices from such an establishment shall be refused admission to the United States on the grounds specified in existing provisions.

(Sec. 418) Requires that any person seeking to export an imported article under provisions relating to the disposition of goods after a decree of condemnation establish that the article was intended for export at the time the article entered commerce.

(Sec. 419) Presumes the existence of a connection with interstate commerce in any action to enforce FDCA requirements regarding a device, food, drug, or cosmetic (currently, regarding a device).

(Sec. 420) Prohibits construing a safety report or other information submitted (or required to be submitted) by an entity about the safety of a product to necessarily reflect a conclusion by the entity or the Secretary that the report or information is an admission that the product malfunctioned or otherwise caused or contributed to a death, injury, or illness.

(Sec. 421) 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.

Title V: Effective Date - Sets forth the general effective date of this Act.