CHAPTER 2

FDA AUTHORITY

Return to Manual Table of Contents

CONTENTS

SUBCHAPTER - SELECTED AMENDMENTS TO THE  FEDERAL FOOD, DRUG, AND COSMETIC ACT(FFD&C Act)

Drug Price Competition and Patent Term Restoration Act of 1984...............33
Anti-Drug Abuse Act of 1988..................................................34
Orphan Drug Act..............................................................34
Health Promotion and Disease Prevention Amendments of 1984...................34
Orphan Drug Amendments of ...................................................34
Prescription Drug User Fee Act of 1992 ......................................35
Generic Drug Enforcement Act of 1992 ........................................35
Drug Export Amendments Act of 1986 ..........................................35
Prescription Drug Marketing Act of 1987 .....................................36
Generic Animal Drug and Patent Term Restoration Act .........................36
Infant Formula Act of 1980 ..................................................36
Saccharin Study and Labeling Act ............................................37
Comprehensive Smokeless Tobacco and Health Education Act of 1986 ............37
Nutrition Labeling and Education Act of 199 .................................37
Dietary Supplement Health and Education Act of 1994 .........................38
Safe Medical Devices Act of 1990 ............................................39
Radiation Control for Health and Safety Act of 1968 .........................40

SUBCHAPTER - OTHER LAWS

Federal Import Milk Act .....................................................40
Pesticide Monitoring Improvements Act of 1988 ...............................40
Anti-Drug Abuse Act .........................................................41
AIDS Amendments of 1988 .....................................................41
Federal Anti-Tampering Act ..................................................41
Public Health Service Act (PHSA) - Biological Products (Part F, Subpart 1)...42
Public Health Service Act (PHSA) - Control of Communicable Diseases (Part G).42
The Mammography Quality Standards Act of 1992 ...............................42
Sanitary Food Transportation Act of  1990 ...................................42
Technical and Miscellaneous Revenue Act of 1988 .............................43
Equal Access to Justice Act (EAJA)...........................................43

-------------------------

SUBCHAPTER

SELECTED AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

(FFD&C Act)

DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984 (DPCPTRA)

On September 24, 1984, the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law (P.L.) 98-417) was enacted. The DPCPTRA consists of two different titles. Title I authorizes the approval of duplicate versions of approved drug products (other than those reviewed and approved under Section 507 of the FFD&C Act (21 United States Code (U.S.C.) 357) under an Abbreviated New Drug Application (ANDA) procedure. Title II authorizes the extension of patent terms for approved new drug products (including antibiotics and biological drug products), some medical devices, food additives, and color additives. Congress intends these provisions to provide a careful balance between promoting competition among brand-name and duplicate or "generic" drugs and encouraging research and innovation.

Title I also amends Section 505 of the FFD&C Act (21 U.S.C. 355) by requiring all New Drug Application (NDA) applicants and holders to provide certain patent information, requiring ANDA applicants to certify as to the status of patents claiming the drug product they intend to copy, providing for the submission and approval of applications for which the investigations relied on by the applicant to satisfy the "full reports" of safety and effectiveness requirements were not conducted by the applicant or for which the applicant had not obtained a right of reference or use from the person who conducted the investigations, establishing rules for disclosure of safety and effectiveness data submitted as part of an NDA, and providing specific time periods during which an NDA or an ANDA cannot be submitted or approved. The DPCPTRA also required the Food and Drug Administration (FDA) to promulgate new regulations implementing the statute.

ANTI-DRUG ABUSE ACT OF 1988

The Anti-Drug Abuse Act of 1988 (P.L. 100-690) amends the FFD&C Act by providing severe criminal penalties for the distribution of anabolic steroids and human growth hormones without a doctor's prescription. It subjects persons convicted of illegally distributing these drugs to up to six years in prison and fines. Convicted violators subject to a sentence of more than a year in prison will be thereby subject to the Controlled Substances Act (law governing addictive substances) and will be subject to criminal forfeiture of property (cars, boats, and home) used to support the illegal distribution or purchased with the profits.

ORPHAN DRUG ACT (ODA)

The Orphan Drug Act (P.L. 97-414) consists of amendments to the FFD&C Act as well as tax credit and grant provisions. The amendments to the FFD&C Act (Sections 525, 526, 527, and 528) encourage the development of products rather than regulate products and practices. These sections were enacted to provide incentives for sponsors seeking to develop products for rare diseases or conditions.

Under these provisions, the Agency will, upon request, provide written recommendations for the nonclinical and clinical investigations of a drug intended to treat a rare disease or condition. These recommendations may specify the investigations which will be adequate or required to obtain marketing approval for the drug.

Additionally, a sponsor of a drug may request a ruling on whether a drug can be formally designated as an orphan drug for a rare disease or condition. Orphan drug designation is a prerequisite for obtaining most of the incentives under the ODA. "Rare disease or condition" is defined as one that (1) affects less than 200,000 persons in the United States (U.S.), or (2) affects more than 200,000 persons, but the drug sponsor has no reasonable expectation of recovering development costs through U.S. sales.

If the Agency agrees that a drug meets the statutory definition for a designated orphan drug, the sponsor is entitled to a tax credit for the cost of clinical trials conducted with the drug on the orphan indications before marketing approval. Further, upon the date of new drug approval or biological licensure of a designated orphan drug, another sponsor's application for marketing the same drug for the same orphan use may not be approved for a period of seven years. In order to maintain exclusivity, the sponsor must ensure an adequate supply of the drug.

The Agency must also encourage sponsors who are designing investigational studies on orphan drugs to include provisions whereby those who need the drug may be added to the study.

Under Section 5 of the ODA, the Agency may make grants to and enter into contracts with public and private entities and individuals to assist in defraying the costs of qualified clinical testing expenses incurred in connection with the development of drugs, biological products, devices, and medical foods for rare diseases and conditions.

HEALTH PROMOTION AND DISEASE PREVENTION AMENDMENTS OF 1984 (HPDPA)

On October 30, 1984, the President signed into law the HPDPA (P.L. 98-551) and extended the provisions of the Public Health Service Act relating to health promotion and disease prevention, and to provide for the establishment of centers for research and demonstrations concerning health promotion and disease prevention.

Of particular interest to FDA is a provision that amends the definition of an orphan drug in two of the three places in which it appears in the Orphan Drug Act. Under the new definition, a drug would qualify as an orphan if it is for a disease or condition that affects fewer than 200,000 persons in the U.S. The old definition required evidence that costs of development would not be recouped by sales. This definition based on profitability is retained, however, in the section that governs the award of tax credits.

ORPHAN DRUG AMENDMENTS OF 1988 (ODA OF 1988)

On April 18, 1988, the President signed into law the Orphan Drug Amendments (P.L. 100-290) to the Orphan Drug Act. The ODA of 1988 extends the authorization for the orphan drug grant program for three years, and expands the scope of the grants program to include medical foods and devices. The ODA of 1988 also directs the Secretary of Health and Human Services (Secretary) to study whether the other incentives in the FFD&C Act and other laws, e.g., tax credits and marketing exclusivity, should be available to orphan medical foods and orphan devices, and requires that companies that choose to stop production of an approved orphan drug provide notice to FDA one year prior to discontinuing the drug.

PRESCRIPTION DRUG USER FEE ACT OF 1992

Title I of the Prescription Drug User Fee Act of 1992 (P.L. 102-571) amends the FFD&C Act to authorize human drug application, prescription drug establishment, and prescription drug product fees. The funds would be devoted to expediting the prescription drug review process.

A fee is assessed on human drug applications or supplements submitted on or after September 1, 1992. This includes prescription drugs approved for over-the-counter (OTC) use, and new drug applications for OTC drugs. A human drug application or supplement submitted by a person subject to the fees will be incomplete and will not be accepted for filing until all fees are paid.

Each person who owns a prescription drug establishment where at least one prescription drug product is manufactured (which is not the same as a product approved under Section 505(b)(2) (a paper NDA) or Section 505(j) (a generic ANDA), and after September 1, 1992 had pending before the Secretary a human drug application or supplement is subject to an annual fee payable on or before January 31 of each year.

Each person named as an applicant in a human drug application for a prescription drug product listed under Section 510, and who after September 1, 1992 had a human drug application or supplement pending before the Secretary shall pay an annual fee for each prescription drug product. The fee is payable, at the time of listing the product, in each calendar year. The fee is paid only once a year for each prescription drug product listed irrespective of the number of times the product is listed under Section 510.

A business with fewer than 500 employees (including employees of affiliates) and which does not have a prescription drug product introduced or delivered for introduction into interstate commerce shall pay one-half of the fee amount for the human drug applications it submits, but shall pay the full fee for supplements. Such a business would not be required to pay any portion of the fee until 1 year after the date of the submission of the application.

GENERIC DRUG ENFORCEMENT ACT OF 1992 (GDEA)

The Generic Drug Enforcement Act (P.L. 102-282), signed into law on May 13, 1992, amended the FFD&C Act (Sections 306-308) to authorize the FDA to debar an individual, convicted of certain crimes or found to have engaged in certain types of conduct, from providing any services to a drug product applicant. The GDEA also authorizes FDA to debar a firm convicted of certain crimes from obtaining or participating in certain subsequent drug approvals. This debarment extends to persons working for applicants of human, animal, and biological drug products.

If an applicant knowingly uses a debarred individual or firm, the applicant may be fined up to $1 million. If a debarred individual works for an applicant, the individual may be fined up to $250,000.

Applicants for drug product approval are required to certify that they did not and will not use the services of a debarred individual or firm in any capacity in connection with the application. Section 306(k) further requires that applicants for approval of certain generic drugs provide information concerning criminal convictions of individuals and firms involved in the applications.

DRUG EXPORT AMENDMENTS ACT OF 1986 (DEAA)

Under the Drug Export Amendments Act of 1986 (P.L. 99-660) unapproved drugs and biological products may be exported to any one of 21 countries listed in the DEAA. These countries have premarket approval systems comparable to FDA's. To be exported, the drug must be approved for use in the importing country. In addition, the drug must be the subject of an Investigational New Drug Application (IND) and the drug manufacturer must be actively pursuing marketing approval in the U.S. FDA must not have found that exporting the drug is contrary to the public health interest of the U.S. Also, the exported drug must be manufactured in accordance with current Good Manufacturing Practice (GMP) Regulations and labeled in accordance with the FFD&C Act.

An unapproved drug for the treatment or prevention of tropical diseases may be exported if FDA finds that the drug is safe and effective for use in the country to which it is being exported, and FDA has not found that export of such drug is harmful to the public health interest of the U.S. The drug must also meet current GMP and labeling requirements.

Under specified circumstances a partially processed biological product may be exported to any of the 21 listed countries. A partially processed product is defined as any biological product that must undergo significant further manufacturing processes before it is usable as a finished product for the prevention or treatment of disease. The DEAA requires that the finished product be approved in the importing country or that approval be sought. FDA must not have found that export of the drug is contrary to the public health interest of the U.S. or the importing country. In addition, the product must be manufactured in conformance with current GMP and be properly labeled.

PRESCRIPTION DRUG MARKETING ACT OF 1987 (PDMA)

The Prescription Drug Marketing Act (P.L. 100-293), which became law in 1988, amended the FFD&C Act to prohibit the reimportation of U.S. produced prescription drugs by persons other than the manufacturer except when authorized by the Secretary for emergency medical care.

Section 503 of the FFD&C Act, as amended by the PDMA, prohibits selling, purchasing, or trading of prescription drug samples and drug coupons. A drug sample is a unit of drug which is not intended to be sold and is intended to promote the sale of the prescription drug product, and a coupon is a form that may be redeemed at no cost or reduced cost for a prescription drug. Counterfeiting of drug coupons is also prohibited. The FFD&C Act also prohibits resale of prescription drugs purchased by hospitals, or other health care entities, or donated or supplied at reduced cost to charitable organizations. The FFD&C Act provides exemptions for group purchasing organizations, non-profit affiliates, and entities under common control. Additional exceptions provide for medical emergencies and for dispensing of drugs pursuant to a prescription.

A manufacturer or distributor is permitted to distribute drug samples to a licensed practitioner or pharmacy of a health care entity by common carrier or through marketing representatives upon written request. Certain drug sample records must be maintained by manufacturers and distributors, and made available to government officials on request. Manufacturers and distributors must maintain prescription drug samples in a manner that will prevent their contamination, deterioration, or adulteration. They must have systems to monitor and audit the distribution of their drug samples; they must provide FDA with the name and phone number of an employee or agent in charge of drug samples; and they must maintain lists of representatives and drug sample storage sites. Manufacturers and distributors must notify FDA of drug sample losses and thefts, and convictions of their representatives for illegal trafficking in drug samples.

A wholesale drug distributor of prescription drugs must be licensed by the State where it does business. State licensing laws must meet minimum Federally prescribed standards. These standards include the requirements for storage, handling, and recordkeeping. Wholesale drug distributors who are not authorized distributors of record for a particular prescription drug are required to provide a statement identifying each prior sale, purchase, or trade of such drug to all wholesale and retail pharmacy customers. This statement must include the date of each transaction and the names and addresses of all parties to the transaction.

GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT (GADPTRA)

The Generic Animal Drug and Patent Term Restoration Act (P.L. 100-670), signed into law on November 16, 1988, provides for the approval of generic copies of previously approved animal drugs. Under GADPTRA, a generic animal drug product may be approved by providing evidence that it has the same active ingredients, in the same concentration, as the approved animal drug product, and that it is bioequivalent to the approved animal drug product. This information is submitted to the FDA in the form of an Abbreviated New Animal Drug Application (ANADA).

All approved new animal drugs not protected by patent or exclusivity are eligible for copying under the provision of the GADPTRA, unless the animal drug has been subsequently withdrawn from the market for safety or effectiveness reasons, or unless it is the subject of a Notice of Hearing that has been published in the Federal Register.

INFANT FORMULA ACT OF 1980 (IFA)

The Infant Formula Act of 1980 and subsequent amendments in 1986 (Section 412 of the FFD&C Act) establish nutrient requirements for infant formulas as defined by Section 201(aa) of the FFD&C Act, and provide FDA authority to establish GMPs and requirements for nutrient quantity, nutrient quality control, recordkeeping, and reporting and recall of infant formulas which pose a potential hazard to health. The IFA also extends FDA's factory inspection authority to permit access to complaint files and other manufacturers' records, quality control records, and test results necessary to determine compliance with the IFA.

The IFA specifies that an infant formula is adulterated: (1) if it fails to provide nutrients as required; (2) if it fails to meet the nutrient quality factors required by regulation; (3) if the processing is not in compliance with the appropriate GMP and quality control procedures or record retention requirements as prescribed by regulation; or (4) if it otherwise fails to comply with Section 402 of the FFD&C Act.

The IFA also requires manufacturers of infant formulas to notify FDA 90 days before any charitable or commercial distribution of any new infant formula or any infant formula that has had a major change in its formulation or processing.

Under authority of the IFA, FDA has promulgated regulations which specify infant formula nutrient quality control procedures (21 CFR 106); the labeling of infant formula; the terms and conditions under which certain infant formula may be exempt from some of the IFA's requirements; and nutrient specifications for infant formula, and infant formula recall regulations (21 CFR 107).

SACCHARIN STUDY AND LABELING ACT

The Saccharin Study and Labeling Act passed November 23, 1977, prohibited for 18 months any new regulations restricting or banning the sale of saccharin or products containing it. Congress has extended the legislation several times, most recently to May 1, 1997. It requires further scientific evaluation of the carcinogenic potential of saccharin, and a label warning: "Use of this product may be hazardous to your health. This product contains saccharin which has been determined to cause cancer in laboratory animals."

COMPREHENSIVE SMOKELESS TOBACCO AND HEALTH EDUCATION ACT OF 1986

On February 27, the President signed into law the Comprehensive Smokeless Tobacco and Health Education Act of 1986 (P.L. 99-252). Section 10 of this Act amends Section 402(d)(2) of the FFD&C Act to provide an exception to a limitation concerning the alcohol content of confectionery products. Section 402(d) provides that a confectionery is adulterated if it bears or contains "any alcohol other than alcohol not in excess of one-half of one per centum by volume derived solely from the use of flavoring extracts." Section 10 provides that this limitation shall not apply to a confectionery "which is introduced or delivered for introduction into, or received or held for sale in interstate commerce, if the sale of such confectionery is permitted under the laws of the states in which the confectionery is intended to be offered for sale."

NUTRITION LABELING AND EDUCATION ACT OF 1990 (NLEA)

In general, NLEA (P.L. 101-535) amends the FFD&C Act, and grants the Secretary explicit authority to require that all foods (except for meat and poultry) bear nutrition labeling. In addition, NLEA gives the Secretary explicit authority to regulate health claims made on food labels.

Specifically, the law does the following:

Nutrition Labeling

Deems a food misbranded unless its labeling discloses serving size; total calories and calories derived from fat; and amounts of various nutrients.

Requires that the Secretary develop and make available to retailers, nutrition information for each of the 20 most commonly consumed raw fruits, vegetables, and seafood.

Exempts various foods from nutrition labeling requirements, e.g., restaurant and deli foods, infant formula, medical foods, etc.

Health Claims

Deems food misbranded unless claims (regarding the amount of any nutrient or relating a nutrient to a health related condition) are made according to regulations promulgated by the Secretary, provided also that the food does not contain any nutrient in an amount that increases to persons in the general population the risk of a disease or health-related condition that is diet related, unless specifically allowed by the Secretary.

Requires that the Secretary establish a "procedure and standard" for establishing the validity of claims relating to dietary supplements, vitamins and minerals, and determine whether claims for four specific condition-supplement relationships are valid: folic acid and neural tube defects, antioxidant vitamins and cancer, omega-3 fatty acids and heart disease, and zinc and immune function in the elderly.

Requires that the Secretary issue regulations defining the following terms: free, low, light or lite, reduced, less, and high.

Requires that the Secretary determine whether claims regarding calcium and osteoporosis, dietary fiber and cancer, lipids and cardiovascular disease, lipids and cancer, sodium and hypertension, and dietary fiber and heart disease are appropriate.

State Enforcement

Allows States to bring actions to restrain violations of various labeling sections of the NLEA, provided that notice has been given to the Secretary and the Secretary is not already diligently prosecuting an enforcement action against the food.

Conforming Amendments

Prohibits foods from being considered drugs solely because the label bears a health claim that conforms to the requirements of NLEA.

National Uniform Nutrition Labeling

Preempts States from passing labeling laws that are not identical to Federal requirements, e.g., food standards, nutrition labeling and health claims labeling, etc.

Requires the Secretary to enter into a contract with a public or nonprofit private entity to conduct a study of State and local food labeling laws.

Ingredients

Requires that the labels of beverages containing fruit and vegetable juices declare the total percentage of juice contained therein.

Requires label declaration of certain color additives.

Requires that the labels of standardized foods declare all ingredients [rather than just optional ingredients].

Standard of Identity Regulation

Removes establishment of standards for all foods, other than dairy products and maple syrup, from formal rulemaking requirements under Section 701(e).

DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 (DSHEA)

The Dietary Supplement Health and Education Act of 1994 (P.L. 103-417) was signed into law by the President on October 25, 1994. DSHEA amends the FFD&C Act to alter significantly the way the FDA regulates dietary supplements and requires the Agency to undertake significant rulemaking and other actions to fully implement the scope of the DSHEA. In summary, DSHEA:

• redefines "dietary supplement" to include the following dietary ingredients: 1) a vitamin; 2) a mineral; 3) an herb or other botanical; 4) an amino acid; 5) another dietary substance for use by man to supplement the diet by increasing the total dietary intake; or 6) a concentrate, metabolite, constituent, extract, or combination of these ingredients. "Dietary supplements" will include articles previously approved as a drug, antibiotic, or biologic, or authorized for clinical investigation, if they had been marketed prior to such approval or authorization as a dietary supplement, unless the Secretary issues regulations finding the article to be unsafe under the FFD&C Act;
• places the burden of proof on FDA to prove that a product is unsafe before it can be removed from the marketplace;
• exempts certain third party literature from treatment as labeling if certain conditions are met with regard to content and presentation of the literature;
• establishes a series of labeling requirements with which manufacturers must comply by December 31, 1996;
• allows dietary supplement manufacturers to make statements of nutritional support ("structure" or "function" claims), under certain conditions without preclearance and without subjecting product to regulation as a drug. Statements claiming to diagnose, treat, cure, or prevent disease continue to subject product to regulation as a drug;
• makes null and void the Advance Notice of Proposed Rulemaking (ANPR) published June 18, 1993;
• provides authority for the Agency to develop and enforce good manufacturing practices for the dietary supplement industry;
• establishes a Commission on Dietary Supplement Labels to develop recommendations on labeling claims for dietary supplements and requires the Secretary to publish through notice and comment rulemaking the Commission's recommendations. If such rulemaking is not completed within 2 years of the issuance of the report, the NLEA final regulations for health claims for dietary supplements, published January 4, 1994, will be null and void;
• creates an Office of Dietary Supplements within the National Institutes of Health (NIH) to explore and study the role of dietary supplements in improving health and health care.

SAFE MEDICAL DEVICES ACT OF 1990

On November 28, 1990, the President signed into law the Safe Medical Devices Act of 1990 (P.L. 101-629), which amended the FFD&C Act (21 U.S.C. 201 et seq.).

Manufacturers who submit a premarket notification claiming substantial equivalence to a class III device introduced into interstate commerce before December 1, 1990 and for which FDA has not yet required premarket approval under Section 515(b) of the FFD&C Act are required to certify that they have conducted a reasonable search of all information known or otherwise available to them about the class III device and other similar legally marketed devices. Manufacturers are also required to submit a summary of the types of safety and effectiveness problems associated with the devices being compared. All manufacturers who submit a premarket notification under Section 510(k) of the FFD&C Act are required to submit to FDA a summary of the safety and effectiveness information upon which an equivalence determination is based or certify that any information on safety and effectiveness will be made available to interested persons upon request.

Class II has been redefined. Previously, Class II devices were devices for which a performance standard could be developed to provide reasonable assurance of safety and effectiveness. Under the new provision, Class II devices will be regulated by "Special Controls. "Special Controls" include the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations and other appropriate actions. The procedure for developing performance standards under Section 514 of the FFD&C Act has been simplified.

FDA has been given additional authority to order the recall of devices and the notification of users, to temporarily suspend premarket approval of a device and to impose civil penalties.

Section 520(f) of the FFD&C Act has been revised to clarify that FDA has the authority to regulate preproduction design validation as part of GMPs.

A manufacturer who submits a premarket notification may not enter the product into commercial distribution until FDA issues an order permitting distribution.

The Radiation Control for Health and Safety Act of 1968 has been combined into the FFD&C Act. This change does not affect the regulation of these products.

Certain device user facilities (hospitals, nursing homes, ambulatory surgical facilities, and outpatient treatment facilities which are not physician's offices) will be required to report deaths related to medical devices to FDA and certain serious illnesses or injuries related to devices to the manufacturer or to FDA, if the manufacturer is not known. FDA is required to provide education (including publications) on these provisions to device users and other affected persons.

Distributors of medical devices will be required to provide copies of reports submitted under Section 519(a) of the FFD&C Act (Medical Device Reporting (MDR) under 21 CFR Part 803) to the manufacturer of the device.

Manufacturers, importers, and distributors who make reports under Section 519(a) will be required to certify the number of reports submitted in a year.

Manufacturers of permanently implantable, life sustaining and life supporting devices used outside a device user facility and that are reasonably likely to have serious adverse health consequences will be required to establish tracking systems for these devices.

FDA must review the classification of all devices classified in Class III under section 520(l) of the FFD&C Act (transitional devices) and Class III devices on the market before May 28, 1976 and substantially equivalent devices for which FDA has not required premarket approval under Section 515(b) of the FFD&C Act and determine whether these devices should remain in Class III or be classified into Class II or Class I.

Manufacturers will be required to report to FDA device removals and corrections to reduce a risk to health posed by a device or to remedy a violation of the FFD&C Act which may present a risk to health. Manufacturers that introduce into interstate commerce for the first time after January 1, 1991 a permanently implantable device, a life supporting or life sustaining device or a device that potentially presents a serious risk to health will be required to conduct postmarket surveillance of the device. FDA may also require any other manufacturer of a device to conduct postmarket surveillance.

FDA may use, for purposes of reclassifying or approving devices, certain data in premarket approval applications where four devices of a kind have been approved.

FDA is authorized to grant humanitarian device exemptions from the standards and premarket approval requirements of the FFD&C Act for manufacturers of devices used to treat or diagnose conditions or illnesses affecting fewer than 4,000 individuals.

The Secretary is directed to establish an Office of International Relations to enter into agreements with foreign countries to facilitate commerce in devices between the U.S. and such foreign countries.

FDA is directed to designate a component of FDA to regulate products that constitute a combination of a drug, device or biological product. The component that is to regulate the product is to be determined by the primary mode of action of the product. The definitions of "drug" and "device" have been revised to accommodate this change.

RADIATION CONTROL FOR HEALTH AND SAFETY ACT OF 1968 (RCHSA)

The Radiation Control for Health and Safety Act (P.L. 90-602) was enacted to protect the public from unnecessary exposure to radiation from electronic products. This law is now part of the FFD&C Act as Chapter V, Subchapter C - Electronic Product Radiation Control (Sections 531-542). Administration of the law is carried on through the setting and enforcement of performance standards to limit radiation emissions. The standards apply to products offered for sale or use in the U.S., whether manufactured in this country or elsewhere. The RCHSA also provides for educational activities to minimize exposure of people to unnecessary radiation by promoting the safe use of electronic equipment. Research programs are aimed at the development of devices and techniques for detecting and measuring radiation and its effects.

Electronic products include all products or equipment capable of emitting ionizing or nonionizing radiation, or sonic, infrasonic, or ultrasonic waves. Television receivers, microwave ovens, X-ray equipment, lasers, ultraviolet lights, diathermy units, infrared heaters, ultrasonic cleaners, and particle accelerators are examples of products required to comply with Subchapter C - Electronic Product Radiation Control. The regulations are published in Title 21, Code of Federal Regulations, Parts 1000 to 1050.

If a manufacturer produces an electronic product which does not meet the provisions of an applicable standard or contains any defect related to its safe use by reason of radiation emissions, the manufacturer has the responsibility to notify the consumer and to repair the defect, replace the product, or refund the purchaser's money.

Inspectors may at reasonable times enter manufacturing establishments to inspect facilities and procedures, if it is found that manufacturers' testing programs related to electronic product radiation safety may not be adequate or reliable.

Manufacturers of certain electronic products are required to maintain relevant product testing records and to make reports necessary to demonstrate compliance with the law.

Subchapter C - Electronic Product Radiation Control specifically provides that test samples may be taken from any import shipment to determine whether a product complies with an applicable standard.

-------------------------

SUBCHAPTER

OTHER LAWS

FEDERAL IMPORT MILK ACT (FIMA)

In addition to being subject to the requirements of the FFD&C Act, milk and cream (including sweetened condensed milk) offered for import into the U.S. are subject to the FIMA (P.L. 69-625) enforced by the FDA. Such products may be imported only under permit after certain sanitary and other prerequisites have been fulfilled.

PESTICIDE MONITORING IMPROVEMENTS ACT OF 1988 (PMIA)

On August 23, 1988, the President signed into law the Omnibus Trade and Competitiveness Act (P.L. 100-418). Included in this law is the Pesticide Monitoring Improvements Act of 1988 which is intended to improve the analytical approaches used by the FDA to determine residues of pesticides in foods.

Specifically, Subtitle G requires FDA to computerize its pesticide monitoring activities, to compile a summary of the information gathered through computerized monitoring activities, and to make its summary and report available to Federal and State agencies and other interested persons. The PMIA also requires the Secretary of Health and Human Services (HHS) to attempt to enter into cooperative agreements with governments of foreign countries that are major sources of food imports into the U.S., for the purpose of better enabling FDA to assure compliance with pesticide tolerances, or otherwise to obtain, information on pesticides used on imported foods where such agreements cannot be obtained. Finally, the PMIA requires the Secretary of HHS to develop, in consultation with the Environmental Protection Agency (EPA), a long-range plan for the development of new and improved methods for detecting pesticide residues, and to make a report and recommendations to appropriate congressional committees.

ANTI-DRUG ABUSE ACT

Section 4015 of the Anti-Drug Abuse Act (P.L. 99-570) requires the Secretary, acting through the Commissioner of FDA and the Director of National Institute on Drug Abuse (NIDA), to conduct a study on alkyl nitrites to be transmitted to the House Committee on Energy and Commerce and the Senate Committee on Labor and Human Resources. The study is to review the extent and nature of the use of alkyl nitrites by the public and the extent of the health risk. The report to Congress must include a recommendation on whether alkyl nitrites should be treated as a drug under the FFD&C Act.

AIDS AMENDMENTS OF 1988

These amendments (P.L. 100-607) set up broad programs for research, counseling, testing, education and information programs, and health care for acquired immune deficiency syndrome (AIDS) patients. Of interest to FDA are provisions that (1) require the Secretary to encourage manufacturers of drugs with potential effectiveness as AIDS treatments to apply for investigational exemptions under the FFD&C Act. The Secretary is authorized to provide technical assistance through grants or contracts to manufacturers, researchers, and physicians to expedite submission of applications and the availability of new drugs under treatment INDS; (2) require the Secretary to establish a data bank that would include a registry of clinical trials and information on AIDS drugs available under INDS, including treatment INDS, superseding the confidentiality provisions of the FFD&C Act with respect to these drugs; (3) authorize the Secretary to add 780 new positions to the Public Health Service (PHS) before October 1, 1990, and require the Secretary to report to Congress after three months on the allocation among the agencies; (4) require the Office of Personnel Management or the General Services Administration (GSA) to respond to priority requests for personnel and administrative support from FDA and PHS agencies within 21 days after the request is made; (5) establish a National Commission on AIDS that would, among other things, evaluate the adequacy of clinical trials and make recommendations on streamlining regulations relating to FDA approval of new drugs and medical devices, including procedures for the release of experimental drugs; (6) require the Secretary of HHS to submit an annual report to Congress on all expenditures by the Department with respect to AIDS; (7) require the National Institute of Allergy and Infectious Diseases (NIAID), after consulting with FDA, to establish the AIDS Clinical Research Review Committee. The Committee to be composed of physicians in clinical practice, would advise NIAID on appropriate research activities to be undertaken, including research on drugs, with respect to clinical treatment of AIDS; (8) authorize NIH, after consulting with FDA, to provide grants and contracts to community-based organizations to conduct clinical trials that are approved by FDA, and require that FDA, among others, approve applications for financial assistance; (9) require the Secretary to establish a program to evaluate the effectiveness and risks associated with unapproved drugs that are being utilized by AIDS patients; (10) require the Secretary, after consultation with FDA, among others, to establish a program of research and education regarding blood donations and transfusions; (11) require that the grant programs for clinical care of AIDS patients must provide patients with information and counseling on the availability of treatments both approved and not yet approved by FDA; (12) require the Secretary to expedite the award of grants, contracts, and cooperative agreements for research projects relating to AIDS and require the submission of a quarterly report to Congress; and (13) require the Secretary to request the National Academy of Science and others to report on the potential use of consortia for research and development of vaccines and drugs.

FEDERAL ANTI-TAMPERING ACT (FATA)

On October 13, 1983, the President signed the Federal Anti-Tampering Act (P.L. 98-127). This amends Title 18 of the U.S.C. to establish graduated penalties for tampering with intent to cause injury or death, ranging from a maximum of $25,000 and 10 years imprisonment in the case of an attempt to tamper, to a maximum of $100,000 and life imprisonment, in a case where death results from the tampering. The FATA also establishes penalties for tampering with or mislabeling consumer products with intent to injure a business; for knowingly communicating false information that a consumer product has been tainted and, if such tainting had occurred, would create a risk of death or bodily injury; for threatening to tamper with a consumer product in a manner to create a risk of death or bodily injury; and for conspiracy to so tamper with a consumer product. "Consumer product" is defined as including any articles subject to the FFD&C Act, and the FDA is designated as having authority to investigate violations.

PUBLIC HEALTH SERVICE ACT (PHSA) - BIOLOGICAL PRODUCTS (PART F, SUBPART 1)

Biological products are defined in Section 351(a) of the Public Health Service Act as "... any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, ... applicable to the prevention, treatment or cure of diseases or injuries of man ..."

Under the PHSA, a manufacturer that ships a biological product interstate, or for import or export must obtain a U.S. license for both the manufacturing establishment and the product intended for shipment. These licenses are granted when the establishment and product meet specific standards to insure continued safety, purity, and potency. All licenses shall be issued, suspended or revoked as prescribed by regulations.

The PHSA specifies that biological products be plainly labeled with the proper name of the article, the name, address, and license number of the manufacturer, and the appropriate expiration date of the product. No person shall falsely label any package containing a biological product.

The PHSA authorizes the inspection of biological product manufacturers.

Upon a determination that a licensed biological product presents an imminent or substantial hazard to the public health, the Secretary shall issue an order immediately ordering the recall of such a product.

Section 351 also provides for civil money penalties, fines and imprisonment for violations and also specifies export requirements for biological products.

PUBLIC HEALTH SERVICE ACT (PHSA) - CONTROL OF COMMUNICABLE DISEASES (PART G)

Section 361 of the PHSA authorizes the creation and enforcement of regulations to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the U.S. or possessions or between states and possessions. These regulations may provide for inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings.

THE MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992 (MQSA)

The Mammography Quality Standards Act of 1992 (P.L. 102-539) was enacted to establish uniform, national quality standards for mammography. The MQSA amends the Public Health Service Act by adding new section 354 (42 U.S.C. 263b) to require certification and inspection of all mammography facilities under the regulatory jurisdiction of the U.S. Only certified facilities that are in compliance with uniform Federal standards for safe, high quality mammography services may lawfully operate. Certification establishes that the facility meets the mammography quality standards. These requirements apply to all facilities producing, processing, or initially interpreting mammograms, whether for screening or diagnostic purposes, except for facilities of the Department of Veterans Affairs. FDA has published regulations to establish requirements and standards for accrediting bodies and application procedures for such bodies (21 CFR 900.1-900.7). The regulations also establish quality standards for mammography facilities and procedures for facility certification (21 CFR 900.10-900.14).

SANITARY FOOD TRANSPORTATION ACT OF 1990 (SFTA)

The Sanitary Food Transportation Act (P.L. 101-500) requires the Department of Transportation (DOT), in consultation with HHS, EPA, and the United States Department of Agriculture (USDA), to issue regulations to provide for the safe transportation of food, food additives, cosmetics, drugs, and medical devices in vehicles also used to transport nonfood products or waste, and the use of dedicated vehicles to transport hazardous materials such as asbestos or municipal waste.

The SFTA authorizes food transportation inspections to be paid from funds designated to carry out the motor carrier safety assistance program if the recipient State agrees to assist in enforcement. DOT is required to issue regulations.

TECHNICAL AND MISCELLANEOUS REVENUE ACT OF 1988 (TMRA])

On November 10, 1988, the President signed into law the Technical and Miscellaneous Revenue Act of 1988 (P.L. 100-647). TMRA amends the Social Security Act and the Internal Revenue Code of 1986 to establish a Blood Donor Locator Service (BDLS). The TMRA permits states, territorials, local governments, or authorized blood donation facilities to require blood donors to give their social security numbers as a quick method of locating and informing those whose blood has been found to be infected with the AIDS virus. The notification process is to be coordinated by a BDLS which the Secretary of Health and Human Services is required to set up.

EQUAL ACCESS TO JUSTICE ACT (EAJA)

The winning party has traditionally been awarded court costs. However, these costs do not include fees and expenses for attorneys and expert witnesses. The purpose of the EAJA of 1980 (P.L. 96-481) and the subsequent 1985 amendments (P.L. 99-80) was to prevent overbearing conduct on the part of the government against individuals and small firms who might not have the financial resources to oppose improper government acts.

Under the EAJA (28 U.S.C. 2412), a "party" is defined as an individual whose net worth does not exceed $2,000,000 or the owner of an unincorporated business or any partnership, corporation, association, or unit of local government whose net worth does not exceed $7,000,000 and which does not have more than 500 employees. Cooperative agricultural associations and tax exempt organizations may be parties without regard to these parameters.

A party prevailing against the government is entitled to be reimbursed for reasonable attorney fees, expenses for expert witnesses and the cost of any study, analysis, engineering report, test, or project which is found by the court to be necessary for the preparation of the party's case. The EAJA applies to civil litigation but does not include torts (injury claims for a civil wrong). The EAJA does not apply to criminal cases.

Pursuant to the EAJA, costs will be awarded to a private party "unless the court finds that the position of the United States was substantially justified or that special circumstances make an award unjust."