Emergency Food and Drug Enforcement Act of 1990 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to direct the Secretary of Health and Human Services to debar an individual from submitting any application for approval of a new drug, or for a different or additional use of a previously approved drug, if the individual has been convicted of a Federal felony in connection with the development or approval of any drug. Prohibits the Secretary from taking any action on any application submitted by such an individual.
Authorizes the Secretary to debar an individual and take no action on an application if the individual: (1) has been convicted of a Federal or State criminal offense in connection with the development or approval of a drug under such provisions, or involving bribery, fraud, or a similar crime, or obstruction of justice; (2) was named by a U.S. Attorney or a Federal grand jury as an unindicted coconspirator involving such an act; or (3) knowingly used the services of a debarred person.
Provides for temporary denial of approval upon probable cause to believe that there has been an actual or attempted bribe or illegal gratuity, or that there has been a pattern of false statements, or a knowing and serious endangering of the public health or safety through multiple violations of the FDCA.
Prohibits discrimination by an employer against any employee because the employee participated in the implementation of the debarment or temporary denial provisions of this Act.
Requires drug approval applications to certify that the applicant did not and will not use the services of a debarred person in connection with the application.
Sets forth civil monetary penalties for false statements, bribes, destruction, or alteration of evidence, obstruction, use of (or actions by) a debarred person, and other acts.
Directs the Secretary to suspend for three years the distribution of drugs under any application of the person involved if the Secretary finds a pattern or practice of offenses or acts, for which this Act provides civil penalties, in connection with the development, approval, manufacturing, or distribution of two or more drugs. Prohibits such a finding if the person demonstrates that the offenses or acts did not influence the development, approval, manufacturing, or distribution. Allows the Secretary to waive the suspension if necessary to protect the public health.
Directs the Secretary to withdraw approval if there are reasonable grounds to believe that the application was approved, expedited, or otherwise facilited, in whole or in part, through actual or attempted bribery, fraud, or false statement.
Directs the Secretary of the Treasury: (1) to destroy any food, drugs, devices, or cosmetics being imported or offered for import if the article presents a threat to the public health; and (2) pending decision on the admission of an article, on request of the Secretary of Health and Human Services, refuse to authorize delivery of the article to the owner or consignee. Prohibits claims for payment for any samples collected, delivered, or examined.
Requires manufacturers of low-acid foods for export to the United States, and importers of such foods, to register with the Secretary of Health and Human Services. Directs the Secretary to establish procedures for the registering of identifying marks used by food processing establishments producing such foods. Adds failure to register to the list of prohibited acts under the FDCA.
Authorizes the Inspector General to investigate various matters involving the Food and Drug Administration, including allegations of employee misconduct; false or fraudulent materials or records; fraud, false claims, waste, or abuse; felony violations of the FDCA; and illegal sale under Federal law of a drug which is not a controlled substance.
Includes agents of the Inspector General in the delineation of powers under the FDCA of enforcement personnel conducting examinations, investigations, or inspections. Removes the requirement that those examinations, investigations, or inspections relate to counterfeit drugs.
Declares that provisions prohibiting the disclosure of trade secrets do not authorize the withholding of information from the Congress or its committees or subcommittees.
Directs the Secretary to maintain for public inspection certain information concerning applications for drug approval, including the names of the persons conducting the chemistry and bioequivalence reviews.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health and the Environment.
Subcommittee Hearings Held.
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