Department of Health and Human Services March 17, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is withdrawing approval of three new drug applications (NDAs) from multiple holders of those NDAs. The basis for the withdrawal is that these NDA holders have repeatedly failed to file required annual reports for those NDAs.

In accordance with section 351a of the Public Health Service Act, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS; hereafter referred to as HHS/CDC) has initiated a review of the HHS list of biological agents and toxins that have the potential to pose a severe threat to public health and safety (HHS select agents and toxins). This review was initiated within two years of the completion of the previous review. In reviewing the list, HHS/CDC is considering whether to propose amending the HHS list of select agents and toxins.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jagen Lewicki for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Lewicki was convicted, as defined in the FD&C Act, of one felony count under Federal law for conspiracy to distribute Human Growth Hormone (HGH) imported from China for a purpose other than the treatment of a disease or other recognized medical condition, the use of which had been authorized by the Secretary of Health and Human Services, and not pursuant to an order of a physician, in violation of the FD&C Act. The factual basis supporting this felony conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Lewicki was given notice of the proposed debarment and, in accordance with the FD&C Act and FDA's regulations, was given an opportunity to request a hearing to show why he should not be debarred. As of October 28, 2019 (30 days after receipt of the notice), Mr. Lewicki had not responded. Mr. Lewicki's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Robert Richard Jodoin for a period of 5 years from importing any drug into the United States. FDA bases this order on a finding that Mr. Jodoin was convicted, as defined in the FD&C Act, of one felony count under Federal law for unlawfully importing and attempting to import a controlled substance into the United States. The factual basis supporting the conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Jodoin was given notice of the proposed debarment and, in accordance with the FD&C Act, was given an opportunity to request a hearing to show why he should not be debarred. As of November 9, 2019 (30 days after receipt of the notice), Mr. Jodoin had not responded. Mr. Jodoin's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA or Agency) has determined that the potassium chloride drug products listed in this notice were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these drug products, if all other legal and regulatory requirements are met.