Department of Justice Files Complaint Against California Company To Stop Distribution of Adulterated Animal Drugs

The United States filed a civil complaint to stop a California company from manufacturing and distributing adulterated animal drugs, the Department of Justice announced today.

The complaint, filed October 27, seeks a permanent injunction against defendants Med-Pharmex, Inc. (MPX), Gerald P. Macedo, and Vinay M. Rangnekar to prevent them from manufacturing and distributing animal drugs under conditions that fall short of the minimum regulatory requirements to ensure safety and quality.  The complaint alleges that multiple inspections by the U.S. Food and Drug Administration (FDA) repeatedly showed that the defendants failed to conform to current good manufacturing practices (cGMPs), including failure to maintain sterility. 

“Americans depend on animal drugs being safe and effective,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “We will continue working with FDA to ensure all drug manufacturers abide by public safety requirements.”

“Ensuring FDA-approved animal medications are safe, effective and manufactured using current good manufacturing practices is an important part of the FDA’s mission to protect human and animal health,” said FDA Chief Counsel Stacy Amin. “The FDA will continue to pursue actions against those who put animal patients in harm’s way by manufacturing and distributing adulterated animal drug products.”

According to the complaint, FDA issued a warning letter to MPX in 2017 regarding numerous deficiencies at the company. The complaint further alleges that the company failed to adequately investigate reports regarding the deaths of animals injected with Med-Pharmex drugs. The complaint also alleges that FDA inspections revealed the company failed to properly clean and disinfect areas used to manufacture sterile drugs. The Justice Department filed the complaint in U.S. District Court for the Central District of California at the request of FDA.

A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.

The case is being handled by Trial Attorney Rachel E. Baron of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel James C. Fraser of the FDA’s Office of the Chief Counsel.

For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at https://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Central District of California, visit its website at https://www.justice.gov/usao-cdca.

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    In 2016, the Federal Assets Sale and Transfer Act (FASTA) created the independent Public Buildings Reform Board (the Board) to support a new, three-round process for disposing of unneeded federal real property. The first of these rounds required the Board to identify and recommend at least five high-value disposal candidates with a total market value between $500 and $750 million. To identify these properties, the General Services Administration (GSA) collected and evaluated agency recommendations; a GSA-hired contractor analyzed real property data; and the Board held public hearings, visited properties, and met with federal officials. This process resulted in identifying 44 properties. The Board then took various steps to evaluate the 44 properties and recommended 12 final disposal candidates that the Office of Management and Budget (OMB) approved in January 2020. (See figure.) However, the Board did not fully document the process used to evaluate these candidates. For example, the Board's rationales for why individual candidates were or were not recommended were vague or incomplete. Full documentation on the decision-making process would better position stakeholders, including members of Congress, to understand the Board's rationales, especially for decisions with financial implications. Process Used by Stakeholders for Identifying and Recommending High-Value Federal Real Property for Potential Disposal Candidates According to Board and selected federal agency officials, FASTA made it easier for agencies to pursue high-value property disposals due, in part, to exemptions from some requirements, such as having to first offer properties to federal, state, or local agencies. However, FASTA's effect on other long-standing challenges, including funding to prepare properties for disposal, is unclear. For example, FASTA created a dedicated funding source to implement Board recommendations including those related to covering disposal costs, such as relocating agency staff. However, officials expressed concern that access to these funds is not automatic and must go through the annual appropriations process, which rarely coincides with the timing of these projects. The administration proposed legislative language to make proceeds from the sale of assets in fiscal year 2021 available without additional actions by Congress. However, as of January 2021, legislation containing the proposed language had not been enacted. This report discusses elements Congress may wish to evaluate when determining whether to grant such budget-related flexibility. GAO designated federal real property management, including the disposal of properties, as a high-risk area in 2003. FASTA included a provision for GAO to review the recommendations and selection processes such as those used in the first round of identifying and recommending high-value properties as candidates for disposal. This report examines: (1) how stakeholders implemented FASTA to identify and evaluate high-value properties as potential disposal candidates and (2) stakeholder views on the extent to which FASTA helped agencies with the disposal of unneeded high-value properties and addressed long-standing challenges in disposing of federal properties. GAO reviewed FASTA and analyzed documents from the Board, OMB, GSA, and selected 14 federal agencies to examine the processes they used and the challenges they encountered under the FASTA process. Agencies were selected based on their recommendations of high-value properties and inclusion on the Board's final list, among other things. GAO also interviewed officials from the Board, OMB, GSA, and selected federal agencies. GAO is recommending that the Board fully document its process for recommending FASTA disposal candidates, including the rationales behind disposal decisions. The Board noted plans to develop more documentation of its future disposal decisions. For more information, contact David Trimble at (202) 512-2834 or trimbled@gao.gov.
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