Ben Venue, FDA Receive Approval for Consent Decree, Potentially Easing Drug Shortages

| 01 February 2013 |  By 

The US Food and Drug Administration (FDA) has received approval from a federal judge for a consent decree of permanent injunction between it and Ben Venue Laboratories, a manufacturing facility long in the crosshairs of the agency's enforcement officials.


The company, a subsidiary of Boehringer Ingelheim, suspended its manufacturing capabilities in 2011 after receiving a string of warning letters from FDA over the maintenance of its current good manufacturing practices (CGMPs).

The quality control problems had led to widespread shortages of various critical medications, including Doxil (doxorubicin), a cancer drug. The shortage of Doxil would ultimately cause FDA to exercise its enforcement discretion to allow an unapproved drug, Lipodox, to be imported into the US from an approved supplier in India. As of October 2012, that enforcement discretion continues even as Ben Venue's manufacturing capabilities have started to come back online.

In October 2012, Ben Venue announced that both FDA and the European Medicines Agency (EMA) were reviewing a new shared manufacturing method that would see initial supplies of Doxil manufactured at Ben Venue, while a second facility would ensure the quality and sterility of the drug. The proposal is unusual, as under the principles of CGMP, quality is generally required to be built-not tested-into a product. It is unclear if FDA or EMA ever signed off on the agreement, though Ben Venue announced shortly thereafter that a "limited number of manufacturing lines" had resumed production.

Consent Decree

But the prospect of returning to full manufacturing capacity had remained elusive. However, a 22 January 2012 announcement from the company indicates that prospect could soon come to fruition.

The announcement states that the company had "voluntarily entered into a consent decree with FDA that relates to CGMP requirements."

"Under the terms of the consent decree, Ben Venue is permitted to continue to manufacture and distribute more than one hundred important drugs that are essential for patient care," the company said in a statement. "Ben Venue is also permitted to continue drug-development activities, and may file abbreviated new drug applications (ANDAs), and, as remediation progresses to the FDA's satisfaction, receive ANDA approvals and manufacture other products."

In a statement, FDA's Acting Associate Commissioner for Regulatory Affairs Melinda Plaiser explained that the consent decree was enacted in response to serious, systemic concerns.

"The company's failure to promptly address these problems put patients at risk of receiving poor-quality drugs and compromises the availability of medically necessary products," said Plaisier. "This company continued to violate the law, and FDA took action to help ensure that medicines that consumers rely on are safe, effective, and of high quality."

Ben Venue acknowledged those concerns in its own statement, noting that it has already spent more than $300 million to upgrade its facilities to address some of the systemic quality deficiencies that had plagued it in recent years. The company also noted that since its October 2012 announcement of the return of limited manufacturing capabilities, it has resumed production on additional manufacturing lines.

That consent decree was subject to the approval of a federal court, which FDA announced it received on 31 January 2013.

FDA's statement on the matter also indicates that Ben Venue's CEO, vice president of operations and vice president of quality operations were all named defendants under the decree, providing it with significant leverage if the company violates its terms.

Good News for FDA as Well?

The agency will also likely be glad to have the facility's capacity back up and running. Ben Venue is a manufacturer of numerous sterile injectable drugs, and in the wake of its shut down and subsequent drug shortages, FDA came under fire from Congress for two reasons: the shortages and pharmaceutical compounding.

In the first instance, FDA was slammed by legislators for not working harder to keep the manufacturing facility open, with a congressional report alleging that FDA did not have a "sufficient focus in ensuring access to and a continued supply of needed medicines over the last several years."

"Although manufacturers are reluctant to speak publicly about problems with their governing agency, the Committee found that the new political regime at FDA is largely to blame for the sudden spike of shortages that began in 2010."

FDA, meanwhile, hit back at that report, saying that responsibilities for the shortages "live largely outside of FDA's purview."

"It is the manufacturer's responsibility to ensure that its products are safe, effective and of high quality," wrote Jeanne Ireland, then-assistant commissioner for legislation at FDA. "When products manufacture under problematic manufacturing conditions pose a safety threat to patients-such as glass shards or metal shavings in vials of injectable drug products or fungal contamination of the product-manufacturers generally must stop production to resolve the problem before resuming manufacturing and distribution."

But regardless of responsibility, FDA officials soon had another crisis of sorts on their hands. With sterile injectables in short supply, many doctors turned to pharmaceutical compounders, which had rushed in to fill the void left by larger manufacturing facilities.

Several compounders have since been the subject of enforcement actions, including Hospira, which recalled large numbers of its ophthalmic products, and the New England Compounding Center, whose products have been linked to dozens of deaths and hundreds of injuries resulting from fungal meningitis.

Congress subsequently called on FDA Commissioner Margaret Hamburg to testify before both the House Energy and Commerce Committee and the Senate's Health, Education, Labor and Pensions (HELP) Committee, both of which subjected Hamburg to withering lines of questioning.

With Ben Venue's capabilities on the mend, the agency might stand to benefit from fewer drug shortages, less pharmaceutical compounding and less congressional scrutiny.


© 2022 Regulatory Affairs Professionals Society.

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