Drugs

DoJ Enforcing cGMP Under False Claims Act

Attorney Anne Walsh (Hyman, Phelps & McNamara) says the Department of Justice (DoJ) enforced FDA current good manufacturing practice (cGMP) regulations through a 1/12 False Claims Act (FCA) global settlement with Baxter Healthcare. In a Washington Legal Foundation Counsel’s Advisory, she raises the question of whether it is appropriate for the department to be enforcing the regulations rather than FDA.

“Counsel should be cognizant of DoJ’s ever-creative theories to coerce an FCA settlement,” Walsh writes. “The Federal Food, Drug, and Cosmetic Act (FFDCA) is appropriately enforced by the agency Congress entrusted to have the expertise to review cGMP requirements: FDA, not D0J.”

The Baxter settlement was based on an allegation that the company violated cGMPs in its manufacturing of large-volume sterile intravenous solutions in clean rooms outfitted with HEPA filters.

Walsh says that under its cGMP procedures, Baxter regularly scheduled inspection and testing of the HEPA filters and replaced any that failed testing. The five filters that were the subject of the settlement showed no “out of limits” test results, Walsh writes, and the government agreed that “there was no evidence of impact on the IV solutions manufactured at North Cove from the mold found on the HEPA filters above the Line 11 clean room.”

She notes that the FFDCA’s focus is not on an actual deviation from the product’s quality and purity, but rather that the methods used to make the product are not cGMP compliant. “Every year FDA inspects hundreds of facilities and cites them for failing to follow cGMP in manufacturing FDA-regulated products,” Walsh says. “FDA has several enforcement tools to require compliance with cGMP, including Warning Letters, import bans, or injunctions. Thus, it is disturbing to see another government agency reviewing and imposing penalties for the same conduct.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome