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Post by Clement on May 21, 2024 9:12:10 GMT -5
Go to LGM Pharma website. Look up treprostinil. You get the comment,
"LGM Pharma is an API distributor. LGM Pharma supplies APIs as per CGMP with DMF support, subject to availability and manufacturer requirements."
LGM asserts their importance as part of supply chain. I don't see UTHR "winning the case". But there is enough going on here to cause a delay.
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Post by agedhippie on May 21, 2024 16:27:42 GMT -5
Go to LGM Pharma website. Look up treprostinil. You get the comment, "LGM Pharma is an API distributor. LGM Pharma supplies APIs as per CGMP with DMF support, subject to availability and manufacturer requirements." LGM asserts their importance as part of supply chain. I don't see UTHR "winning the case". But there is enough going on here to cause a delay. That's interesting but irrelevant since LQDA buy their API from YS Lifesciences. LGM handles the importation. This will not affect the approval timeline. |
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Post by prcgorman2 on May 21, 2024 16:51:59 GMT -5
Go to LGM Pharma website. Look up treprostinil. You get the comment, "LGM Pharma is an API distributor. LGM Pharma supplies APIs as per CGMP with DMF support, subject to availability and manufacturer requirements." LGM asserts their importance as part of supply chain. I don't see UTHR "winning the case". But there is enough going on here to cause a delay. That's interesting but relevant since LQDA buy their API from YS Lifesciences. LGM handles the importation. This will not affect the approval timeline. Gonna tease you just a little. I think you predicted they would already be selling by now. June starts next week. I assume the FDA attorney to whom the petition was assigned will perform due diligence and issue a response. You'd think that could be done in a day, but the attorney may be busy, or be outside counsel and they earn billable hours.  |
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Post by phdedieu12 on May 21, 2024 18:03:44 GMT -5
More will come out.... this thing is not done getting delayed.... just my prediction...
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Post by hellodolly on May 21, 2024 18:49:45 GMT -5
I'm also curious what agedhippie thinks. Given LQDA was up 5% today you would have thought investors were celebrating UTHR's petition. This goes nowhere. The manufacturer is YS Lifesciences, not LGM as UTHR claim so the cGMP issue UTHR raises is irrelevant to LQDA. This is purely an attempt at a delaying tactic. LGM is just the importer so if this was going to impose a delay LQDA would simply switch importers. Doing a quick spot of research (I have been slacking on the LQDA front) this was bought up at the BoA Healthcare conference and the response was that in the FDA have not been in touch with them in the year since the consent order was issued, and that the petition inaccurately identifies LGM as the manufacturer of the drug. The FDA action would be to review the data associated with the petition relating to the complaint. If it's lung safety they will want to see the lung data, if it's a supplier they will want to see the supplier's role. The delay is directly related to the complexity of the review which in this case is trivial (show that the drug is not manufactured by LGM - evidenced by the contracts with LGM for the import and YS Lifesciences for the manufacture.) UTHR also rather misses the point of a consent order - it's not to prevent a company from doing business (nobody can use a drug you handle) but to provide a legal framework allowing the company to continue doing business in exchange for remediating an issue. In other words a consent order is not disqualifying for a supplier. All true with caveats specifically for LGM: January 2023 Today, the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction against LGM Pharma LLC, an importer and distributor of active pharmaceutical ingredients (API), used by the company’s customers to manufacture and/or compound finished drug products, and two of the company’s executives, Chief Executive Officer and part owner, Prasad Raje, and Shailesh Vengurlekar, the company’s Senior Vice President of Quality and Regulatory Affairs. The consent decree sets a strict timetable and requirements for the firm to ensure it obtains compliance with current good manufacturing practice (CGMP) requirements under the Federal Food, Drug, and Cosmetics Act (FD&C Act). Among other things, the consent decree requires ongoing compliance auditing and reporting to the U.S. Food and Drug Administration and also provides that the FDA may take appropriate action, including ordering the company to cease receiving, labeling, holding and/or distributing any or all drug substances, in the event the defendants further violate the FD&C Act, its implementing regulations or the consent decree. According to the complaint filed by the U.S. Department of Justice on behalf of the FDA, LGM Pharma LLC introduced into interstate commerce adulterated drugs that were manufactured, processed, packed or held in conditions that do not comply with CGMP requirements under the FD&C Act. “Protecting patients means we must hold all parts of our drug supply chain to the highest standards of quality allowed by law, including importers and distributors of both finished drug products and active pharmaceutical ingredients,” said Jill P. Furman, J.D., acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “LGM Pharma LLC’s failure to adhere to CGMP requirements put patients at risk. This consent decree requires the firm to implement and adhere to rigorous quality standards, under close FDA supervision. We will continue to do everything in our power to ensure compliance and address violations of federal law to protect the American public and the safety of the drug products they rely on.” The agency inspected the company’s Florida and Kentucky facilities in 2022. During these inspections, the FDA identified significant departures from CGMP requirements, including the company’s failure to perform adequate investigations of quality-related customer complaints involving out-of-specification (OOS) API that it distributed, failure to adequately qualify foreign manufacturers of API imported and distributed by the company and failures to establish adequate procedures for the distribution of drugs after an API supplier has been disqualified by the company. A previous inspection of LGM Pharma LLC’s Kentucky facility also revealed significant non-compliance with CGMP requirements, including the company’s improper re-labeling of API, lack of sufficient qualification procedures for the company’s foreign API suppliers and failure to perform adequate investigations of quality-related customer complaints involving OOS API distributed by the company. Today’s action will require the company to undertake detailed quality-related compliance actions to ensure that the company’s processes for importing and distributing drugs conform to CGMP requirements and federal law. The case was filed by the U.S. Department of Justice’s Consumer Protection Branch, on behalf of the FDA. Source:https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-florida-based-drug-importer-and-distributor YS Lifesciences not involved other than using LGM as their distributor. |
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