Posts Tagged ‘FDA’
Statement on the FDA and HHS enforcement discretion policy for 503a compounding with certain peptides
“Today’s decision leaves Americans in a grey area as to whether peptides are safe or not, even though the FDA’s own scientists recommended against voting in favor of these substances due to concerns with evidence.”
[...]PSM files Citizen Petition with FDA to stop unsafe compounding of untested peptides
Partnership for Safe Medicines filed a citizen petition (CP) with the FDA asking them to refrain from taking action to allow for compounding of drug products using seven peptide bulk drug substances (BPC-157, KPV, TB-500, MOTS-c, emideltide, semax, and epitalon). Learn why here.
[...]Statement from Partnership for Safe Medicines on new litigation alleging illegal distribution of retatrutide
Partnership for Safe Medicines Executive Director Shabbir Imber Safdar released the following statement on the six lawsuits Eli Lilly filed today against businesses it accuses of illegally distributing unapproved copies of its investigational drug, retatrutide. Lilly is suing these defendants for illegal distribution of retatrutide including, in one case, a licensed 503A compounding pharmacy.
[...]Statement from Partnership for Safe Medicines on the appeals court’s decision in Gilead Sciences v. Meritain Health
The appeals court’s decision in Gilead Sciences v. Meritain Health is unambiguous: you cannot import untraceable medicine with foreign-language labels, hand it to American patients, and call it equivalent to an FDA-approved medicine. Track-and-trace is a cornerstone of why the U.S. drug supply chain is the safest in the world, and it is not optional.
[...]PSM joins PSI, Rx360 and PDSA in letter urging FDA to protect the traceable drug supply
PSM joined three other organizations for a sign-on letter explaining our concerns that unrestricted mass compounding increases the untraceable drug supply. An explosion of 503B compounding of these three substances, semaglutide, tirzepatide, and liraglutide, would dramatically increase the compounded medicine supply which is not serialized, and therefore, not traceable.
[...]PSM submits comment supporting the continued exclusion of GLP-1s from the 503B Bulks List
PSM supports the FDA’s proposal, which will help protect patient safety and the integrity of the drug approval process.
[...]Statement from Partnership for Safe Medicines Executive Director Shabbir Imber Safdar on the FDA PCAC vote to advance peptide compounding
The advisory committee voted to advance substances that FDA’s own scientists flagged as lacking adequate evidence of safety, efficacy, or quality. Its recommendation will inevitably be interpreted as an endorsement of broader clinical use. It is not.
[...]Death of woman in New York from compounded drug shows the risk of allowing compounding of untested substances
Fatality reported as the FDA’s Pharmacy Compounding Advisory Committee weighs adding more untested peptides to the compounding list
[...]Partnership for Safe Medicines urges FDA advisory committee to reject compounding of unapproved peptides
On July 23-24, the FDA will evaluate seven peptides for custom pharmacy compounding. Citing a critical deficit in human safety data, widespread consumer confusion, and systemic supply chain vulnerabilities, PSM urges the committee to block mass compounding and protect patient safety.
[...]Partnership for Safe Medicines statement on FDA authorization of Colorado’s Section 804 Importation Program
“Colorado is now poised to repeat Florida’s failed attempt to implement Canadian drug importation,” said PSM Executive Director Shabbir Imber Safdar. “Since beginning their program in 2019, Florida has spent $132 million and still not imported a single unit of medicine, proving that these bulk importation programs are not reducing drug costs for Americans.”
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