Drugs

SARMS Pharm Sentenced in Unapproved Drug Case

The U.S. Justice Department says Jeffrey McIndoo (Phoenix, AZ) and his company, JeffMac Investments LLC doing business as SARMS Pharm LLC , were sentenced following prior guilty pleas over the alleged illicit sale of potentially dangerous chemical substances known as selective androgen receptor modulators (SARMs). SARMS mimic the effects of anabolic steroids when ingested into the body and are not approved by FDA.

Based on an FDA Office of Criminal Investigations probe, McIndoo admitted to introducing an unapproved drug into interstate commerce, and SARMS Pharm pleaded guilty to a conspiracy to smuggle SARMs from China into the U.S., according to the government

“In total, between 2017 and 2022, SARMS Pharm earned gross profits totaling at least $3.5 million from selling SARMs,” a Justice Department release says. “As part of its plea, SARMS Pharm agreed to forfeit $1.8 million of the sum of the proceeds retained by the company.”

McIndoo was sentenced to four months in prison and a $1,000 fine. SARMS Pharm was ordered shuttered, and to forfeit $1.8 million in proceeds derived from the company’s unlawful conduct.

In 2023, FDA issued a warning about adverse event reports related to SARMs, which are often marketed as dietary supplements but the agency considers them unapproved drugs.

FDA says that studies and reports have shown SARMs to be associated with serious or life-threatening health problems, including:

Increased risk of heart attack or stroke
Psychosis/hallucinations
Sleep disturbances
Sexual dysfunction
Liver injury and acute liver failure
Infertility
Pregnancy miscarriage
Testicular shrinkage

FDA Releases 27-Page Mylan FDA-483

FDA has released the 27-page Form FDA-483 with six observations from a 5/4-5/15 inspection at the Mylan Laboratories drug manufacturing facility in Maharashtra, India. The inspection observations were: * failure to fully follow the responsibilities and procedures applicable to the quality control unit; * failure to exercise

Advocacy Group Files Petition Urging FDA to Block Peptide Compounding

The Partnership for Safe Medicines (PSM) has filed a citizen petition urging FDA to ban compounding of unapproved peptides and to disregard the advisory committee vote that recommended allowing them. The advocacy group contends the committee was constituted in violation of the Federal Advisory Committee Act and the Ethics in

Support For and Ideas to Change GDUFA 4

The Association for Accessible Medicines (AAM), which represents America’s generic and biosimilar drug sector, says it “strongly supports” the proposed GDUFA 4 commitment letter outlining the agreement negotiated between FDA and the industry. “GDUFA has played an essential role in strengthening the generic drug review process, helping to ensure

BDR Pharma Sues FDA Over Generic Voquezna Exclusivity

BDR Pharmaceuticals International has filed a lawsuit against FDA, alleging the agency unlawfully extended market exclusivity for Phathom Pharmaceuticals’ acid-suppressing drug Voquezna (vonoprazan), preventing BDR from submitting an ANDA for a generic version until 5/2032. In a 10/21 complaint filed in the U.S. District Court for

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FDA Releases 27-Page Mylan FDA-483

Advocacy Group Files Petition Urging FDA to Block Peptide Compounding

Support For and Ideas to Change GDUFA 4

BDR Pharma Sues FDA Over Generic Voquezna Exclusivity