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‘Don’t Panic’: San Antonio doctor on FDA weight loss drug deadline

Dr. Paula Bilica says it’s business as usual at this time as litigation continues

SAN ANTONIO – A San Antonio weight loss clinic owner is encouraging consumers of the GLP-1 drug semaglutide not to panic now that the U.S. Food and Drug Administration deadline for compound pharmacies to stop making it is in place.

That deadline kicked in on May 22, but the FDA gave the pharmacies enough time to prepare.

“The pharmacies knew this was coming, so they have a lot of medication they still have. So I think they are just playing the long game, waiting on the courts to see what officially happens,” said Dr. Paula Bilica, who owns IMAXweightloss. “The other thing is that these medications could very well go back on the shortage list.”

Bilica referred to name-brand weight loss drugs, including Ozempic and Wegovy, among others.

“When any medicines are on a shortage list, the compounding pharmacies are allowed to make a copy of the medication,” she said. “So semaglutide is the active ingredient in Ozempic and Wegovy. Tirzepatide is the other active ingredient in Mounjaro and Zepbound.”

Now that name-brand products are off the shortage list, a decision was made to discontinue the off-brand semaglutide due to its lack of FDA approval for weight loss purposes.

However, Bilica believes, in her experience, that the drugs serve a bigger purpose.

“There are also now many studies coming out where we know there are other health benefits, like decreased risk of cardiovascular disease, high blood pressure, cholesterol, addiction, sleep apnea, a lot of benefits,” she said.

At this time, she said pharmacies have a workaround as they play the long game.

“I spoke with several pharmacies because of my concern and the concern of my customers, but they said right now they are business as usual,” Bilica said. “They are able to use a different dosing, and they would often add B12 (an essential water-soluble vitamin that plays a crucial role in various bodily functions) and B6 (a water-soluble vitamin essential for various bodily functions including metabolism, red blood cell creation and brain function.) to their formulation so it is a little different formulation to help with energy and nausea. Don’t hit the panic button yet.”

She said while the battle plays out between big pharmaceutical companies and compound pharmacies, people who have been using semaglutide have two options.

“Option A, they can buy the name brand medicine, which most people can’t afford,” Bilica said. “The second option is that you would have to go off the medicine, and hopefully, while you were on the medicine, you were using it as a tool to work on your nutrition and fitness. That way, if you do decide to come off of it, you can maintain on your own and just hope the name brand products would go back on shortage lists.”

Bilica said with 40% of Americans being obese, she is hopeful that things work out for the better with the FDA.

“We are good for a while. There is still a lot of litigation going on between big pharmaceutical companies and compounding pharmacies, and name-brand drugs could get back on shortage lists with this decision being made,” she said. ”But you shouldn’t have to afford $1,000 a month to be on medicine that can help you overall in total help your health. I would like for them to come to an agreement so both can make it, and so everyone can have it.”

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