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SC pharma company rebuked by FDA after marketing drug as COVID-19 symptom treatment

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Nephron Pharmaceuticals Corp., a respiratory drugmaker headquartered in West Columbia. The FDA sent a warning letter dated Sept. 22 to the generic drugmaker, threatening regulatory action if it did not cease any marketing materials that give a "misleading impression about the safety and effectiveness of Budesonide for the treatment of COVID-19." Nephron Pharmaceuticals/Provided

WEST COLUMBIA — Nephron Pharmaceuticals is in trouble with federal regulators after its chief executive shared emails last month that pitched a children's asthma drug as a possible treatment for COVID-19 symptoms.

The U.S. Food and Drug Administration sent a warning letter dated Sept. 22 to the West Columbia generic drugmaker, threatening regulatory action if it did not cease any marketing materials that give a "misleading impression about the safety and effectiveness of Budesonide for the treatment of COVID-19."

"We are working diligently with FDA to resolve the matter and have no further comment at this time," Nephron CEO Lou Kennedy said in a statement.

The FDA's warning letter did not say how widely the emails had been shared but combating fraud and misinformation related to the coronavirus has been an ongoing battle for medical professionals. 

"These fraudulent products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness and might be dangerous to you and your family," the agency wrote in an unrelated public service announcement posted to its website the day before the letter was sent to Nephron.

"The FDA is particularly concerned that these deceptive and misleading products might cause Americans to delay or stop appropriate medical treatment, leading to serious and life-threatening harm," the announcement went on to say, adding that unproven drugs could interfere with other medications a person is taking.

President Donald Trump was reproached in the early months of the crisis for repeatedly promoting hydroxychloroquine, a malaria drug, as a treatment, saying he was taking it himself. That same month, the FDA had revoked emergency authorization for the drug, calling it “unlikely to be effective” and that it carried potential risks. The National Institutes of Health also halted clinical trials of the drug.

In the case of Nephron, FDA points to two emails sent in July, one by Kennedy and another by an unnamed member of her marketing staff. The agency received copies of the emails via a complaint filed with its Bad Ad Program.

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According to the FDA, Kennedy's email stated: “Over the last few weeks, doctors and researchers have touted the benefits of using Budesonide as a treatment for symptoms associated with COVID-19. One physician, who went viral this month, called Budesonide a ‘silver bullet.’”

An email sent a week earlier by a sales representative contained a link to a YouTube video that reportedly shows a doctor talking about pairing Budesonide with an antibiotic to successfully treat COVID-19 patients.

"You may want to share this with your respiratory team and pulmonary docs. Cost effective way to treat Coronavirus!” the sales rep wrote.

In the letter to Nephron, the agency also chastised the company for not including any risk associated with the drug, typically printed on the medication's warning label. Some of the most common reactions include respiratory infection, coughing, viral infection, vomiting and abdominal pain, to name a few.

The FDA called on Nephron to create a plan for sending corrected messages to those who received the emails or any other marketing materials deemed misleading. 

The FDA called the emails "alarming from a public health perspective" due to significant deaths related to the virus.

To date, more than 7.4 million Americans have been diagnosed with COVID-19 and 209,690 have died because of complications from the disease caused by the coronavirus. Those numbers include 147,116 South Carolinians who have tested positive for the disease, including 3,258 who died, according to the state Department of Health and Environmental Control.

While the administration has fast-tracked studies of various vaccines, tests and treatments, regulators stress there is currently no FDA-approved treatment for COVID-19.

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