FDA warns Midlands company for pushing unproven medication to treat coronavirus
A West Columbia-based pharmaceutical company has been issued a warning letter from the U.S. government that asks the company to immediately stop sending false or misleading information about an unapproved drug to treat patients with the coronavirus.
In the letter, a director for the U.S. Food and Drug Administration said Nephron Pharmaceutical Corporation CEO Lou Kennedy and a company sales representative wrongly sent emails on July 7 and 14 promoting the drug Budesonide, saying it relieves respiratory problems associated with COVID-19, while also failing to send any directions for use or its risks.
The drug, an inhalation suspension used to treat asthma for children ages 1 to 8, is not approved for use for COVID-19 symptoms, the federal agency said. Nephron had claimed the drug is a “cost effective way” to treat the novel virus and that it’s being touted by doctors and researchers, the FDA said.
“These claims and representations, which misleadingly suggest that Budesonide is safe and effective for a use for which it is not approved and for which you have provided no evidence to support, are particularly alarming from a public health perspective because COVID-19 has caused significant morbidity and mortality, and because there is currently no FDA-approved treatment for symptoms associated with COVID-19,” wrote Robert Dean, director for the FDA’s Office of Prescription Drug Promotion.
Some of the most common Budesonide side effects include respiratory infections, coughing, vomiting, diarrhea, rash, abdominal pain and ear infections, according to the FDA.
Nephron, one of the top producers of respiratory medication in the country, was reported through the FDA’s “Bad Ad” program. The company has been asked to immediately cease misbranding the drug and to quit pushing for its sales nationwide to treat the virus. Nephron must also submit a plan to the FDA about its efforts to correct the misinformation, which could include follow-up emails about the “violative” promotion sent in July, according to the letter.
The company would not answer questions from The State newspaper on Monday, including about what evidence it had to support the drug’s success in treating the virus. But the company emailed a statement from Kennedy, the company’s CEO.
“We received a Warning Letter from FDA regarding the marketing of Budesonide inhalation suspension, a copy of which is available on FDA’s website. We are working diligently with FDA to resolve the matter and have no further comment at this time.”
Since the global pandemic hit the United States in late January, more than 200,000 people have died from the virus across the country, accounting for a fifth of the deaths worldwide. South Carolina has seen more than 147,000 of those cases and at least 3,258 deaths as of Monday afternoon.
Companies like Nephron have ramped up production of inhalation solutions to help patients suffering from coronavirus since the pandemic hit the nation. In May, U.S. Sen. Lindsey Graham toured the facility and praised its efforts while shining light on the need to produce personal protective equipment and medications in the United States, rather than overseas from countries like China.
This story was originally published October 5, 2020 at 2:01 PM.