Candidate with ad criticizing Chinese drug manufacturing says she had no role in husband’s business that misbranded Chinese drugs | WJHL

KINGSPORT, Tenn. (WJHL) – Republican First District Congressional candidate Diana Harshbarger’s web site says reliance “on overseas powers like China for prescribed drugs is detrimental to Individuals’ effectively being and rewards unhealthy actors.”

The Kingsport pharmacists’s new marketing campaign advert requires bringing medical manufacturing again to the U.S. However Chinese language medical manufacturing hit near house for Harshbarger in 2013, when her husband and fellow pharmacist Robert pleaded responsible in federal court docket to misbranding medicine and healthcare fraud.

These medicine, administered to kidney dialysis sufferers in Kansas to assist replenish their iron shops, had been from China. They had been misbranded as being from a New York firm that made the one FDA-approved drug for such therapy at that tine.

Robert Harsbharger was ordered to pay greater than $800,000 restitution and imprisoned following a responsible plea in Kansas federal court docket.

Diana Harshbarger mentioned in a press release Wednesday she had nothing to do with Robert Harshbarger’s enterprise, American Inhalation Medicine Specialists, Inc. (AIMS). Her marketing campaign mentioned she didn’t have time to go on digicam Wednesday.

“It didn’t influence me in any respect as a result of I had nothing to do with it,” Harshbarger mentioned of the expertise and whether or not it modified her enterprise method after 2013.

A Kansas federal prosecutor’s work led to a 2012 indictment of Robert Harshbarger for misbranding medicine and well being care fraud perpetrated by AIMS.

Harshbarger’s “America First” part bemoans the human price of drug shortages and says counting on China for drug provides should finish.

“I’ve by no means bought any medicines for my enterprise that weren’t provided by a U.S. producer,” Harshbarger mentioned Wednesday. “I’ve used Cardinal Well being for purchases for over 30 years.”

Diana Harshbarger runs Customized Compounding Facilities of America. A marketing campaign spokesperson, Kristin Davison, mentioned Harshbarger by no means was on the payroll for AIMS, although she grew to become its registered agent in mid-2013. Davison mentioned AIMS didn’t do any additional enterprise after the federal case, although it didn’t formally de-incorporate till 2017.

State information present that Robert Harshbarger was the registered agent for Customized Compounding Facilities of America from its inception in 1990 till September 2012, when Diana grew to become the registered agent. The identical was true for Customized Compounding Facilities of America II.

Each these companies stay lively.

Harshbarger mentioned her husband’s previous didn’t give her any pause in mentioning Chinese language medicine in her marketing campaign.

“It’s the explanation I ran the business,” she mentioned. “I’ve made the assertion many occasions over the past 25 years, that over 85-90% of the medicine provided to america come from China….

“China is the issue. I’ve seen it firsthand. We lastly have a president who needs to convey manufacturing jobs again and put America first. My opponents — who collectively have over 80 years of expertise taking part in political methods and tried to smear me with this story — evidently don’t perceive these points. In the event that they had been to go to Washington, they wouldn’t perceive easy methods to repair them there both.”

Qingdao Shengbang Chemical Co.

AIMS was named within the November 2012 Kansas indictment of Robert Harshbarger.

The indictment alleged that by AIMS, Robert Harshbarger provided Kansas Dialysis with iron sucrose labeled as FDA-approved Venofer, which was manufactured by American Regent of Shirley, N.Y. Venofer was the one FDA-approved iron sucrose drug for pre-dialysis and post-dialysis therapy.

Harshbarger had really bought iron sucrose from different sources, together with Qingdao Shengband Chemical Co. of Qingdao, China. Shipments of Chinese language-manufactured iron sucrose, the indictment alleged, lasted from at the least September 2004 by June 2009 and likewise got here from Shanghai Rory Wonderful Chemical substances of Shanghai.

After a failed try and have the case transferred from Kansas to the Japanese District of Tennessee in Greeneville, Robert Harshbarger finally pleaded responsible to 2 of seven counts.

Proof included a recorded cellphone name from a Kansas Dialysis worker “below the guise that Kansas Dialysis was being questioned by an American Regent gross sales consultant about Kansas Dialysis’s supply for his or her Venofer.”

Invoices from AIMS indicated the syringes despatched to Kansas Dialysis had been stuffed with Venofer. Kansas Dialysis in flip billed well being care profit packages, together with Medicare, Medicaid, the VA, TriCare (protection division insurance coverage) and Blue Cross/Blue Defend.

The indictment revealed $845,232 in quantities billed to these suppliers. It alleged Robert Harshbarger “uncovered dialysis sufferers to unknown and unreasonable dangers, and precipitated them to obtain and pay for misbranded medicine.”

Iron sucrose medicine assist replenish the physique’s iron shops in grownup sufferers who’ve iron deficiency anemia related to power kidney illness.

The well being care fraud rely acknowledged, “had the well being care profit packages recognized that its beneficiaries had been receiving misbranded medicine, they might not have paid for them.”

In the long run, Robert Harshbarger agreed to a 48-month federal jail sentence, restitution of $845,504, a $25,000 wonderful and asset forfeiture of an extra $425,000.

Diana Harshbarger changed Robert Harshbarger as AIMS’ registered agent with the submission of the corporate’s 2013 annual report, in keeping with Tennessee Secretary of State’s workplace information.

AIMS stayed in enterprise till Aug. 8, 2018, altering its principal deal with from 109 Jack White Drive, the place Premier Pharmacy can be situated, to 1242 Ridgetop Path in Kingsport with its 2016 annual report submitting.

Sticking with criticism of China

Diana Harshbarger isn’t alone in her criticism of America’s reliance on China as a provider of generic medicine. A September 2019 article in Healthline, a web-based publication, cited a high-level worker of the company that gives prescribed drugs to U.S. navy members.

“The nationwide safety dangers of elevated Chinese language dominance of the worldwide API (lively pharmaceutical elements) market can’t be overstated,” Healthline quoted Christopher Priest as saying. Priest delivered the remarks at an August 2019 U.S.-China advisory panel.

One other supply within the article, Southern Methodist College professor David Jacobson, mentioned China was taking part in the lengthy recreation whereas U.S. corporations and shoppers had been specializing in discovering the lowest-cost suppliers. Gaining strategic management over essential provides of medicine and drug corporations (together with presumably Cardinal Well being, which had its personal big Chinese language operation till promoting it in 2015), “retains america at China’s mercy within the occasion of a well being disaster, even when China doesn’t have in poor health intent,” the article paraphrased Jacobson as saying.

He instructed Healthline that “bright-thinking U.S.-based healthcare communities,” are working to convey again generic manufacturing “due to the hazard of being so depending on a rival for our well-being.”

The truth is, such concern wasn’t a partisan problem. Two California Democratic representatives, Adam Schiff and Anna Eshoo, wrote an opinion piece for the Washington Publish final September during which they warned towards Chinese language dominance within the generic medicine market.

“If relations decline additional, the Chinese language authorities might search for “strain factors” the place it could possibly wield outsize leverage or power a change of U.S. coverage,” the opinion learn partly. “Pharmaceutical elements might be such a vulnerability: By reducing again their provide or manipulating costs, China might trigger pharmaceutical prices to surge. Or worse, we might expertise shortages.”

Diana Harshbarger mentioned regardless of the previous actions affiliated with Robert Harshbarger’s enterprise, she is a candidate voters can belief. If individuals need somebody “who’s an outsider who will maintain China accountable and who will put Individuals again to work, not the Chinese language, they may vote for me.”