Updated: Feb 15
August 16th, 2019 Senator Charles E. Grassley sent a letter to Alex Azar Secretary of The Department of Health and Human Services and Dr. Norman Sharpless, the Acting Commissioner of the Food and Drug Administration. In his letter, he raised concerns regarding the FDA's foreign drug inspection program.
His letter to the FDA indicated that unannounced inspections have "exposed widespread malfeasance" that normally would have been hidden had the inspection been announced. Bird infestations, missing samples, and fake laboratories were all examples of the improprieties found on surprise inspections of foreign manufactures of antibiotics, cosmetics, and other imports from foreign countries.
"Unbeknownst to many consumers, according to recent news reports and a GAO
report highlighting safety and quality concerns at foreign drug manufacturing facilities, 80 percent of Active Pharmaceutical Ingredients (API) are produced abroad, the majority in China and India; however, the FDA only inspected one in five registered human drug manufacturing facilities abroad last year," Grassley wrote. He went on to write, " I have learned that the FDA does not track in its databases whether a foreign inspection was subject to an announced or unannounced visit. Further, I have learned that the FDA generally does not perform unannounced visits of drug manufacturing facilities in foreign countries but does perform unannounced visits at facilities based in the United States."
One such company under scrutiny is Zhejiang Huahai Pharmaceutical (ZHP). This company is the manufacturer of Valsartan, a medicine used in the treatment of High Blood Pressure. According to reports by Politico, Valsartan became contaminated with a cancer-causing chemical that has been used to make liquid rocket fuel. Regardless of the contamination incident, "ZHP still leads the U.S. market share in 10 of its product lines, it said, including drugs used to treat high blood pressure and Alzheimer’s disease."
The Corvid-19, which is giving the world some concern, originated in China in the province of Wuhan. Despite the Chinese government efforts, it has not been contained. Currently, there are 15 confirmed cases of the virus found in the United States.
Secretary Azar declared Corvid-19 a public emergency. “While this virus poses a serious public health threat, the risk to the American public remains low at this time, and we are working to keep this risk low,” Secretary Azar said. “We are committed to protecting the health and safety of all Americans, and this public health emergency declaration is the latest in the series of steps the Trump Administration has taken to protect our country.”
The list of companies who either own factories or have contract factories producing their products in China is extremely long. Included in this list are Allergan Laboratories, Ashland Chemical, Bausch and Lomb, and Hoffman-LaRoche to name a few. 3M a major manufacturer of medical supplies such as masks and gloves has a production plant in China.
Given this information, knowing that there are insufficient FDA inspectors working to secure health and beauty products from China, how likely is it that America is ready to fight a virus that has very short immunity, no vaccine, and easily spread from person to person?