|Vaccine Manufacturing Plant Receives FDA Warning
By Daria Belov
A vaccine manufacturer, operating a plant in the state of Pennsylvania, received a regulatory warning from the Food and Drug Administration (FDA) involving multiple quality-control observations made after review of the manufacturing plant, at the company's West Point facility.
The company is Merck, makers of blockbuster selling human papilloma virus vaccine Gardasil, makers of a hepatitis A vaccine, two hepatitis B vaccines, and the makers of Vioxx. According to news reports, the company does not expect the regulatory warning to hamper the vaccine makers ability to sell their currently marketed product.
According to a number of news reports, the FDA's warning letter sent to Merck & Co. mentioned "significant deviations from current good manufacturing practice ... in the manufacture of licensed biological vaccine products, bulk drug substances, and drug components" at the plant based in Pennsylvania.
The letter was dated April 28 and it is based on a November 2007 through January 2008 FDA inspection of the vaccine manufacturing plant. According to news reports, the FDA noted that certain lots of pediatric vaccines were recalled as a precautionary measure in December 2007, and production was suspended, with distribution not expected to resume until the fourth quarter of 2008. Amongst the lots of vaccines recalled, were those chemically manufactured to prevent disease caused by Haemophilus influenza type B in infants.
Chiropractor, Darrel Crain, authored a lengthy article regarding the FDA and lawsuit preemption, published just last week. Perhaps news of these warning letters made to vaccine manufacturers are intended to ease the public's concerns that drug companies are getting away with murder.
It was only two weeks ago that the same drug company manufacture was in the news regarding reports of manipulation of data and scientific fraud. While a number of people may be thinking these types of revelations are new, there's undoubtedly scores of people within the scientific community that are far too familiar with a dark side of the manufacturing and marketing of vaccines and pharmaceuticals.