Scientific Labs banned from making drugs by FDA
injunction preventing it from producing drugs until
manufacturing operations are brought up to code.
The US Department of Justice alleges that Scientific Laboratories failed to seek Food and Drug Administration (FDA) clearance to market several new medications and therefore is in breach of the 2004 Federal Food, Drug and Cosmetics Act. The DoJ also believes that the firm failed to comply with current good manufacturing practice requirements (cGMP). The FDA's most recent inspection of Scientific Laboratories' production facility in Columbia, Maryland, last August, revealed that Scientific Laboratories had not followed GMP guidelines when testing its products for microbial contamination, according to the Baltimore Sun newspaper. The FDA has been fighting a long running campaign to clampdown on the sale of unapproved drugs. In 2006 the agency issued a Compliance Policy Guide (CPG) which detailed its efforts to stop the sale of such products, focussing particularly on those that pose a significant risk to public health. FDA associate commissioner Margaret Glavin, said that the agency "will take action against companies and their executives who violate the law and endanger public health." Glavin added that "the FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs." Unapproved Scientific Laboratories generic drugs identified by the FDA included B-Vex Suspension; D-Tann Suspension; Duratan DM Suspension, L-All 12 Suspension and Nazarin HC. In-PharmaTechnologist.com was unable to contact Scientific Laboratories prior to publication. FDA crackdown The FDA's Consent Decree of Permanent Injunction, which has been signed by Scientific Laboratories' president Rajeshwari Patel and CEO Amit Roy, prevents the firm from selling or making any drugs until the necessary regulatory clearances and accreditations are obtained. The ruling also requires that existing stocks of unapproved products are destroyed. Scientific Laboratories is also liable to pay liquidated damages of $5,000 per day if it fails to comply with the conditions of the injunction and an additional charge of $5,000 for each subsequent breach up to a total value of $1m (€642,994) per year. Current laws require that drugs marketed in the US demonstrate safety and efficacy prior to marketing and widespread use in the general population. However, for a variety of reasons, some drugs continue to be sold illegally without the required approval.
