FDAは欺瞞および陰謀の訴えられるPharma Companyからの18の薬剤を承認する

によって デイヴィッドGutierrez

FDAは会社が標準以下プロダクトを作り、それを隠すことを共謀のためのCongressによって現在不正に調査されているのに、ジェネリック医薬品の製造業者のRanbaxyの実験室からの市場のための18のプロダクトを承認した。

「確かな筋およびサポート文書からの主張FDAにRanbaxyによって偽のおよび製造された情報を含んでいる服従を含む全身の詐欺的な行ないのパターンを」、は法務省言った示す。

The Department of Justice is investigating claims that Ranbaxy, India’s largest drug manufacturer, produced HIV medication that contained insufficient active ingredients or was adulterated with other ingredients. These drugs were then used to treat patients in Africa.

Other drugs are also suspected of containing active ingredients in concentrations that are either too low or too high. The company also stands accused of attempting to conceal manufacturing procedures that do not meet FDA standards and of forging documents relating to U.S. government investigations of its practices.

Finally, Ranbaxy is being investigated for falsifying data suggest that its generic drugs are absorbed into the body in a similar fashion to brand-name products. This proof is an essential part of the process of gaining FDA approval for a generic drug without going through large clinical trials.

In July, Congress also began a probe into why the FDA had not taken action against Ranbaxy, even though it had known for months of allegations against the company. As part of this probe, the FDA was asked to provide information on every FDA-approved Ranbaxy product and the approval process that it went through.

Former FDA Deputy Commissioner Mary Pendergast has criticized the FDA’s failure to take action against Ranbaxy and its products.

Because the FDA “wouldn’t be confident of the accuracy and reliability of the information in the applications,” Pendergast said, “they might be approving a product that ought not be approved.”

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